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Beta Bionics’ iLet ACE Pump, Dosing Decision Software OK’ed

The two devices will create a new system called the “iLet Bionic Pancreas."

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By: Sam Brusco

Associate Editor

Beta Bionics has gained U.S. Food and Drug Administration (FDA) clearance for the iLet ACE pump and iLet dosing decision software for people six and older with type 1 diabetes.
 
The two devices—along with an FDA-cleared integrated continuous glucose monitor (iCGM)—will create a new system called the “iLet Bionic Pancreas.” The new automated insulin dosing (AID) system leverages an algorithm to determine and command insulin delivery.
 
“[This] 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’s Center for Devices and Radiological Health, told the press. “The FDA is committed to advancing new device innovation that can improve the health and quality of life for people living with chronic diseases that require day-to-day maintenance like diabetes through precision medicine approaches.”
 
The iLet Bionic Pancreas uses an adaptive closed-loop algorithm that is initialized only with a user’s body weight and needs no additional insulin dosing parameters. This adaptive algorithm removes the need to manually adjust insulin pump therapy settings and variables, as needed, with conventional pump therapy.
 
The iLet device also simplifies use at mealtime by replacing conventional carb counting with a new meal announcement feature. With the new feature, users can estimate the amount of carbs in their meal as small, medium, or large and the algorithm learns over time to respond to users’ individual insulin needs.
 
The iLet Dosing Decision Software independently determines and commands an increase, decrease, maintenance, or suspension of all basal insulin doses and determines and commands correction doses of insulin based on input from an iCGM. It also independently determines and commands meal doses of insulin based on meal announcements.

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