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Aug 18, 2023

FDA clears next

Press Release Press Release The FDA had granted clearance for a

Press Release

Press Release

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."

Diana Isaacs, PharmD, BCPS, BCACP, BC-ADM, CDCES, FADCES

I am so excited about the FDA approval of the iLet. This offers more choices for people with diabetes.

This system is unique in that it greatly simplifies the management for both the person with diabetes and the health care provider. Traditional insulin pumps, even other automated insulin delivery systems, require a number of calculated settings like basal rates, carbohydrate ratios, insulin sensitivity factors and insulin action time. This system requires only the person's weight and connection to continuous glucose monitoring, and then one can "go bionic." It uses meal announcements of usual, less or more compared to precise carbohydrate counting. Also, the size of the pump is pretty small. Although FDA approved for type 1 diabetes, I could see this being a great option in insulin-requiring type 2 diabetes, especially with its simplicity of use and start-up.

Of note, the insulin cartridge holds only 160 U compared with other pumps that hold 200 U to 300 U, so those on higher doses may need to change it out more frequently. The pump is considered an [alternate controller enabled, or] ACE insulin pump, and I would be curious to see if they would be open to future partnerships with other FDA-approved automated insulin dosing algorithms like Tidepool and other iCGM devices. Overall, I am thrilled to have a new option to offer to my patients.