FDA OKs Continuous Glucose Monitoring Device

Published Online: Thursday, September 28th, 2017
Officials with the FDA have approved the first continuous glucose monitoring system that allows individuals to make diabetes treatment decisions without using a blood sample from the fingertip. The device is intended for adults 18 years of age an older with diabetes. 

By using a small sensor wire inserted below the skin’s surface to continuously measure and monitor glucose, the system allows individuals to make diabetes treatment decisions without using a blood sample from the fingertip. A mobile reader, which is waved above the sensor wire, determines glucose levels and how they are changing.  

After a 12-hour start up period, the system can be worn for up to 10 days.

The approval is based on a clinical study of adults with diabetes. The device’s performance was reviewed by comparing readings obtained by the system to those obtained by an established laboratory method used for analysis of blood glucose.  

Risks may include hypoglycemia or hyperglycemia in cases where the device provides inaccurate information. Skin irritations around the insertion site is also a risk. Additionally, the device does not provide real-time alerts in the absence of user-initiated action, and cannot alert users to low blood glucose levels when they are asleep.

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

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