I’m thrilled to share that the results of the first RCT on open source automated insulin delivery (AID) is now published in a peer-reviewed medical journal (New England Journal of Medicine, known as NEJM). You can find it at NEJM here, or view an author copy here. You can also see a Twitter post here, if you are interested in sharing the study with your networks.
(I previously wrote a plain language summary of the study results after they were presented at ADA Scientific Sessions in June. You can read the plain language summary here, if you haven’t already seen it.)
I wanted to highlight a key few takeaway messages from the study:
- The CREATE study found that across children and adults, the percentage of time that the glucose level was in the target range of 3.9-10mmol/L [70-180mg/dL] was 14.0 percentage points higher among those who used the open-source AID system compared to those who used sensor augmented pump therapy. This difference reflects 3 hours 21 minutes more time spent in target range per day!
- For children AID users, they spent 3 hours 1 minute more time in target range daily (95% CI, 1h 22m to 4h 41m).
- For adult AID users, they spent 3 hours 41 minutes more time in target range daily (95% CI, 2h 4m to 5h 18m).
- Glycemic improvements were evident within the first week and were maintained over the 24-week trial. Meaning: things got better quickly and stayed so through the entire 24-week time period of the trial!
- The CREATE study also found that the greatest improvements in time in range (TIR) were seen in participants with lowest TIR at baseline. This means one major finding of the CREATE study is that all people with T1D, irrespective of their level of engagement with diabetes self-care and/or previous glycemic outcomes, stand to benefit from AID. There is also no age effect observed in the trail, meaning that the results of the CREATE Trial demonstrated that open-source AID is safe and effective in children and adults with type 1 diabetes.
I’d also like to highlight some meta aspects of this trial and the significance of these results being published in NEJM.
The algorithm (open source, from OpenAPS) used in the trial, as well as the open source app (AndroidAPS) used to automate insulin delivery, were built by people with diabetes and their loved ones. The algorithm/initial AID work was made open source so other people with diabetes could use it if they chose to, but also so that researchers and clinicians could research it, learn from it, use it, etc. Speaking on behalf of Scott (Leibrand) who worked with me endlessly to iterate upon the algorithm and then also Ben West whose work was critical in communicating with insulin pumps and putting the pieces together into the first open source “closed loop” automated insulin delivery system: we all wanted this to be open source for many reasons. You’ll see some of those reasons listed at the bottom of the plain language OpenAPS “reference design” we shared with the world in February 2015. And it is exceptionally thrilling to see it go from n=1 (me, as the first user) to thousands worldwide using it and other open source AID systems over the years, and be studied further in the “gold standard” setting of an RCT to validate the real-world outcomes that people with diabetes have experienced with open source AID.
But these results are not new to those of us using these systems. These results every day are WHY we use and continue to choose each day to use these systems. This study highlights just a fraction of the benefits people with diabetes experience with AID. Over the years, I’ve heard any of the following reasons why people have chosen to use open source AID:
- It’s peaceful and safer sleep with less fear of dying.
- It’s the ability to imagine a future where they live to see their children grow up.
- It’s the ability to manage glucose levels more effectively so they can more easily plan for or manage the process of having children.
- It’s less time spent doing physical diabetes tasks throughout the days, weeks, and years.
- It’s less time spent thinking about diabetes, diabetes-related short-term tasks, and the long-term aspects of living with diabetes.
All of this would not be possible without hundreds of volunteer contributors and developers who iterated upon the algorithm; adapted the concept into different formats (e.g. Milos Kozak’s work to develop AndroidAPS using the OpenAPS algorithm); wrote documentation; troubleshot and tested with different pumps, CGMs, hardware, phones, software, timezones, etc; helped others interested in using these systems; etc. There are many unsung heroes among this community of people with diabetes (and you can hear more of their stories and other milestones in the open source diabetes community in a previous presentation I gave here).
There are thousands of hours of work behind this open source technology which led to the trial which led to these results and this publication. Both the results and the fact of its publication in the NEJM are meaningful. This is technology developed by people with diabetes (and their loved ones) for people with diabetes, which more people will now learn is an option; it will fuel additional conversations with healthcare providers who support people with diabetes; and it will likely spur additional research and energy in the ongoing development of diabetes technologies.
From developers, to community contributors and community members, to the study team and staff who made this trial happen, to the participants in the trial, and to the peer reviewers and editor(s) who reviewed and recommended accepting the now-published article in the New England Journal of Medicine: