FDA clears next-generation insulin pump with algorithm-based insulin dosing software
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Key takeaways:
- The FDA cleared the iLet ACE insulin pump and iLet dosing decision software for people with type 1 diabetes.
- The insulin dosing system uses an adaptive closed-loop algorithm to calculate insulin needs.
The FDA had granted clearance for a next-generation automated insulin dosing system for people with type 1 diabetes, according to a press release.
The iLet ACE pump and iLet dosing decision software (Beta Bionics) were granted clearance for use among people aged 6 years and older with type 1 diabetes. The two devices, along with an FDA-cleared integrated continuous glucose monitor, will form the iLet bionic pancreas, which uses an algorithm to determine and command insulin delivery.
The bionic pancreas uses an adaptive closed-loop algorithm that is initialized using the person’s body weight with no additional insulin dosing parameters needed. The algorithm removes the need to manually adjust insulin pump therapy settings and variables. The device also replaces conventional carb counting at mealtimes with a meal announcement feature that people can use to estimate the amount of carbs in their meal as small, medium or large. The algorithm learns over time to respond to each person’s individual insulin needs.
As Healio previously reported, people with type 1 diabetes who used the bionic pancreas in a trial had a greater reduction in HbA1c and greater time in range than those receiving standard of care, with no increase in hypoglycemia.
“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 [automated insulin delivery] technology,” Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in a press 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.”