FDA Authorizes Tidepool Loop, an Automated Insulin Dosing App
The U.S. Food and Drug Administration (FDA) authorized the Tidepool Loop, an automated insulin dosing app intended for the management of type 1 diabetes (T1D). The Loop is, essentially, an algorithm that can, eventually, be used to work with commercially available insulin pumps and continuous glucose monitors (CGMs). The goal of the interoperable design: Provide flexibility for users and their healthcare teams to choose the compatible components that work best for them in managing their care.
It will be available as an app on iOS, to enable insulin delivery from a compatible Apple Watch. Tidepool has not yet announced its initial launch device partners, but the company has a development partnership with Dexcom and additional yet-to-be-named medical device companies for future inclusion of their components with the Tidepool Loop platform.
JDRF started the Artificial Pancreas Project over 15 years ago to ensure people with T1D have better, more innovative ways to manage their T1D until there are cures. Our goal was to ensure life-changing options for people with T1D and a competitive ecosystem that drove continuous innovation. To date, JDRF has funded more than $140 million in artificial pancreas research.
Through these grants, JDRF supported the development of the algorithm and other open source programs—in partnership with the Helmsley Charitable Trust—through grants to Tidepool.
This is a win for the T1D community and provides people with T1D another option to improve daily blood-sugar management, until cures are found.
Here is Aaron J. Kowalski, Ph.D., announcing the approval, highlighting JDRF’s role in the research and regulatory process, and reiterating that people with T1D should connect with their physician about the treatments best for them:
To learn more, visit the Tidepool Loop website.