Abbott FreeStyle Libre 2

FDA Clears Abbott’s Continuous Glucose Monitoring System for Use in Children

By MedTech Intelligence Staff
Abbott FreeStyle Libre 2

The FreeStyle Libre 2 now has indications for children ages four and older.

Abbott FreeStyle Libre 2
The Abbott FreeStyle Libre 2 iCGM system. Image courtesy of Abbott.

Abbott announced that its FreeStyle Libre 2 integrated continuous glucose monitoring system (iCGM) received FDA 510(k) clearance for use in children ages four and older. The system consists of a next-generation self-applied sensor applied to the back of the upper arm. It is about the size of two-stacked quarters and removes the requirement of fingersticks for testing glucose levels.

“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.” – Larry Kurt Midyett, M.D., pediatric endocrinologist, Midwest Women’s and Children’s Specialty Group

The system transmits glucose every minute and has optional real-time alarms that notify a patient when glucose levels are too low or high without scanning (enabled via the use of Bluetooth technology). Abbott touts the technology as the first and only iCGM system that has sustainable performance for up to 14 days.

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