Abbott's Freestyle Libre 2 CGM Receives FDA Clearance for Children and Optional Alarms

Abbott Laboratories announced its Freestyle Libre 2 continuous glucose monitoring (iCGM) system has received U.S. Food and Drug Administration (FDA) clearance. The updated system provides glucose readings every minute and broadens its use to children as young as four years old, a significant step for pediatric diabetes care.

The system is recognized as the longest-running self-applied sensor on the market, offering 14 days of wear. It measures glucose every minute, five times more frequently than many other CGMs. The new version also features optional, customizable alarms that alert users to high or low glucose levels without requiring a scan.

Abbott states the Freestyle Libre 2 system is priced significantly lower than other CGMs, at an estimated 70% reduction. This aims to increase access to care for the estimated 34 million Americans living with diabetes. The device eliminates the need for routine fingersticks, reducing user burden.

The small sensor of the Freestyle Libre 2 system is applied to the back of the upper arm and transmits data to a reader or smartphone. The device displays the current glucose level, an eight-hour history, and a trend arrow indicating the direction of glucose levels. The collected data assists users and healthcare providers in making informed treatment decisions, such as diet adjustments or insulin dosing.

Overall, the Freestyle Libre 2 system update and FDA clearance offer substantial improvements to diabetes management and quality of life, particularly for pediatric users. Abbott's Libre system is currently used by over two million people worldwide.