FDA Clears New Insulin Pump and Algorithm-Based Software

Enhanced automatic insulin delivery system cleared for people with type 1 diabetes ≥6 years
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Medically Reviewed By:
Mark Arredondo, M.D.

THURSDAY, May 25, 2023 (HealthDay News) -- The U.S. Food and Drug Administration (FDA) cleared the Beta Bionics iLet ACE Pump and the iLet Dosing Decision Software (Beta Bionics) for use in people at least 6 years of age with type 1 diabetes.

These two devices, in addition to a compatible FDA-cleared integrated continuous glucose monitor (iCGM), form a new system called the iLet Bionic Pancreas. This automated insulin dosing (AID) system uses an algorithm to determine and command insulin delivery.

The iLet Bionic Pancreas uses an adaptive closed-loop algorithm that requires no additional insulin dosing parameters, only the individual’s body weight, eliminating the need to manually adjust insulin pump therapy settings as is needed with conventional pump therapy. Furthermore, the iLet device simplifies mealtimes by replacing conventional carb counting with a meal announcement feature in which users estimate the amount of carbs in their meal as small, medium, or large, and subsequently learns over time to respond to users' individual insulin needs.

"Today’s action will provide the type 1 diabetes community with additional options and flexibilities for diabetes management and may help to broaden the reach of AID technology," Jeff Shuren, M.D., J.D., director of the FDA Center for Devices and Radiological Health, said in a statement.

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