Abbott (NYSE:ABT) announced today that it received FDA clearance for its next-generation FreeStyle Libre 3 continuous glucose monitor.
FDA clearance for the latest iteration of the company’s FreeStyle Libre platform — designed as the smallest and thinnest CGM sensor in the world — covers use by people 4 years of age and older living with diabetes.
According to a news release, the FreeStyle Libre 3 CGM recorded a 7.9% mean absolute relative difference (MARD). Abbott said the MARD measure of accuracy makes FreeStyle Libre 3 the most accurate 14-day CGM with readings sent directly to a smartphone every minute.
The Abbott Park, Illinois–based company said FreeStyle Libre 3 is the first CGM to demonstrate a sub-8% MARD and, at the size of two stacked U.S. pennies, the smallest and thinnest CGM sensor in the world is worn inconspicuously on the back of the upper arm and is uncomplicated to apply thanks to a one-piece applicator.
FreeStyle Libre 3 also has strong Bluetooth integration, with a range of up to 33 feet representing a 50% increase on competitive CGMs, Abbott said.
The platform will be priced the same as previous versions of the FreeStyle Libre, Abbott said, in an effort to enable the greatest number of people living with diabetes to benefit from the technology. It was cleared for use with the FreeStyle Libre 3 iOS and Android mobile apps, allowing for real-time glucose level viewing, history tracking and optional alarms plus notifications for events like hypoglycemia.
FreeStyle Libre 3’s mobile app integrates with the FreeStyle Libre digital ecosystem to allow caregivers and healthcare professionals to remotely monitor users. Abbott intends to make FreeStyle Libre 3 available at participating pharmacies later this year.
“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,” SVP for Abbott’s diabetes care business Jared Watkin said in the 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.”
BTIG analyst Marie Thibault pointed out that, according to the 510(k) database, the FreeStyle Libre 3 is classified as a factory-calibrated iCGM not intended for use with automated insulin delivery systems. She wrote that BTIG will wait for more details and specific U.S. rollout timing, but it considers the clearance a “significant win” for Abbott.
“We think conversion from patients using multiple daily injections will continue to be robust and attrition from the existing customer base will continue to be low,” Thibault wrote. “We also believe the opportunity to tap into the non-intensive insulin using population will be a significant growth driver as payors continue to evaluate the economic value proposition of CGM for these patients.”