The FDA has approved marketing of the Dexcom G6 integrated continuous glucose monitoring system to determine blood glucose levels in adults with diabetes and children ages 2 years and older, the agency announced on March 27.
The system is the first approved to be used with other diabetes devices, such as automated insulin-dosing systems, insulin pumps, or blood glucose meters, according to the FDA. The patch device, which is about the size of a quarter and applied to the skin of the abdomen, contains a sensor that continuously measures glucose levels in body fluid. Every five minutes, it transmits readings to a compatible display device, such as a mobile phone app, and triggers an alarm if glucose levels are too high or too low. When integrated with an automated insulin-dosing system, hyperglycemia would trigger the release of insulin from the pump.
Two clinical studies of 324 participants compared blood glucose readings from the system with those from a laboratory test method. No serious adverse events were reported, but risks associated with the system include hypoglycemia or hyperglycemia in cases where device information is inaccurate and used to make treatment decisions or where configuration issues disable alarms and alerts. In addition, patients may experience skin irritation or redness around the patch site.