FDA Authorizes Dexcom G6 CGM

FDA https://www.fda.gov has just permitted marketing of the first fully “Interoperable Continuous Glucose Monitoring” (iCGM) system called Dexcom G6 to be used by children aged two and older and for adults with diabetes.

This is the first type of iCGM system approved by FDA to be used as part of an integrated system with other compatible medical devices and electronic interfaces. These include automated insulin dosing systems, insulin pumps, blood glucose meters, and other electronic devices used to manage diabetes.

The Dexcom G6 is a patch device about the size of a quarter applied to the skin of the abdomen containing 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. Then an alarm will trigger when a patient’s blood sugar enters a danger zone which can mean that the blood sugar level is soaring too high or dropping too low.

FDA evaluated data from two clinical studies done on the device which included multiple clinical visits within a ten day period. System readings were then compared to a laboratory test method that measures blood glucose values. No serious adverse events were reported during the studies.

“The device is able to work with different types of compatible devices which gives patients the flexibility to tailor their diabetes management tools to best meet personal preferences,” said Donald St. Pierre, Acting Director, Office of In-Vitro Diagnostics and Radiological Health in FDA’s Center for Devices and Radiological Health https://www.fda.gov/MedicalDevices.

FDA’s authorization also classified this device as Class II which subjects the device to certain criteria called special controls. This will enable developers of future iCGM systems to have less difficulty in bringing their products to market.

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