FDA Clears iLet Bionic Pancreas for Patients With Type 1 Diabetes

The Food and Drug Administration (FDA) has cleared the Beta Bionics iLet ACE Pump and the iLet Dosing Decision Software for individuals 6 years of age and older with type 1 diabetes.

When combined with a compatible FDA-cleared integrated continuous glucose monitor (iCGM), the iLet ACE Pump and the iLet Dosing Decision Software form a new automated insulin dosing (AID) system called the iLet Bionic Pancreas. 

The iLet Bionic Pancreas uses an adaptive closed-loop algorithm requiring only a user’s body weight for start-up and no additional insulin dosing parameters. This adaptive algorithm is able to determine and command insulin delivery removing the need to manually adjust insulin pump therapy settings and variables. The device also includes a new meal announcement feature that allows users to estimate the amount of carbs in their meal as small, medium, or large. The adaptive algorithm will learn over time to respond to the users’ individual insulin needs. 

Based on input from the iCGM and meal announcements, the device is able to independently determine and command all basal insulin dose adjustments, along with meal doses of insulin. 

“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,” said Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health. “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.”