People ages 6 and older who suffer from Type 1 diabetes have the option to receive devices that can help manage their condition through insulin delivery.
The Beta Bionics iLet ACE Pump and iLet Dosing Decision Software were cleared by the Food and Drug Administration (FDA) on May 19, according to a press release.
"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," Dr. Jeff Shuren, director of the FDA's Center for Devices and Radiological Health, said in the release. "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."
According to the release, the two devices paired with an approved integrated continuous glucose monitor, form the iLet Bionic Pancreas, which is an automated insulin dosing system. The system incorporates an algorithm to schedule and control insulin delivery, offering additional options and flexibility for diabetes management while supporting advancements in precision medicine approaches.
The iLet Bionic Pancreas eliminates the need for manual adjustment of insulin dosing parameters, the release stated. It simplifies pump therapy by automatically adjusting basal insulin doses, correction doses, and meal doses based on a user's needs. The system replaces traditional carb counting with a meal announcement feature, which allows users to estimate meal size and enables the algorithm to learn and respond to insulin requirements over time. This innovative approach aims to mimic the body's natural insulin supply.
According to the FDA, more than 11% of Americans are diagnosed with diabetes. The pancreas does not make insulin in people diagnosed with Type 1 diabetes, so they must monitor their glucose levels constantly and receive insulin therapy to prevent becoming hyperglycemic.
