FDA Authorizes Automated Insulin Dosing App

Source: JDRF.org

The U.S. Food and Drug Administration (FDA) has 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

Another partner, the JDRF (Juvenile Diabetes Research Foundation), 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. With a goal to ensure life-changing options for people with T1D and a competitive ecosystem that drove continuous innovation, JDRF has funded more than $140 million in artificial pancreas research to date.

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.

What if there was a world where anyone with diabetes and a smartphone might access the latest innovations coming from medical technology and the flexibility to choose the components they believe reduce their diabetes burden in the most meaningful way to them? That’s the promise of interoperability.

The FDA has created new pathways for components (and the companies that make them) to work together so that users might one day have more choices in the systems they use. They’ve determined three types of components and a regulatory pathway for each.

To learn more, visit the Tidepool Loop Web site.

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