FDA Authorizes First Fully Interoperable Continuous Glucose Monitoring System

On March 27, 2018, FDA permitted marketing of the Dexcom G6 integrated continuous glucose monitoring (iCGM) system for determining blood glucose levels in:

• children aged two and older
• adults with diabetes.

This is the first type of continuous glucose monitoring system permitted by the agency to be used as part of an integrated system with other compatible medical devices and electronic interfaces, which may include automated insulin dosing systems, insulin pumps, blood glucose meters or other electronic devices used for diabetes management.
 

The Dexcom G6 is a patch device, about the size of a quarter, that is applied to the skin of the abdomen and contains a small sensor that continuously measures the amount of glucose in body fluid. The device transmits real-time glucose readings every five minutes to a compatible display device such as a mobile medical app on a cell phone and will trigger an alarm when a patient’s blood sugar enters a danger zone soaring too high or dropping too low. If it’s integrated with an automated insulin dosing system, a rise in blood sugar would trigger the release of insulin from the pump. The patch device should be replaced every 10 days.

For more information on the Dexcom G6 integrated continuous glucose monitoring system please see the FDA Press Announcement.

The updated label will soon be available at drugs@fda or DailyMed

Steve Morin
Office of Health and Constituent Affairs
Food and Drug Administration

Visit the FDA Patient Network for more Information about the FDA Diabetes Liaison Program