FDA Approves Continuous Glucose Monitoring System for Diabetes

SEPTEMBER 27, 2017
Officials with the FDA have approved FreeStyle Libre Flash Glucose Monitoring System (Abbot Diabetes Care Inc.), the first continuous glucose monitoring system for adult patients that reduces the need for fingerstick testing. The product is intended for individuals 18 years of age and 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. . Accessed September 27, 2017.