FDA Approves New Continuous Glucose Monitor for Diabetes

From Drugs.com - September 28, 2017

FDA Approves New Continuous Glucose Monitor for Diabetes

THURSDAY, Sept. 28, 2017 -- The first fingerstick-free blood sugar monitoring system for adults with diabetes has been approved by the U.S. Food and Drug Administration.

The FreeStyle Libre Flash Glucose Monitoring System features a small sensor wire that's placed below the skin's surface and continuously monitors blood sugar (glucose) levels. People with diabetes can wave a mobile reader above the sensor wire to check their glucose levels.

The system is approved for use in people with diabetes aged 18 and older. After a 12-hour start-up period, it can be worn for up to 10 days, the FDA said.

"This system allows people with diabetes to avoid the additional step of fingerstick 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 said in an FDA news release. He is deputy director of new product evaluation in the FDA's Center for Devices and Radiological Health.

Approval of the system, made by Abbott Diabetes Care, was based on a clinical trial of diabetes patients aged 18 and older.

The system does not provide real-time alerts on its own, the FDA noted. For example, it cannot warn patients about low blood glucose levels while they are sleeping.

Potential risks associated with the system include low or high blood sugar if data it provides is inaccurate and used to make treatment decisions, the FDA said. Some patients may also have mild skin irritation around the area where the sensor wire is inserted.


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