Abbott’s Freestyle Libre 2 iCGM Receives FDA Clearance For Adults And Children With Diabetes In The U.S.

Abbott Freestyle Libre 2 FDA Clearance
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Abbott, the worldwide leader in continuous glucose monitoring (CGM), received FDA clearance for its FreeStyle Libre 2 integrated continuous glucose monitoring (iCGM) system for adults and children ages 4 and older with diabetes.

FreeStyle Libre 2  is the only iCGM system with optional real-time alarms that measures glucose levels every minute, meeting the highest level of accuracy standards over 14 days, including superior day one accuracy compared to the other iCGM and excellent accuracy and alarm performance at low-end glucose levels.6 With a 14-day wear time, the FreeStyle Libre 2 system is the longest-lasting, self-applied iCGM sensor currently available, eliminating the need for fingersticks– and priced at a third of the cost of other CGM systems.

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“We’re thrilled to bring our next-generation technology on our world-leading sensing platform to both children and adults with diabetes in the U.S.,” said Jared Watkin, senior vice president, Diabetes Care, Abbott. “With unsurpassed 14-day accuracy and enhanced features including optional alarms at a fraction of the cost of other CGMs, Abbott’s FreeStyle Libre 2 system will change the future of diabetes care in the U.S. the same way it has around the globe.”

Using Bluetooth technology, the FreeStyle Libre 2 system automatically alerts users when their glucose is high or low without needing to scan the sensor. Users also have the option of turning off the customizable, real-time alarms. The system has a combined mean absolute relative difference (MARD), a measurement of performance for CGMs, of 9.3% (9.2% for adults and 9.7% for pediatrics), making it the only iCGM sensor sustaining a high level of accuracy over 14 days, says a press release.

Continuous glucose monitoring system
Image: PRNewswire

“Innovations like FreeStyle Libre 2 will change the way people manage their diabetes, especially among children,” said Larry Kurt Midyett, M.D., pediatric endocrinologist, Midwest Women’s and Children’s Specialty Group. “Using this technology can improve time in optimal glucose range and lower HbA1c because we can get a full picture of what a child’s glucose levels are doing without having to disrupt their play or sleep with painful fingersticks. The alarms are a bonus because they provide parents a level of reassurance.”

The FreeStyle Libre 2 system met or exceeded the FDA’s rigorous iCGM special control standards. The system is designed to digitally connect and communicate with other devices. This can allow people to tailor and potentially simplify how they manage their diabetes.

The FreeStyle Libre 2 next-generation sensor, which is a third less bulky than other CGM sensors, is worn on the back of the upper arm for up to 14 days and measures glucose every minute to help users and their healthcare providers make informed treatment decisions. With a one-second scan using a handheld reader, users can see their glucose reading, trend arrow and eight-hour history. It is also designed for use with a mobile app, which Abbott is working to bring to the U.S. market.

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The FreeStyle Libre 2 system will be available in the coming weeks at participating pharmacies and durable medical equipment suppliers (DMEs) across the U.S. Abbott will offer the new system at the same price as the currently available FreeStyle Libre 14-day system, which was approved by the FDA in July 2018.