A win for the DIY diabetes community: artificial pancreas app scores FDA clearance

In October 2018, medtech nonprofit Tidepool published a blog post announcing that it was officially kicking off a project to explore and support a “do-it-yourself (DIY), open source automated insulin delivery app for iPhone.”

The project represented a significant contribution to the DIY diabetes movement, an effort to address the innovation bottleneck in diabetes technology by Type 1 Diabetes (T1D) patients themselves.

Now, two years after their initially submission to the U.S. FDA, the first fully-interoperable, automated artificial pancreas app, Tidepool Loop, has scored FDA clearance.

Illustration: Mary Delaney
Illustration: Mary Delaney

#WeAreNotWaiting: The DIY Diabetes Movement

Long before this announcement from Tidepool, T1D patients and their parents have been taking matters into their own hands.

The DIY diabetes community first used the #WeAreNotWaiting hashtag in 2013, at the first-ever DiabetesMine D-Data ExChange gathering at Stanford University.

Tidepool’s CEO, Howard Look, led the discussion that resulted in this hashtag, and then summarized it, saying: “The aim is to make diabetes data more accessible, intuitive, and actionable… We’d like to get the data into a format where it can help increase time in (glucose) range, and achieve fewer lows and better A1C.”

The essence of the DIY community could be summarized with that fact: they don’t want to wait for the digital health industry to get its act together on interoperability—not when their (an, in many cases, their children’s) health depended on the ability of these tools to work in tandem.

In the T1D world, the term “Loopers” refers to the community of patients and families who have used open-source technology to build custom, closed-loop artificial pancreas systems. They’ve manually rigged interoperability between their continuous glucose monitors (CGMs) and insulin pumps.

Until now, Loopers’ tools have included “Nightscout,” a grassroots CGM-in-the-cloud initiative for users of the Dexcom CGM, as well as Dexcom itself, which made headlines for being one of the first major medtech players to launch a public API.

Tidepool Loop and Interoperability

Tidepool’s Loop app sprang up from this community of innovators and entrepreneurs, many of whom have been involved from the start—from leadership to Loop’s clinical trials.

One of the Loop project’s core missions from the start has been to bringing the possibilities of automation and interoperability to the entire T1D community—not just those with the technological literacy and resources to DIY themselves.

The current product connects wirelessly to supported CGMs and pumps. From there, users can monitor both devices in one place and forego manual adjustments, as the app automatically adjusts insulin doses based on CGM readings.

“Tidepool Loop’s groundbreaking FDA clearance represents a pivotal step towards a world where people with T1D can choose the pump, CGM and algorithm that are best for them—and have all three work together,” said Aaron Kowalski, CEO of the Juvenile Diabetes Research Foundation (JDRF), one of Tidepool’s collaborators in developing Loop. “It’s also a testament to the innovation, commitment, and spirit of the T1D community. We look forward to continuing to work with Tidepool to make open protocol a reality, and we anxiously await news on future AID systems that will utilize this tremendous platform.”

Our takeaway: why patient leadership and open source innovation wins

There’s no doubt that the development (and successful clearance) of this technology underscores the important roles of patient leadership, interoperability, and open protocol collaboration in driving medtech innovation.

It’s not lost on us that, unlike the majority of medtech players, Tidepool is a nonprofit. 

In fact, with their announcement, Tidepool emphasized that their own 510(k) clearance should act as a green light for other similar tech to follow. Since they succeeded through open collaboration with patients, other nonprofits, and private industry, they hope others will embrace that spirit, too.

However, patient advocacy in private industry played a significant role as well. Medtronic executive Lane Desborough (a T1D dad) was one of the co-hosts of the original #WeAreNotWaiting gathering. Now, Medtronic is a key Tidepool Loop collaborator.

As we’ve emphasized with our discussions of medtech’s innovation-implementation gap, centering the true beneficiaries of medical technology—patients and providers—is key to successful adoption. From Tidepool Loop’s story, it’s also clear that patient leadership—in its most ambitious forms—is driving revolutionary product development. 

We must continue prioritizing and advocating for interoperability to help them with their cause.

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