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Nonprofit announces plans to deliver Loop as supported, FDA-regulated mobile app
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A nonprofit, open-source technology company that provides a cloud platform for diabetes device data has launched a project to officially support Loop, an app designed for do-it-yourself automated insulin delivery devices.
The initiative, first announced on the company’s blog Oct. 8, includes plans to submit the app to the FDA and an observational study of “loopers” slated to begin in November. The project is the first of its kind, according to Howard Look, founder, CEO and president of Tidepool, and would allow people with diabetes to potentially create their own closed-loop insulin delivery system using the latest, in-warranty insulin pumps and continuous glucose monitors — no “hacking” of older devices required.
In an interview with Endocrine Today, Look said the DIY artificial pancreas community continues to innovate and build on what its members have created. Detailed instructions for creating a basic closed-loop insulin delivery system with a compatible insulin pump, a CGM and a small computer are available on several online forums, and those instructions are updated in live time frequently. The goal of the Tidepool-backed project, Look said, is to allow people interested in the technology to create a closed-loop system that is backed by an FDA- approved and regulated app.
“We are huge fans of the DIY community — I believe over half of the Tidepool team is currently using Loop or has a child using Loop — and we have all been participants in the DIY community in one form or another,” Look told Endocrine Today. “The DIY community will keep going on. Our intent here is to make a regulated, approved version of Loop, so that people who don’t want to build their own artificial pancreas system don’t have to in order to gain the benefits of great, closed-loop care.”
Loop, an Apple-only framework compatible with iPhone, runs an algorithm every 5 minutes to automatically adjust basal insulin rates by communicating with a circuit board that “hacks” into an older insulin pump and a variety of available CGMs via Bluetooth, effectively creating a DIY artificial pancreas. The app, which is not regulated or approved by the FDA, was developed as an open-source, shared project, including people with type 1 diabetes, to allow customization in closed-loop technology. The project continues to be maintained and improved by volunteers in what is now known as the “DIY” community, which includes the Facebook groups Looped, CGM in the Cloud, xDripG5 and Nightscout for Medtronic.
If approved by the FDA, Loop would be available in the iOS App Store and designed to work with commercially available insulin pumps and CGMs, potentially changing the artificial pancreas landscape, Look said. Currently, the only FDA-approved hybrid closed-loop system is the Medtronic 670G. The Omnipod Horizon system (Insulet) and Tandem Control IQ system are both in development.
“We expect the Tidepool Loop app to be compatible with at least one, and hopefully many more, commercial, in-warranty insulin pumps,” Look wrote in the blog post. “We are working closely with pump vendors on their ‘iPump’ capabilities, analogous to the ‘iCGM’ de novo designation released by the FDA in March 2018.”
Look said it was too early to comment on how the Loop app would be submitted to FDA. The nonprofit is part of the FDA’s digital health precertification pilot program and Tidepool has already met with the FDA several times regarding Loop, Look said.
In a blog post on diaTribe.org, a patient-focused online publication, Adam Brown, an employee of Close Concerns, volunteer for diaTribe and a DIY artificial pancreas user for about 2 years, speculated that a Tidepool-backed Loop launch might be possible in 2 to 4 years.
“If Tidepool is successful, this news has important implications for the future of automated insulin delivery — opening up a new FDA and product pathway,” Brown wrote. “Instead of one complete approved ‘system’ like the MiniMed 670G, Tidepool Loop would bring together three interoperable components that are separately approved and communicate seamlessly with each other — app, CGM, pumps. This approach would give users another choice in automated insulin delivery (mix-and-match a compatible CGM and pump), allow companies to innovate on their separate components with potentially less hassle, and make the FDA’s job much easier.”
Look said the pathway conversation has only just begun.
“We’ve got a lot more to do before we can say for sure what the pathway will be,” Look said. “The FDA has clearly been supportive of this interoperability pathway with the iCGM de novo, and lots of companies have talked about their intent to do an iPump de novo.”
As part of the Loop effort, Tidepool is also partnering with the Jaeb Center for Health Research to conduct a 12-month observational study to assess Loop safety and efficacy among 150 to 300 current and new Loop users, Look said. The study is enrolling only those currently using Loop and will also assess quality of life metrics. Tidepool is providing the software that will collect data for the study. – by Regina Schaffer
- References:
- Brown A. Tidepool will submit Loop to FDA, the DIY iPhone app for automated insulin delivery [diatribe.org blog post]. Oct. 17, 2018. Available at: diatribe.org/tidepool-will-submit-loop-fda-diy-iphone-app-automated-insulin-delivery.
- Tidepool intends to deliver Loop as a supported, FDA-regulated mobile app in the App Store [Tidepool blog post]. Oct. 8, 2018. Available at: tidepool.org/tidepool-delivering-loop/.
- For more information:
- Howard Look can be reached at howard@tidepool.org.
Disclosure: Look reports he is the founder, CEO and president of Tidepool.