FDA OKs Tidepool Loop App Connecting CGMs, Insulin Pumps

Tidepool, a 501(c)3 nonprofit company specializing in diabetes management, has earned U.S. Food and Drug Administration (FDA) clearance for Tidepool Loop, an automated insulin dosing app to manage type 1 diabetes (T1D) in patients six years and older.
 
The patient-led Tidepool Loop project is the first application of its kind to earn FDA clearance, according to the company. It’s also the first to allow insulin delivery from a compatible Apple Watch. Tidepool Loop’s algorithm tech is intended for use with compatible integrated continuous glucose monitors (iCGM) and alternate controller enable (ACE) pumps to automatically increase, decrease, and suspend basal insulin delivery based on iCGM readings and predicted glucose levels.
 
It can also recommend and deliver correction doses when glucose values are predicted to surpass 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,” Howard Look, CEO and co-founder of Tidepool told the press. “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 aims to be a predicate device for future interoperable automated insulin dosing (AID) submission for a more clearly defined pathway through the regulatory process. The work was supported by grants from JDRF, The Helmsley Charitable Trust, the Tullman Foundation, and a diverse community of individual funders.
 
“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.”
 
Tidepool is now finalizing agreements with device partners. Initial launch device partners haven’t yet been revealed, but the company has a development partnership with Dexcom and yet-to-be-named medical device firms for inclusion of their components with Tidepool Loop.