What you shouldn’t take away from my talk about patient experiences of using AI in clinical healthcare

by Dana Lewis

I was asked to contribute a talk in a session at Stanford’s recent AI+Health conference. I spoke alongside two clinician researchers, and we organized the session so that I would talk about some individual patient experiences & perspectives on AI use in health, then scale up to talk about health system use, then global perspectives on AI for health-related use cases.

One thing I’ve been speaking about lately (including when I was asked to present in DC at the FDA AI workshop) is about how AI…is not one thing. There are different technologies, different models, and they’re going to work differently based on the prompts (like our research showed here about chart notes + LLM responses, as evaluated by a patient and clinician) as well as whether it’s a one-off use, a recurring use, something that’s well-defined in the literature and training materials or whether it’s not well-defined. I find myself stumbling into the latter areas quite a bit, and have a knack of finding ways to deal with this stuff, so I’m probably more attuned to these spaces than most: everything from figuring out how we people with diabetes can automate our own insulin delivery (because it was not commercially available for years); to figuring out how to titrate my own pancreatic enzyme replacement therapy and building an app to help others track and figure things out themselves; to more recent experiences with titration and finding a mechanistic model for an undiagnosed disease. The grey area, the bleeding edge, no-(wo)man’s land where no one has answers or ideas of what to do next…I hang out there a lot.

Because of these experiences, I see a lot of human AND technology errors in these spaces. I see humans make mistakes in chart notes and also in verbal comments or directions to patients. I see missed diagnoses (or wrong diagnoses) because the medical literature is like a game of telephone and the awareness of what conditions are linked to other conditions is wrong. I see LLMs make mistakes. But I see so many human mistakes in healthcare. One example from my recent personal experiences – it’s 2025 and a clinical team member asked me if I had tried cinnamon to manage my glucose levels. This was after she had done my intake and confirmed that I had type 1 diabetes. I looked at her and said no, because that would kill me. She looked surprised, then abashed when I followed that comment that I have to take insulin because I have type 1 diabetes. So I am maybe less bothered than the average person by the idea that LLMs sometimes make mistakes, say a wrong (or not quite right, even if it’s not wrong) thing, or don’t access the latest evidence base. They can, when prompted – and so can the human clinical teams.

A big point I’ve been bringing up in these talks is that we need everyone to care about the status quo of human, manual healthcare that is already riddled with errors. We need everyone to care about net risk reduction of errors and problems, not focus on additive risk.

We saw this with automated insulin delivery – people without diabetes were prone to focus on the additive risk of the technology and compare it to the zero risk they face as a person without diabetes, rather than correctly looking at the net risk assessment of how automated insulin delivery lowers the risk of living with insulin-managed diabetes even though yes, there is some additive risk. But almost a decade later, AID is now the leading therapy choice for people with insulin-managed diabetes who want it, and OS-AID is right there in the standards of care in 2026 (and has been for years!!!) with a strong evidence base.

I also talked about my experiences observing the real use of clinical scribe tools. I talked more in detail about it in this blog post, but I summarized it in my talk at Stanford, and pointed out how I was surprised to learn later – inadvertently, rather than in the consent process – that the scribe tool had access to my full medical record. It was not just transcribing the conversation and generating chart notes from it.

I also pointed out that my health system has never asked me for feedback about the tool, and that I’ve actually seen my same clinician use multiple different scribe technologies, but with no different consent process and no disclosure about chart access or any differences in privacy policy, retention timeline, etc. (Don’t pick on my clinician: she’s great. This is a point about the broader systematic failures.)

This is where I realized later people might have taken away the wrong point. This was not about me being a whiny patient, “oh they didn’t ask for my feedback! My feedback is so important!” and self-centered.

It was about flagging that these technologies do not have embedded feedback loops from ALL stakeholders, and this is more critical as we roll out more of these technologies related to healthcare.

It’s one thing to do studies and talk about user perspectives and concerns about this technology (great, and the other two presenters did an awesome job talking about their work in these spaces).

But we need to do more. We need to have pathways built in so all stakeholders – all care team members; patients; caregivers/loved ones; etc. – have pathways to talk about what is working and what is not working, from everything from errors/hallucinations in the charts to the informed consent process and how it’s actually being implemented in practice.

It matters where these pathways are implemented. The reason I haven’t forced feedback into my health system is two-fold. Yes, I have agency and the ability to give feedback when asked. Because I’ve worked at a health system before, I’m aware there’s a clinic manager and people I could go find to talk to about this. But I have bigger problems I’m dealing with (and thus limited time). And I’m not bringing it up to my clinician because we have more important things to do with our time together AND because I’m cognizant of our relationship and the power dynamics.

What do I mean? The clinician in question is new-ish to me. I’ve only been seeing her for less than two years, and I’ve been carefully building a relationship with her. Both because I’m not quite a typical patient, and because I’m not dealing with a typical situation, I’m still seeking a lot from her and her support (she’s been great, yay) to manage things while we try to figure out what’s going on. And then ditto from additional specialists, who I’m also trying to build relationships with individually, and then think about how their perceptions of me interplay with how/when they work with each other to work on my case, etc.

(Should I have to think about all this? Do I think about it too much? Maybe. But I think there’s a non-zero chance a lot of my thinking about this and how I’m coming across in my messages and appointments have played a role in the micro-successes I’ve had in the face of a rubbish and progressive health situation that no human or LLM has answers for.)

So sure, I could force my feedback into the system, but I shouldn’t have to, and I definitely shouldn’t have to be doing the risk-reward calculation on feedback directly to my clinician about this. It’s not her fault/problem/role and I don’t expect it to be: thus, what I want people to take away from my talk and this post is that I’m expecting system-level fixes and approaches that do not put more stress or risk on the patient-provider relationship.

The other thing I brought up is a question I left with everyone, which I would love to spur more discussion on. In my individual case, I have an undiagnosed situation. A team of specialists (and yes, second opinions) have not been able to diagnose/name/characterize it. I have shifted to asking providers pointedly to step away from naming and thinking broadly: what is their mental model for the mechanism of what’s going on? That’s hard to answer, because providers aren’t often thinking that way. But in this situation, when everything has been ruled out but there is CLEARLY something going on, it’s the correct thing to do.

And for the last year, the LLMs had a hard time doing it, too. Because they’re trained on the literature and the human-driven approach to make differential diagnoses, the LLMs have struggled with this. I recently began asking very specifically to work on mechanistic models. I then used that mechanistic model to frame follow up questions and discussions, to rule things in/out, to figure out where there are slight overlaps, to see where that gives us clues or evidence for/against our mechanistic model hypothesis, and to see what treatment success / failure / everything in between tells us about what is going on. Sure, a name and a diagnosis would be nice, but it’s been so relieving to have at least a hypothetical mechanistic model to use and work from. And it took specific probing (and the latest thinking/reasoning models that are now commonly available). But why am I having to do it, and why are my clinicians not doing this?

Do clinicians have an obligation to disclose when they are not using AI?I know some of the answers to the question of why clinicians aren’t doing this. But, the question I asked the Stanford AI+Health audience was to consider why we focus so much on informed consent for taking action, but we ignore the risks and negative outcomes that occur when not taking action.

And specifically in rare/undiagnosed diseases or edge cases of known diseases…do clinical providers have an obligation now to disclose when they are NOT using AI technology to facilitate the care they are providing?

It’s an interesting question, and one I would love to keep discussing. If you have thoughts, please share them!

What it was like to start subcutaneous infusion of immunoglobulin (ScIG) and how ScIG compares to IVIG

by Dana Lewis

After several months on IVIG, I recently switched to subcutaneous administration (infusion) of immunoglobulin, aka “ScIG”. As per usual, I went looking for information on what it was like and comparisons to alternatives (such as IVIG) and couldn’t find much. So this post is everything I wish I knew before I decided to switch to ScIG and what would have been helpful for the transition and getting adjusted to subcutaneous infusion of immunoglobulin.

Why I thought about ScIG

For context, I don’t have the indications (diagnoses) most people have for IG, whether that is IVIG or ScIG. So my situation doesn’t necessarily translate to other diseases: I won’t speak specifically to symptoms etc. in detail, because it’s not relevant to anyone else, but what I will focus on is the general situation. My background is also relevant: I went on IVIG with a protocol of two days every 4 weeks. I noticed an improvement to IVIG in the second week of this cycle, but I had increasing symptoms in weeks 3 and 4. My doctors were not super experienced with (did not have many patients on) IVIG and weren’t aware that this is common, depending on what type of disease you have. I went to two days every 3 weeks. I still had the week 3 “dropoff”. We transitioned me to one day every two weeks, and that cut off the ‘dropoff’ of the cycle, but things still weren’t great and I was still experiencing the symptoms that caused me to need IVIG. So – this told us that my thing is autoimmune related, because IG is slightly quieting things, but that IVIG isn’t a perfect fit for me. (However, there is no other alternative treatment.) Additionally, because I was getting frequent IVs, my infusion nurse(s) gave me a heads up that at some point I might want to discuss a port with my doctor, because I am “one valve-y human being”. My infusion nurse who commented on this indicated it’s common in weight lifters (I am not) and people who do a lot of cardio (I guess I am – see ultrarunning). This can make it more challenging for IV access even though I only ever had 1-2 failed first IV’s, they wanted me to be aware that a port may be something I would need to or want to transition to. But, the idea of a port made me really nervous, in terms of the surgery required and the healing required from that. Plus I had some grief thinking about how it would be ‘committing’ me to this long term plan of IVIG, which no one really wants to do. Especially when, see above, it’s not perfectly managing everything. I started doing some research into ScIG, which my doctor was also aware of but has had zero patients on, so I had to do a lot of the research myself to understand the plans and how to transition, what to ask her to write for the order, how to push back (!!!!) on the pharmacist when they tried to change the plan, and get the timing right when transitioning from IV to ScIG.

What I knew about ScIG is that it would be subcutaneous, infusing the volume of IG under the skin in a similar way to that of insulin from an insulin pump. I knew it was different, though, in terms of the volume of liquid, and that it would involve using infusion sites and tubing for several hours every week – but then the sites get removed, so it’s infuse & done rather than being similar to an insulin pump site that stays inserted and delivers a constant infusion. The idea is once per week (although some people split and do twice per week) infusions that I could do by myself and at home once I got trained.

Pros/Cons – compared to IVIG

One big obvious advantage of ScIG is doing it myself, at home, on a schedule of my choosing. I wouldn’t have to schedule appointments and drive 30 minutes each way and deal with other people and the inconsistencies of them swapping my nurses out last minute. (Doesn’t sound like a big deal but when you run into substitute infusion nurses who unsolicited and out of context suddenly ask you if you have tried treating your (type 1) diabetes with cinnamon, and you have to point out that no, you take insulin because not taking insulin would kill you…well, the rotating cast of characters has a variety of risks in terms of how they do things infusion-wise, too.) Theoretically, ScIG should save me time, although that’s not true at first (more on that below), even though I would be doing it once a week.

Another advantage is the subcutaneous route, e.g. infusion under the skin rather than through IV access. But this is also a disadvantage, because the volume being infused is a LOT (and mine is larger than most due to my body size, it is dosed based on weight) and requires several needle sites and then infusion under the skin results in ‘pancakes’ in each area (more below). There’s the possibility of allergic site reactions happening, which fortunately didn’t happen to me, so I didn’t have to deal with red, itching, sensitive skin during or after the infusion – but I was aware that it could be a short or longer term issue.

The next advantage is not only time savings (eventually) but flexibility. It’s a shelf-stable liquid, you don’t have to keep it in the fridge. This makes it – and the supplies and the mechanical infusion pump – easy to travel with. In fact, I did my first travel ScIG as my fifth week, and it was flawless, just like at home. The only ‘concerns’ I had was remembering to bring the bag with me on the trip and not accidentally leaving it on the plane.

Cost is another big relative advantage of ScIG over IVIG. IG is expensive. IVIG is expensive because you’re paying for facility time and nurse time, and IG itself is expensive. Weirdly, even though it’s the same thing, the subcutaneous formulation of IG is less expensive. I used an LLM to research and guesstimate costs and thought the IG itself would be the same and I’d mostly be saving a few thousand dollars per month on the facility/people time. Instead, once I saw my first claim for ScIG, I was surprised that the ScIG IG formulation was a lot cheaper per gram! (It’s still expensive: but it’s less expensive formulation wise, which I wasn’t expecting).

The major cons are having to do all this (below) myself and having to subcutaneously infuse. It can feel really overwhelming when getting started, and I’m also nervous about long-term site management. This is in part because I have type 1 diabetes and have worn/used an insulin pump for 23 years, which involves rotating those sites around my body. With ScIG, you use the same general areas of the body to infuse, but it’s actually limited further because some of the areas you’re supposed to be able to use (like back of hips or arms) are impossible to do by yourself and/or aren’t feasible because of how long the ‘pancakes’ or fluid depots take to absorb, so it would be uncomfortable. This means my legs are my prime ScIG real estate, and occasionally abdomen – but I use my abdomen (and arms and back of hips and upper butt) for my pump sites and don’t want to take away my abdomen from pump site territory, so I have fewer site options than an average person looking to start ScIG. Again, unique to my situation, but managing the number of sites (below) can feel overwhelming when you have limited real estate.

None of the cons, for me, outweighed the reasons to try ScIG, but I was aware that they might eventually be reasons why I need to discontinue.

Onboarding/getting set up nightmare

I expected getting insurance approval and getting set up to start ScIG would be hard, with the hard part being prior auth from insurance. Actually…no.

The hard part was getting the doctor’s office to get the prescription/orders to the right mail order infusion company, then getting the mail order infusion company to do everything in a timely manner. I gave them a 6 week heads up that I needed (wanted) to start on November 4, because my last IVIG would be October 28, and I needed to start ScIG exactly one week after the last IV infusion, because it takes a week for ScIG to absorb and ramp up activity. The infusion company took dozens of phone calls with various people to get things to the point of finally submitting the prior authorization to the insurance company, who immediately within hours approved it. (They probably knew it was going to be a lot cheaper than IV, which I was already approved for.)

(This is likely unique to my situation). But then there was still delay after delay of the pharmacist being confused about how I would start, because of the “high” volume I was on. (It’s a normal volume for my weight, but most people who end up on IG therapy are a lot more frail and often lower body weight than I am, at the start of whatever this disease is. Thus, more volume than they usually see.) The IG formulation I’m on has FDA limits for how much volume per needle site you can do the first week and the rate per site for the first week. Those limits meant I needed to use 8 needles the first week, but that was doable: it’s actually in the infusion pump manufacturer’s guide to use 8 needles, which FDA says is allowed. But for some reason the pharmacist kept saying only 6 was possible and that I needed to split to do the dose in two days the first week, 6 needles each time. I kept telling him 8 was allowed; I was looking at the pump manufacturer’s guide AND the 510k approval documentation from the FDA. Finally he told me he was looking at the website from the pump manufacturer which ‘said’ 8 was not allowed. He finally gave me the URL, I went to look…and it said no such thing. It’s a basic calculator that was only configured up to 6 needle sites, because (7 or) 8 are less commonly needed, but it’s possible either by running two pumps each with 4 needles, or, PER THE FDA APPROVAL, using a ‘y-connector’, which is an approved part they just order just like the infusion sites. Neither pharmacist nor pharmacy manager had ever seen/heard of it and even though they could order it, it just broke their brains over and over again, but after 8 phone calls we finally got everyone sorted on the fact that I would do one day, 8 needles, and that was that. Then I got passed to the scheduler who said after the 6 weeks advance notice, no one had scheduled me, and they couldn’t send a nurse to me on November 4. WHAT! Then there was back and forth about how it needed to get pushed back a week – which means I needed to go get IVIG again and then ScIG a week after that. I was going to do that, but it turns out I was essentially evicted as a patient from the IV place I go to (!) without knowing it, so they would’ve had to re-set me up completely with new prior auth etc. Finally, luckily, we found a slot for my ScIG start/training at an ambulatory center, and so the plan was to go there instead of a nurse coming to my house for my first infusion/training.

TL;DR: coming from IVIG, insurance approved the swap to ScIG without any denials. The infusion pharmacy was weirdly the process nightmare, when they shouldn’t have been. I am simultaneously mad and thankful that I was informed and aware enough to know what the plan should be, advocate for actually following that plan, and questioning if someone says something that doesn’t make sense. Sometimes they’re doing things the easy way or the way it’s been done for other people, even when that is irrelevant to your care. After this first infusion though, it gets easier, because after this they’ll be mailing a box of supplies to my house every month.

First ScIG (training, nurse supervision)

I was really nervous going into my first ScIG, in part because I didn’t know what to expect. Thanks to people who post pictures and info on Instagram and Reddit, I had searched for “ScIG” and “subcutaneous immunoglobulin” and the IG product’s name to at least see pictures of what the sites and infusion pump looked like, which helped. But I knew I was going to be using 8 needles and I was nervous that they would hurt and that the infusion would hurt and I wasn’t sure how long it would take for things to stop hurting after. (Spoiler alert: it was a LOT better than I was fearing of the worst case scenario, comfort-wise!)

The first appointment at the ambulatory center took a lot of time because we had to do onboarding type stuff and open boxes and a lot of supplies. We got everything set up and laid out, and the nurse did the priming of the tubing and inserted the first two needles for me. Then I did the rest. I was pleasantly surprised that inserting the needles did not hurt – which I thought was because we used lidocaine cream (more on that below), and covered it with tape and let it sit for 20 minutes before we started. I found it slightly challenging to gently hold the plastic ‘wings’ of the site after I had inserted the needle while I placed the large piece of tape down, to securely hold the site, but this is probably because of the muscle weakness/clumsiness (why I’m getting IG), and I’ve gotten better over time. But that was the hardest part of the first infusion, which tells you that it wasn’t really that hard to do. Once you get the needles placed, you put the first syringe (attached to the tubing and your sites) into the pump, and pull back the spring-loaded plastic mechanism: it’s not electronic, let alone powered, like an insulin pump, just a spring-loaded plastic device that applies constant pressure to the end of the large syringe. Then you turn the pump on (a mechanical on/off switch) and it basically makes some noise as it pushes the tab at the end toward the end of the syringe, and then that pressure is what starts the infusion. (Pressure on the liquid into the tubing; not pressure on or near the sites). I did feel when the infusion started and it felt a little uncomfortable – not painful. But I got used to the feeling since it was constant and it was fine from there on. Because of the volume I’m on, I swap cartridges a few times during my infusion, which is easy (twist one off, twist one on, re-start the pump). At the end, you stop the pump, gently pull the tape off the sites and pull the site straight out, put gauze pressure to stop any bleeding, then pop a bandaid on, and you’re done.

All in all, it was better than I expected, but I did still feel overwhelmed at the idea of doing this all every week, even though I knew I would gradually decrease the number of needle sites, which would help. But the thought of doing the next one a week later felt overwhelming, especially because it took about 18 hours after the infusion was done for the fluid depots or “pancakes” as I call them to fully absorb, and my legs were uncomfortable. I didn’t want to get bumped or bump anything where I had infused and I didn’t want to let the cat walk across my legs. Subsequent ScIGs though have confirmed (see below) that it has gotten more comfortable over time and if I do have an uncomfortable site, it is pretty much all gone 16-18 hours after my infusion ends, so it doesn’t drag on.

I left the ambulatory center with the pump and supplies I would need for the next 3 weeks of infusions. I went home and rested the rest of the day, because my muscles were worn out from the way I sat in the infusion chair (and was tensed with stress). That’s probably specific to my situation.

After I got home from my first ScIG, I had boxes of supplies to go through. I waited a day, then when I had more energy, sat on the floor and spread everything out and sorted it into piles so that I had a bag with the supplies (IG boxes of cartridges; needle sites; tubing; gauze; bandaids; etc.) divided up for each week. That way, each infusion I just had to grab a bag and the pump and wouldn’t have to sort through a mountain of supplies. That was a good call, because it made it a lot more simple for my first at-home, by myself, ScIG.

Note: they offered to send a nurse to my home for ~2 more visits or that I could go back to the ambulatory center, and my insurance would easily cover that. But, I felt confident after the first one, because I also came home and made notes of what I would do and checked my supplies above and had anchored the process in my mind so I felt confident doing the second one myself.

Second ScIG (home, solo)

I was nervous, again, about doing my next ScIG as my first one alone, because it felt like there were a lot of supplies and steps to do. This includes starting with “pre-meds” of taking Tylenol and a Benadryl in advance. There was also putting on lidocaine cream in the spots where I was going to stick the needles. For the second infusion, I was “only” doing 6 sites, but that’s still a lot. I put on lidocaine cream and stuck squares of press and seal over them. This was recommended by the infusion nurse, and also because they didn’t send tape in my box to accommodate doing this, even though they did send lidocaine cream. The press and seal seemed to work ok, but it added time where I needed to do it before I started setting everything up because it needed to sit for 20-30 minutes. I also had to be careful not to brush off the press and seal, so that felt physically stressful. Once I had everything set up (all the cartridges opened; tubing connected to sites; the tubing primed; the pump set out), I was able to sit and pull off a press and seal square; use gauze to wipe off the cream; use an alcohol swab to clean the area, then grab a needle and pull off the rubber band, pull back the wings, remove the needle guard (and put the rubber band and needle guard somewhere I wouldn’t drop later for the cats to eat), and insert the needle. Like the first time, I found placing the tape on each site challenging. The ‘site prep and insertion’ process felt like it took forever. Then once that was done, I unclamped my tubing and turned the pump on, and whoosh – we were off. Like before, I jumped a little when the infusion started but it didn’t bother me after that. Everything went smoothly, but I did feel like I noticed the pressure over time in a few of the six areas (but not all) during the infusion. After the infusion was done, I did the same process of peeling off tape gently, then pulling off the site, then gauze pressure, then bandaid. Then I was done! I was pretty pleased with myself but again, exhausted from sitting up and doing it, so I decided I would do my next one laying down to save muscle energy.

I was satisfied with only having one training and glad I didn’t bother asking for a second nurse visit to supervise, so I was able to do this on my own schedule. I realized I liked doing it starting in the early evening so that when I would’ve been home sitting around anyway…I could be home sitting around and infusing while I read or listened to a podcast. I was already appreciating the schedule flexibility!

Like the first infusion, my legs were uncomfortable after the infusion, and overnight. It again took about 16 hours before that feeling went away. I also noticed a few days later that one of the sites that had bled a little when I pulled the needle out, had a slight bruise. I made note of that so I could avoid the area for the next few infusions (more on site rotation below). But other than that, no issues with the first solo home infusion, which was my second ScIG.

Subsequent ScIGs, site rotation

Each week has gotten a little easier, to the point where (after 5 weeks) it now feels routine and manageable.

It does help that I was transitioning down in the number of needle sites. During week 1 I used 8; week 2 I was able to use 6 (because I wasn’t limited by the first week safety limits on volume per site); and week 3 I went down to 5 sites.

I didn’t realize at first but even if you want to use fewer sites than you have needles for, e.g. you have a set of 6 sites and you want to use 5, you can clamp one of the sites and only insert 5. So even though I was sent home with 6 and 4-sites for my three weeks, the pharmacist confirmed over the phone that I could clamp and do 5. I actually ended up doing 5 sites in weeks 3, 4, and 5. I wanted to transition to 4 sites, but this will result in a larger volume per site and take a little bit longer. I have one more set of faster tubing (which is what determines the speed; the pump applies constant pressure and the tubing determines the speed) but I can’t switch to it until week 6, so I stayed on 5 sites with the medium speed tubing for a few weeks. However, in week 3, I did notice a few sites bruised underneath the skin. They weren’t painful, but I could feel a slight lump exactly where the needle had been under the skin. The pharmacist confirmed this was likely a hematoma (i.e. a bruise or tissue clot) from the site insertion and if the skin was not raised, red, spreading, etc – it should heal and go away on its own. Most of them have, but I have one that is still there three weeks later. It’s not a big concern, but I am keeping an eye on the rate at which I get these bruises and whether that impacts what areas of the legs I can infuse in. It also factors in to wanting to use fewer needles per week, because these lumps seem to be more related to the simple presence of a needle under the skin than to total volume per site or the speed: I will confirm the latter when I graduate on week 7 to the fastest tubing speed possible. It doesn’t happen with every site, so I’m not sure if that’s just a leaner area (where I have more muscle and less fat) or if it happened to be somewhere I accidentally bumped or pressed it down while taking off the tape, etc. Regardless, because of some combination of any of those reasons, I’m planning to eventually go down to 4 sites per week. This will make it easier to rotate, because I can do one each on the inner and outer thigh of each leg, and it will be easier to track week by week. In the meantime, in week 6 I also tried shorter needles. Originally, I was given 9mm. 6mm is also an option, and this matches the length of my insulin pump infusion sites, which suggests it should be sufficient length to reach my subcutaneous tissue with ScIG, too. The insertion was a little easier (because I have to push in 3mm less of needle length into the skin) and I’ll need a few weeks to see if that reduces my under the skin bruising rate.

I was very cognizant the first two weeks about making sure my needle sites were more than 2 inches apart. My first week I had all 4 needles in a square, two inches apart from each other. That was technically fine, but my ‘pancakes’ or fluid depots ended up bumping into each other and made my legs more uncomfortable. For week 2 I did kind of the same thing, avoiding the previous needle areas and being two inches apart, but one set of pancakes touched whereas the other leg and other areas didn’t…and those areas with pancakes that didn’t touch were more comfortable. I realized I needed to optimize for enough distance apart so the pancakes don’t touch each other, and preferably away from last week’s pancake spread area. That causes me to have to pay more attention when I am still using 6/5 needles a week because I’m focusing on my legs. The more I keep the sites separated, the easier they are. In fact, I began using my inner thighs in week 4 and week 5 and while some people say (and the nurse repeated to me) that they are ‘sensitive’, it actually did not hurt at all to put the needle there – even without lidocaine cream in advance – and I couldn’t feel the infusion during or after. Awesome. That gave me a lot more real estate than just my outer legs, and since I have a lot of muscle on the top of my thighs but plenty of fat on the inner and outer side thighs, I try to target using there, and keeping them separate from each other + last week’s sites works really well.

I did on week 3 also try abdomen sites for the first time. I didn’t want to use this area much because I want to preserve it for insulin pump real estate, but I tried it. It was fine, but I also have to be cognizant of pants waistbands/not putting pressure the next day while it’s still sensitive. It doesn’t hurt by default, but it is uncomfortable to have tight clothing against the pancake, whether that’s a tight legging/pant leg or a waist band. Or in my case, a back brace that I wear – so I’ll only use my abdomen site occasionally when I know the next day I don’t need to be wearing my back brace for riding in the car or sitting up unsupported somewhere. (Again, much of this is unique to my personal situation).

Why did I stop using lidocaine cream? A few reasons. One is that it was a hassle and added time to needing to do that then wait 20-30 minutes before I started. It also involved using gauze to wipe it off and then alcohol swab and then go to insert the needle – but by the time I wiped it off and cleaned it, I couldn’t always see the spot that had been lidocaine creamed! So one time I ended up inserting definitely not in the cream spot and I could tell a difference, but it didn’t hurt. So the next time I tried without it (week 4) and it went fine. I have had one (out of the 12) needle slightly hurt as I put it in but that’s because I went super slow and didn’t quite break the skin so I need to try again. Now, since I’m not doing lidocaine cream, I find it easier to use the alcohol swab and clean a much larger area (think a two inch square) rather than just cleaning the inch around the lidocaine cream spot and that way I can just pinch the area and insert without having to find the magical spot and worry about whether it’s right, and it’s faster. The other reason is because I looked it up and apparently you do need to put tape (not just press and seal) on the lidocaine cream so it can get through the skin barrier. Press and seal keeps it from getting on your clothes but doesn’t actually help it get through the skin barrier, so it’s mostly placebo. Argh. I’m frustrated that the nurse gave me wrong information and that the pharmacy didn’t send tape in the first place. I could have asked them to send it in the next box, but I was tired of arguing with them and it doesn’t hurt and it is a lot easier (for me) without the whole process.

The other thing that has made things easier over time is that weeks 3-6, I chose to lay down in bed while infusing. I sit up to get everything inserted and start, then lay down and read a book on my phone or listen to a podcast. This may be unique to my situation with my muscles, but I found that while I’m still a little tired the next day, it’s a lot more manageable when I rest during my infusion.

TL;DR (this section): keep an eye on the ‘pancake’ or fluid depot of where the liquid goes. If you’re like me, you may find that the tissue there is sensitive for a week or two and so while you can insert nearby for your next infusion, you may (like me) prefer to keep them spread farther apart to limit discomfort.

Traveling with ScIG

One of the major benefits is the ability to travel with your ScIG. You can really do it anywhere and it’s nice that it’s shelf-stable, so other than not letting the IG itself get too warm (package says keep it below 77 F and also don’t freeze it), it’s not something you have to think much about. If you’re like me and you take each shipment and organize it so each ‘week’ is in a bag ready to go, it’s as easy as being at home to grab the week’s bag + the pump bag and taking it with you.

The one thing to think about is managing your ‘sharps’ at the end of the infusion. My nurse told me I can use scissors and cut the needle ends off the tubing, and put the needles in a sharps container, and throw everything else (tubing, tape, cartridges) in the trash. To save space in the sharps container, she suggested cutting the needle ends off. So at the end of each infusion, when I pull a needle site out, I place it into a (very) small tupperware container and use scissors to cut the tubing. The needle part drops into the tupperware container. I do that with all needles, then put the lid on and give it to my husband who goes and puts it in the big sharps container in the other room. When I did my first travel ScIG, the only supply that I didn’t bring with me and needed was a pair of scissors for this (and opening some packets), but we were staying at an rental house that had them. Otherwise I would’ve found a way to wrap them thoroughly in bubble wrap or similar to bring them home and then dispose of them. But since I have this little tupperware container (one inch tall), I put labels on it that says “SHARPS” on the top and the side in case I need to show TSA my bag and disclose yes that I have sharps but they should be labeled and sealed for safe transport while traveling.

When I’m at home, I have been using a little laptop table set on the bed that I put my sterile drape on top of and lay out supplies onto. During my trip, I ended up cleaning and using a ‘cookie sheet’ with a lip in the same way, putting the sterile drape on top and using it like a big tray to hold everything. That was actually so convenient I’ve switched to doing that at home, because it makes it easy to set everything up and do my site insertion, then move the tray and myself onto the bed to lay down for the infusion and have everything I need (other cartridges during; gauze and bandaids and scissors at the end) in arm’s reach.

Resupply and dealing with the pharmacy

After my first infusion I was sent home with the rest (three weeks’ worth) of the supplies. I got a call from my patient navigator from the infusion company two weeks later to talk about my next box. I needed to get it early because of travel after the Thanksgiving holiday, and luckily they had no problem shipping it the Tuesday before Thanksgiving. They went over everything that would be in my box and I was able to make requests about which number of sites and tubing I wanted. I was also able to speak to a pharmacist (this time, someone with a better clue about things) about the ‘lump’ bruises under the skin and my needle choices and talk through things, so generally that felt like a smooth process. I also ran into an issue where I got my supplies and had everything they ordered, but they didn’t send me more gauze. Because I had been doing lidocaine the first few times, it meant I used up my box of gauze wipes for the first month and they sent me zero gauze the second month. But I called them back and they shipped just a box of gauze to my doorstop easily and without hassle, which was nice. So thankfully despite the annoyance of onboarding and getting set up, the re-order process has generally been fairly reasonable to deal with and easy to correct mistakes. That’s a good reason to sort your supplies within a few days of them arriving, and put them into each ‘week’ of what you need, so you can see if you’re going to run out of anything. In my case, I know I need to make sure there are more bandaids in my third box, because I sorted the end of my bandaids into the second box’s worth of supplies.

How much time does ScIG take? Does it save time compared to IVIG?

The first infusions take longer than the others, especially the very first one where you are limited to very conservative per-site volume limits and per-site flow rate limits.

The rest of this is influenced by how many sites; what tubing speed; and what volume you are getting, which is determined by your body weight. The fewer needles means it actually takes longer (despite the same size/speed of tubing) because at some point the infusion dispersion under your skin slows down. Therefore, more needles is faster, so if you want to prioritize time saving, you would prefer more needles (and faster tubing, if you can tolerate the higher speeds). For me, I care less about the total time, but I am happy that in week 7 when I can try transitioning to the fastest possible tubing, for my volume that will mean going down to 2h15-2h30min infusion times (depending on whether I am using 5 or 4 sites) as opposed to the 3h30-3h50min infusion times (for 5 or 4 sites) that I’ve been doing on the tubing speed I have now. As I mentioned, on top of the infusion time, it takes me about half an hour (sometimes less now without lidocaine) to open and prep everything and insert and tape all the sites. It also takes me 15-20 minutes to take everything out, because I am trying to go slow and put pressure on each site to minimize bleeding and lumps before placing bandaids, so 5 sites times 2-3 minutes of removal means 15 minutes of removal, minimum. (People who don’t typically have bleeding/bruises/lumps maybe can do this faster than I do.) All in all, right now it’s a 4.5 hour ish process for me, but in a few weeks it should go down to 3-3.5 hours overall and feel more manageable. Again, that’s because it takes time to transition down in the number of needles and transition up in tubing speed.

But for the first month or so, I’m spending about 1.5x time total than what I would be spending (including drive time) for an IVIG session every two weeks. But starting week 7, I will go down to matching the time it would take to do an IVIG session every two weeks versus ScIG every week. For me, timing wasn’t a big factor, and again, for most people with lower volumes etc. this math will probably work out better in their favor for ScIG being faster/less time than IVIG, depending on volume and regimen, etc.

The verdict of ScIG versus IVIG after 6 weeks of ScIG – and is it worth it?

I was lucky (in a sense, after being unlucky by getting whatever disease this is) that ScIG clearly works for me. I started to feel/notice a difference within the end of the first 7 days from my infusion, and it’s continued to improve things from there. Unlike IVIG (see above), I’m not experiencing a “tail off”. I was a little nervous that maybe I was just getting a first week or two “boost”, but I’m over 6 weeks in and still seeing the sustained improvement. Hooray. That made it easier to push through the first few weeks of discomfort and the learning curve of figuring out how to do ScIG, because it is clearly working for me much better than IVIG did (even on a two week cadence!!), it’s getting easier to do over time, and I’m figuring out how to optimize my site placement so it’s more comfortable. Hooray, hooray, hooray. Also, I don’t have to take as much Tylenol throughout the week like I did on IVIG to prevent or manage headaches. I still take “pre-med” doses of Tylenol (to avoid a headache) and Benadryl (to help limit allergic reactions, although I could probably go without this since I’ve never had an allergic reaction) but most weeks don’t find myself taking Tylenol later in the week anymore like I did post-IVIG.

I am still apprehensive about long term site management but hopeful that getting down to only using 4 needles will be manageable with the volume per site and being able to rotate areas of my body that get the infusion each week. There’s a chance my disease will progress and this will no longer work. But there’s also a chance that for me, ScIG will continue suppressing my disease. The mechanism of administration results in lower amplitude difference between the ‘peak’ and ‘trough’ levels of IG, because it is slow to absorb (because it takes a while to go from pancakes into systemic absorption) and then get used by the body. That’s very different from a big bolus/dose on a single day of IVIG which gives you 100% of the dose within hours, into your bloodstream via an IV. That’s a big peak and a fast tail down to lower troughs, versus a medium ‘steady state’ on ScIG. There is also a possibility for me that I may be able to titrate down (e.g. decrease the volume) and use less, which means smaller pancakes. This won’t be a fast experiment and I won’t start testing titration strategies until 2-3 months of steady dosing on my starter dose. But it’s possible I don’t need this much, and also it is easier to test lower doses on ScIG (where I can just infuse less) without having to re-go through prior authorization and change doctor’s orders via the insurance company in order to do this. We can just…do it ourselves. That’s the whole point of ScIG and also makes titration a lot easier than IVIG.

Tips and tricks for those on ScIG

Everyone probably has different ways of doing ScIG and probably has different advice. But I wanted to share some of the things I wish I knew or figured out sooner or things that help smooth the process.

  1. Lidocaine cream can be helpful, but not necessary. If you find the timing/taping/waiting/wiping/etc. process annoying, use one of your sites on a spot where you didn’t lidocaine (don’t forget to cleanse it, though) and try it at least once. If you don’t mind it, then you can consider skipping the lidocaine cream process next time and see if you prefer doing it with or without. You can always swap back to it, but if you’re like me and find the benefit minimal and the process burdensome, it is an option to cut back on some of the steps for infusing. And save time.
  2. Cut a piece of cardboard (or something) with slits on the side so you can unwind your site tubing and put one per slot so it is easier to ‘dry’ prime (priming so that the IG gets close to the end but doesn’t actually end up in the needle: this cuts down on skin reactions) and also easier to grab one site at a time as you are inserting. I have a piece of cardboard I cut and keep in my bag of supplies along with the pump that I use every time.
  3. Spread out your sites and watch where your fluid depots go and whether there’s any relationship to discomfort during or after your infusion and the tissue you’re infusing in. Areas where I’ve infused more recently or had pancake (fluid depot) edges touching tend to be more sensitive during and after. Areas that are very lean/very muscle-y tend to result in it being more of a hill/dome than a flat pancake, with less spread outward but the bigger bump can be more uncomfortable for me.
  4. If you can, make notes of where you infused. You can draw on a piece of paper and use numbers (e.g. weeks) or symbols (e.g. x’s and triangles and boxes and stars) to track where you did sites. But per above, it’s not just about where the needle went in – it may also be that you want to think about how big the pancake was. I finally realized that each week marking down what I just infused and putting hypothetical sites marked for the next week was helpful, both in terms of making sure I was thinking about the current infusion pancake and staying far away from it, which was easier to do when the pancakes are visible as opposed to a week later right before I infuse. I actually found I most prefer a powerpoint slide where I have circles showing the pancakes, and numbers in the center representing the week, to be able to see how I’m using my real estate over time. I can also mark lumps/bruises that I want to avoid for longer than a one week gap, and this will also help me see if I have a trend of any problems and if they’re location specific or more general.
  5. Get comfortable for your infusion time, however that looks for you. Maybe that’s finding a way to sit with a laptop tray up off your lap so you can work while you infuse. Maybe that’s being like me and finding it easier to do in the evening when you can lay down and watch TV or read or hang out with family. Don’t feel like you have to do it the way anyone else does or even the way you used to do it. I figured out that I like to have a heating pad on low that I can place over my lower legs or later push down near my feet, which is both for staying warm and cozy but also as a sensory distraction at the start of the infusion.
  6. Take your time applying the tape over your needle sites. The first week I was anxious (at the ambulatory center) and clumsy (because my hand muscles were worn out) and my tape job was a little sloppy. Because of that, and the site placement, as the fluid depot grew one of the wings was up away from the skin, and I eventually had a little leakage (not all of the IG was going under the skin). Argh. It was a waste of IG and risked my skin getting irritated at/around the needle site because of the IG leaking. Luckily, it didn’t irritate my skin, but now I go as slow as I need to and take my time placing the tape to fully cover the wings. If I have a wing ever so slightly at the edge of the tape, I peel off the number strip of tape on the end (a bonus piece of tape you can ignore, or use as an extra piece) to make sure it’s fully covered and taped down on the ends. (Or you can use another piece of tape if needed). But ever since I started focusing on a better tape job, nothing has leaked (and after 29 sites, having only one ever leak the very first time is a pretty good rate of success!).
  7. Use the infusion pump guide or the online calculator to see how long 1 cartridge takes to infuse. Put in the volume of one cartridge (not your full dose) and the correct size gauge and number of needles (e.g. 24G or 26G, 4 or 6 or whatever number of sites you are using), then look at the “average time” to infuse. That usually is a good estimate of how long it will take the cartridge to run. Since my mechanical pump doesn’t tell you when it’s done, you have to watch and estimate when it’s done. The best method I’ve found for doing this is starting the stopwatch on my phone every time I turn the infusion pump on. Then I can track how long it’s been and around the time I’m expecting it to finish, watch the pump and see. Sometimes it’s a little faster or slower, but it’s about right. This is useful to do if you’re watching TV or reading or working or not staring at the pump, that way you don’t waste time not infusing. I ended up making a spreadsheet that shows the number of sites and how long a cartridge takes for each of those: that way as I change from 6 to 5 to 4 needles – and change tubing speed – I can track how long it takes overall to infuse (so I can plan my schedule) and watch as I go to make sure I don’t lose 10 minutes in the middle where I’m not infusing because one cartridge is done and needs to be swapped for the next. Like during IVIG, I don’t like the uncertainty of not knowing how long an infusion will take and having to pay attention during to cartridge changes timing (because I want to optimize and minimize downtime but also not have to stare at it and babysit it), so a spreadsheet helps overall and running the stopwatch during helps track each cartridge.
  8. Don’t be afraid to ask for help. Or rather: don’t be shy about asking for an extra pair of hands to chip in where it’s convenient. I found it less overwhelming to ask my husband to help, even though I don’t need or want him to do a lot. This is partly because I wanted him to be familiar with the supplies and process and also because it made it feel less overwhelming and reassuring the first few times. I mostly have him help at the start and at the end. I have him open the needle sites tubing and pull off the paper and unwind the tubing lines. I then get a cartridge ready to connect and together we prime the tubing. Then I do everything else myself, but after the prep part he clears away the pile of trash and at the end after I have removed and clipped all the needle ends into a mini tupperware, he takes that and deposits them in the bigger sharps container and also throws away the rest of the trash. Could I do all that? Yeah, but I don’t have to, and it’s nice to not have to do “it all”.

If you have any other tips to share with others (or me!), please do comment below to share them.

How to help someone on ScIG

If you’re reading this because someone you know or love is considering or starting on ScIG – thanks for caring. You can be a big help just by understanding what is going on and listening to us vent or share our concerns about the process or how hard it is. Because, while it is beneficial (otherwise we wouldn’t keep doing it), it is hard. It’s hard to insert needles (sometimes that’s a big mental blocker) and infuse liquid into the skin, knowing that it will sometimes hurt and often be uncomfortable. And the discomfort can last for hours to days. Obviously, you should ask the person doing ScIG what would be helpful before, during, and after.

Here are some areas you can ask whether it would be helpful/not or if they would prefer you to do (but you’re not limited to this list!):

  • For mail order shipments, you have to sign for the box which means someone has to be at the address. Offer to help cover part of the day when the shipment might arrive, so the person doesn’t have to lose an entire day to watch for the shipment and sign for it.
  • Offer to help sort supplies once they arrive: checking that everything that was supposed to come did come in the box, and organizing into weekly bags/boxes to make it easier each week to grab and go.
  • Ask if they want help figuring out an easy way to record their infusion sites, if they haven’t figured out a good method for them. (Could be using an app, a hand written list, a hand drawn picture, a spreadsheet, a digital picture e.g. like my powerpoint)
  • Ask what you can do to prepare for/during ScIG. For example, offer to carry in their supplies to where they want to set up and offer to wash your hands, lay out the sterile drape, and open supply bags, etc. I prefer to do my own needle insertions but it’s nice to have my husband help open the tubing bags and unwind the sites and lay them out (into my slotted cardboard), plus help prime so we have two sets of eyes making sure we ‘dry prime’. Offer to come take away a pile of trash after they do the insertions, so they have less ‘stuff’ around.
  • You could also offer to do the needle insertions, if you’re comfortable doing that and if they are comfortable/prefer someone else to do that! You can also offer to stay around – or be out of the way – when they start or during the infusion, depending on their preference. I like to have a quiet room to myself when I put the needles in, but the first few infusions I wanted my husband to come back in when I was starting (mostly because the noise of starting the mechanical infusion pump was so noisy and stressful until I got used to it), and found it nice to have him rub my feet as it started infusing, as a sensory distraction so it wasn’t just the infusion in my thighs feeling at the time I started infusing.
  • Because my infusions take a long time, he’ll also bring a chair in and come hang out, eat dinner with me, or putter on his phone so I don’t feel isolated from the house. (He also plays defense with the cats, who LOVE to lay on me when I’m laying down, but isn’t something I want during infusions!) There’s probably a bunch of “small” things like this that are unique to your person and your house and the situation as to what they find helpful or find not having to deal with to be a nice change from having to do it themselves. Offer a few things if you think of them, but say yes to the ones they ask for if you can – it does make the experience a lot nicer! Even if it’s something you don’t think you would care about – it doesn’t matter, it’s what they care about and what they would find helpful.
  • Also ask for the after process. This starts with cleanup – my husband carries away the last pile of trash and also takes my mini sharps container that I find it easiest to use (when cutting off the ends of the needle sites) and putting the needle sites into the big sharps container, as well as taking the leftover supplies and pump bag back to the supply stash.
  • Be aware that the infusion sites will be sensitive for a day or two: for us, that means being careful when my husband gets in the bed not to roll over and into an area where I just infused on the side of my leg, or avoiding my infusion area if he reaches over to give me a hug or comforting squeeze. I’m really sensitive the first ~24 hours and then a little less cautious but still sensitive a day or two after that, then back to normal. Some people may have longer or shorter timelines for when they want to be careful around the areas they just infused.
  • Overall – also be willing (and ask) to listen to any frustration, or any type of emotion people have. It’s a lot to deal with whatever disease or condition is going on that necessitates the ScIG, and then ScIG itself is painful or uncomfortable or just overwhelming and annoying to have to do on top of that. It can take a while to get comfortable with the process of doing ScIG, although it does get easier over time and you and they will find ways for it to feel easier and integrated into your life and find what works well. But, that takes time, so be patient with them and each other as everyone figures it out.

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ScIG vs IVIG: what it is like to switch to subcutaneous immunoglobulinScIG works for me (in a possibly very unique situation) better than IVIG does, and helps confirm that my disease is likely autoimmune related since it is responding to IG therapy, even though it’s still technically undiagnosed/doesn’t have a name (and no, isn’t one of the conditions that IG is usually used for). I am thrilled to finally be feeling somewhat better even though ScIG is not a cure but a partial bandaid (for me). A really expensive bandaid. But ScIG is a more flexible bandaid that I can do on my schedule and have control over and without having to hassle with other people’s schedules or the variety of administration approaches that comes from a rotating cast of infusion nurses at the ambulatory infusion center. And it’s cheaper than IV. But, we’ll see how long this is sustainable in terms of being able to manage the real estate that it requires to be subcutaneous. Keep your fingers crossed, please, that I can keep doing it as long as it’s working for me.

And if you’re looking into ScIG for yourself and have any questions, feel free to drop them below: I’m happy to answer questions if there’s anything about the experience you’re wondering about.

Chicken, foxes, rattlesnakes, and the Hypershell X Ultra

by Dana Lewis

A chicken, a fox, and a rattlesnake (mountain) equals an adventure, and one I didn’t think I would get to do this year.

(If you are new to the idea of an ‘exoskeleton’ or you know me and haven’t read my prior post about it, read this post first for context on exoskeletons, my experience with it so far – and more details on why I have been using one for the last few months.)

In August, I bought a Hypershell X Pro exoskeleton, for many reasons. For me, and my individual situation, it has been a huge instrument of freedom, allowing me to get back to some semblance of ‘normal’ volumes and duration of activity (at least for hiking) than I was able to do earlier this year. I put ~250 miles on it within the first 3 months of using it.

Because I’ve been using it, I joined one of the Hypershell groups on Facebook and saw them post about a contest, where they were seeking 10 people who would create user-generated content (aka, take pictures and videos of themselves using it) of their next version, called the Hypershell Ultra. It was centered around doing a ‘challenge’ hike or experience. I applied, thinking I wouldn’t get selected, because 1) I have a condition which is why I’m using it; 2) and/or I already have the Pro so they’d maybe pick people who are all brand new to exoskeletons and 3) I post a lot of trail/adventure pictures but it’s more of nature, not myself, and I don’t have a ton of followers on public platforms – I’m not really an “influencer”. But you don’t get a ‘yes’ unless you apply and try, so I applied anyway. And somehow, I was selected! That means they sent me a Hypershell X Ultra, for free. If I meet all the terms and conditions of the challenge, I get to keep it, if not they’ll want it back. But I was given it to use for free, so factor that in below accordingly (although you might be surprised when you read to the very end of this post).

Why I wanted to do the challenge and try the Hypershell X Ultra

There are a few specific reasons why I really wanted to try the Ultra and was excited about getting access to one. For context, they came out this fall and were marketed at $1,999. That’s…a lot of money. I spent $1,199 on a Pro model which was a lot (but I’m definitely getting my money’s worth from it and am glad I got it). However, as someone who just bought a Pro, I was not interested in buying an Ultra at the $2,000 price point. But I definitely wanted to try it, because the Ultra has some differences from the Pro. Namely, 1) it supposedly has reengineered motors that are more efficient, so they claimed you would get more mileage out of each battery; 2) it has Apple watch support so you don’t have to pull your phone out and unlock it and open the app in order to do certain things while active.

Those, for my use case, would be a nice improvement. In most of my hikes, I have had Scott (my husband) carry the spare battery and we swap it out mid-hike so that I can use as much power as I need. With two batteries, I can do 8-10 mile round trip hikes (and even those with ~3000+ feet of elevation gain) without fully running down the second battery. For me, and the type of adventures I’m doing, one battery isn’t enough (it handles about 4-5 miles of moderate-high intensity flat and maybe 3-4 miles of uphill adventures). So more mileage out of the same two batteries sounded great. That’s also where the watch view comes into play. I found, with the Pro model, that I didn’t like leaving adaptive mode on and instead, having it on Walking mode worked better for me (it still adapts to downhill etc automatically). (More on why about the modes in my other post). But, there are times where I would want to change the mode or would need to check the battery because I’m prone to getting in the zone and charging uphill on my hike and running the battery all the way down to 0, where it dies without warning. There’s no audio or visual cue on the device if you’re actively moving to indicate that you’re about to run the battery down – you just get to the point where it suddenly stops providing assistance and you notice it. Then you stop and change the battery. Which is not a major big deal, but the Hypershell mobile app on iOS has a long-running bug where if you don’t open your app during the hike and you manage to run the battery down to zero…it tracks none of the steps or the mileage. It’s not the only way I’m tracking mileage, but it usually means I lose 4+ miles off the lifetime mileage which I think (because I’ve now done this half a dozen times already!) is going to add up over time and influence my ability to see where I am relative to the expected lifetime of the device. (This is an app issue they should be able to fix with software, they just haven’t yet). TL;DR for that part – the Ultra has a watch app where you can change settings AND see the battery, so I’d have more of a clue without having to pull my phone out to know when I’m getting close to the end of the battery and better plan for it so it doesn’t die halfway up a hilly stretch or that I remember to open the app before that happens.

I also wanted to do it as a motivation to get back out there and do a patented, Dana-and-Scott-special, which is what we jokingly call a chicken and fox adventure day (named after the river-crossing puzzle).

A chicken-and-fox adventure is something we started doing years ago, when I got into ultrarunning. Scott runs, but he doesn’t have the patience for long, flat runs like I do. He’d rather do long distance biking (which I have less patience for), or hike. So on long ultra training days, we’d drive out to the mountains somewhere and I’d pick a running route where Scott could drop me off and then go bike somewhere long and/or interesting, and we’d meet up at the end. Often, that turned into him dropping me off then parking the car at the end of the route, then he’d bike elsewhere, and I’d run my 20-30 miles to the car, grab the car, and drive to wherever his adventure ended and pick him up. Or vice versa with dropping him off at the start and then going for my run. We have had many awesome adventures like this, where “together” we are going out for really cool adventures even though we do them slightly differently, and we have great experiences to share with each other.

In the past year and a half or so…we haven’t had those adventures, because I haven’t been running, and I can’t ride my bike in the same way, and I didn’t feel confident hiking alone for very long. But, since August, my confidence began to grow after a lot of hiking (I’ve put 40,000 feet of elevation gain into my hikes between August and now, all with the Hypershell X Pro exoskeleton).

Thinking about the Hypershell X Ultra “Challenge” made me realize that I could – and wanted – to challenge myself to get back out and do a chicken-and-fox adventure.

The challenge I chose was a chicken and fox adventure on Rattlesnake Mountain (the one in western Washington state in the US)

The adventure I had in mind was a route I have always wanted to do, which is the full end to end Rattlesnake mountain hike. I’ve done parts of it – many people have, especially from Rattlesnake Lake to the Rattlesnake Ledges, which is a famous hike near Seattle that a lot of people do. Rattlesnake Ledges is one of our favorite places to take visitors, so we’ve actually done that twice this year. The other side of the mountain is also a good hike, although more about the wander through the forest. It starts at a mountain biking shared trailhead and meanders up to a few turnaround views (e.g. Grand Prospect) that also makes for a good out and back hike. If you want to hike the entire mountain, you need two cars…or you need someone who will do part of the hike, turn around and hike back down, drive around and meet you at the other side while you hike up and over the rest by yourself.

I had mentioned this hike / idea of an up and over several times, but the idea of hiking by myself made me nervous, especially with my physical abilities changing, because I sometimes need a hand getting up or down really steep, rocky terrain and I’m less sure-footed than most people. However, after ~250 miles of experience hiking with the Hypershell X Pro, my perspective was changing, and I was less nervous hiking in general *and* with the idea of hiking ~6-7 miles by myself up and over the mountain. So I pitched it to Scott and got him to agree to be the chicken* in our chicken-and-fox adventure day, with the plan of starting our hike on the Rattlesnake Ledges side, hiking up to the Ledges, then having him turn around and hike down and drive around to meet me on the other side…while I hiked from Rattlesnake Ledges up and over the remaining segments of the mountain trail by myself!

And that’s what we did (*although Scott claims he was the raft, as the car driver, rather than the chicken or the fox).

PS – if you’re in the area and doing the Rattlesnake Ledges hike, the “Ledges” you come to are actually the “first” ledges – there are two more ledge areas that you can hit! Yes, it’s more climbing, but only a few hundred feet between the ledges and the second ledges, and then up to the third ledges. There are really cool views at each set of ledges where you can see the other ledges, so it’s worth doing on some of your Ledges hikes.

What using the Ultra was like

Like I do for all my hikes, I got out of the car at the parking lot and put it on, which entails clipping the belt around my waist, clipping on each leg strap, and turning it on by pressing the button on the device. It auto-connects to the app and your phone without you having to open your phone each time (which is why, see above, I sometimes manage to run down an entire battery without having the app open so it doesn’t record the mileage in that scenario).

(Also like on most of my hikes, I made it 20 steps from the car before someone I walked by commented on the exoskeleton. It’s always really fun to be able to share with people, because often it’s people who have previous injuries or knee problems or other challenges who have heard about them, watched a video online, but never seen one in person before!)

Based on my experience using the Pro version, I know I like to do most of my flat or slightly uphill efforts on “eco” (green) mode at about 50% power. When I get to hillier sections, I’ll put it into “hyper” (red) mode and toggle the power up as needed for a bigger boost of power on lifting my legs as I climb, but for this hike with smooth terrain with more gradual climbs, I start on my personal defaults (eco, 50%). However, with the Ultra, the ‘re-engineered’ motors mean that the settings I use from my Pro don’t feel strong enough to assist me at the same level. I found myself bumping up to “eco” 75% to feel closer to what I experience with “eco” 50% on the Pro. (I thought maybe this was a one-off, but that does seem to hold true across a couple weeks of using it.)

Dana is hiking on a smooth trail through a forest, with light coming through the trees. She is wearing a small hiking vest/pack and wears a long sleeve black tshirt with dark purple leggings and you can just barely see the exoskeleton's dark straps against her from behind. Like using the Pro, having the Hypershell X Ultra makes it so I could do this full hike. It’s not a short hike: the full Rattlesnake Mountain hike is marked as 10.2 miles but from parking lot to parking lot it is closer to 10.9 miles and I tracked over 3,000 feet of elevation gain. I could do “just” the Rattlesnake Ledges hike (4.3 miles round trip, ~1100 feet of elevation gain), I could do the other side, but my muscles would be too fatigued to safely do a 10+ mile hike, so we wouldn’t even try it without an exoskeleton. And, there’s no way I would have considered doing it alone. Which…I did!

Scott hiked up with me to the main Rattlesnake Ledges (the ‘first’ ledges), and we took some pictures, then decided he would hike up with me to the next ledges as well. (In part because I estimated the hiking speed and he would be killing a lot of time waiting on me at the other side, and so he’d have more enjoyable views going up to the extra ledges than hiking through the forest without a view on the other side). We went up to the next ledges, and then he handed over my poles and headed back down the mountain, while I took off up the rest of the mountain…by myself!

Dana is a dark silhouette where you can see the sides of the exoskeleton's motors next to each hip, looking down at the sunlit valley with Rattlesnake Lake and Ledge ahead of her

(Earlier this year, I found that I needed to use hiking poles on uphill climbs to help me compensate for the very specific leg muscle function I was impaired by. But with the exoskeleton helping target lifting my leg, I have found that I rarely need poles going uphill anymore. Instead, we usually carry them folded up and bust them out of the backpack and use them for stability/confidence on downhill terrain. When Scott turned around, I still had another few thousand feet of elevation gain to go, so I didn’t need the poles, but I took them with me just in case and also so that I had them for the downhill side, which I would do solo.)

Dana is facing the camera, standing not very near the edge of the second ledge, with views of the dry Rattlesnake Lake and Rattelsnake Ledge behind her. It is a bright sunny day with the valley lit behind her.

We swapped batteries before Scott left, so that I had a fully charged battery for my solo segment. I think at the time I had used only ~40% of the first battery. In retrospect, I should’ve kept the other battery with me, but I didn’t (we put it in his backpack).

I hiked up all the way to East Peak, which is the farthest I had ever been up this side of the trail. I eventually crested onto a ridge where there was a logging area and really clear views on both sides – and the weather had cleared so I had several miles of visibility south to see areas that I had never seen before! I saw one trail runner pass me between this section and Grand Prospect, but otherwise I had over 4 miles solo with no one else in sight…and no concerns about my ability to cover the distance, alone, up in the mountains. Which was so, so, cool. (My only hesitation came with the occasional blowdowns of trees across the trails, one of which was a little challenging to climb over. Otherwise, it was smooth sailing along the trails by myself.)

I made it over to Grand Prospect and took a picture to document being there, because this marked the section of the trail I was familiar with. At this point, I still had 4 miles to go to the trailhead! Right after this, the trail began trailing downhill into the forest and this was where I was glad I had my poles, because although this trail is very smooth (as far as trails go), it had rained pretty heavily the previous two days and was muddy and slippery in a few places. Eventually, as I meandered down and was about 1.7 or so miles from the trailhead, I suddenly noticed my legs felt heavy. I looked down and…no lights. I had run down the full battery on the exoskeleton. Oops (see note above about my partially charged battery being with Scott). Luckily we had planned for Scott to hike up and meet me (rather than sitting around at the car), so I had less than 10 minutes before he reached me and we swapped the batteries back. Ahhhh, that felt so much better. (Although you don’t lift your legs as much on downhill terrain, you still lift your leg and that’s specifically where I have muscle impairment that is really aided by the exoskeleton, so it is night and day even on flat or downhill terrain for me when I use the exoskeleton versus walking without it. So I was glad to have my powered assist back on!)

We finished out the hike at the mountain biking shared trailhead, on the other side of Rattlesnake Mountain. I did it! I was so jazzed. I had been confident about the mileage and elevation, because since August I have done some other hikes in this ballpark of elevation gain and mileage, but it was really rewarding to feel confident enough to do that many miles up on a mountain ridge all by myself and feeling confident enough to deal with whatever situations would arise while hiking solo. And I would not, at this point in my situation, have done this without an exoskeleton.

I previously wrote about some of the benefits of using an exoskeleton, especially for hiking, but two months since writing that post, some of the specific aspects of using it that I wanted to highlight include:

  1. I can step up and over things more easily. This could be stepping up onto a rock step, or up and over a branch on the trail. These things used to require poles more often; see above where now I very rarely need poles for the uphill even when stepping up and hiking up a long series of rock steps!
  2. I also less often ‘need’ poles for downhill smooth terrain, like most of the Rattlesnake Ledges hike. I still like having them for trying to move quickly, or for wet/slippery terrain, or bigger step downs, but for rolling smooth terrain I often will go without for the downhill. I didn’t feel like that was even a choice before!
  3. Because I can get my legs moving back at a reasonable pace for both flat walking and for hiking, I found that I can actually get a good cardiovascular workout again. Meaning, I used to be limited by my legs rather than my cardiovascular system, and my heart rate rarely was elevated and I couldn’t push myself because I was leg-limited. Now, I can actually walk briskly and raise my heart rate intentionally; same for hiking. This is huge for my overall health.
  4. At the end of hikes and walks, because the rest of my muscles are less fatigued for compensating for the missing muscle action, I am rarely scuffing my feet at the end of walks and hikes the way I was pre-exoskeleton. I also have less fatigue in my muscles, even though I am going farther and longer and working my legs and my cardiovascular system harder! Pre-exoskeleton, I realized that I was limiting us to 8 mile hikes and then more commonly 4-6 mile hikes. Now, I’m back up to regularly wanting to choose 8-10 mile hikes on a regular basis. (And same for elevation: I had limited us down to ~2000 feet of elevation gain hikes for a while, because of fatigue concerns for the end of hikes, and now have no problem choosing >3,000 feet of elevation hikes again!)

All of this was in play during my challenge hike. I actually chose to do this long hike, alone, because I felt like I could do it. I got more physically out of the hike, because I was able to actually locomote and activate my cardiovascular system more, because I wasn’t wasting all my energy just moving my legs. I didn’t need my poles for going uphill. And I didn’t scuff my feet or trip on the entire hike, even though I was out there moving nonstop for 4 hours and 15 minutes!

What using the Ultra is like, compared to the Pro

Remember that my review/experience is skewed by having a lot of experience with the Hypershell X Pro. If you want to read my gushing about how exoskeletons are an instrument of freedom and the best thing since sliced bread for me lately – read my previous post about it. Otherwise, keep in mind this is mainly a comparison between the Pro and the Ultra, rather than never having used an exoskeleton then trying the Ultra.

You should take away from my first blog post (really, read it first if you haven’t!) and this one so far that exoskeletons are awesome and for people like me, they are a huge instrument of freedom. I never want to be without one, especially as long as I’m in whatever situation I’m in where my muscles work differently than they used to. That being said, I do see a lot of people asking online about the Ultra, the Ultra versus other models, etc, and I want to explain – from my perspective – what the differences are. And this needs a major caveat: my experience is 1) that of a person with some kind of condition that affects my leg muscles and 2) that of a person who personally bought and heavily used the Pro model before being given free access to the Ultra. Then read the below two sections because I’m going to give specific answers to what you should consider getting (or not) if you already have an exoskeleton versus what you should consider if you don’t already have one.

The difference between no exoskeleton and the Pro is probably 5x stronger than the difference between the Pro and the Ultra. The Ultra does have re-engineered motors supposedly causing it to be more efficient…but in my use case (which is likely different than the average person – remember my default ‘walking’ mode is eco 50% which is a lot higher than most people’s) I found that I had to bump the power up so much higher on the Ultra – to default eco 75% for just flat walking, and often 75% hyper mode for hills, too, then also often going up to 100% hyper for bigger hills. I rarely did that on the Pro. It is possible that I’m getting more mileage per battery, but I still don’t feel confident that it is because it’s more efficient or if they changed the power settings relative to each of those modes so I’m not using as much power as I was before. And while most people maybe wouldn’t notice that, I actually do. Because of how my leg muscles are specifically impaired, I can absolutely tell the difference between these. So I was less excited after using it, because of those factors for my unique situation.

The watch mode IS a game changer, though, for people like me who are busy hiking and not looking at our phones. It gives you a way to quickly turn adaptive mode on and off or switch between eco and hyper if you’re not familiar with the on-device button way of doing it (although it’s easy to learn: it’s a two second long press to switch you back and forth). But for me, the biggest benefit is having the watch app to show me the battery level! That helps me better see as I’m getting to the end of one battery as I often do, so I can remember to open my app (until they fix that bug) and also to look at where I am on the hike and decide if I want to go ahead and swap it out if I’m in the middle of a big steep section and don’t want to have to stop mid-climb when it suddenly dies. I did see a post somewhere that the watch app will eventually come to the other models (I hope so!), in which case this will also be a selling point for the other models rather than a differentiator for the Ultra. Update: as of early December 2025, the watch app now supports all models! So this is no longer a key differentiator.

The Ultra does look different: instead of orange and silver reflector material on the leg straps and waist belt, it is primarily black. The bars that extend down your legs are also black, because they’re the lighter carbon fiber material. I think aesthetically, the Ultra is a little more ‘subtle’ because of those color changes, especially when you’re wearing it against pants. In summer, when it’s against bare legs with shorts, I think it’ll be noticeable the same amount, but because I got access to the Ultra when I started wearing longer pants for hikes and walks this fall, it does feel like it’s less visually noticeable. Weight-wise, though, I don’t notice a difference from the carbon fiber material and the Ultra being slightly lighter overall weight than the Pro. This is something I actually considered about whether to buy the Pro versus the “Carbon” version originally..but I actually am not bothered by the Pro weight at all. The weight difference is maybe there, but because the Pro weight doesn’t phase me at all, it doesn’t feel like a big differentiator to me. However, I do see some people online who perceive the weight of the Pro to be a factor for them, so I’m guessing they’d benefit more from the lighter weight than I do.

Takeaways for those considering an exoskeleton if you don’t already have one

If you’re on the fence about getting an exoskeleton – yes, you should get one. Especially for those of us who have conditions that have changed our activity levels and patterns – it really is a game changer. The question shouldn’t be “should I get one” but “which one should I get”.

And based on my experience, I look at the math on battery, power output, and my experiences with both (see the chart on my previous post if you want to breakdown all the variables for the 3 main models outside of Ultra), and say…I still think the Pro is the best deal, for most people with the current pricing models. 

  1. The $200 difference is absolutely worth it for the higher output and second battery that you get with the Pro versus the lower “Go” model.
  2. I chose the Pro originally because I didn’t think the main difference between the Pro and the Carbon, the weight difference, was worth $500. After using it for several months and after trying the carbon fiber (lighter weight) based Ultra, I still think that’s true.
  3. I originally thought, before trying it, that maybe the extra mileage from the ‘re-engineered, more efficient motors’ on the Ultra would be worth it, so it would be a question between the $1200 Pro and the $2000 Ultra, with it being worth it IF you were someone like me who was really putting a lot of miles in and was regularly running down 1.5-2 full batteries per activity. But…after using it… in the current iteration, I don’t think that’s the case. (Again, my perspective might be skewed by ‘how high’ I run my default power levels, starting at eco 50% most of the time. So maybe that mileage boost is more for people who don’t by default use as much power as I do for all mileage. People who are fine with lower power output and are high mileage probably would like the Ultra.)
  4. I still think most people are best suited by the “Pro” model. And if you’re like me and really putting the mileage in, it would be cheaper to get the Pro and later buy an extra battery or two than it would be to go for the Ultra. Unless you’re not like me and are a lower power need and also maybe someone who would notice the weight difference when wearing it.

TL;DR: you should absolutely get an exoskeleton. But, for most people, see above – go with the “Pro” unless you have specific reasons (e.g. lots of mileage and/or strongly preferring the slightly lighter weight of the device) to choose the Ultra.

Takeaways for those considering an Ultra if they already have another model

I think the same outline above applies here, which is that most people who have a Pro or a Carbon likely won’t benefit enough from the Ultra to justify an upgrade while theirs is still in good working order. I think the people who would benefit would be if you started on a “Go” model which only came with one battery and doesn’t put as much power out. Then, a switch to the Ultra is a reasonable shift for a second version exoskeleton, if you can afford it: otherwise going to the Pro gives you likely 90% of the benefit of the switch. However, a Pro to Ultra or a Carbon to Ultra doesn’t make as much sense until you wear down your existing exoskeleton and it reaches end of life, or you are someone with a Pro who really needs a lighter weight version and uses lower power output but still runs the battery down, in which case you might be the use case that is suited to the Ultra. But if you’re not in those situations, you may not have as much need to upgrade until your existing one reaches its end of life.

And who knows, maybe subsequent firmware and software upgrades will change the Ultra. If they manage to change the power levels back to something that better matches the Pro where I have more range to use the upper end of the power *and* get more mileage per battery? Then I will be a huge fan and encourage people to factor that into their decisions. But until then, see above.

—

Powered-exoskeleton-is-instrument-of-freedom-my-experience-Hypershell-X-Ultra-DanaMLewisTL;DR: I love exoskeletons, they’re an instrument of freedom. I paid $1,200 in August 2025 for a Hypershell X Pro exoskeleton and love it (still love it). In late October/early November, I was given for free a Hypershell X Ultra exoskeleton after being selected for the Hypershell X Ultra Product Explorer program and have been using it and comparing it for the last several weeks. I love the opportunity and appreciate being chosen in the explorer challenge program so I could try it, and because it motivated me to head out on a big chicken-and-fox adventure up and over the full length of Rattlesnake Mountain, which I wouldn’t be able or willing to do without an exoskeleton to support my adventuring.

A powered exoskeleton is an instrument of freedom – my experience with the Hypershell Pro X

by Dana Lewis

Instruments of freedom are devices, tools, hacks or things that help us do more than we could otherwise, and often do more with less pain or hassle or risk.

Instruments of freedom can be small everyday things, like noise cancelling headphones that help you focus or an effective rolling suitcase that’s easier to roll through the airport. They can be anything that reduces the energy cost of doing something, or increases your comfort or confidence, or expands your choices and flexibility and independence. Instruments of freedom are for everyone, but they can be especially meaningful for people with various health conditions, especially those of us impacted by physical limitations as a result of these health conditions.

I first considered the framework of instruments of freedom a few years ago. A few years ago, my mindset went from “I don’t need poles” for hiking to “I wonder if poles might be beneficial”. I tried them, and they were immensely helpful. I didn’t know if it was because my balance and proprioception has changed ever since I broke my ankle (and later a toe), or if I would have benefited from them all along. Nevertheless, they were highly impactful for helping me power up and more confidently come down hills. As my body changed for other reasons (a new autoimmune disease affecting my lungs and muscles), poles went from optional to the only way I would be able to hike at all. But as hiking has become even harder, I have kept my eyes open for additional instruments of freedom that might be helpful. Specifically, for over a year and a half I have been wanting to try a lower body exoskeleton, but could not find one that was commercially (and easily) available, light enough, and at a price point that I was willing to pay.

Until now.

I discovered one called “Hypershell”. There were 3 versions available (“Go”, “Pro”, and “Carbon”) at the time I was evaluating them, with different price points ($999, $1199, $1799) with different features and accessories.

Here’s what the features were at the time I was evaluating them:

Hypershell Go X Hypershell Pro X Hypershell Carbon X
Peak “Horsepower” output 0.5 HP (400W peak) 1 HP (800W peak) 1 HP (800W peak)
Motion Postures Recognized 6 10 10
Weight of device 2 kg 2 kg 1.8 kg
Battery range ~15 km (9 miles) ~17.5 km (10.5 miles) ~17.5 km (10.5 miles)
Temperature rating of battery IP54 & Anti-Cold
Down to −10 °C		 IP54 & Anti-Cold
Down to −20 °C		 IP54 & Anti-Cold
Down to −20 °C
Number of batteries included 1 2 2

(As I’m writing this in August 2025, note that they’re announcing a new “Ultra” model in September 2025 but it’s not clear yet what additional features or capabilities it will have.)

I wasn’t sure, though, if I would be able to use and benefit from the Hypershell. It’s hard to explain what my physical limitation is, but it results in me feeling like I can’t press off my ankle effectively (I wear ankle braces on both side) and there’s weakness in my thigh and hip, especially on the right side, that makes it hard to step up and over when going up the stairs and hiking. I can do it, but it’s exhausting, and it results in a weird sick-muscle type feeling after I do it a lot. I joined a Hypershell user group on Facebook and also the “Hypershell disability users” Facebook group. The second disability-based group kept cautioning that you needed to be able to lift up your foot 3-4 inches and take a step in order for the device to kick in. I was nervous about getting it and it not being able to work for me. But, there is a 2 week (14 day) return period, so I was hopeful that if it didn’t work I would be able to return it and get a refund. (But there were also not-so-great reviews of their customer service communication and the refund process, so I was nervous about that.)

I decided to get one and try it. I also specifically decided to choose the “Pro” model (see table above).

Why I chose a Hypershell Pro model instead of the Hypershell Go or Hypershell Carbon

The reasons I chose the “Pro”:

  1. $200 difference from the base model (Go), but with the 10 motion patterns. Given that I’m hopeful that I can do more types of activities like I used to, I wanted to be able to have as much capability as possible.
  2. More power output – the Go only has half as much peak power as the Pro/Carbon.
  3. More range (mileage, albeit slightly)
  4. Two batteries, including the better cold-resistant ones, on the Pro/Carbon instead of only 1 on the Go.
  5. …but I didn’t care about the .2kg weight difference, and that was really the only difference between the Pro and Carbon. That wasn’t worth $500 between the Pro and the Carbon.

(Update – December 2025 – are you curious about the latest version, the Hypershell X Ultra? I was able to try one: here is a separate post about my experiences with the Hypershell X Ultra and my comparison to the Hypershell X Pro, with my Pro experiences described below.)

Unboxing the Hypershell exoskeleton and getting set up

Before the Hypershell arrived, I went ahead and downloaded the app. It required an email address and a password, and it also asked about height and weight. It had a decent onboarding experience in the app with videos embedded to show you how to open and get started and how to size it. The height and weight was used to give you a starting setting for the waist. But then I couldn’t do anything else in the app until I had connected the device.

When it arrived, I had low expectations for being able to use it right away, because people online talked about how long it took to charge/having a hard time charging it at first. Because of that, I expected to need to wait an hour or two of charge time before I used it and also was ready with a higher power wall plug to charge it. For some reason, the Hypershell batteries came (both) at 6% charge, but it was enough to turn on and get started for setting up the device. I was able to turn it on and get it connected in the app, do the onboarding (walking you through the first mode changes etc and taking test walks around the house in the different modes) even with it in 6% low battery status.

But then I took it off and put it on the charger to charge it up. I used the same wall plug I use for my laptop, and that was sufficient for its 65W charge rate. It takes a little over an hour to charge the 72 Wh battery up to full, and the lights on the device itself will show you (4 lights) when it’s fully charged, or you can see it in the app. It’s handy to have it lit up on the device because my husband, without access to the app, can see and change batteries to charge the next one himself.

A Hypershell Pro X model worn over grey loose-fitting pants. This is a side view, so you can see the motor against my hip, the bar as it wraps around toward the front bottom of my leg, and the knee strap. In terms of getting set up and putting it on, it’s very straight forward. It gave me a starting suggestion to use for the waist size. I used that (and have never changed it), tightened up the waist strap and leg straps, and it was good to go from there. Once I got the waist strap tightened, I haven’t had to re-tighten or change that. I have had to tweak the leg straps a little bit here and there, partially because of how it slides around on my leg (see below re: sweating, chafing, and wearing in the summer as opposed to wearing it over a layer of clothing), but it’s quick and easy to tighten the leg strap or loosen it when needed and not a big deal adjustment wise. I did read a few people saying it slips down their hips and they got suspenders to help, but I haven’t had that experience (I’m female, so I have plenty of hip bone for it to rest against, and maybe that’s in part what makes the difference?). The first time I put it on, because I was adjusting straps, I put it on while sitting at the edge of a chair and getting everything set up and tightened, then stood up and tweaked the straps, then turned it on and began using it. Now, I can grab it and put on the waist belt while standing, then slightly lean over and attach each leg strap (so I don’t have to sit down to put it on). Because it carries the battery in the back and the design also has the support bar around the back, it’s not really comfortable to sit with for long if you want to lean back against the back of the chair, but it’s fine if you’re sitting down briefly on something (a chair, a bench, etc) if you’re not trying to lean back or sit up against the back of anything.

My first time using the Hypershell Pro X

I was conservative with my first time using the Hypershell, in part because of users in various groups warning about taking it easy and not overdoing it. (If you have no disease/physical limitation as your reason for wanting to use this, you can probably ignore this.) After it charged fully, I put it on and went for a short mile and a half walk to see how it felt.

I knew from the onboarding experience (where it has you testing different modes) that I didn’t need “hyper” mode turned on to walk. “Eco” mode is the base mode, and you can adjust the power setting either on device (pressing a button twice increases it by 25%, triple pressing it drops it by 25%) or in the app with a slider that allows you to adjust it 5% increments.

I tried 25% power for my first walk, which was enough to feel the lift pulling my thigh and knee up. It felt so good! It made walking feel smooth and easy, especially on the right side where my thigh/hip muscles are more impaired. It felt like it made my walk more balanced in terms of not slogging along on the right side compared to my gait without assistance. I noticed a sensation of a few muscles feeling activation that normally aren’t getting activated (this is probably unique to my situation), but had no soreness or issues right after or the next day as a result of this test walk.

The next day, I did my normal length walk (of about 4 miles) with the Hypershell.

The third day? I took it hiking. And…(more about this below)

Small hiccups with adaptive mode recognition (that may be unique to my gait)

I had my app set to ‘adaptive motion recognition’, which is where it detects what you are doing (e.g. walking, going downhill or down stairs, idling, etc) and adjusts the assist based on the motion. It takes a step to kick in any assist and it takes about 2-3 steps into a new pattern (e.g., starting to go down the stairs) to swap modes. This means if I was walking toward the stairs and starting to go down the stairs, it would be the second or third step down where I would feel it change into downhill mode where I could feel it providing resistance against my thighs, as opposed to lifting my thighs as I stepped down. It was also very noticeable when I got to the landing and would take the 2-3 steps to turn the corner and continue down the flight of stairs. It would feel stiff-legged like I needed to tip toe to walk and then just as it switched to walk mode, I was going down the next flight of stairs and again it took 2-3 stairs before it was back on down hill mode. Not a big deal, but it did make me aware of it. I went down the stairs (carefully) while looking at the app which shows which motion pattern it is detecting, so I was able to see (and not just feel) that it was switching those modes and that’s why it suddenly felt different.

The other hiccup was when I was out walking on the sidewalk, which is flat. It was in walking mode and I was indeed walking, when suddenly it threw a stiff legged resistance at me. Huh?! I looked at the app and it showed “downhill” when I was walking on a flat surface. Weird. It reverted back to walk mode after 2-3 steps. It happened again later on my same walk. I must have something weird about my balance or gait that leans backward (?) or otherwise causes it to sense downhill, so it shifts to downhill mode. It didn’t trip me but it did make me go “woah” and I didn’t love it because I wanted to just be able to forget and walk without thinking about wearing it.

So as a result, I decided to turn off adaptive motion recognition and use it in ‘manual’ mode, rather than having it auto-detect. I’ve used it in “walking” mode ever since as my default mode, and it works great. It also still auto-detects and shows you what motion it detects in the app, but even with over a dozen miles of flat walking, it’s not thrown the downhill resistance in unexpectedly again. And, even in walking mode it still provides enough support and resistance for actually going down the stairs/downhill, regardless! So I get the same benefits without the risk of the sudden incorrect downhill resistance.

Kicking the tires of the Hypershell Pro X with hiking. A lot of hiking. Three days in a row!

Before using Hypershell, I could still hike. I used to hike three days in a row almost every week, but with this muscle disease, I found myself not being able to easily do it, so I would often hike Friday, rest and do something easier Saturday, then do another hike (maybe) on Sunday. This has been true for the last 6 months (or longer).

But my first hike with the Hypershell was on a Friday, and it went great. I played around with using the adaptive motion recognition and found that I couldn’t tell a big difference in the assist with ‘uphill’ mode versus ‘mountain climbing’ mode versus ‘walking’ mode. Downhill mode was good, but I also tested going downhill while in ‘walking’ mode and found it was good enough. Since all of these mode changes have to be done in the app, and the exoskeleton itself covers my pockets in a way that makes it hard to get my phone in and out of my pocket (plus I’m carrying poles), I decided I would try staying in ‘walking’ mode for everything from flat to uphill to downhill…and it did great. I felt so much more at ease stepping up and over steps and rocks and powering up hills the way I used to, and I also was thrilled that the little bit of resistance to my thighs for downhill made it easier to step and control my downsteps. All of this increased ease and control somehow resulted in me not generating the ‘sick muscle’ feeling I have been getting in my legs and glutes after hiking. In fact, I felt like I hadn’t been hiking at all! I was so thrilled that we decided we would hike again with it on Saturday, a second day in a row.

I did wake up with really tight calves on Saturday…but normal hiking tight calves, the way I used to get after the first few hikes of a new season when my calves are out of shape for climbing. I was thrilled because that meant that I was activating and using my legs MORE (despite the powered assistance of the exoskeleton!) on that first hike. Tightness and all, we decided we would hike again, and we actually chose a longer second-day hike with reasonable elevation now that I felt confident I could handle more of it with the exoskeleton. And I could: the second hike was also great, and I left it in ‘walking’ mode the entire time on the way up, but did find that I wanted to use higher power settings (still in eco) as a baseline and increase it further for hills. I think I used 30-40% as my base power, then would increase it more for bigger inclines. The nice thing is that for downhill, you are using less power, so even with ⅔ or so of the battery used up on my first and uphill half of the hike, I ended up at the bottom of the second hike with just above 10% battery left because the downhill uses so much less battery. (I had it in ‘downhill’ mode for the way down, where it provides resistance on the way down but when you’re on flats it’s not lifting your legs much as it would in walking mode.)

That went so well that…we headed out for a third day in a row. My first three-day weekend in a long time! Again, we chose a long hike with more elevation than we ever would have predicted would be possible for even a second day in a row, let alone a third day. This time, I was feeling more overall fatigue (hello, three days of hiking in a row!) and so I started with 50% power (eco mode) and cranked it up on hills. I finally remembered that I could adjust power with the button on the device, double clicking to add 25% as I went up a hill and triple clicking once I was on a flat (to decrease it back by 25%), without having to pull out my phone and open it and navigate to the app and slide the toggle. That made it easier, because I could still do that with poles in my hand.

Because I was cranking up the power more on this third day in a row, I did run out of battery on this hike. This was in part because there was a pretty steep climb on our return route about 2 miles from the end (of an 8.8 mile hike), and I wanted to crank the power all the way up to 100% (still on eco). I managed to get the battery down to 10% about halfway up that steep climb, and when it hits 10% it still goes but it definitely decreases the output. So we stopped and swapped to the second battery (that I had Scott carrying in his backpack). It’s quick and easy to pop off and swap (I let Scott do it). I powered it on and it instantly reconnected to the app, I put it back on 100%, and cranked my way up the rest of the hill with relative ease. Then I bopped the power back down to 50% for the rest of the hike. One of the reasons I ran down the first battery is because on the downhill/return portion, I kept it in “walking” mode for more assist rather than “downhill” mode. Again, three days in a row meant I was more tired overall and my legs were tired (but normal tired, not disease-tired), so I wanted the extra power to make sure I kept good form and didn’t cause injury by doing an atypical gait in my fatigue.

And I didn’t – I finished the hike, tired (normal tired) and with legs feeling in no way like we had hiked for three days, even though we did.

In three days in a row (which I can’t do without the Hypershell), we hiked 25 miles and over 6000 feet of elevation gain (which I wouldn’t be able to do without the Hypershell).


Instrument of freedom, indeed.

A view of me walking on a trail through an alpine meadow (green grass, flowers) with the mountain I hiked in the background and bright sun against a clear blue sky. I'm on the trail through the meadow and at first glance you may not notice it, but if you look you'll see black straps above the knee, which is the Hypershell strap, and you can also see the bar that goes around the back of my hips with the black battery, and you can also see the motors on the sides of my hips. But at a glance, you may not even notice it.
A view of me walking on a trail through an alpine meadow with the mountain I hiked in the background. At first glance you may not notice it, but if you look you’ll see black straps above the knee, which are the Hypershell straps, and you can also see the bar that goes around the back of my hips with the black battery, and you can also see the motors on the sides of my hips. But at a glance, you may not even notice it.

Did I keep the Hypershell Pro or did I return it? Is it worth it?

By the middle of the very first day of hiking, I knew I was keeping the Hypershell.

It works so well for me, and it really is an instrument of freedom for me. I love walking even on my flat paved trails with it, again because it makes my right hip and leg movement so much closer to what I used to experience (before my muscle disease).

Between my daily walks and the first two weekends of hiking, I have put around 60 miles on foot with the Hypershell Pro.

I’m definitely keeping it. It will be interesting to see if I run into any issues with my high-mileage use. The warranty is supposed to last for a year, and the website estimates ‘normal use’ service lifetime is 3000 km (1,900 miles). If I kept up my current pace of use (averaging 60 miles in two weeks) for a year, that would be around 1,560 miles, still under the expected lifetime use. I’d probably run into that life expectancy (which doesn’t mean it’ll stop working but might be when I expect it to run into issues) in about 14-15 months (or less if I increase my mileage).

But given how much it empowers me to move in the ways I want to move… it’s worth it. And I’m excited to see what other exoskeletons are coming to the market in the future, too. There may be more options for me to consider when this one eventually breaks or wears out.

Does it help with downhill or going down the stairs?

One of the things I really was hoping the Hypershell would help with is going downhill. I have trouble exerting power all the way through my foot, which is really noticeable when I am going downhill on looser dirt or rocks, where it feels like my foot is likely to slip sideways and cause me to jolt/lose my balance. As a result, my downhill hiking became as slow as the outbound uphill hikes (instead of faster, which is common for many people and the way it used to be for me) and made me really rely on my poles for balance. Plus it was super stressful and made hiking less fun, and I also skipped a lot of hikes that had a lot of rocky steps or rocky and loose rock downhill gravel terrain. But because of the Hypershell experience on my first hike, I actually chose a pretty rocky hike for the second hike because I was hopeful that it would help my sure-footedness. And it did! So much so that my second weekend of hiking, I chose a 9 mile hike with 3,100 feet of elevation gain that had a two mile stretch of loose rock and loose dirt with a good portion (1800 feet) of the downhill elevation. And I did great, with the Hypershell on.

But I didn’t know it would help when I got it. A lot of people talked about how it ‘didn’t help going down stairs’, so I had low expectations. When I went down stairs the first time, I didn’t notice a big difference, but when I hit the landing and took those 2-3 steps toward the next flight of stairs, I could feel that stiff legged feeling that definitely indicated it was providing resistance! So it was doing SOMETHING, but sometimes it was hard to tell what it was. Over time, with more experimentation on stairs and testing ‘downhill’ and ‘walking’ mode on different downhill terrains while hiking, I realized that I could feel the thigh-based resistance more strongly when in a higher power setting. The way it seems to work is it either provides some kind of down force against the leg as you are stepping down, or it provides resistance against your leg movement. I’m not quite sure which it is, but it results in a bit of pressure against your thigh, and probably some resistance on the sides (to limit lateral movement while stepping down), and it definitely helps me.

The other way I’ve figured out how to notice it is that with higher power modes while walking (and in walking mode), you can feel the lift ‘up’ from the thigh but depending on how quickly your leg is moving you can also feel the bar pushing back down into the down step. So the motor is able to move the bars (and thus your thighs) both up and down, and that’s likely also similar to what’s happening in downhill/stairs mode, but it’s less noticeable because you don’t lift your thigh as high (or at least, I don’t) when stepping down and it’s a much subtler force against your legs. But if you have stairs with landings, that’s a great place to put it in downhill mode and feel that type of sensation when you get to the landing and take a few steps before you do the next flight of stairs down.

There is also a setting you can adjust call “hill descent control” and once you toggle it on, you can adjust it between ‘weak’ and ‘strong’ (defaults to the middle of that range). I turned mine on but haven’t experimented with adjusting the slider to be stronger, but that may be another reason why I notice a benefit on downhills, whereas other people may not have turned that on.

Is it annoying to charge?

You have to charge the battery on the device itself (with a USB-C cord, and as I mentioned a beefy enough wall charger) or in a special hub that doesn’t come with it. The special hub can charge 4 batteries at once, off-device. Mine came with two batteries and since they charge up in an hour-ish, even if I run both batteries down and get home, it’s always going to be 12+ hours before I want to use it again and that’s plenty enough time to re-charge everything, even with swapping to the second battery to recharge.

I can see how if I went to having 3 batteries and using them regularly that I might want to also get the multi-battery charger, but for 1-2 batteries and my usage, it’s generally not a big deal.

Is there anything I don’t like about the Hypershell Pro X?

I have two (ok, three) issues with the Hypershell. All are minor.

For me, the adaptive motion recognition setting triggering ‘downhill’ when I am walking on a flat surface (albeit randomly and only occasionally) is annoying. Again, I don’t know if it is because of my gait or if there’s a bug in the pattern recognition. There is a workaround – putting it in ‘walking’ mode. I have found that it’s totally fine to keep it in ‘walking’ mode when going up or down stairs, up or down hills, on varying terrain, on flat surfaces. It still provides the lift to pull my thigh up just fine, and it also does the ‘resistance’ force for downhill and down stairs the same (or very similar) to the actual downhill setting. If I want to do more, I can easily turn the power up or down using the on-device button and get more force (for either lifting or resisting), and that is faster than trying to swap modes on my phone.

The second issue is chafing against bare skin. Ohhh, the chafing. You’ll notice that all of the pictures on their website and videos are of people wearing it over pants for winter-type activities. Some people hike in pants during the summer, but I got mine in July and I don’t wear long pants to walk or hike, so the straps around my thighs are against bare skin. I didn’t have any issues for the first few walks (which were all around an hour) but my first hike, which was 3 hours, caused some chafing. So on the second day, I covered those spots with bandaids. It wasn’t enough, I ended up with more chafing spots. So on the third day, I tried putting kinesio tape on my legs where I thought spots would chafe or were already chafed. That did help, but because I’m hiking so long (3-4 hours, multiple days in a row), just like ultrarunning in dealing with pack chafing, it’s hard to deal with once you have chafed spots.

The second week, I tried additional solutions. First I tried wrapping the pads themselves with “adhesive bandages” (think ‘vet wrap’, the stretch stuff that can stick to itself). I was trying to see if just covering the back of the front thigh pad would work, because there are seams underneath it. That helped some, but the force of the corner of the pad itself was chafing. I then bought a roll of 5 inch “tubular bandages”. I got 5” because I have more muscular thighs and I wanted to try putting a piece on my leg like a leg sleeve, and then having the pads against that, so it would rub against the bandage and not my skin. It helped some, but it was still digging in at the corners. So then I tried the leg bandage sleeve AND adding a layer of that material over the pad, double wrapping it at the corners. It helped some. But again, because I already had chafing, I don’t quite know what would work best to completely prevent or eliminate chafing. (I also have tried a 4 inch tubular bandage that was black, to better blend in with the leg strap, because the 5″ worked well but really popped in color and drew the eye to my legs, whereas the black better matches the leg bars and leg straps. In terms of functionality, I like the 5″ tan color better for using as a leg sleeve actually on my leg, so I’ll probably use that as a base layer if I’m not taping as described below when I’m not actively chafed, and then use the black on top of the leg pads and around the buckles directly.)

The next thing I have tried is hydrocolloid bandages (example, there are a lot of different brands and sizes and I’ve found no difference between name brand and off brand versions) on top of the biggest already-chafed spots, with the idea that it will provide cushion and also the pad corners will be more likely to slip on that versus digging in at the exact same spot. Because hydrocolloid (“blister” bandages) stick directly on the skin, I added a bit of neosporin on top of the chafing before applying, so that the bandages don’t stick to the slightly raw skin. The challenge with hydrocolloid bandages is that they take up any fluid, like blister fluid, but also sweat – so as you get sweaty, they’re more prone to peeling up or getting rubbed off via the edges. If you have a big enough bandage that’s less of an issue, but don’t expect to be able to cover a tiny area with a tiny hydrocolloid bandage and not have it peel up from the friction of the leg strap/pad itself or have it start to come off from sweat. I also tried applying larger strips of kinesio tape on top of the hydrocolloid bandages that are smaller, and the hydrocolloid seems to provide a nice cushion against the already chafed spots and the kinesio tape helps prevent it from rubbing the hydrocolloid bandage off.

It’ll be better in winter, when I’m wearing it on top of a layer of pants, and it’s not a reason to stop using it. In fact, most people probably won’t wear it long enough even in hot weather to experience it, but I wanted to document some of the solutions I tried in case anyone else does run into it.

UPDATE: the best solution I found is:

1) as soon as I notice the chafing begin in any spot, I stop and put a strip of kinesio tape in that area. (I pre-cut kinesio tape strips and carry them in my pack).

2) if I miss preventing a chafing spot and something has rubbed, I do a combined strategy of first putting a piece of hydrocolloid tape (I bought a roll so I could cut strips rather than using bandaid-sized – it’s cheaper and easier to apply different shapes) AND then putting a piece of kinesio tape over it. Why? Because as noted above, the hydrocolloid will collect sweat and fluid under the skin and start to come up during an activity, unless it’s anchored – and it’s best to do that when you apply it. That double strategy (hydrocolloi+kinesio, applied when your skin is dry) lasts for several days or longer (I’ve had it last up to a full week, even with multiple showers per day and using the exoskeleton every day), and it both heals up the chafed raw spots and protects subsequent spots from building up. So that’s a great solution during multi-hour bare-legged hike/activity season.

We’ve now also gotten to fall and I can confirm that chafing is not an issue at all when wearing it over long pants.

The third minor issue is accessing my pockets. The motor is on the outside of my hips and although the bars curve around down the front of my thighs, the access to my side pockets on my shorts is blocked. This is where I typically store fast-acting carbs on one side (because I have type 1 diabetes) and my phone on the other side, but I basically have to stop walking and pause and really finagle my hand in under the motor and bar to access something in my pocket. It’s annoying, so I actually stopped carrying my phone in my pocket while wearing it. I decided to get a phone carrying case that mounts to a backpack strap – or in my case, a Hypershell waist strap! It lives on the strap and I’m able to slip my phone into the 4 corners whenever I want to. I also like that the webbed strap comes out of the case, so I can pull my phone off it and use it (while it’s still in the straps) and then quickly put it back on the belt mount. There’s a little more friction to the experience than without the Hypershell, but it’s 5x easier than finagling my phone out of my pocket under the Hypershell.

If you want a referral code for a Hypershell, here is a referral code.

Right after I bought my Hypershell, I automatically got an email for a referral program. If you use this code, and you buy a Hypershell, it gets you $30 off. It’s not a lot, but it’s better than nothing. Sometimes they run deals where you can get accessories for free or some dollars off particular accessories. The ones I’ve seen are usually for more than the value of the referral code – e.g. they might offer an additional battery which is a $99 value instead of the $30 off. Depending on your situation, you may like one or the other better. I mention it because it doesn’t seem like it’s compatible to use the $30 off referral code at the same time as the other deals (or it wasn’t at the time that I tried to use someone else’s referral code at the time of my purchase).

Referral code (click this to generate the $30 off code which you use at checkout on Hypershell’s site): https://hypershelltechglob.refr.cc/referral30/u/danalewis

Should you get a Hypershell? Why or why not?

My experiences above are as someone living with an autoimmune disease that is affecting my muscles. But now that I’ve gotten it and tried it, I think I would love it even without the need for assistance with my muscle disease. Why? It’s like an e-bike for the legs. Not in the sense that it can do all the work (it can’t, it can only provide up to 20-30% assistance: you’re still doing a lot of work), but because it is an equalizer.

My husband and I have had e-bikes for years. We loved them, because of the equalizing effect. I can bike longer with e-bikes than I would without an e-bike. In fact, before we got e-bikes, we didn’t have bikes and would only sporadically ride (rentals), because biking wasn’t my thing. When we got e-bikes, we biked for dozens of miles at a time, together. I could bike at whatever power assist level I needed or wanted for the day, and he could use less assist and get more of a workout, but it enabled us to bike together (and to WANT to bike together) in ways that we couldn’t or wouldn’t otherwise.

An exoskeleton is the same situation, roughly, as e-biking in this sense. I talk to several people who ask questions when I’m out walking or hiking with the Hypershell on. Sometimes people ask about it for bad knees (I don’t have knee problems but I can imagine it would help – if you have knee issues and Hypershell experience, please share in a comment below!), but a few people have asked about it for backpacking experiences. One couple immediately said “I wonder if this would help for backpacking” and I said probably, yes – because the company advertises it to be able to do more for longer, especially with gear (e.g. they show people hiking with photography gear or big backpacks). So even without medical conditions, I could see getting a lot of use out of it when you have a pair of people who have different capabilities or range who want to go adventuring together. Especially if you’re a set of people (or an individual) who like to put in a lot of miles throughout the year…just like I am. I’ve already done 5 hikes in two weeks (plus a bunch of paved walks) and just hiking alone, that takes the per-hike cost down to $240, and will drop further each time I use it – remember that I wouldn’t have done some of these hikes at all (either because I couldn’t do them in subsequent days or I couldn’t do particular terrain at all). That per-hike cost will continue to drop over the course of the year (or more) of use that I expect to get out of this Hypershell Pro X.

How much work are you really doing when you wear a Hypershell exoskeleton? Doesn’t it do all the work for you?

Each of the two Hypershell batteries I have are 72 Wh (5000 mAh). That’s…actually not that much. It’s the equivalent to ~62 kcal if you’re thinking about food calories as a comparison. If you could continuously run the motors at full power, it would d only last 5-6 minutes. (That’s why I ran it down fast on 100% power on a really steep hill at the end of my third hike). With less power output, it goes longer time/mileage (e.g. the around 10 miles range estimation on lower power setting in eco mode), but it’s still only 62 calories of total energy, whereas I might be burning the equivalent of 1000+ calories of active energy in the course of a 3-4 hour hike. Yes, it provides power, but it’s targeted power to your legs (and there’s also heat loss), and you do a LOT of other work controlling your trunk, hips, core, arms, balance, etc. so it maybe contributes to 10-20% of energy savings. But again, you’re likely to do more – remember the e-bike analogy – and burn a lot more than you would without the Hypershell by doing more, well above and beyond anything you saved by using the Hypershell. You still do 90% of the work, for longer time and longer mileage and more elevation, resulting in more effort overall. You will still do plenty of work, but it will be easier to go further, longer, etc.

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TLDR: I got a Hypershell Pro, I love it, and it’s enabling me to do more than I could before (in my unique situation with a muscle-related autoimmune disease). I do recommend it, for a variety of different situations, whether or not you have any physical limitations. It’s an instrument of freedom for anyone who wants it.

Feel free to ask any questions below. I can’t answer questions specifically about whether it would work for your specific setup or medical condition, but I can try my best to generalize from my experience & what I’ve read from others online.

PS – are you curious about the latest version, the Hypershell X Ultra? I was able to try one, and here’s a separate post about my experiences with the Hypershell X Ultra and my comparison to the Hypershell X Pro.

Powered exoskeleton is an instrument of freedom (my experience with a Hypershell Pro X), a blog by Dana M. Lewis on DIYPS.org

A new symptom score for people with exocrine pancreatic insufficiency (the EPI/PEI-SS)

by Dana Lewis

One of the frequent complaints in the literature about exocrine pancreatic insufficiency (known as EPI in some parts of the world, or PEI for pancreatic exocrine insufficiency elsewhere) is that the symptoms are not specific and they can overlap with other conditions. Diarrhea, for example, can happen from a lot of conditions and a lot of medications. Not everyone with EPI has diarrhea, though. Another problem is that there are other symptoms that occur in EPI other than diarrhea and weight loss, but there’s not been any data on which groups of people experience which types of symptoms with EPI, or how common the other symptoms are, so they often aren’t listed. This leads to a cycle of lack of awareness, lack of screening, lack of diagnosis, and lack of treatment.

There’s been little effort to date to solve this problem, and I found myself wondering if we as patients, who experience the symptoms directly, could find a way to address this. Between my systematic review papers (where I’ve read hundreds of papers about the symptoms & diagnostic approaches to EPI) and personal experience with EPI, I made a list of 15 symptoms. But it’s not just about which symptoms people have: that’s where the overlap problem comes in. With EPI, many people have a lot of symptoms, a lot of the time, and they are VERY annoying. So the frequency and severity of the symptoms are a hallmark as well. I put together a way to quantify the frequency and severity (using plain language)of symptoms, and the EPI/PEI-SS (Exocrine Pancreatic Insufficiency Symptom Score) was born.

With help from more than a dozen people, some with EPI and some who didn’t have EPI, I ran a pilot test with the symptom score to see if the people with EPI would generate scores, the way I did, and whether people without EPI (and with either everyday gastrointestinal symptoms, or other conditions that sometimes cause GI symptoms) would have scores to match. They did not: it was a stark difference, and there wasn’t any overlap. The EPI symptom burden was quantifiably much higher than everyday GI symptoms for someone without a condition, and also higher compared to people with other conditions with GI symptoms (think food intolerances, IBS, other non-EPI GI conditions).

So I launched a bigger study that many of you participated in (thank you!), with the goal of exploring whether this score would be useful in the general population to help distinguish EPI from other conditions and whether it might possibly aid in screening for EPI.

And now, the results are published! (You can read the full open access paper here: https://doi.org/10.3390/epidemiologia6030048).

Here’s what we learned:

There were 324 participants at the time I cut off data collection for the analysis (after three weeks). This included 155 people who identified as having EPI, and 169 people without EPI. Everyone answered whether or not they had any of the 15 symptoms (falling into three groups: abdominal, toilet-related, and food-related symptoms) and indicated frequency and severity. Multiplying frequency (0–5) x severity (0–3) by each of the 15 symptoms, the EPI/PEI-SS score range is 0–225. (See Table 1 for a list of the symptoms and rating description).

The key finding: people with EPI had higher scores than people without EPI.

In this real-world study, the mean total score of those with EPI was 98.11 (min 1, max 213), in contrast to a mean total score of 38.86 for those without EPI (min 0, max 163). The difference is practically as well as statistically (p<.001) significant.

Figure 1 from the paper showing the sub-scores and total scores broken out by EPI and non-EPI groups, respectively.

Even when I separated the people without EPI into two groups, those with other gastrointestinal conditions and those without, the scores were still distinct and statistically significant from the people with EPI. I also did a sub-analysis of each individual condition and none had a significant impact on the overall score. (Because there are so many people with diabetes in my network who participated in the study, I also ran a separate sub-analysis to deeply analyse the contributions of type 1 diabetes and type 2 diabetes – and made a separate paper on this analysis, which is also open access and available to read here.) Also in the bucket of “things that did not affect the score” was age. However, females in the study reported higher scores compared to males (this matches other studies showing a higher gastrointestinal burden, so this isn’t necessarily unique to EPI).

In addition to the overall score, you can see the difference by looking at the number of symptoms people reported and the difference in frequency and severity:

  • EPI group: 12.39 symptoms, average frequency 3.02, average severity 1.73
  • Non-EPI group: 8.15 symptoms, with nearly half the frequency (1.55) and severity (0.91)
Figure 3 from the paper, showing each of the 15 symptoms and the range of scores for the EPI group (purple) and non-EPI group (blue), respectively.

Nerdy notes (you can read more in the full paper): Cohen’s d (1.475) indicated a large effect size; all comparisons overall and across sub-groups and across symptom categories were statistically significant (p<0.001). Cronbach’s alpha for sub-score categories was “good” (0.88 abdominal, 0.83 toilet, 0.88 food), indicating high internal consistency and good construct validity. Using an EPI/PEI-SS cutoff of 59 (out of possible 225), area under the curve was 0.85, sensitivity was 0.81, and specificity was 0.75.

Were there limitations for this study? You bet. It was online and based on people who happened to fill it out, so follow up studies will help confirm these results in different populations to confirm if it is representative of the average EPI experience. (Note though that this study population did have a lot more diversity of people with EPI, though, compared to most other EPI-related symptom assessment studies, which are often limited to chronic pancreatitis and cystic fibrosis, and/or pancreatic surgery/cancer.) There was a large number of people with diabetes who participated, in part because of my network and where I recruited participants from – however, as seen in this sub-study, presence of diabetes (any type, or split in type 1 and type 2) did not influence scores (analysis here). This study was also exploratory, meaning it was not powered for a specified outcome. We’ve now been able to use this data to power follow up studies, now that we know what to expect score-wise in people with and without EPI!

What should you take away from this study?

If you are a person with some kind of gastrointestinal symptoms, you can use the EPI/PEI-SS to explore your symptoms and quantify them based on frequency and severity. If your score is near or above the cutoff, you may want to consider discussing your symptoms with your doctor and exploring whether testing for EPI (often fecal elastase testing) is warranted. This tool hasn’t been validated as a diagnostic method, but this data can help the shared decision making process and hopefully also aid you in a better conversation with your doctor as you explore pathways to solutions.

The EPI/PEI-SS is available online, for free, and you can use it right now: https://danamlewis.github.io/EPI-PEI-SS/

If you are a person with EPI and you are still struggling with symptoms of EPI (PEI), you may find it handy to take the EPI/PEI-SS to document your symptom burden. Then, as you adjust your enzyme dosing, you can periodically take the EPI/PEI-SS again (every few weeks or months) and use it to help you track whether things are improving. You can use the web version, or if you want to also track your enzyme (PERT) dosing, you can use the EPI/PEI-SS in both the iOS (https://bit.ly/PERT-Pilot-iOS) and Android (https://bit.ly/PERT-Pilot-Android) versions of “PERT Pilot”. Then you can see your scores and view them over time in the same place.

Note that the scores of people with EPI in the study don’t mean that ‘this is as good as it gets’ when you go on enzymes. Many people with EPI indicate that they feel they are not dosing enough enzymes (see this study); the scores on the EPI/PEI-SS reflect this. It is possible for people with EPI to get scores in the non-EPI range, once enzymes are regularly dosed to match what you’re eating. (For example, my score went from well above the cutoff to well below the average non-EPI score once I started enzymes.)

If you are a doctor, take a look at the EPI/PEI-SS (see links, or Table 1 in the paper) so you know what some of the symptoms of EPI are. Notably, be aware that diarrhea and weight loss are not the only symptoms of EPI. In the diabetes sub-study, for example, we found food-related behaviors to be a key variable, as many people intuitively adjust what or how they are eating to try to eliminate symptoms on their own. Pain is not prominent in all corners of the EPI community (it’s more common among people with pancreatitis). Feel free to have patients use the EPI/PEI-SS any time and use it as part of your shared decision making process.

A new symptom score for exocrine pancreatic insufficiency: new research on the EPI/PEI-SS (a blog by Dana M. Lewis on DIYPS.org)If you have any feedback (for example, if it’s been helpful or not), you can email me any time (Dana+EPI-PEI-SS@OpenAPS.org). I’d also love to collaborate, if you’re interested in partnering on any research studies. We have some ongoing studies in different countries (US, Ireland, New Zealand, Australia) in different populations (general population; people with diabetes; people with pancreatic cancer; etc) and I’m looking forward to partnering with other researchers on additional validation studies and exploring if and how the EPI/PEI-SS can help us address some of the gaps of real-world clinical practice and life with EPI.

If you’re a researcher with shared interest in EPI…ditto the above!

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Read the research referenced in this blog post: https://doi.org/10.3390/epidemiologia6030048

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Cite it: Lewis DM, Landers A. Development of Novel Symptom Score to Assist in Screening for Exocrine Pancreatic Insufficiency. Epidemiologia. 2025; 6(3):48. https://doi.org/10.3390/epidemiologia6030048

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Questions? Please comment below!

If you have EPI-specific questions, you might also like this blog post with 25 questions and answers about EPI (PEI) ranging from symptoms and diagnosis to treatment and dosing titration.

Exocrine Pancreatic Insufficiency (EPI) FAQ – Symptoms, Testing, Enzyme Dosing & More

by Dana Lewis

EPI FAQ: Symptoms, Testing, Enzyme Dosing & More, a blog from @DanaMLewis on DIYPS.orgHere are the top questions I see about exocrine pancreatic insufficiency (EPI / PEI), especially when someone is newly diagnosed.

Section 1 of 7: Symptoms

What are the symptoms of exocrine pancreatic insufficiency? Are my symptoms possibly EPI? I don’t have this symptom that someone else does, does that mean I don’t have EPI?

EPI can produce greasy stools, diarrhea or constipation, bloating, gas, weight change, or urgent bowel movements: any combination is possible.

EPI can have a variety of symptoms. The symptoms of EPI vary person to person in terms of frequency and severity and what symptoms you have.

Here are some common examples of symptom patterns, but if you don’t have the same exact cluster of symptoms, that doesn’t mean you don’t have EPI! These are just some of the examples.

  • I have diarrhea several times a day and I’m losing weight.
  • I see globs of oil in my stool (poop) or when I wipe with toilet paper. I have a lot of gas and I’m really bloated most of the time.
  • My stool (poop) is really hard to clean out of the toilet bowl, it’s really sticky and messy and smells bad.

Those aren’t the only symptoms (diarrhea, weight loss, fat/steatorrhea, messy stools, excessive gas, bloating) of EPI, though.

You could also experience constipation as an EPI symptom, as well as pain in your abdomen after you eat, trapped gas, nausea, feeling excessively full for hours after you eat (e.g. not wanting to eat lunch because breakfast keeps you so full), urgently needing to rush to the toilet for a bowel movement, or 4+ bowel movements a day. You may find yourself excluding certain foods or food groups, trying to eat smaller meals, or avoiding fatty foods.

How can I check if my symptoms match EPI?

The free 15-item EPI/PEI-SS survey; scores above 60 suggest you may need fecal elastase testing.

One of the ways you can tell is using the free online EPI symptom tool, the EPI/PEI-SS, to look at which of the 15 common symptoms you have and to indicate how frequently they happen and how severe/annoying they are. It will generate a score out of 225, and you can use that score to discuss with your doctor whether you should be screened with fecal elastase or other screening methods. This survey hasn’t been validated yet to replace elastase screening, but in a real world study of people with and without EPI, people with EPI had much higher scores than people without EPI. If you have a score above 60 or so, the likelihood of your symptoms matching EPI goes up. For example, someone with a score of 178 is much more likely to have EPI than with a score of 61, but someone with a score of 61 might still have EPI. On the other hand, a score below 60 makes it less likely that you might have EPI (although not impossible), because some of these symptoms may occur everyday in people without any condition (sometimes people get diarrhea! Or get bloated!) but that’s usually with a lot less frequency and severity (the average non-EPI score is around 30, including other non-EPI GI-related conditions).

Can I still have EPI if I don’t have diarrhea or weight loss?

Yes—many people with confirmed EPI are overweight or symptom-light, so absence of diarrhea or weight loss never rules it out.

Many people have EPI and don’t have diarrhea, or steatorrhea, or any vitamin deficiencies. You can be overweight and have EPI, you can be not losing weight and have EPI. A lack of these specific symptoms do not necessarily rule out EPI (unless they are saying this in conjunction with fecal elastase testing or other test results, see below).

If your clinician dismisses EPI based solely on the absence of steatorrhea, diarrhea, or weight loss, share your EPI/PEI-SS symptom score and request objective testing such as a fecal elastase test.

Does lack of abdominal pain mean I don’t have EPI?

Pain is not a core EPI symptom; absence of pain neither confirms nor excludes the diagnosis.

When present, it often comes from trapped gas or an overlapping condition such as chronic pancreatitis. So lack of pain doesn’t exclude EPI, and pain doesn’t confirm EPI.

TL;DR: any combination of symptoms can occur in people with EPI. Use the EPI/PEI-SS to help you characterize your symptoms and discuss them with your doctor.

Section 2 of 7: Testing & Diagnosis

How is EPI diagnosed?

The simplest test is fecal elastase; a stool value ≤ 200 µg/g strongly indicates EPI.

The most common and non-invasive test for EPI is fecal elastase test. It involves you going to the lab and getting a collection kit, taking it home, using it to get a stool (poop) sample and put it in a tube, refrigerating it, and taking it back to the lab.

Pay attention to the instructions about when you need to get it back to the lab (within a certain number of days, depending on the lab). It’s better to get a less watery sample so if you’re having a short term bout of less formed stool due to eating certain foods, it’s better to wait and try to get a more formed sample on another day, if possible.

How do I get a fecal elastase test?

Your primary-care or GI doctor can order it; pay-per-order labs are an option when insurance won’t.

Your doctor can order a fecal elastase test for you. This can be your primary care provider or GP, an endocrinologist, a gastroenterologist, etc.

If you don’t have a doctor or your doctor refuses and you still want to get a fecal elastase test, it looks like some of the order-your-own lab services do have fecal elastase testing as an option, so you can get it ordered and run at labs like Labcorp or Quest. (Here’s an example, I haven’t used them and have no affiliation with them.) Insurance doesn’t cover tests ordered this way, so it would be an out of pocket cost for you.

Do I have to stop enzymes for a fecal elastase test?

No, continue PERT; it does not affect elastase results.

In general, a value ≤200 µg/g on a fecal elastase test indicates EPI. Some doctors and researchers want to only use ≤100 µg/g, but you should consider it a degree of confidence rather than an absolute yes/no for defining EPI. If you have a test result below 200, you warrant trying pancreatic enzyme replacement therapy (PERT). Even though you’ll find <100 labeled “severe” and 100-200 labeled as “mild/moderate”, elastase values don’t necessarily correlate with severity of symptoms, amount of enzymes needed, or just about anything else.

Note that you do not have to stop taking enzymes for a fecal elastase test. (But you would stop taking enzymes for a fecal fat test. Different test!)

What if my elastase result is over 200 µg/g?

Borderline scores (201–500) can still benefit from a therapeutic enzyme trial, especially if symptoms persist.

Technically, elastase >200 doesn’t indicate EPI, but there are two caveats here.

One is that these tests aren’t perfectly 100% precise. Think about a 199 score: if you’re ready to believe that this indicates EPI, then you should also be willing to believe that a 201 score indicates EPI. These tests have some limitations in terms of accuracy, AND the sample matters – watery samples (less firm stool, more mushy) may result in inaccurate results.

The second caveat is that some people even with scores between 201-500 ug/g show benefit from PERT.

(You can read a lot more in this post about fecal elastase accuracy.)

I got two different elastase results—which is right?

The elastase number can move around from natural fluctuations of how much elastase your pancreas is producing.

Here are some examples where the changes may or may not matter:

  • 36 -> 145. (Even though it goes from “severe”, aka <100, to above 100, that change isn’t meaningful)
  • 135 -> 78. (Ditto, even though it changes categories, it doesn’t change the result).
  • 185 -> 387. (May be meaningful – if you’ve been on enzymes, it may be worth considering a trial without enzymes and see if your symptoms continue to be resolved. The slightly low elastase result could have been from a watery sample and/or a temporary reduction in elastase that resolved on its own.)
  • 185 -> 745 (Meaningful change. The first sample may have been watery and/or a result of a temporary reduction in elastase that was resolved. A good reason to try stopping enzymes and see if your symptoms continue to be gone.)

Remember that watery or diarrheal samples dilute elastase and can produce a falsely low reading: retest when stools are well-formed, and know that levels can fluctuate naturally or with acute infections or other conditions (like SIBO). Some people who treat the SIBO then see elastase return to and stay normal; other people happen to have both SIBO and EPI, and treating the SIBO does not change the fact that they have EPI.

Section 3 of 7: Enzyme Dosing

How much pancreatic enzyme replacement therapy should I be taking for EPI?

Adults generally begin at 40 000–50 000 lipase units per meal and half that for snacks.

Doctors are often unaware of the guidelines and up to date clinical practice recommendations, which are that the starting dose should be 40-50,000 units of lipase; it is common to need more than this; and that the dose of pancreatic enzyme replacement therapy (PERT) needs adjusting to match your food intake.

If your doctor prescribes 40,000 units per meal and 20,000 units per snack, that’s an acceptable starting point that aligns with guidelines.

If your doctor prescribes 10,000 units per meal and 5,000 (or none) per snack, that’s well below guidelines. You could share this systematic review article with them and ask for an increased dose to match the guidelines (but also be aware you may need even more in future, although you’d likely see an improvement in symptoms when bumping from 10,000 to 40,000 or 50,000!). This blog post might also help you think through the conversation with your doctor about increasing your dose.

How much Creon should I take? How much Zenpep should I take?

Ignore everyone who answers this question definitively, unless it’s in the context of starting dose guidelines, like I did above.

Your body and your food intake are different from everyone else’s! Just like a person with type 1 diabetes takes a different amount of insulin than their friend who also has type 1 diabetes, your needs will be different than someone else, even if they also have EPI.

Instead, follow this simple guide:

  • Start with the starting dose recommended by guidelines (e.g. 40,000 or 50,000 units, or more depending on condition.)
  • If you’re still having symptoms every time you eat, you may need more enzymes. Try increasing by one pill per meal. Also spend a few days recording what you eat and how many grams of fat and protein are in the meal (you can use something like PERT Pilot). This may help you see which meals are causing symptoms and whether it’s the quantity of fat/protein that may be the issue. For example, if sometimes your meals are 10g of fat and do ok on 50,000 units of lipase, but sometimes your 30g of fat meals have symptoms with 50,000 units of lipase, this can help you adjust for larger meals.
  • Look at the size of pill you’ve been prescribed. If your doctor prescribed 10,000 unit capsules, know that depending on the brand, there may be capsules with more lipase (eg 24,000 or 36,000 or 40,000) that you can get, so that you can get more lipase per meal with a small number of pills to swallow. If you need around 75,000 units of lipase for most meals, you’d want to increase to 2 pills per meal of 36,000 or 3 pills of 25,000. (Exact numbers vary by brand).

How quickly can I tell if my enzymes are working?

Most people notice symptom improvement within a few meals or days when the dose is adequate.

More details in this post, but in general you should be able to tell the difference for most meals within a few hours or the next day (eg bowel movement improvements). It may be harder to tell if you don’t have obvious symptoms, but for people who have bloating, gas, diarrhea, messy stools, etc., you should be able to tell within days. It would be harder if you eat really different size meals, e.g. sometimes 10g of fat and sometimes 45g of fat per meal, but take the same dose of enzymes, and don’t record the meals. So consider using some tracking tools like a spreadsheet, journal, or app like PERT Pilot to help you keep track of things and more quickly see changes in symptoms so you can adjust your dose more quickly.

When do I take enzymes? When, relative to meal timing, and when, in terms of what foods need enzymes?

Enzymes are to help your food get digested. If you’re not eating or drinking something with fat/protein/carbs, you don’t need enzymes.

Things that don’t need enzymes:

  • Water
  • Beverages without fat, protein, or many calories (for example a 5 calorie drink doesn’t need enzymes)
  • Medicines that are taken on an empty stomach

Things that do need enzymes:

  • Milky drinks (because milk has fat and protein, so it needs help digesting)
  • Protein shakes
  • Food with fat and protein

Things that may or may not need enzymes, depending on your body:

  • Carb-only food or drinks. For example, a fruit smoothie that’s just fruit and water and ice mixed up, may or may not need enzymes. Or a piece of fruit, or a piece of candy (that doesn’t have fat or protein). It may also be a quantity thing: with a few bites or < X grams of carbs you may do ok without enzymes, whereas larger amounts may need enzymes to help you digest the carbs.
  • Small amounts of fat and protein. Some people may be able to consume a few grams of fat, without needing enzymes. Ditto for protein. This amount is going to vary person to person, but if you’re for example taking a taste test of food you are cooking to season the food, 0.3 g of fat hitting your tongue likely doesn’t need enzymes. However, you might be sensitive enough that 3g of fat (eg several bites) may need some enzymes. When you’re not eating much, you could also choose to take a cheaper over-the-counter (non-prescription) enzyme pill with a lower dose of enzymes, and save your prescription PERT for meals.

When should I take my enzymes during a meal?

Swallow at least one capsule with the first bite and the rest mid-meal if eating longer than 15 minutes.

  • At least one pill at the start of when you’re eating and drinking. (This can be swallowing your pill and starting eating, or taking your first bite and then swallowing the pill. The timing is not that precise, so whatever works for you.)
  • If you’re taking multiple pills and/or if you are eating/drinking spread out beyond 15 minutes, you may want to split your dose and take one at the start and the others in the middle or toward the end.

(The point is to get your enzymes into your digestive tract close to when your food needs digesting. It’s not super precise to the matter of seconds or single digits of minutes. If you have three pills and you take one up front and two with your last bites, it’s pretty close to taking one at the start, one at the middle of your plate, and one at the end, assuming your meal isn’t spread out over hours. You may be able to notice a small difference, but getting the right amount to cover the fat/protein is likely to have a bigger impact than timing within a handful of minutes. Don’t stress if you eat a few bites and only then remember to take your first pill(s).)

What if I’m eating multiple courses, like at a restaurant?

You may need more pills than you would for the same amount of food when it’s spread out over time. Imagine a meal with an appetizer, entree, and a few bites of dessert that in terms of meal composition could be covered by 3 of your pills. However, the appetizer comes out and then it’s another 30 minutes to your entree, and the dessert is 30 minutes later. You may want to take one with the appetizer, two with the entree, and then another pill with the dessert bites, even though the total amount of food “should” be ok with 3 pills, the timing may necessitate 4 pills in this meal example.

(Some strategies to get around this include asking for dessert to come out at the same time as your entrees, or appetizers + entree at the same time, etc. or just accepting that the ‘cost’ of a spread out meal is additional pills compared to what you would do at home, eating all your food within ~15 minutes or so).

Section 4 of 7: Diet & Food Choices

Do I have to adjust my diet or eat low fat for EPI?

Short answer: no.

No. You adjust your enzymes to match your diet, rather than the other way around. A low fat diet is no longer recommended for people with EPI as a general rule (although some people with EPI and additional conditions may have other reasons why their clinicians think they may benefit). 

Long answer, with caveats:

It’s common for people before they get diagnosed with EPI to do all kinds of gymnastics with food intake. You may have eliminated certain foods, tried reducing how much fat you consumed, eating smaller, more frequent meals, tried a low FODMAP diet, or made any number of other food changes. All of that was because you were not digesting your food well.

When you start taking PERT, you may find an initial dose that works for you (let’s say 50,000 units of lipase or 72,000 units of lipase) for most foods that you eat. But, that’s based on your limited roster of foods that you had reduced to. As you feel better, you may experiment with more foods, adding them back in, and/or different quantities of food. Sometimes people make the mistake of thinking symptoms after a new food are a result of the food itself, because they haven’t accounted for the fat or protein that they’re consuming. You should read this post with a lot more detail, but sometimes symptoms are a result of needing more enzymes and not a sensitivity to the food/ingredient, so track the quantity as well as the food type and be willing to try it again with more enzymes before you rule it out.

A common example I see is people saying they can only eat X grams of fat per meal, or they get symptoms. That’s based on a certain dose. Let’s say you can only eat X grams of fat on your dose of 50,000 units of lipase. You could probably consume more if you increased by one pill, to 75,000 units of lipase. It takes a bit of work, but you’ll likely end up being able to eat a lot more foods and more flexibility on quantity, if you put in the work to track and figure out what one pill “covers” for you so you can adjust per-meal. The same goes for protein, it’s common to see people struggle with “low fat meat” like chicken or fish when the problem is that they need more enzymes for the protein content – in that case it’s not about the fat.

Why do some people or clinicians recommend low fat diets?

Some people with EPI have found success with low fat diets and stick with it because it works for them and they’re ok with those tradeoffs, or they have other conditions that necessitate it. They don’t always mention those other conditions, so be aware that this might be driving that decision for some people. When they give advice, it’s really “_____ works for me” even if they phrase it as “you should _____”. Reframe and look at the variety of advice you’re getting (sometimes conflicting!) and you’ll see it’s the case that different people find different things that work well for them. You might ultimately choose a lower fat diet than me, but that may or may not be “low fat”. A lot of the “low” aspects of fat or fiber are relative.

Sometimes this kind of advice comes from clinicians who’ve read older research papers: back in the 1990s we didn’t have encapsulated enzymes (so they didn’t work as well), and eating lower fat was a way to compensate for less effective enzymes and not result in symptoms and malabsorption and weight loss. Nowadays, though, prescription enzymes are encapsulated and the modern clinical best practice guidelines for EPI no longer recommend low fat. If they do, it’s a copy-paste game of telephone error. Sometimes clinicians will make population-based recommendations that aren’t a fit for you, individually, and sometimes this may be one of the cases.

Section 5 of 7: Side Effects & Brand Switching

What do I do if my enzymes are causing side effects?

First rule out other causes of symptoms, then trial a different prescription brand or over the counter enzyme under doctor guidance.

For most people, there are no side effects to taking enzymes. Yes, side effects are listed on the label, that means it’s an entire list of everything anyone ever reported during clinical trials…even if those were caused by other conditions.

Do enzymes cause hyperglycemia (high blood sugar) or hypoglycemia (hypoglycemia)?

No: blood-sugar changes reflect changing nutrient absorption, not a direct drug effect.

A low or high blood sugar can occur while taking enzymes. It’s not directly from enzymes – it’s a result of changing how your body is digesting food (with enzymes), and those changes then sometimes result in high or low blood sugar. And sometimes those changes are temporary, as your body gets used to digesting food successfully again. If you are concerned about your blood sugars, talk with your doctor and ask for an A1c test, which represents a 3 month average of your glucose level. That can be more helpful for seeing trends and whether you are seeing recurring high glucose for example, versus fingerstick blood glucose testing or CGM graphs that show you sometimes rise after a meal. That’s actually normal for everyone, including people without diabetes! So an A1c test can help put things into context. Keep in mind also that 10% of people have diabetes and so while you will see some people discover that they have type 2 or pre-diabetes, for example, around the time they started taking enzymes, it wasn’t “caused” by enzymes but likely was developing previously and happened to be discovered then, especially if you weren’t paying attention to blood sugars before and now are. It is possible to have type 3c (a different type) of diabetes develop either with EPI or as the cause of EPI (among many other causes of EPI – see below), but a lot of people may happen to have type 2 (or type 1) diabetes alongside EPI and that’s a result of how common both diabetes and EPI are; taking enzymes doesn’t cause diabetes.

Why do all the enzyme labels mention hyperglycemia or hypoglycemia? As I mentioned, it’s because people with diabetes are included in the clinical trial studies for enzymes, and when you have diabetes you have high or low blood sugar sometimes. For an infinite number of reasons. Clinical trial staff asks if you had hypo or hyperglycemia during the trial; you say yes, because you did; there’s no direct correlation with enzymes but because it happened in the trial it gets written down as a list of possible side effects. That doesn’t mean it happens to everyone or will happen to you, and if it does happen, it doesn’t mean you have diabetes. Again, people without diabetes see their glucose go up when they eat, too.

The bigger question is what if you see other side effects when taking enzymes. 

What if enzymes are giving me diarrhea?

If your symptoms of EPI don’t include diarrhea, and you start taking enzymes and experiencing diarrhea, that might be a side effect of the enzymes. Or, it could correlate with bad timing where you happened to get foodborne illness or another type of illness that causes diarrhea.

Depending on your symptoms and when they started, you could consider:

  1. Waiting a few days to see if it continues
  2. Asking your doctor about trying a different kind of enzyme

Some people do react to fillers in one brand of enzyme, switch enzymes, and do just fine on the other brand. For example, they may react to Creon and switch to Zenpep and do fine. Or they react to Zenpep and switch to Creon. (Or fill in the name of a prescription enzyme brand).

Technically, these enzymes have not been studied for interchangeability…but in practical real-world terms, you can try them and use the lipase dosing to compare. For example, if you were prescribed 2 pills of Creon 24,000, you could switch to 2 pills per meal of Zenpep 25,000. If you were on Creon 10,000 and taking 4 per meal, you might switch to a single pill of Zenpep 40,000. Again, they haven’t been studied for equivalence, but they all have the same unit size of lipase and thus can generally be changed in that manner. Your doctor may not be aware of other brands (pharmaceutical marketing plays a big role in which ones they know about!), so you can look up what is approved in your country and ask to try another brand of an equivalent size dose. Again, remember to pay attention to your total dose per meal so you end up with a close equivalent size on the new brand.

Which enzymes do people react more to? Is there a better brand to start with?

Clinical data has no answers to this; tolerance is individual, so switch brands if needed but it’s more likely down to insurance coverage and doctor familiarity.

Plain and simple, there’s no data on this.

Any anecdata you see from people in a thread reporting their issues with one enzyme or another is not a representative sample.

The only reason to consider one brand or another at the start is if your insurance will only cover brand A and not brand B, or if they cover both and one is cheaper than the other (again, remember to look at the total number of pills you need, not just the cost per pill or per bottle.

If you have side effects, you could also try switching to over the counter (OTC) enzymes

Using over the counter (OTC) enzymes is slightly different, though, than switching between prescription types. These aren’t tested and vetted through FDA manufacturing practices. These enzymes are not encapsulated like prescription enzymes are, so when they break down in your body may be differently timed. There’s been no testing for reliability in terms of how much they actually contain compared to the label. And, they’re not able to be covered by insurance, so you’ll have to pay out of pocket for these.

That being said, some people really like OTC enzymes and/or can’t tolerate the fillers in all prescription brands but can tolerate an OTC version.

Other people might prefer prescription but can’t afford them, so even out of pocket, OTC may be cheaper.

Just be aware of all the caveats above, including that you should also pay close attention to the label on OTC enzymes. Many list the serving size for 2 pills and often contain a lot less lipase than prescription pills, which means you might end up needing to take a much higher number of pills for an equivalent size dose…and possibly even more than an equivalent dose size, since they are unencapsulated.

What do I do if all enzymes give me side effects?

This is a good example of when you should be working with your doctor.

It’s possible that your symptoms are caused by another condition that is occurring alongside or happens to be in addition to EPI, or was causing EPI-like symptoms. It can be hard to tell when a medicine is causing side effects or if you happen to be having other symptoms from another GI-related condition. Your doctor is trained and can help you think through when your symptoms occur relative to when you eat and when you take enzymes and whether they may be related to something else.

(See below sections for other overlapping conditions.)

Section 6 of 7: Possible Misdiagnosis

Can EPI be misdiagnosed or temporary?

Yes—watery stools, untreated celiac disease, or SIBO can transiently lower elastase; repeat testing after treatment clarifies.

It’s possible to have a misdiagnosis with EPI. Remember or re-read the sections above about how EPI is diagnosed and how the symptoms can overlap with other conditions. It’s also possible to have low elastase temporarily due to another condition, where it later resolves and returns to normal.

This can happen for a small number of people with celiac disease, for example, and there are studies showing people with newly diagnosed celiac with EPI-like symptoms and lowered elastase that eventually (on a fully gluten free diet) have their elastase return to normal levels and not require enzymes. That’s not true for all cases of celiac, though.

It’s also common to hear people report that they had SIBO (small intestinal bacterial overgrowth) and once treated, sometimes their elastase returns to normal and they no longer need enzymes.

It’s also possible to have SIBO and EPI, and even after successfully treating SIBO and eliminating it, they still have EPI and lowered elastase and need enzymes.

There are no good numbers, unfortunately, on how common these different scenarios are. Just in general, remember:

  • It is possible to be misdiagnosed. This can be from having a condition that temporarily causes lowered elastase, or it can be due to a watery stool sample during the elastase test.
  • It is also possible to have multiple conditions at the same time, which makes it challenging to track whether your enzyme dosing is optimal for EPI.

Section 7 of 7: Causes & Long-Term Outlook

What causes exocrine pancreatic insufficiency?

EPI may follow pancreatic surgery or occur in people with diabetes, chronic pancreatitis, cystic fibrosis, or certain cancers, but often occurs without a clear cause; the enzyme problem itself does not usually cause diabetes or cancer.

There is no single cause of EPI.

Another way to put it: there are a lot of ways to have EPI and likely from different mechanisms in your body. It’s also not always possible to tell what the causal mechanism is, even if you have a condition that is known to have higher rates of EPI than in the general population.

For example, if you had pancreatic surgery and removed part or all of your pancreas, such that there isn’t a part left that produces enzymes? Then you’d have EPI.

Sometimes cancer (GI cancers or pancreatic cancer or other) can result in people having EPI, and it’s unclear whether it’s an effect of treatment (such as chemotherapy) or if it is a mechanism of the cancer itself impacting the pancreatic function.

People with diabetes (type 1 or type 2) sometimes get EPI, but not all do. It’s possible this is due to atrophy of the pancreas or there could be other mechanisms. Note that it’s more common for people with EPI to have diabetes than any other co-conditions (prevalence of low elastase can be as high as 30% among people with diabetes, much higher than gastroparesis or celiac, and diabetes is far more common than the rare conditions like CP or PC that have high rates of EPI). So if you have gastrointestinal symptoms and you have type 1 or type 2 diabetes, you should ask your doctor about testing for EPI.

People with chronic pancreatitis often, but not always, get EPI.

Did these conditions “cause” EPI? It’s hard to say and people (including doctors) sometimes will casually use this language to mean that it’s highly associated with getting EPI when you have this other condition, but whether or not it was caused by that condition, or both conditions were caused by the same underlying factor, we don’t have evidence to prove it.

And importantly: the majority of people have no idea what caused their EPI, and have EPI without any other common co-condition (e.g. diabetes, pancreatitis, certain cancers, etc.) or health related risk factor (such as drinking alcohol or having a higher body weight or being older).

If I get EPI, will I develop diabetes or cancer?

EPI itself rarely leads to diabetes or cancer; these conditions usually stem from shared underlying physiology, not directlyfrom enzyme loss.

Most people do not develop diabetes when they have EPI. There’s no good study data on how many people do, but you can look at general population estimates of diabetes overall (roughly 10%) and estimate that you having EPI doesn’t raise your chances beyond that, otherwise we’d have a lot of studies showing this. If you do develop diabetes, it’s not necessarily because you have EPI: it could have just happened, anyway. Remember how common it is in the general population!

Most people with EPI do not have it because of cancer and most people with EPI do not develop cancer. 

If you’re interested in more data on the % prevalence of each of these conditions and visualizing the size of these populations relative to each other, you will like this blog post outlining the most common ‘causes’ of EPI. Looking at the data on how few people have pancreatic cancer and chronic pancreatitis compared to the general population rates of EPI can be eye opening.

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That’s a lot of information that can be summarized simply as:

  1. Symptoms of EPI are more than diarrhea and weight loss, and tools like the EPI/PEI-SS can help you track and communicate which symptoms, how frequent and severe they are, and contribute to deciding whether or not you should get a fecal elastase or other diagnostic tests.
  2. Fecal elastase tests are the most common way to diagnose EPI. You don’t have to stop taking enzymes when taking a fecal elastase test. This result can slightly fluctuate: changes within the EPI range don’t matter or change or your enzyme dose, but changes due to water in your sample or other conditions can cause this number to be temporarily low sometimes.
  3. Most people don’t take enough enzymes and could spend more time optimising their dose relative to what they eat. If you only have EPI, you should be able to resolve the majority of your symptoms to non-annoying levels with optimal enzyme dosing. The timing of when you take your enzyme matters.
  4. You don’t have to eat a low fat diet or a specific diet with EPI; it is more important to match the right amount of enzymes that you need for the fat (and protein) that you eat. Apps like PERT Pilot (available on iOS and Android) may help.
  5. Sometimes people do experience side effects to one enzyme type or another. You can change brands. Most people do fine on another brand even if they react to the first one they try (which isn’t that common, but isn’t rare either). Most people don’t have any side effects from enzymes.
  6. It is possible to be misdiagnosed, so if increasing dosing is not resolving your symptoms, continue to work with your doctor to evaluate what might be going on instead of, or in addition to EPI. SIBO can be a common cause of similar symptoms.
  7. There’s no one cause of EPI, and most people don’t know the “cause” of their EPI or have any other conditions that are known to have high prevalence of EPI. EPI is likely more common outside of other conditions, but commonly occurs in people with diabetes, chronic pancreatitis, cystic fibrosis, and some types of cancer. EPI doesn’t cause those conditions, though.

AI is often an accessibility tool, even if you don’t use it that way

by Dana Lewis

Talking about AI (artificial intelligence) often veers conversations toward lofty, futuristic scenarios. But there’s a quieter, more fundamental way AI is making a big difference today: serving as an accessibility tool that helps many of us to accomplish tasks more efficiently and comfortably than otherwise would be possible. And often, enabling us to complete tasks we might otherwise avoid or be unable to do at all.

One way to think about AI is as the ultimate translator. But I don’t just mean between languages: I mean between ways of interacting with the world.

Imagine you’re someone dealing with a repetitive stress injury like carpal tunnel syndrome, making prolonged typing painful or even impossible. Traditionally, you might use dictation software to turn spoken words into text, alleviating physical strain. No issues with that, right? But somehow, suggesting people use AI tools to do the same thing (dictation and cleaning up of the dictated text) causes skepticism about “cheating” the “correct” way of doing things. If you imagine the carpal tunnel scenario, that’s less likely to be a reaction, but imagine many other situations where you see outrage and disgust (as a knee jerk reaction) to the idea of people using AI.

In reality, there are three ways of doing things to accomplish a note-taking task:

  • A human types notes
  • A human speaks notes to a voice dictation tool
  • A human speaks notes to an AI-based dictation tool, that also when prompted could clean up and transform the notes into different formats.

All three introduce the possibility of errors. The difference is how we perceive and tolerate those errors: the perception often reflects bias rather than logic.

For example, the focus disproportionately in the third example is about errors, where errors might not even come up in the other two. OMG, the AI might do something wrong! It might hallucinate an error! Well, yes, it might. But so too does the dictation software. There was similar outrage years ago when voice dictation software became common for doctors to use to dictate their chart notes. And yes, there were and are errors there, too. And guess what? Humans typing notes? ALSO RESULTS IN ERRORS. The important thing here is all three cases: human alone, human plus basic tech, human plus AI, all result in the possibility of errors.

(I actually see this frequently, where I see three different providers who either use voice dictation to write my chart notes, introducing errors; AI-assisted notetaking, occasionally introducing errors; and one manually types all of their notes…still occasionally introducing errors. They’re typically different types of errors, but the result is the same: error!)

This is more about cultural change than it is about the errors in and of themselves. If people actually cared about the errors, we would be creating pathways to fix errors by humans and other approaches, such as enabling wiki-style editing requests of medical charts so that patients and providers can collaboratively update and keep medical records and chart notes free of errors so they don’t propagate over time. This almost never happens: chart notes can only be corrected by providers, and patients often have to use scarce visit time if they care enough to request a correction. Instead, most discussions focus more on where theoretical errors came from rather than practical approaches to fix real-world errors.

Back to AI specifically:

Note taking is a simplistic example of what can be useful with AI, but there’s more examples of transformation, such as transforming data into different formats. Converting data from JSON to CSV or vice versa – this is a task that can be tedious or impossible for some people. Sure, this could be done manually, or it can be done with hand-written scripts for transforming the data, or it can be done by having an AI write the scripts to transform that data, or it can be done with the AI writing and executing the scripts to “transform the data itself”. AI can often do all of these steps quickly and efficiently, triggered by a plain-language request (either typed or dictated by voice).

Here are other examples where AI can be an accessibility tool:

  • A visually impaired user has AI describe images and generate ALT text and/or convert unreadable PDFs into something their screen reader can use. They might also have the AI summarize the text, first, to see if they want to bother spending the time screen reading all that text.
  • Individuals with mobility limitations control their home environment or work environment, by using AI to pair together tools that allow them to do things that weren’t possible before, and can brainstorm solutions to problems that previously they didn’t know how to solve or didn’t have the tools to solve or build.
  • People in a country where they don’t speak the language and are needing to access the healthcare system can benefit from real-time AI translation when there’s no medical interpreter services, if they bring their own AI translator. US healthcare providers are generally prohibited from using such tools and are forced to forego translation entirely when human translators are not available.
  • People with disabilities (whether those are mental or physical) using AI to help understand important healthcare or insurance forms or paperwork they need to understand or interpret and take action on.

Personally, I keep finding endless ways where AI is an accessibility tool for me, in large and small ways. And the small ways often add up to a lot of time saved.

One frequent example where I keep using it is for finding and customizing hikes. Last year, I had to change my exercise strategy, which included hiking more instead of running. Increasingly since then, though, I also have had to modify which hikes I’m able to do, including factoring in the terrain. (Super rocky or loose rock terrain are challenging whereas they used to not be a limitation). I used to spend a lot of time researching hikes based on location, then round trip distance, then elevation gain, then read trail descriptions and trail reports from recent weeks and months to ensure that a hike would be a good candidate for me. This actually took quite a bit of time to do manually (for context, we did 61 hikes last year!).

But with AI, I can give an LLM the parameters of geography (eg hikes along the I-90 corridor or less than two hours from Seattle), round trip mileage and elevation limits, *and* ask it to search and exclude any hikes with long sections of loose, rocky or technical terrain. I can also say things like “find hikes similar to the terrain of Rattlesnake Ledge”, which is a smooth terrain hike. This cuts down and creates a short list that meets my criteria so I can spend my time picking between hikes that already meet all my criteria, and confirming the AI’s assessment with my own quick read of the trail description and trail reviews.

It’s a great use of AI to more quickly do burdensome tasks, and it’s actually found several great hikes that I wouldn’t have found by manual searching, which is expanding my ‘horizons’ even when it feels like I’m being limited by the increasing number of restrictions/criteria that I need to plan around. Which is awesome. As hiking itself gets harder, the effort it takes to find doable hikes with my new criteria is actually much less, which means the cost-effort ratio of finding and doing things continues to evolve so that hiking continues to be something I do rather than giving it up completely (and drastically reducing my physical activity levels).

Whenever I see knee jerk reactions along the lines of “AI is bad!” and “you shouldn’t use it that way!” it often comes from a place of projecting the way people “should” do things (in a perfect world). But the reality is, a lot of times people can’t do things the same way, because of a disability or otherwise.

AI is an accessibility tool, even if you do not use it that way). A blog by Dana M. Lewis from DIYPS.orgAI often gives us new capabilities to do these things, even if it’s different from the way someone might do it manually or without the disability. And for us, it’s often not a choice of “do it manually or do it differently” but a choice of “do, with AI, or don’t do at all because it’s not possible”. Accessibility can be about creating equitable opportunities, and it can also be about preserving energy, reducing pain, enhancing dignity, and improving quality of life in the face of living with a disability (or multiple disabilities). AI can amplify our existing capabilities and super powers, but it can also level the playing field and allow us to do more than we could before, more easily, with fewer barriers.

Remember, AI helps us do more – and it also helps more of us do things at all.

IUD insertion or IUD replacement is more manageable with a paracervical block

by Dana Lewis

If you’re someone who is considering an IUD (intrauterine device) or has an IUD and is considering a replacement or the removal process, this post is for you. You should know about this! Feel free to share it with a friend.

I recently decided to replace my IUD. I was dreading it, because I found the insertion process the first time I got one to be the most painful thing I had ever experienced. For context, years later I massively broke my ankle in 3 places. I now am able to articulate that the pain level of an IUD insertion, for me, is like broken bone level pain inside. It “only” lasts for a few minutes at that level, but nevertheless, it is excruciating.

When I was due for my first ever replacement (swap), I asked my doctor’s office if there were any better pain management options than what I experienced for the insertion process. They told me no, the only thing they could offer was an oral medication I could try to soften the cervix. I took it in advance as directed, and also took full doses of ibuprofen and Tylenol, went for the swap process and…it was just as bad as the first insertion, even though I had previously had one. Ugh.

The good news related to IUDs is that they keep getting extended, in terms of how many years they are approved for birth control efficacy. Mine went from 5 years approval to 8 years approval, so I was looking forward to having more years in between the terrible experiences. However, my experience was that this time around when I reached a little over 5 years (fully expecting to go to 8 years with it), my period bleeding picked back up to a degree that I decided I would go ahead and swap to a new one. (Birth control-wise, they’re approved for 8 years, but the approval indication for heavy bleeding is still at 5 years, so it makes sense that some people who see a reduction in period bleeding on IUDs may see a return after that 5 year timeframe. Not everyone, but some will, and I did.)

So that’s why I was going in to get a replacement, at about 5.5 years from my last one. This time, I had a new provider’s office, but since my last office couldn’t offer me any reasonable pain mitigation, I didn’t bother asking in advance and just went in with an active dose of Tylenol in my system, mentally prepared for the pain.

But then, at my appointment when going over the risks and discussing any questions I had before the procedure, my new provider said “what pain mitigation would you like?”

I said: “What? You’re offering me something?!”

And yes, there are options and she did offer them! She talked about ibuprofen/Tylenol (I already had taken Tylenol), a hot pack for the stomach, or something called a paracervical block. It’s an injection, so she asked how I felt about needles. I laughed and told her I had type 1 diabetes (the implication being, I deal a lot with needles and regardless of what I feel about them, they keep me alive so I am used to dealing with them).

The side effects of this paracervical block include potentially experiencing ringing in the ears and a metal taste in your mouth, plus obviously the potential pain from the injection itself.

I quickly evaluated my thoughts – I didn’t think it would help (because softening the cervix previously didn’t help), and I didn’t love the idea of a block. That’s because my previous ‘nerve block’ type injections, such as when at the dentist, result in a LOT of pain for me for the injection. But, then again, the IUD replacement process is even more painful, so I thought for the small chance that it would help cut down on that pain, it was worth trying at least once. So I said yes.

While she was getting set up, I asked her if this was new (because I was surprised I hadn’t heard of it) and she said no, it’s been around but early research showed it wasn’t much more effective than placebo so it didn’t really pick up in clinical practice, but that later studies DID show efficacy of it. (I later looked that up and she was right – there’s a 2012 study showing similar efficacy on pain reduction to placebo, aka around 30%); whereas international studies and a later 2018 study with an increased dose DID show pain reduction for more people.) And we all know it takes time for things to translate to clinical practice (see this visual and imagine it as a game of telephone), so knowing this now helps me better understand why in 2015 (my first insertion) and 2020 (my first replacement), this was not an option offered to me by my old clinic. I don’t like it, but I understand the context better.

What the experience of a paracervical block was like

The first step was a numbing spray. Then came the injection. Maybe because of the numbing spray, it didn’t feel like an injection the way I normally experience injections for nerve blocks. I felt a minor pinch and a little bit of pressure from the fluid going in. I was surprised that it took a few (it was injected into several areas) and I was borderline slightly uncomfortable, not in the sense that I was going to ask her to stop, but I was ready for that part to be done. (And probably anticipatory pain for the actual removal/swap process). But it was done and then I realized, this was nothing like the other injections for nerve blocks and it was indeed very tolerable.

(Side effect wise, I did not experience ‘ringing’ in my ears, but I did feel like I could hear more easily (e.g. sounds in the room suddenly got louder). Afterward when I got up, I did feel a little odd for about 60 seconds, but that could have also been because I was laying down and then hopped back up (see below) pretty soon after. I didn’t have any taste in my mouth, and the ‘louder sounds’ didn’t persist beyond a few minutes. None of the side effects phased me nor would influence my decision to get another one.)

Then it was time for the IUD removal. She asked me to cough and I did while it came out. It felt uncomfortable like a pinch with friction, but it wasn’t stabbing excruciating pain. It wasn’t “sharp” feeling like pain. I breathed a bit while she got ready to do the insertion of the new IUD and she asked me to take a few deep breaths. I did, and the IUD was inserted. Like the removal, it felt slightly uncomfortable, but again more like friction, and it was less than the removal.

No excruciating, stabbing pain!!!

She was done, and I immediately sat up and told her the paracervical block helped, I was so glad I had done it, and now I wasn’t going to dread my next swap.

Previously, for my first insertion and my subsequent first swap, it took me a minute or two of laying there, breathing deeply, to recover from the intense, excruciating pain. I would be able to get up and get dressed and leave on my own, but it definitely was an intense full body experience that required a few minutes and then I would feel like I had to recover from it (psychologically) the rest of the day. And obviously carry that experience 5 years forward.

In contrast, I immediately sat up and was ready to get dressed and go. I didn’t need to recover. I left and drove home in great spirits, then started texting everyone I know who had IUDs that it was a jaw-dropping, wildly different experience and they should look up paracervical blocks and when it’s time for swap/replacement IUDs, ask in advance if their doctor/clinic offers it and shop around for somewhere that will offer it if not. It is THAT wildly different of an experience. I hate making phone calls, but I will 100% make as many phone calls as it takes in the future to make sure I always have this option. It took the painful experience from broken bone level pain (e.g. 9-10/10 excruciating pain) to a tolerable discomfort with only a little bit of pain (e.g. 2-3/10 experience). I say that as someone who was told by an ER doc while he was setting my ankle, broken in 3 places, that I have a high pain tolerance.

The other benefit of the paracervical block is she said it helps reduce cramping for up to an hour. And it did! I made it home before I started to feel cramping (like strong period cramps), almost exactly an hour after the injection. I continued to alternate between Tylenol and ibuprofen the rest of the day, but this was like managing a period, and I didn’t have any pain hangover from the injection or the IUD replacement process. (Again, previously it felt like it took me hours to recover from the experience, when I had it without the paracervical block).

IUD insertion (or IUD replacement) is more manageable with a paracervical block, a blog post from Dana M. Lewis on DIYPS.orgNot everyone finds IUD insertions or replacement to be excruciating. If you don’t, I’m so glad for you. But my experience was that it’s the most painful thing I’ve ever experienced. Over half the people I talk to with personal experience also say it is incredibly painful. So if you are one of the people, like me, who find IUD insertions or IUD replacements to be a terrible, painful experience…ask about a paracervical block. It makes an incredible difference and I’m now not dreading the replacement or future removal.

(And if you have any other questions about the experience that I can answer, happy to do so – leave a comment below.)

The data we leave behind in clinical trials and why it matters for clinical care and healthcare research in the future with AI

by Dana Lewis

Every time I hear that all health conditions will be cured and fixed in 5 years with AI, I cringe. I know too much to believe in this possibility. But this is not an uninformed opinion or a disbelief in the trajectory of AI takeoff: this is grounded in the very real reality of the nature of clinical trials reporting and publication of data and the limitations we have in current datasets today.

The sad reality is, we leave so much important data behind in clinical trials today. (And every clinical trial done before today). An example of this is how we report “positive” results for a lot of tests or conditions, using binary cutoffs and summary reporting without reporting average titres (levels) within subgroups. This affects both our ability to understand and characterize conditions, compare overlapping conditions with similar results, and also to be able to use this information clinically alongside symptoms and presentations of a condition. It’s not just a problem for research, it’s a problem for delivering healthcare. I have some ideas of things you (yes, you!) can do starting today to help fix this problem. It’s a great opportunity to do something now in order to fix the future (and today’s healthcare delivery gaps), not just complain that it’s someone else’s problem. If you contribute to clinical trials, you can help solve this!

What’s an example of this? Imagine an autoantibody test result, where values >20 are considered positive. That means a value of 21, 58, or 82 are all considered positive. But…that’s a wide range, and a much wider spread than is possible with “negative” values, where negative values could be 19, 8, or 3.

When this test is reported by labs, they give suggested cutoffs to interpret “weak”, “moderate”, or “strong” positives. In this example, a value of 20-40 is a “weak” positive, a value between 40-80 is a “moderate” positive, and a value above 80 is a strong positive. In our example list, all positives actually fall between barely a weak positive (21), a solidly moderate positive in the middle of that range (58), and a strong positive just above that cutoff (82). The weak positive could be interpreted as a negative, given variance in the test of 10% or so. But the problem lies in the moderate positive range. Clinicians are prone to say it’s not a strong positive therefore it should be considered as possibly negative, treating it more like the 21 value than the 82 value. And because there are no studies with actual titres, it’s unclear if the average or median “positive” reported is actually all above the “strong” (>80) cutoff or actually falls in the moderate positive category.

Also imagine the scenario where some other conditions occasionally have positive levels of this antibody level but again the titres aren’t actually published.

Today’s experience and how clinicians in the real world are interpreting this data:

  • 21: positive, but 10% within cutoff doesn’t mean true positivity
  • 53: moderate positive but it’s not strong and we don’t have median data of positives, so clinicians lean toward treating it as negative and/or an artifact of a co-condition given 10% prevalence in the other condition
  • 82: strong positive, above cutoff, easy to treat as positive

Now imagine these values with studies that have reported that the median titre in the “positive” >20 group is actually a value of 58 for the people with the true condition.

  • 21: would still be interpreted as likely negative even though it’s technically above the positive cutoff >20, again because of 10% error and how far it is below the median
  • 53: moderate positive but within 10% of the median positive value. Even though it’s not above the “strong” cutoff, more likely to be perceived as a true positive
  • 92: still strong positive, above cutoff, no change in perception

And what if the titres in the co-condition have a median value of 28? This makes it even more likely that if we know the co-condition value is 28 and the true condition value is 58, then a test result of 53 will be more correctly interpreted as the true condition rather than providing a false negative interpretation because it’s not above the >80 strong cutoff.

Why does this matter in the real world? Imagine a patient with a constellation of confusing symptoms and their positive antibody test (which would indicate a diagnosis for a disease) is interpreted as negative. This may result in a missed diagnosis, even if this is the correct diagnosis, given the absence of other definitive testing for the condition. This may mean lack of effective treatment, ineligibility to enroll in clinical trials, impacted quality of life, and possibly negatively impacting their survival and lifespan.

If you think I’m cherry picking a single example, you’re wrong. This has played out again and again in my last few years of researching conditions and autoantibody data. Another real-world scenario is where I had a slight positive (e.g. above a cutoff of 20) value, for a test that the lab reported is correlated with condition X. My doctor was puzzled because I have no signs of this condition X. I looked up the sensitivity and specificity data for this test and it only has 30% sensitivity and 80% specificity, whereas 20% of people with condition Y (which I do have) also have this antibody. There is no data on the median value of positivity in either condition X or condition Y. In the context of these two pieces of information we do have, it’s easier to interpret and guess that this value is not meaningful as a diagnostic for condition X given the lack of matching symptoms, yet the lab reports the association with condition X only even though it’s only slightly more probably for condition X to have this autoantibody compared to condition Y and several other conditions. I went looking for research data on raw levels of this autoantibody, to see where the median value is for positives with condition X and Y and again, like the above example, there is no raw data so it can’t be used for interpretation. Instead, it’s summary of summary data of summarizing with a simple binary cutoff >20, which then means clinical interpretation is really hard to do and impossible to research and meta-analyze the data to support individual interpretation.

And this is a key problem or limitation I see with the future of AI in healthcare that we need to focus on fixing. For diseases that are really well defined and characterized and we have in vitro or mouse models etc to use for testing diagnostics and therapies – sure, I can foresee huge breakthroughs in the next 5 years. However, for so many autoimmune conditions, they are not well characterized or defined, and the existing data we DO have is based on summaries of cutoff data like the examples above, so we can’t use them as endpoints to compare diagnostics or therapeutic targets. We need to re-do a lot of these studies and record and store the actual data so AI *can* do all of the amazing things we hear about the potential for.

But right now, for a lot of things, we can’t.

So what can we do? Right now, we actually CAN make a difference on this problem. If you’re gnashing your teeth about the change in the research funding landscape? You can take action right now by re-evaluating your current and retrospective datasets and your current studies and figure out:

  • Where you’re summarizing data and where raw data needs to be cleaned and tagged and stored so we can use AI with it in the future to do all these amazing things
  • What data could I tag and archive now that would be impossible or expensive to regenerate later?
  • Am I cleaning and storing values in formats that AI models could work with in the future (e.g. structured tables, CSVs, or JSON files)?
  • Most simply: how am I naming and storing the files with data so I can easily find them in the future? “Results.csv” or “results.xlsx” is maybe not ideal for helping you or your tools in the future find this data. How about “autoantibody_test-X_results_May-2025.csv” or similar.
  • Where are you reporting data? Can you report more data, as an associated supplementary file or a repository you can cite in your paper?

You should also ask yourself whether you’re even measuring the right things at the right time, and whether your inclusion and exclusion criteria are too strict and excluding the bulk of the population for which you should be studying.

An example of this is in exocrine pancreatic insufficiency, where studies often don’t look at all of the symptoms that correlate with EPI; they include or allow only for co-conditions that are only a tiny fraction of the likely EPI population; and they study the treatment (pancreatic enzyme replacement therapy) without context of food intake, which is as useful as studying whether insulin works in type 1 diabetes without context of how many carbohydrates someone is consuming.

You can be part of the solution, starting right now. Don’t just think about how you report data for a published paper (although there are opportunities there, too): think about the long term use of this data by humans (researchers and clinicians like yourself) AND by AI (capabilities and insights we can’t do yet but technology will be able to do in 3-5+ years).

A simple litmus test for you can be: if an interested researcher or patient reached out to me as the author of my study, and asked for the data to understand what the mean or median values were of a reported cohort with “positive” values…could I provide this data to them as an array of values?

For example, if you report that 65% of people with condition Y have positive autoantibody levels, you should also be able to say:

  • The mean value of the positive cohort (>20) is 58.
  • The mean value of the negative cohort (<20) is 13.
  • The full distribution (e.g. [21, 26, 53, 58, 60, 82, 92…]) is available in a supplemental file or data repository.

That makes a magnitude of difference in characterizing many of these conditions, for developing future models, testing treatments or comparative diagnostic approaches, or even getting people correctly diagnosed after previous missed diagnoses due to lack of available data to correctly interpret lab results.

Maybe you’re already doing this. If so, thanks. But I also challenge you to do more:

  • Ask for this type of data via peer review, either to be reported in the manuscript and/or included in supplementary material.
  • Push for more supplemental data publication with papers, in terms of code and datasets where possible.
  • Talk with your team, colleague and institution about long-term storage, accessibility, and formatting of datasets
  • Better yet, publish your anonymized dataset either with the supplementary appendix or in a repository online.
  • Take a step back and consider whether you’re studying the right things in the right population at the right time

The data we leave behind in clinical trials (white matters for clinical care, healthcare research, and the future with AI), a blog post by Dana M. Lewis from DIYPS.orgThese are actionable, doable, practical things we can all be doing, today, and not just gnashing our teeth. The sooner we course correct with improved data availability, the better off we’ll all be in the future, whether that’s tomorrow with better clinical care or in years with AI-facilitated diagnoses, treatments, and cures.

We should be thinking about:

  • What if we design data gathering & data generation in clinical trials not only for the current status quo (humans juggling data and only collecting minimal data), but how should we design trials for a potential future of machines as the primary viewers of the data?
  • What data would be worth accepting, collecting, and seeking as part of trials?
  • What burdens would that add (and how might we reduce those) now while preparing for that future?

The best time to collect the data we need was yesterday. The second best time is today (and tomorrow).

Exhausting and familiar, the experience of living with autoimmune diseases

by Dana Lewis

A new autoimmune disease is exhausting and foreign, until it becomes exhausting and familiar.

Exhausting is such a good word for it. Sometimes, it’s the disease process itself that is exhausting and causes fatigue physically. Other times, it’s the coping and figuring out how to wrangle your life into a pretzel around it that is exhausting. It’s exhausting continually finding new things that are changing, out of your control, that you have to adapt to both physically and mentally. Sometimes, it’s exhausting trying to explain to others how it affects you and what you need support-wise, especially when it doesn’t come with a clear name, a neat bow, and an easily explainable narrative about what the trajectory will look like. Because you don’t know. You don’t have answers, and it’s exhausting to deal with the unknown and uncertainty.

On the flip side, it’s also exhausting when you don’t talk about it. It’s exhausting to be dealing with it, struggling to adjust, and not talking about it. Because of stigma, because of concern about how other people will treat you differently (even if well-intentioned), because you don’t have answers or a name and can’t fully articulate what is going on in a way other people will understand, because you worry about how it impacts the people you love and whether you’re an anchor holding them back.

Sometimes that also means it’s exhausting to articulate to your healthcare providers. I am lucky that my healthcare providers listened to me and believed me, even when I was coming from a high state of health and physical fitness (e.g. cross country skiing for 6 hours, run/walking ultramarathons, exercising every day, etc) and respect that when I said “I can’t run and press off through my ankle and now it feels weird in my thigh and to lift my hip, and my hands are now weak”, that it was indeed a problem, even when my bloodwork and other biomarkers and clinical exams were mostly normal. (Except for my lungs, the canary in the coalmine for me, and a few sporadic blood biomarkers showing immune shenanigans, most of my data makes me look like the healthiest horse standing outside of the glue factory. I look sick compared to healthy horses, but I look too healthy compared to the horses going into the glue factory. So to speak.)

It’s exhausting to not gaslight myself, coming out of doctor’s appointment after doctor’s appointment where they repeat “you remain a mystery” while also doing everything they can to help to try to diagnose the exhausting, now-familiar thing that evades naming, evades mechanistic understanding, and evades effective curative treatment. They’re doing everything they can despite the fact that they can’t provide answers. Nor can I. I have to hold on to my data (experiential, lived, wearable, and the few lab results and pulmonary function testing that clearly show the level of the problem) tightly and push back against gaslighting myself.

But while it’s all exhausting, it has slowly shifted from foreign to familiar.

I am grateful for the familiarity in a way, because with familiarity comes a newly developed language to put words to the indescribable; a reinforced skill for adaptation and new ‘hacks’ and discovered instruments of freedom; and a commitment to find the glimmers of joy buried under all the exhaustion.

My newly developed language is evolving, because I constantly test this new language on my family and friends in the know. I have to differentiate how this impacts my muscles, especially because I come from a land of ultrarunners who specifically train in discomfort for the purpose of being able to tolerate discomfort in endurance activities. When I say something bothers me, it means it’s intolerable and not what a healthy body would experience in terms of discomfort. I know what tired, sore muscles feel like (hello, 82 miles of run/walking or 6 hours of cross country skiing 50 kilometers/31 miles) and what acute muscle damage feels like from physical activity. This is not that. It’s struggling to initiate a muscle movement, but still being able to move, even though it progressively feels like moving through jello. It’s not something that anyone I know, or I when healthy, experienced, and so I have to figure out and evolve the ways to describe it. Mostly, I found success in describing the consequences of what is happening, when I can’t run and I find it more challenging to walk and hike, even though I can still do those things. Those are things that people can understand, and understand that it’s important to me that I can’t do them and/or that these activities are immensely harder to accomplish, even if they don’t understand the sensation causing that outcome. I can generally describe having an autoimmune disease that affects my muscles, and that’s enough (people understand autoimmune diseases) to be understood.

Like Icarus flying too close to the sun (analogy at top of mind from recently reading to my nephew a Percy Jackson book…), it’s like my muscles are melting, but not to the point of my falling into the ocean. And that’s where healthcare providers most usually see patients, when they’re about to or have hit the ocean when their wings (muscles) fully stop working. I am still flying, but less high, a little melty, a little wonky. I know something is clearly wrong and I see the ocean and where things will go without a solution. But even by flying lower (aka, doing less, stopping running, etc), I’m still melting – it’s still happening, and limiting my physical activity or activities of daily living doesn’t change the trajectory.

Thus, the reinforced skills for adaptations. I learned a lot from my decades of type 1 diabetes and having to “DIY” things myself outside of the healthcare solution. I’m more quick to go from “ugh this is a problem” to wondering about possible solutions. This is everything from changing how I sit (different chairs, with cushions) or lay down to work (with my laptop on a stand to reduce neck muscle strain and a separate bluetooth keyboard and trackpad so I can iterate positions as needed) to bracing early and often (ankle braces, a back brace, a foam neck brace) to a variety of things to lower the challenge to my hands. This includes using little slide tins for meds instead of flip top containers, because even the easy to open containers sometimes bother my hands. I also found a ski carrying strap so I can carry my cross country skis in the winter over my shoulder with the strap, rather than holding them in my hands. Sometimes I ask Scott to make my dinner or prep things (like cutting fruit in advance) so I don’t make my food choices based on not wanting to use up my hand energy to prep the food rather than for eating it. (Ongoing shout out to Scott, who epitomizes the ultimate supportive partner/husband and if he gets annoyed at anything, it’s my occasional hesitation or resistance of wanting him to ask him to do more, because I worry about asking him to do much. He recently spontaneously reminded me that I am a sail…and that always helps.)

It’s important for me to also remember that every bit helps and it doesn’t have to cure but that doesn’t mean it won’t help. Because the help adds up. But it requires pushing back the mental knee-jerk response of saying “that won’t help” because it’s not a cure for the root of the problem. Nope, no cures here. But that doesn’t mean a little bit of help for a little corner of the problem isn’t worth trying. Usually, 2 out of 3 times that little bit of help is a huge relief and reduces the physical burden, even if it’s ‘small’ like something for my hands. Sometimes it’s only a little bit of a help, and so we keep looking for better solutions for that particular challenge. Sometimes I can’t adapt a solution and I adapt my behavior. But my success rate has gone up, and that is great knowing that I can adapt solutions to fit my needs, even though sometimes it gets overwhelming to think about the volume of adaptations, especially when comparing it to a few years ago of how I lived and locomoted and worked.

Because the adaptations mean I can continue to find the glimmers of joy in life. No, I can’t run and I hike and walk more slowly, but I can still get out into the trees and under the blue skies and sunshine and feel the breeze on my face as I move through space. On days I choose to rest, I can sit out on the porch, sometimes braced, sometimes reclined in a chair with pillows, and watch the kittens sun themselves or jump up and stretch out on my legs. I can still spend time with family and friends, enjoying what I can still do with my ten niblings (nieces and nephews) and honorary niblings in my life. I can remind myself that while it feels like I’m falling out of the sky and I am dipping down, I have (hopefully) miles to go before I hit the ocean and stop flying at all. The delta in altitude sucks, especially in comparison to what I could do before, but with less comparison I can find more glimmers of joy both now and on the horizon. There is still a lot I can (and do) do, even as the list of things I can’t do or must adapt grows.

Exhausting and familiar, the experience of living with autoimmune diseases, a blog by Dana M. Lewis on DIYPS.orgIf you find yourself in the exhausting-but-foreign space of a new or suspected autoimmune disease, it sucks. I’m sorry. I wish I could help. (And if I can help you, let me know). But I hope it helps you to know that you are not alone. That yes, it does suck, but there is some solace when it turns from completely foreign to somewhat familiar, even if that doesn’t mean that it got easier or got better. But maybe it’ll be more known, maybe you’ll find more adaptations, and maybe you’ll still be able to find some glimmers of joy.

I did (I have), and I hope you do, too.