Sam Brusco, Associate Editor05.31.22
Abbott today announced U.S. Food and Drug Administration (FDA) clearance for it’s next-gen FreeStyle Libre 3 14-day continuous glucose monitoring (CGM) system for people four years and up with diabetes.
The system will be the same price as previous versions, which is about one-third the cost of competing CMG systems available today, according to the company. FreeStyle Libre 3 is about the size of two stacked U.S. pennies.
"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 VP of Abbott's diabetes care business told the press. "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 new system touts a 7.9% overall mean absolute relative difference (MARD), the standard way to measure continuous glucose accuracy. It’s the first CGM to show a MARD under 8%, according to Abbott.
Cleared for use with the FreeStyle Libre 3 iOS and Android mobile apps, its Bluetooth integration has a range of up to 33 feet. The mobile app links with the FreeStyle Libre digital ecosystem, including LibreView and LibreLinkUp to remotely monitor loved ones and patients.
"I have seen real-world evidence that diabetes technologies like CGMs have helped my patients safely achieve improved glycemic control," said Dr. Eugene E. Wright, Jr., 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."
FreeStyle Libre 3 gained CE mark approval in September 2020.
The system will be the same price as previous versions, which is about one-third the cost of competing CMG systems available today, according to the company. FreeStyle Libre 3 is about the size of two stacked U.S. pennies.
"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 VP of Abbott's diabetes care business told the press. "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 new system touts a 7.9% overall mean absolute relative difference (MARD), the standard way to measure continuous glucose accuracy. It’s the first CGM to show a MARD under 8%, according to Abbott.
Cleared for use with the FreeStyle Libre 3 iOS and Android mobile apps, its Bluetooth integration has a range of up to 33 feet. The mobile app links with the FreeStyle Libre digital ecosystem, including LibreView and LibreLinkUp to remotely monitor loved ones and patients.
"I have seen real-world evidence that diabetes technologies like CGMs have helped my patients safely achieve improved glycemic control," said Dr. Eugene E. Wright, Jr., 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."
FreeStyle Libre 3 gained CE mark approval in September 2020.