FDA Clears New Insulin Pump and Dosing System for Type 1 Diabetes Patients

The U.S. Food and Drug Administration (FDA) cleared a new insulin pump and insulin dosing software that will aid in determining and steering better insulin delivery for patients 6 years and older with type 1 diabetes (T1D), as announced in FDA press release on May 19, 2023.

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

The adaptive closed-loop algorithm requires only the patient’s body weight for start-up. This algorithm eliminates the need to manually adjust insulin pump therapy settings and variables. Also, there is no need for additional insulin dosing parameters. The device also includes a new feature that allows users to estimate the amount of carbs in their meal as small, medium, or large.

“Today’s action will provide the T1D community with additional options and flexibilities for diabetes management and may help to broaden the reach of AID technology,” said Jeff Shuren, MD, director, 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.”

More than 11% of Americans are diagnosed with diabetes, according to the FDA.

Reference:
FDA clears new insulin pump and algorithm-based software to support enhanced automatic insulin delivery. FDA news release. May 19, 2023.