FDA Okays First Continuous Glucose Monitoring System of Its Kind
This week, the U.S. Food and Drug Administration began allowing marketing of the first integrated continuous glucose monitoring (iCGM) system – the Dexcom G6 – for measuring blood sugar levels in adults and children over age 2 with diabetes.
This system is the first that the FDA will allow to be part of an integrated system with other compatible medical devices and interfaces, such as automated insulin dosing systems, pumps, and glucose meters used to manage diabetes. The device is classified as a class II – moderate risk – medical device with special controls. Previous continuous glucose monitoring systems were class III (high risk) devices.
The Dexcom G6 is a small patch applied to the skin of the abdomen and replaced every 10 days. It contains a sensor that continuously measures blood sugar and transmits glucose readings every five minutes to a display device – a mobile medical app, for example. An alarm is triggered when glucose levels soar too high or drop too low and, if equipped with an automated insulin dosing system, insulin is released when blood sugar increases.