FDA/CDC

FDA approves first non–finger-stick glucose monitoring system


 

The Food and Drug Administration has approved the FreeStyle Libre Flash Glucose Monitoring System for the continuous monitoring of glucose in adults with diabetes, the first system of its type that does not require blood samples for calibration, according to a press release.

Instead of using a more standard finger stick with which patients must draw blood samples multiple times a day to measure glucose levels, the FreeStyle Libre Flash Glucose Monitoring System uses a thin wire less than 0.4-mm thick inserted underneath the skin in the back of the upper arm to continually monitor glucose. Blood glucose levels are read by swiping a mobile reader over the wire. After a 12-hour start-up period, the wire can be worn for 10 days.

FDA approval was based on results from a study of diabetes patients older than 18 years, as well as a performance review comparing readings obtained by the device with readings obtained in a traditional laboratory method utilizing blood samples.

“This system allows people with diabetes to avoid the additional step of finger-stick calibration, which can sometimes be painful, but still provides necessary information for treating their diabetes – with a wave of the mobile reader,” Donald St. Pierre, acting director of the Office of In Vitro Diagnostics and Radiological Health and deputy director of new product evaluation in the FDA’s Center for Devices and Radiological Health, said in the press release.

Find the full press release on the FDA website.