CGM News: FreeStyle Libre 3 Cleared by FDA for Persons Aged 4 Years and Older with Diabetes

The FreeStyle Libre 3 continuous glucose monitoring (CGM) system (Abbot) received clearance from the US Food and Drug Administration for use by individuals aged 4 years and older who live with diabetes, according to an Abbott press release dated May 31, 2022.

The company says the “next generation” FreeStyle Libre 3 will be be priced to match previous versions of the system and will be 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," said Jared Watkin, senior vice president of Abbott's diabetes care business in the press statement. "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."

The ”smallest and thinnest” sensor is the size of 2 stacked US pennies and has a 7.9% overall mean absolute relative difference (MARD), making it the first CGM to demonstrate a sub-8% MARD, according to Abbott. The sensor, applied using a one-piece applicator, is designed to be worn on the back of the arm and has a Bluetooth integration range of up to 33 ft.

The system was cleared to pair with FreeStyle Libre 3 iOS and Android mobile apps and sends glucose readings directly to a smartphone every minute, making it possible for users to view their glucose levels in real-time and to track glucose history and trends. The app connection also lets users set up optional alarms and other notifications.

In addition, the app integrates with LibreView and LibreLinkUp, both products in the FreeStyle Libre digital ecosystem that provide remote patient monitoring capability for both health care professionals and caregivers, according to Abbott.

"I have seen real-world evidence that diabetes technologies like CGMs have helped my patients safely achieve improved glycemic control," said Eugene E. Wright, Jr, MD, consulting associate at Duke University's department of medicine.

"I applaud Abbott for making their CGM system the most affordable and addressing disparities in care so patients living with diabetes can avoid complications and optimize their quality of life."