Newly Approved Continuous Glucose Monitoring System Does Not Require Fingerstick

After examining data that compared the performance of the FreeStyle Libre Glucose Monitoring System to established laboratory methods for assessing glucose levels, the US Food and Drug Administration approved the new device for the management of diabetes in adult patients. This is the first continuous glucose monitoring system that can be used by adults with diabetes to make treatment decisions without calibration using a blood sample from the fingertip (fingerstick).
_______________________________________________________________________________________________
RELATED CONTENT
Continuous Glucose Monitoring May Benefit Adults with Type 2 Diabetes
New Studies Compare Continuous Glucose Monitoring with Standard Care in Patients with Type 1 Diabetes
_______________________________________________________________________________________________
The FreeStyle Libre Glucose Monitoring System uses a small sensor wire inserted below the skin’s surface that continuously measures and monitors glucose levels, which eliminates the need for fingerstick testing. Glucose levels are obtained using a mobile reader that is waved over the sensor wire, allowing patients to easily monitor changes in glucose levels. Patients can wear the wire for 10 days after a 12-hour start-up period.

The most common adverse reaction is mild skin irritation at the insertion site. Risks associated with the device include hypoglycemia or hyperglycemia if the information provided by the device is inaccurate. In addition, the device does not provide real-time alerts or alarms in the absence of user-initiated action.

—Melissa Weiss

Reference:

FDA approves first continuous glucose monitoring system for adults not requiring blood sample calibration [press release]. FDA. September 27, 2017. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm577890.htm. Accessed September 28, 2017.