The iLet Bionic Pancreas system has received FDA clearance for use in patients aged 6 and older with type 1 diabetes, according to the announcement made by the agency on Friday. This innovative system, designed in a pocket-sized form, combines the Beta Bionics iLet ACE pump with the iLet Dosing Decision Software. The newly cleared components of the system are paired with a compatible integrated continuous glucose monitor (CGM) that has also received FDA clearance.
The FDA's decision to grant clearance to the iLet Bionic Pancreas system follows the Breakthrough Device Designation it received in late 2019. This designation recognizes the potential of the system to offer additional options and flexibility for diabetes management, benefiting the type 1 diabetes community.
Jeff Shuren, MD, JD, director of the FDA's Center for Devices and Radiological Health, expressed enthusiasm about the clearance, stating, "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." Dr. Shuren further emphasized the FDA's commitment to advancing innovative devices that improve the health and quality of life of individuals managing chronic diseases like diabetes through precision medicine approaches.
Closed-loop functionality, which eliminates the need for insulin dosing parameters during initialization. The system relies solely on the patient's body weight, eliminating the manual adjustment of insulin delivery rates commonly found in other available automated insulin dosing (AID) systems.
Meal announcement feature, which estimates the amount of carbohydrates consumed during meals as small, medium, or large. This advancement removes the traditional reliance on carb counting for mealtime insulin dosing. The system's algorithm then adapts to the individual's insulin needs over time, reducing the requirement for bolus insulin deliveries for meals or corrections.
Furthermore, the iLet Bionic Pancreas system offers versatility as it can be configured as an insulin-only bionic pancreas, a glucagon-only bionic pancreas, or a bihormonal bionic pancreas using both insulin and glucagon.
The system's efficacy has been demonstrated in a successful pivotal trial published in the New England Journal of Medicine in September. Users of the iLet Bionic Pancreas system experienced a significant average drop in HbA1c levels from 7.9% to 7.3% over a 13-week period, in contrast to the standard-of-care group, which maintained a steady hold at 7.7% (mean adjusted difference -0.5%, 95% CI -0.6 to -0.3, P<0.001). Additionally, users of the bionic pancreas spent an average of 11% more time within the target glucose range of 70 to 180 mg/dL, representing a 2.6-hour increase per day compared to the standard-of-care group. Furthermore, they spent significantly less time in hyperglycemia (above 180 mg/dL) and severe hyperglycemia (above 250 mg/dL). The standard-of-care group involved the use of real-time CGM with Dexcom systems, paired with any insulin delivery method.
Overall, the FDA's clearance of the iLet Bionic Pancreas system marks a significant milestone in diabetes management for patients with type 1 diabetes aged 6 and older. With its features, adaptability, and demonstrated efficacy, this system has the potential to transform the lives of T1 individuals managing this chronic condition. More to come.