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FDA Approves FreeStyle Libre System for Adults

FDA news release; 2017 Sep 27

The FDA has approved the FreeStyle Libre Flash Glucose Monitoring System, a continuous glucose monitoring system for adults not requiring blood samples calibration. The system is available from Abbott Diabetes Care Inc., Abbott Park, IL, and can be used by adult patients with diabetes to make diabetes treatment decisions without calibration using a blood sample from the fingertip.

The system reduces the need for “fingerstick” testing by using a small sensor wire inserted below the skin’s surface that continuously measures and monitors glucose levels. Users can determine glucose levels by waving a dedicated, mobile reader above the sensor wire to determine if glucose levels are too high to too low, and how glucose levels are changing. After a 12-hour start-up period, the device can be worn for up to 10 days.

Citation:

US Food and Drug Administration. FDA approves first continuous glucose monitoring system for adults not requiring blood sample calibration. FDA Web site. September 27, 2017. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm577890.htm. Accessed October 1, 2017.

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