FDA clears next-generation integrated continuous glucose monitor
The FDA has cleared a next-generation integrated continuous glucose monitoring system for adults and children aged 4 years and older with diabetes, according to a press release from Abbott.
The FreeStyle Libre 2 integrated continuous glucose monitoring (iCGM) system is the only system with optional, real-time alarms that measure glucose levels every minute. The system has a 14-day wear time, making it the longest-lasting, self-applied iCGM available, according to the release.
"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.," Jared Watkin, senior vice president of diabetes care at Abbott, said in the release. "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."
According to the FDA, an iCGM can be used as part of an integrated system with other compatible medical devices and electronic interfaces, which may include automated insulin dosing systems, insulin pumps, blood glucose meters or other electronic devices used for diabetes management. In the release, Abbott states this system must not be used with an automated insulin dosing system, such as a closed-loop insulin delivery system, and insulin suspend systems.
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 of 9.3% (9.2% for adults and 9.7% for children), allowing it to sustain a high level of accuracy over 14 days, according to the release.
The system’s next-generation sensor is worn on the back of the upper arm for up to 14 days and measures glucose every minute, allowing users to see their glucose reading, trend arrow and 8-hour history when scanning the sensor with a handheld reader. The Libre 2 is also designed for use with a mobile app, which Abbott is working to bring to the U.S. market, according to the release.
Abbott said the FreeStyle Libre 2 system will be available in the coming weeks at participating pharmacies and durable medical equipment suppliers 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.
"Managing diabetes is expensive, even for those with insurance coverage," Watkin said in the release. "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."