FDA Clears FreeStyle Libre 3 System For Use by Individuals 4 Years and Older With Diabetes

The FreeStyle Libre 3 is the most accurate 14-day continuous glucose monitor with a 7.9% overall mean absolute relative difference and readings are sent directly to a smartphone every minute.

The FDA has cleared the next-generation FreeStyle Libre 3 system (Abbott) for use by individuals 4 years or older living with diabetes.

"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 business at Abbott, said in a 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 an Abbott press release, the FreeStyle Libre 3 is the most accurate 14-day continuous glucose monitor (CGM), with a 7.9% overall mean absolute relative difference (MARD), and readings are sent directly to a smartphone every minute.

It is the first CGM to demonstrate a sub-8% MARD, which is the standard way to measure continuous glucose accuracy, according to Abbott.

The device is about the size of 2 stacked US pennies and is worn on the back of the upper arm with a 1-piece applicator that allows for easy application. According to Abbott, it’s the smallest and thinnest CGM censor in the world.

Additionally, FreeStyle Libre 3 has approximately 50% further Bluetooth range than other CGMs with up to a range of up to 33 feet, according to the press release.

The company will price the FreeStyle Libre 3 the same as the previous version to allow the greatest number of individuals living with diabetes to benefit from the next-generation technology, according to Abbott.

"We continue to disrupt the notion that CGMs have to sacrifice quality or accuracy for affordability," Watkin said in the press release. "Access to breakthrough diabetes technologies should not be out of reach for the [individuals] who can benefit most from them. Innovation for access and affordability is a core pillar in Abbott's business and sustainability strategy."

The new system was cleared for use with the FreeStyle Libre 3 iOS and Android mobile apps that lets users view their glucose levels in real time, track their glucose history and trends, and set up optional alarms with notifications to alter the user of serious medical events, such as hypoglycemia.

The mobile app also integrates with the FreeStyle Libre digital ecosystem, including LibreView and LibreLinkUp, and enables caregivers and health care professionals to remotely monitor patients as needed.

Abbott expects the FreeStyle Libre sensor to be available at participating pharmacies later this year.

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

Reference

Abbott’s Freestyle Libre 3 receives US FDA clearance – features world’s smallest, thinnest, and most accurate 14-day glucose sensor. Abbott. News release. May 31, 2022. Accessed May 31, 2022. https://abbott.mediaroom.com/2022-05-31-Abbotts-FreeStyle-Libre-R-3-Receives-U-S-FDA-Clearance-Features-Worlds-Smallest,-Thinnest-and-Most-Accurate-14-Day-Glucose-Sensor