The US Food and Drug Administration (FDA) has recently permitted marketing of the Dexcom G6 integrated continuous glucose monitoring (iCGM) system for determining blood glucose levels in children aged ≥2 and 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.

Indications: 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 5 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.

Adverse reactions: Risks associated with use of the system may include hypoglycemia or hyperglycemia in cases where information provided by the device is inaccurate and used to make treatment decisions or where hardware or set-up issues disable alarms and alerts. Patients may also experience skin irritation or redness around the device’s adhesive patch.