FDA Approves Abbott's FreeStyle Libre Pro System for Diabetes

Miriam E Tucker


September 28, 2016

The US Food and Drug Administration (FDA) has approved the FreeStyle Libre Pro System, developed by Abbott, for use by physicians for monitoring glucose in patients with diabetes.

The FreeStyle Libre is the third "blinded" professional continuous glucose monitoring (CGM) system on the US market, joining the Dexcom G4 Platinum Professional Real-Time CGM and the Medtronic iPro2 Professional CGM.

But, in contrast to those systems, the Libre does not require finger-stick calibration, has no reusable components requiring disinfection, provides a longer period of data capture (14 days, compared with 7 for the Dexcom and 3 for Medtronic), and lower cost, an Abbott spokesperson told Medscape Medical News.

The Libre Pro's small round sensor is applied to the back of the patient's arm by a healthcare professional, where it is held in place with adhesive for up to 14 days, measuring and recording interstitial fluid glucose every 15 minutes through a small filament that is inserted just under the skin. The patient does not interact with the device.

After 2 weeks, the patient returns and the doctor uses the device's practice-owned reader to scan the sensor, thereby downloading the glucose data and generating a visual report. The physician can then show the patient the results and discuss them during the visit.

In an Abbott statement, Eugene E Wright, Jr, MD, of Duke Southern Regional Area Health Education Center, Fayetteville, North Carolina, explains why he needs a device like this. "My patients are often out of range, due to inconsistent self-monitoring and insufficient data from traditional glucose meters that are unable to provide a full view of their glucose levels."

The FreeStyle Libre Pro is covered under the existing current procedural terminology (CPT) code for collecting and interpreting CGM data, which is widely reimbursed in commercial health insurance plans and national Medicare fee for service. The reader costs $65 and each sensor is $60, the Abbott spokesperson told Medscape Medical News.

Abbott recently submitted for FDA review the consumer version of the FreeStyle Libre system, which has been on the market in Europe since 2014. Trial data in patients with both type 1 and type 2 diabetes were presented earlier this month at the European Association for the Study of Diabetes (EASD) 2016 Annual Meeting.

The Pro version will be available to US healthcare professionals in the coming weeks. More information is available at www.FreeStyleLibrePro.us.

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