FDA Okays 14-Day Version of Libre Continuous Glucose Monitor

Miriam E. Tucker

Disclosures

July 27, 2018

The US Food and Drug Administration (FDA) has approved Abbott's Freestyle Libre 14-Day Flash Glucose Monitoring System, to replace the current 10-day version.

The Libre is now the longest-lasting continuous glucose monitor (CGM) on the US market. The 10-day patient-use Libre was approved by the FDA in September 2017, following approval of the professional-use version in September 2016. It is currently approved for adults aged 18 years and older by prescription.

The 14-day version has been available in Europe since 2014. 

The Libre sensor, about the size of two stacked quarters, is inserted on the back of the upper arm. The patient waves a mobile scanner over the area to obtain a reading. The Libre is approved as a replacement for fingerstick blood-glucose monitoring and does not require fingersticks for calibration.

Studies have shown that the Libre improves glycemic control and reduces hypoglycemia without raising HbA1c.

The 14-day version is more accurate than the 10-day, with a mean absolute relative difference of 9.4% compared with 9.7%, respectively.

The Libre is less costly than other CGM systems but currently does not include an alarm feature for low or high glucose levels as other CGMs do. 

The new 14-day system will be available by prescription in the coming months at participating pharmacies and durable medical equipment suppliers in the United States, according to Abbott.    

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