The new iLet Bionic Pancreas system was cleared by the FDA for patients 6 and older with type 1 diabetes, the agency announced Friday.

The pocket-sized system features the the Beta Bionics iLet ACE pump fitted with the iLet Dosing Decision Software. Both newly cleared arms of the system are then paired with a compatible FDA-cleared integrated continuous glucose monitor (CGM).

The clearance comes after the FDA granted the system Breakthrough Device Designation in late 2019.

“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 [automated insulin dosing] technology,” said Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, in a statement. “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 closed-loop system doesn’t require any insulin dosing parameters to initialize — only using the patient’s body weight — and doesn’t require manual adjustment of insulin delivery rates, making it “easier to initiate than other available AID systems” on the market.

The system also boasts a meal announcement feature, estimating carb consumption at meal-time as either small, medium, or large, thus removing the need for traditional carb counting. From there, the algorithm adapts to the individual’s insulin needs over time, not requiring bolus insulin devilries for meals or corrections.

The pump can be configured as an insulin-only bionic pancreas, a glucagon-only bionic pancreas, or a bihormonal bionic pancreas using insulin and glucagon.

The fully automatic system demonstrated its efficacy in a successful pivotal trial published last September in the New England Journal of Medicine. Here, users of the system saw an average drop in HbA1c from 7.9% to 7.3% compared with a steady hold at 7.7% for the standard-of-care group over 13 weeks (mean adjusted difference -0.5%, 95% CI -0.6 to -0.3, P

Users of the bionic pancreas also spent on average 11% longer in target glucose range (70 to 180 mg/dL) versus the standard-of-care group, representing a 2.6-hour increase per day. They also spent significantly less time in hyperglycemia (above 180 mg/dL) and severe hyperglycemia (above 250 mg/dL). Standard of care involved real-time CGM with Dexcom systems paired with any insulin delivery method.