Abbott gets FDA clearance for FreeStyle Libre 2

Patients with diabetes will soon have a new glucose monitoring system to help manage their condition.

The Food and Drug Administration has cleared Abbott’s next-generation FreeStyle Libre 2 integrated continuous glucose monitoring system for adults and children ages 4 and older with diabetes.

This 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. 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, Abbott said.

"We're thrilled to bring our next generation technology on our world-leading sensing platform to both children and adults with diabetes in the United States," said Jared Watkin, Abbott senior vice president, Diabetes Care. "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 United States 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, 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, the company said.

"Innovations like FreeStyle Libre 2 will change the way people manage their diabetes, especially among children," said Larry Kurt Midyett,  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 will be available in the coming weeks at participating pharmacies and durable medical equipment suppliers. 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.

"Managing diabetes is expensive, even for those with insurance coverage," said Watkin. "From the start, Abbott designed FreeStyle Libre technology with affordability in mind. We set a global price for our sensing technology that's closer to that of traditional blood glucose fingerstick systems, and significantly less than other CGMs, because we wanted to make sure our life-changing technology was accessible to as many people as possible."