FDA clears next-generation FreeStyle Libre 3 CGM for people with diabetes
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The FDA has cleared a next-generation integrated continuous glucose monitor for people with diabetes aged 4 years and older, according to a press release from Abbott.
The FreeStyle Libre 3 is the CGM with the lowest overall mean absolute relative difference in glucose on the market, as well as the smallest and thinnest sensor developed to date, according to the release.
“The FreeStyle Libre 3 system is a direct result of listening to our customers — and giving them the innovation and sensing technology they've been looking for," Jared Watkin, senior vice president of diabetes care for Abbott, said in the press release. "It's a game changer for the millions of people living with diabetes. They'll be able to manage their health minute-by-minute with the world's smallest and thinnest sensor and most accurate 14-day continuous glucose monitoring system.”
According to the release, the FreeStyle Libre 3 improves on the 9.3% mean absolute relative difference of its predecessor, the FreeStyle Libre 2. The next-generation device has a mean absolute relative difference of 7.9% at 14 days of use and is the first device to have a mean absolute relative difference of less than 8%. The device is the small and thin, the size of two stacked U.S. pennies. The FreeStyle Libre 3 also features improved Bluetooth integration with a range up to 33 feet.
The device has been cleared for use with the FreeStyle Libre 3 iOS and Android mobile apps, allowing users to view glucose levels in real time, track glucose history and trends, and set up optional alarms and notifications to be alerted of serious medical events, such as hypoglycemia. The app integrates with the FreeStyle Libre digital ecosystem to give caregivers and health care professionals monitoring access.
The FreeStyle Libre 3 will be available at the same price of its previous two iterations, according to the release. As Healio previously reported, the original FreeStyle Libre system was approved in July 2018 and its successor, the FreeStyle Libre 2, was cleared in June 2020. The new device is expected to be available at pharmacies later in 2022.
"We continue to disrupt the notion that CGMs have to sacrifice quality or accuracy for affordability," Watkin said. "Access to breakthrough diabetes technologies should not be out of reach for the people who can benefit most from them. Innovation for access and affordability is a core pillar in Abbott's business and sustainability strategy."
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