The insulin pump and dosing decision software, when combined with a compatible, FDA-cleared integrated continuous glucose monitor, form the iLet bionic pancreas device
Beta Bionics has secured clearance from the US Food and Drug Administration (FDA) for its iLet ACE automated insulin pump and iLet dosing decision software for type 1 diabetes patients of six years of age and older.
The insulin pump and dosing decision software, when combined with a compatible, FDA-cleared integrated continuous glucose monitor (iCGM), form the iLet bionic pancreas device.
According to the FDA, this new automated insulin dosing (AID) system determines and commands insulin delivery by using an algorithm.
The iLet Bionic Pancreas is said to employ an adaptable closed-loop algorithm. It needs a user’s body weight for initialisation and does not need any other insulin dosing parameters.
The FDA said that the algorithm is simpler to launch than previous AID systems and eliminates the need to manually alter insulin pump therapy settings and variables.
Additionally, the iLet device further simplifies mealtime usage by replacing conventional carb counting with a new meal announcement feature.
The feature allows users to categorise their meal’s carbohydrate content as small, medium, or large, and the algorithm gradually learns to adapt to each user’s different insulin requirements.
The iLet software determines and orders the increase, decrease, maintenance or suspension of basal insulin doses. It also determines and orders correction doses of insulin based on data from an iCGM.
Furthermore, it independently decides and orders insulin meal doses based on meal announcements.
FDA Centre for Devices and Radiological Health director Jeff Shuren said: “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.
“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 US health regulator used the 510(k) premarket approval procedure to examine the iLet ACE Pump and iLet Dosing Decision Software.
In September last year, the iLet Bionic Pancreas was found effective in maintaining blood glucose levels in type 1 diabetes patients against the standard insulin delivery methods in a US National Institutes of Health (NIH)-funded study.