FDA Clears New Insulin Pump and Algorithm

FDA News Release

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Today, the U.S. Food and Drug Administration cleared the Beta Bionics iLet ACE Pump and the iLet Dosing Decision Software for people six years of age and older with type 1 diabetes. These two devices, along with a compatible FDA-cleared integrated continuous glucose monitor (iCGM), will form a new system called the iLet Bionic Pancreas. This new automated insulin dosing (AID) system uses an algorithm to determine and command insulin delivery.

"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, M.D., J.D., 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."

More than 11% of Americans are diagnosed with diabetes, which impairs the body's ability to make or properly use the blood glucose-regulating hormone insulin. Because the pancreas does not make insulin in people with type 1 diabetes, they have to consistently monitor their glucose levels throughout the day and have insulin therapy through injection with a syringe, an insulin pen or insulin pump to avoid becoming hyperglycemic (high glucose levels). In addition, management of type 1 diabetes includes following a healthy eating plan and physical activity.

The iLet Bionic Pancreas uses an adaptive closed-loop algorithm that is initialized only with a user's body weight and requires no additional insulin dosing parameters. This adaptive algorithm removes the need to manually adjust insulin pump therapy settings and variables as is needed with conventional pump therapy and is easier to initiate than other available AID systems. 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 human pancreas naturally supplies a low, continuous rate of insulin, known as basal or background insulin. In patients with type 1 diabetes, the body's ability to produce insulin is impaired. 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.

The FDA reviewed the iLet ACE Pump and iLet Dosing Decision Software through the 510(k) premarket clearance pathway. A 510(k) is a premarket submission made to the FDA to demonstrate that a new device is substantially equivalent to a legally marketed predicate device.

The FDA granted clearance of the iLet ACE Pump and iLet Dosing Decision Software to Beta Bionics Inc.

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

05/19/2023

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