Next-Generation Integrated Continuous Glucose Monitor Now Available Following FDA Clearance

An integrated continuous glucose monitor (iCGM) is now available for adults and now children (4+ years) living with diabetes, following its clearance in June from the U.S. Food and Drug Administration (FDA). Abbot is marketing this new technology as the FreeStyle® Libre 2.

The FreeStyle Libre 2 system uses Bluetooth to 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).

This new CGM 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 sensor 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.

“Innovations like FreeStyle Libre 2 will change the way people manage their diabetes, especially among children,” says Endocrine Society member Larry Kurt Midyett, MD, a pediatric endocrinologist at 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.”