Tidepool lands long-awaited FDA nod for artificial pancreas app connecting CGMs, insulin pumps

More than two years after submitting it for FDA review, Tidepool has scored the agency’s clearance for a smartphone app that allows people with Type 1 diabetes to build their own closed-loop “artificial pancreas” system.

Tidepool, a Silicon Valley-based nonprofit and former Fierce 15 winner, originally submitted the Loop app for clearance in December 2020. In a news roundup this week, the FDA noted that it had finally granted that request on Monday. According to Tidepool, that makes its prescription-only app the first to be cleared by the FDA to connect a variety of diabetes management devices and automate insulin dosing.

“We knew this day would come, but we couldn’t have achieved it without the support of the entire diabetes community, including the FDA,” CEO Howard Look said in a company announcement Tuesday, offering his specific thanks to the “DIY” diabetes community and all participants in clinical studies of Loop.

The technology was cleared for all Type 1 diabetes patients aged 6 and older.

The app connects wirelessly to certain continuous glucose monitors and insulin pumps that are compatible with alternate controllers. From there, rather than managing each device separately and manually updating insulin dosages, users can monitor both devices in one place, and the app automatically tweaks basal insulin doses based on CGM readings. Loop’s algorithm can also predict spikes in glucose and recommend correction doses of bolus insulin—which users have to manually accept.

Tidepool hasn’t yet announced which devices will be available for integration with the app at its launch but said in this week’s release that it’s in the process of finalizing agreements with some makers of CGMs and insulin pumps. The nonprofit also has ongoing development partnerships with Dexcom and other unnamed devicemakers to bring their current and future products into the Loop.

Though the company didn’t disclose when the app’s official rollout will begin, it will first be available for download only by iPhone users, via the Apple App Store. Those who also have an Apple Watch will be able to use the wearable to control their insulin dosing, too. The app will eventually be made available to Android users, but, according to Tidepool’s website, “We do not have an estimate on when this work will be completed.”

The Loop app was born out of Tidepool’s collaborations with patients with Type 1 diabetes, plus other nonprofits like the Juvenile Diabetes Research Foundation (JDRF) and diabetes devicemakers including Insulet, Dexcom and Medtronic.

In keeping with that spirit of collaboration, Tidepool made a point in this week’s announcement to celebrate the fact that its own 510(k) clearance has now helped pave an easier regulatory pathway for other automated insulin dosing (AID) apps and algorithms like Loop.

“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 JDRF. “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.”