PALO ALTO, Calif.– Tidepool, a 501(c)3 nonprofit committed to empowering the next generation of innovations in diabetes management, today announced the FDA clearance of Tidepool Loop, an automated insulin dosing app intended for the management of type 1 diabetes (T1D) in persons six years of age and greater.
Tidepool Loop, a patient-led project, is the first application of its kind to receive clearance from the FDA, and is also the first to enable insulin delivery from a compatible Apple Watch. The algorithm technology in Tidepool Loop is intended for use with compatible integrated continuous glucose monitors (iCGM) and alternate controller enabled (ACE) pumps to automatically increase, decrease, and suspend delivery of basal insulin based on iCGM readings and predicted glucose values. It can also recommend and deliver correction boluses when glucose values are predicted to exceed predefined thresholds.
“We knew this day would come, but we couldn’t have achieved it without the support of the entire diabetes community, including the FDA,” said Howard Look, CEO and co-founder of Tidepool. “I’d also like to personally acknowledge and celebrate the contributions of the DIY community and participants in the Loop Observational Study conducted by the JAEB Center for Health Research who made this milestone possible.”
Tidepool Loop can now serve as a predicate device for future interoperable Automated Insulin Dosing (AID) submissions, providing a more clearly defined pathway through the regulatory process. This work was supported by grants from JDRF, The Helmsley Charitable Trust, the Tullman Foundation, and a diverse community of individual funders impacted by their experience with diabetes.
“Tidepool helped bridge the gap between the fast pace of innovation in the community and the rigor of current quality management systems. This is a triumph for stakeholders across the diabetes industry, and most importantly, will make a real impact in the lives of people with diabetes,” said David Panzirer, Trustee at The Leona M. and Harry B. Helmsley Charitable Trust.
“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.”
With the clearance of Tidepool Loop, the organization is now finalizing agreements with device partners to create a seamless experience for both physicians prescribing Tidepool Loop and the patients using it. Though Tidepool’s initial launch device partners have not been announced, the company has a development partnership with Dexcom (DXCM) and additional yet-to-be-named medical device companies for future inclusion of their components with the Tidepool Loop platform.
