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Tidepool announces plans to deliver Loop as supported, FDA-regulated mobile app
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Tidepool has launched a project to officially support Loop, an app designed for do-it-yourself automated insulin delivery devices, that includes plans to submit the app to the FDA and an observational study of “loopers” slated to begin in November, according to an announcement posted on the nonprofit company’s blog Oct. 8.
“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,” Howard Look, founder, CEO and president of Tidepool, 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 continuous glucose monitors 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.
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.
“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.”
In an interview, Look said it was too early to comment on how the Loop app would be submitted to FDA.
“We’ve really just started the pathway conversation with the FDA, so 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, 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
Disclosure: Look reports he is the founder, CEO and president of Tidepool.