Introducing the #OpenAPS project
The Open Artificial Pancreas System (#OpenAPS) is 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.
Background on the current state of diabetes management
Type 1 diabetes (T1D), an autoimmune disease that destroys pancreatic beta cell functionality, is treated using injections or infusions of synthetic insulin. Insulin is a potentially lethal drug whose dosing must be constantly adjusted based on blood glucose (BG) levels, meal content, activity levels, and many other hard-to-measure factors. Even with state-of-the-art technology (insulin pumps and continuous glucose monitors (CGMs)), every person with T1D (or their caregivers, as T1D often manifests in children) has to make approximately 300 decisions a day related to their diabetes self-care to have any chance at all of mostly avoiding short-term sickness and preserving long-term health. And nearly everyone with T1D, and all their loved ones, live with the ever-present fear that they may not wake up in the morning as a result of severe hypoglycemia. These are incredible burdens for every person with T1D: because treatment is so difficult, even the most diligent, successful, and lucky patients with T1D have both an elevated risk of death from acute hypoglycemia (low blood sugar) and a high rate of complications and early death from acute or usually chronic hyperglycemia (high blood sugar).
Patients are shaping the future of diabetes management
Many patient innovators, industry non-profits, and some device makers have begun backing recent open-source efforts by patient innovators and others to help drive faster innovation in technology for treating T1D. These efforts have been centered around the #WeAreNotWaiting movement, and have gained broad public support and involvement through the CGM in the Cloud group on Facebook. The Facebook group has 10,000+ members, and over 2,000 of them have installed and are actively using an open source project called Nightscout to remotely monitor CGM data. In addition to meeting a very real need in the community, this effort seems to have accelerated the path to regulatory approval and widespread market acceptance of similar FDA-approved commercial solutions. For example, the Dexcom Share was in development for a couple of years and submitted to FDA for approval before widespread adoption of Nightscout, but only recently approved by the FDA, initially as a medical device (a cradle for overnight use) and quickly thereafter as a mobile medical app approved under a de novo application that will pave the way for future products to transmit and display data without requiring FDA pre-market approval (just registration and listing).
In order to relieve the incredible burden of T1D, many research teams and manufacturers have developed and are testing Artificial Pancreas Systems (APSs) that connect CGMs to insulin pumps and use various algorithms to automatically adjust insulin dosing (and sometimes dose glucagon, a counter-regulatory hormone) to attempt to mimic some of the functions of a healthy pancreas, and keep blood sugar levels in a safe range. While quite successful in clinical trials so far, current APS systems have been in development for many years, and are still likely at least 3 years away from FDA approval. It is also unclear whether first-generation APS technology will be suitable for, or available to, all patients, even in rich countries.
Why we are building our own DIY Artificial Pancreas Systems
Additionally, some of the patient innovators involved in the #WeAreNotWaiting movement have gone a step further, and have figured out how to connect up existing FDA-approved medical devices such as the Dexcom G4 CGM and the Medtronic Minimed insulin pump, using commodity computer / mobile phone hardware and open-source software, to create a complete closed loop Artificial Pancreas System (APS). The first public example of this was the #DIYPS closed loop system, created in their spare time by @DanaMLewis and @ScottLeibrand in the fall of 2013 based on their earlier work to build the #DIYPS remote monitoring and decision assist system. Shortly thereafter, another independent researcher (@bustavo) created and announced the #simPancreas, an independent implementation using solely Medtronic CGM data and the Medtronic pump.
#DIYPS uses the Nightscout project’s uploader to get Dexcom CGM data off the device. Both #DIYPS and #simPancreas use the open-source decoding-carelink project created by Ben West (@bewestisdoing) to communicate with Medtronic insulin pumps, retrieve data and issue insulin-dosing commands to pumps that support it. In addition to those of us who’ve gone public with our work, there are up to a dozen independent researchers currently implementing DIY insulin control systems of various sorts based on Ben’s work, and probably many more who’ve been working completely independently and have not yet shared their work publicly.
Often, word of systems like #DIYPS are met with interest and a lot of questions – mainly, does it work, and how safe is it? Initial results for #DIYPS closed loop (for n=1) have been excellent, with improvements in time in range, a reduction in time spent low, and a dramatic reduction in overnight alarms.
Now is the time for #OpenAPS
In light of recent success of #DIYPS closed loop and other simple APS systems built by individuals, we have decided that now is the time to further apply the #WeAreNotWaiting ethos to APS research. We believe that we can make safe and effective APS technology available more quickly, to more people, rather than just waiting for current APS efforts to complete clinical trials and be FDA-approved and commercialized through traditional processes. And in the process, we believe we can engage the untapped potential of dozens or possibly hundreds of patient innovators and independent researchers and also make APS technology available to hundreds or thousands of people willing to participate as subjects in clinical trials.
At the end of the process, we hope to have produced an #OpenAPS reference design and reference implementation that can be used by any individual with diabetes who has the necessary medical equipment and is willing to build their own system – and potentially one day have an FDA-approved algorithm that can be implemented or utilized by medical device manufacturers with minimal additional regulatory burden. We believe this will in turn allow manufacturers (and the academic research teams they work with) to turn more of their attention to designing and testing more advanced APS systems, and thereby accelerate the pace of innovation toward new and improved Type 1 diabetes treatments, and eventually a cure.
But most importantly, in the mean time, it will make basic overnight closed loop APS technology more widely available to anyone with compatible medical devices, thereby reducing the burden of Type 1 diabetes on everyone who lives with the disease.
So what exactly is the #OpenAPS?
The #OpenAPS is an open reference design for and a reference implementation of an overnight closed loop APS system that uses CGM sensors’ estimate of blood glucose (BG) to automatically adjust basal insulin levels, in order to keep BG levels inside a safe range overnight and between meals.
#OpenAPS is not intended to be a “set and forget” APS system. To maximize safety, #OpenAPS only doses basal insulin (not boluses), so patients still need to bolus for meals as they do today. However, #OpenAPS will estimate the size of a meal based on pump-entered carbohydrate counts or based on BG and bolus size, and can adjust basal insulin to help predict and prevent/mitigate any dangerous drop or rise in BG after a meal bolus has taken effect.
For more information on the #OpenAPS design philosophy and details, read more about the #OpenAPS Reference Design.
#OpenAPS will be an open source project
In addition to being a usable Artificial Pancreas System, #OpenAPS is also a project founded on open-source and open-science principles. All versions of the #OpenAPS design are, and will remain, open source: free for open source projects, researchers, and non-profits to use, and available on an open and non-discriminatory basis for all commercial manufacturers to use in proprietary products if desired.
Because #WeAreNotWaiting, #OpenAPS will be initially developed through the collaboration of multiple independent researchers performing their own n=1 studies and publishing their results in open-access journals / databases, where they can be aggregated through meta-analysis. In addition, the #OpenAPS project is now seeking partners with expertise in performing formal phase II/III clinical trials under IRB and IDE approval, to perform randomized clinical evaluations of #OpenAPS in human subjects who are not themselves independent researchers. In keeping with the goals and principles of the #OpenAPS project, we will seek to design the trials to be as open and inclusive as possible.
For more details on our approach to testing, clinical trials, and getting regulatory approval for #OpenAPS, read the #OpenAPS Testing and Clinical Trial Vision.
How you can help with #OpenAPS
We are well along in developing a basic #OpenAPS system (as you can see from the #OpenAPS Reference Design and the “oref0” reference implementation on Github), but we are just getting started on the road toward building a movement of like-minded people, and making #OpenAPS a reality for more people, so we need your help.
- If you are someone who wants to engage in cutting-edge medical technology development, we need your help. (If you have a personal connection to T1D, that’s a great motivation, but it’s not a requirement by any means.)
- If you are with a medical device company that wants to help accelerate the pace of technological improvement for patients, we want to collaborate with you.
- If you have experience with formal clinical trials, especially of APS or similar systems, we’d love to talk to you.
- If you’d like to talk about how to fund the #OpenAPS project, we’re all ears. We will almost certainly need funding to start formal clinical trials.
- If you or someone you love has T1D and you’re not already using Nightscout to remotely view and share BGs with loved ones as needed, join the CGM in the Cloud Facebook group or visit Nightscout.info to get started.
- If you’d like to stay up to date on progress toward an #OpenAPS, you can join the OpenAPS-info mailing list and follow @OpenAPS, @DanaMLewis and @ScottLeibrand on Twitter.
- If you’re a developer or independent researcher interested in getting involved, please join the OpenAPS-dev Google Group and review the available OpenAPS documentation on Github.
- If you’re still reading this, you undoubtedly have other skills that can be applied to this project. Let us know what you can and would like to do: the more help we can get the faster we can get to the goal of #OpenAPS technology for everyone with T1D.