FDA Clears Next-Generation Libre Glucose Monitor for Diabetes

Miriam E. Tucker


June 15, 2020

The US Food and Drug Administration (FDA) has cleared the FreeStyle Libre 2 integrated continuous glucose monitoring (CGM) system for adults and children ages 4 years and older with diabetes.

The Libre system reads glucose levels through a sensor worn on the back of the upper arm for up to 14 days. Users wave a scanner over the device to obtain a reading and view trend arrows and 8-hour glucose history.

Compared with the previous FreeStyle Libre 14-day version that was approved by the FDA in July 2018, the next-generation Libre 2 features optional real-time alarms. These use Bluetooth and automatically alert the user to high or low glucose readings without the need to scan the sensor.

The new Libre is now an "integrated CGM," meaning that it is authorized to be interoperable with other compatible diabetes devices or interfaces, says its manufacturer, Abbott.

Also new in Libre 2 is the pediatric indication — the previous one was approved for adults only — and better accuracy, with an overall mean absolute relative difference (MARD) of 9.3% versus reference values, compared to 9.4% with the previous version. The Libre 2 MARD is 9.2% for adults and 9.7% for pediatric patients.

As with the prior version, the Libre 2 measures glucose levels every minute (compared to every 5 minutes with other CGMs), and the cost is about one third that of other CGM systems.

The Libre 2 will be priced the same as the FreeStyle Libre 14-day system.

The Libre 2 should not be used with automated insulin dosing systems, including closed-loop and insulin suspend systems, however.

The sensor should be removed before MRI, CT scans, X-rays, or diathermy treatment. Use of high-dose vitamin C (> 500 mg/day) can interfere with readings.  

Patients should also be instructed that if the glucose alarms and readings from the system don't match symptoms or expectations, they should use fingerstick blood glucose values to make treatment decisions.

The FreeStyle Libre 2 system will be available in the coming weeks at participating pharmacies and durable medical equipment suppliers across the United States. Abbott is also working on obtaining clearance for a mobile app that would function as a receiver.

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