“Should I build an artificial pancreas?” (It’s a personal question)

Given that many (7 almost 8!) of us have closed the loop with OpenAPS, and sometimes show pictures of great overnights like the below, and given the fact that diabetes is a complicated, annoying, unfair disease, there is a lot of interest in closing the loop. Scott and I definitely get that, which is why we started the #OpenAPS movement.

I have been asked more and more lately, “Are you going to make this available to less tech-savvy people?” and “Should I build one?”.

The answer to the first question is emotionally hard, because a DIY build of a medical device that auto-adjusts insulin will always involve some technical knowledge – or at the very least, a growth mindset and willing to learn many new things to build a technical knowledge in order to proceed through the murky process of building a not-100%-documented artificial pancreas. You don’t have to be a programmer or an engineer; but you do have to have time and energy to spend learning as well as doing. I say this every day: the DIY part is important.

(And, I know people always want to hear “yes! It’ll be out on X date, and just as easy as installing Nightscout.” But it’s not as easy as installing something like Nightscout and never will be.)

That leads into the second question as an explanation of why it’s not as easy as we would wish:

Even if you have a very technical background, you’ll still spend time learning new languages, new pieces of software, and building pieces of your own. Things will break, things will need to be improved, and you need to have the knowledge of what’s going on and understand the logic of what you’re trying to achieve at each stage in order to be able to troubleshoot both the code part of things and the diabetes part of things.

It is hard. And it is a lot of work.

What you don’t see when someone says they’ve (DIY) closed the loop:

For every “I had such a great night” picture someone posts, that probably represents at least (10?+) hours of working on building or troubleshooting their system. Scott and I have each spent hundreds of hours working with my system, from trouble shooting, to building in new features, to reaffirming that things are all working as planned, etc. That figure should be a bit lower for new people as a result of our efforts, but it will never be as easy as just plugging something in, giving it your weight, and letting it take over. The system only does what you program it to do.

I often say this is “not a set-and-forget” system. And this is also true in the wearability of it. Right now, I use a Raspberry Pi and Carelink USB stick to communicate with my pump. They’re great, but the separate power source I also have to keep charged, plus keeping the USB in range of my pump, plus making sure it’s all working, can be a headache sometimes. (Which is why I’m so glad we made an offline mode, to reduce one of the biggest headaches of using the system.) When I’m on the go during the day, sometimes I don’t take it with me, or I choose to stop and un-power it and resume it when I get home. At this point, I wouldn’t be surprised if most people use it for nighttime use only (at least for the most part). But even with nighttime use only, there’s still constant changing of the code (in some cases daily), tweaking, altering, fixing, breaking, and un-breaking various parts.

Did I mention it was a lot of work?

And does a closed loop prevent all lows and highs? No.

It’s important to realize this is not a cure. I work really hard to do eating soon mode before meals to prevent spikes from the amount of carbs I choose to eat. I still have to test my blood sugar and calibrate my CGMs multiple times a day. I still have to change out my pump site every 2-3 days, and deal with the normal hassles of wonky pump sites, etc. I still have some highs – although the loop helps me handle them and I spend less time above range. And I still have some lows – although usually they’re from human error related to bolusing, the loop helps prevent them from always being a true low and/or blunting the drop so I don’t require as much correction. But diabetes is still a good amount of work, even with a closed loop.

Is it worth it to self-build an artificial pancreas?

This is a personal question. It’s a lot of work, with risk involved.

For me, I have decided and continue to decide that it’s worth it.

But only you can decide if the work and the risk are worth the potential rewards for you.

Does the FDA care more about safety than people with diabetes do?

Today my inbox was suddenly flooded with links to a video with some commentary about artificial pancreas technology at a conference by a representative of the U.S. FDA. The implication many people are getting after watching the video clip is that this FDA representative is implying that people are being unsafe by building their own artificial pancreas. He mentions it is consumer prerogative to build an artificial pancreas – which is correct. The implication of his analogy is that changing your car and killing yourself is similar to a DIY artificial pancreas effort.

The scary takeaway from the video, in my opinion, as well as other public comments in the past, is the implication that the FDA cares more about the potential harms of taking action than the almost certain harms of inaction. And it’s increasingly frustrating that the FDA appears to imply publicly that those of us in the #wearenotwaiting community are doing things unsafely as a result of taking action.

Safety is what drives the #wearenotwaiting movement. In my case, I refuse to sleep another night with the fear that I won’t wake up in the morning because there’s not an FDA-approved system on the market that will wake me up if my life is in danger, let alone a system that can take action and change the situation to be more safe. So I built my own (#DIYPS), because the current FDA-approved CGM devices were not (and still are not) loud enough to wake me up at night, putting me at risk of dying in my sleep. And yes, it ultimately turned into an artificial pancreas – with the same goal of ensuring I wake up every morning, safely (alive). That is my prerogative for sure.

But I fail to see why the FDA, which collectively has no particular knowledge of these systems (especially as they have no jurisdiction, acknowledged on all fronts, over what I do myself – it’s my prerogative), is making public statements implying that these types of systems are categorically unsafe.

As a matter of fact, every DIY system I’ve seen is safer than the FDA-approved standard of care available for people with diabetes. The thousands of people using Nightscout, which is currently a DIY remote view-only monitoring system? Provides more safety and security for people with diabetes, not to mention it is helping achieve better outcomes for people with diabetes than they were able to achieve before with the standard of diabetes care as it exists today. (This was originally for the most part because of restricted access to data, although while that has improved there’s still interoperability issues getting access to real-time data in the same place from the 3+ average devices a person with diabetes uses…unless they have Nightscout or another DIY tool running.) The dozens of people working on their DIY version of an artificial pancreas system (many of whom are collaborating and sharing data in the #OpenAPS community)? These systems are safer than the standard of care, which is to let an insulin pump continue to overdose you if you are dangerously low while you sleep.

(You can see some of my personal data from #DIYPS, before we closed the loop, here and more about outcomes after we closed the loop and had #OpenAPS here. My closed loop artificial pancreas system continues to work excellently nine plus months in, and you can continue to watch my outcomes as I post them to Twitter regularly using the #DIYPS and #OpenAPS hashtags. I’ve also shared the other powerful lessons that DIY tech has helped me learn about diabetes care that helps all people with diabetes, regardless of technology.)

Are there risks to DIY efforts? Yes. But there’s risks to living with diabetes regardless. And as a person with diabetes, I am well aware of the risks that I choose to take. Diabetes is a disease in which you carry around large amounts of a lethal drug in your pocket that you are supposed to inject daily in order to save your life. As a person with diabetes, we are nothing but aware of the multitude of risks of living with this chronic disease 24/7/365.

In fact, even without a DIY artificial pancreas system, I am at risk every day simply from using my FDA-approved insulin pump that does not accurately track how much insulin I am given. (Read more here about how most insulin pumps on the market calculate IOB only from boluses, and often do not provide a record let alone incorporate any temporary adjustments to your basal rates and do not in any case track the impact of suspending your pump completely.)

And as someone who has founded the #OpenAPS movement, with the goal of an open and transparent effort to make safe and effective basic Artificial Pancreas System (APS) technology widely available to more quickly improve and save as many lives as possible and reduce the burden of type 1 diabetes…..we approach it with safety first in mind, and is a big part of why the DIY part is critical and is a part of our number one priority of safety.

Not everyone will choose to go the DIY route. In fact, most people do not and I am told all the time “Oh, I would never do that.” And that’s fine! Everyone can choose what they want for themselves.

But technology has made it increasingly feasible for those of us who want to improve our own safety to do so, because the industry and the FDA are not moving quickly enough to meet our needs.

That, indeed, is our prerogative – to increase our own safety.

#DIYPS and the wedding

“Diabetes wasn’t in the picture during the wedding, and that was exactly how it should be.”


 

 


 

 

If you’re not familiar with Scott & me (Dana), and how we ended up building #DIYPS and later #OpenAPS, you might be interested to read this great article in Business Insider. (And I’ve been told it’s guaranteed to make you go “awww” even if you already sort-of know us!)

I love that it also highlights how #DIYPS played into our wedding, which was exactly how I wanted it: I hardly thought about diabetes at all. I didn’t have to cut into the lining of my wedding dress to carry d-supplies. In fact, up until the last minute, I wasn’t sure if I was going to carry the closed loop during the wedding itself, because I had decided not to put pockets in my dress and I wasn’t sure Scott’s suit had big enough pockets to hold everything.

But just like all things in this #DIYPS and #OpenAPS journey, a couple of serendipitous events gave us our solution.

First, we were in Alabama for the week before the wedding, and I was working a few days remotely there. But I like to move while I work, and so I’d move around the house (and go outside) with my laptop while I was on calls. This led to Scott getting no data alerts and no-loop-running alerts, and randomly chasing me down to re-plunk the loop down into range. Finally, he asked if I would consider a fanny pack. I laughed, and told him no way, and that HE should wear a fanny pack. Then I remembered hearing about flip belts and thinking about getting one at one point to try for running. So, we made a quick Amazon purchase (where all great artificial pancreas parts come from ;)).

Scott probably thought he’d get me to wear the flip belt around the house (it is purple, after all), and maybe at the wedding, but when it arrived two days before the wedding and I was busy working, he actually put it on, placed all the loop parts inside, and then decided to try putting his tux coat on over it.

It didn’t show.


 

And this is how *Scott* ended up wearing the belt and the AP parts during the wedding (he’s wearing it above and you can’t see it!). I obviously was stilling wearing my pump and my CGM sensor under my dress where it wasn’t showing. We also gave my second CGM receiver to Tim (pictured here, Scott’s brother and best-man-extraordinaire), who also wore Scott’s watch for much of the day and helped give me updates on my BGs when Scott & the loop were out of range prior to our “first look”.

As a result of having #DIYPS/#OpenAPS, my BGs had been picture perfect the night before the wedding, and were within range all afternoon leading up to the wedding. (They were fine during and after the wedding, too, so much so that it never occurred to me to take more pictures of my graph, which shows how perfect it was to have diabetes not on my mind!)

This may have been (one of) the first wedding(s) with an artificial pancreas in it, but we bet it won’t be the last – one of our friends in the Seattle area who is now up and running on #OpenAPS is also getting married next month, and he may wear his loop during his wedding, too!

We like this trend.