Tidepool Makes a Splash with FDA Green Light for Automated Insulin Delivery System

Putting the power of automated insulin delivery (AID) in the hands of grateful patients, a do-it-yourself system from Palo Alto-based diabetes management nonprofit Tidepool has earned clearance from the FDA. Paired with the aptly named Tidepool Loop is a hybrid closed-loop AID app, which allows for a wide variety of continuous glucose monitors as well as insulin pumps to work with the system. The baked-in algorithm can work with compatible integrated CGMs and alternate controller-enabled (ACE) pumps.

“What we submitted was different from other [AID] solutions on the market, because our submission did not depend on proprietary insulin pump or continuous glucose monitoring hardware that we develop or control,” said Tidepool Chief Executive Officer Howard Look. “Giving people living with diabetes the freedom and flexibility to collaborate with their healthcare providers, to select the interoperable hardware components, and to establish the settings configurations that work best for their particular situation is part of our bigger goal.”

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The Tidepool Loop was developed for type-1 diabetes management in individuals aged six years or older, and its compatibility with the ubiquitous Apple Watch makes it an easy sell for skeptics of the “DIY” aspect of the tech. The company believes the system could possibly act as a predicate device for interoperable AID submissions going forward, in addition to clearing the way for accelerated innovation in the diabetes management space.