FDA clears two CGM sensors for integration with automated insulin delivery systems
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The FDA has granted clearance to allow two integrated continuous glucose monitoring sensors to be used with automated insulin delivery systems, according to an industry press release.
As Healio previously reported, the FDA approved the FreeStyle Libre 2 (Abbott) in 2020 and the FreeStyle Libre 3 (Abbott) in 2022 for people with diabetes aged 4 years and older for a wear time of up to 14 days. The FDA’s newest clearance allows both of these devices to be used with automated insulin delivery systems and extends clearance to children as young as age 2 years and for a wear time of up to 15 days. The clearance also allows the modified sensors to be used by pregnant women with type 1, type 2 or gestational diabetes.
“Our goal is to make diabetes care as easy as possible,” Jared Watkin, senior vice president for Abbott’s diabetes care business, said in a press release. “The FreeStyle Libre portfolio is already the most prescribed CGM in the U.S. and, with the integration of automated insulin delivery systems, people in the U.S. will soon have an affordable option to pair with insulin pumps. This means less time thinking about diabetes and more time living.”
The new clearance comes after Abbott made modifications to the sensors to allow for integration. In the press release, Abbott said it is working with leading insulin pump manufacturers to allow for both sensors to be integrated into their systems. The company states it is partnering with Insulet and Tandem for future integrations in multiple countries, including in the U.S.
The modified CGM sensors will be available in the U.S. later in 2023 and will gradually replace the currently available sensors, according to the company.
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