FDA approves Abbott's FreeStyle Libre Pro CGM for clinical use

Freestyle Libre
FreeStyle Libre Flash (consumer version)--Courtesy of Abbott

The FDA has approved Abbott’s FreeStyle Libre Pro continuous glucose monitoring system for clinicians to use with diabetic patients.

While Abbott markets a consumer version of the FreeStyle Libre in Europe, the Pro version is FDA-approved for clinical settings. A clinician applies a small disposable sensor to the patient’s upper arm, where it is worn for up to 14 days, Abbott said in a statement. It does not require the twice-daily fingerstick calibration that other CGMs need.

The adhesive sensor uses a tiny filament inserted just under the skin to continuously measure the glucose in the patient’s interstitial fluid. It tracks glucose levels every 15 minutes for a total of up to 1,340 glucose results over a 14-day period, Abbott said. The patient then returns to the doctor’s office, where the clinician uses a reader to scan the sensor and download the data. The doctor may view a visual representation of the patient’s glucose data, including patterns and trends.

The device’s advantages include convenience for both clinicians and patients as well as saving on costs, maintenance and time, according to the statement. A clinician needs only one FreeStyle Libre Pro reader to treat multiple patients, and the system doesn’t require the patient to take any other components--such as receivers and transmitters--aside from the patch home with them.

Abbott recently submitted the consumer version of the system for FDA review, the company said in the statement. The FreeStyle Libre Flash earned a CE mark in 2014 and scored another in February this year, which expanded the device’s indication to include children. Meanwhile, an FDA panel voted this year to allow Dexcom’s G5 CGM to be used without confirmatory fingersticks to inform diabetes treatment decisions.