The Food and Drug Administration has approved the marketing of a new continuous glucose monitoring system, called Dexcom G6, to determine blood glucose levels in children starting at age two and adults with diabetes.
The system is produced by Dexcom, which is based in San Diego.
Dexcom G6 is a patch the size of a quarter that is placed on the abdomen and includes a sensor that measures the amount of glucose in body fluid. Glucose readings are transmitted in real-time every five minutes to a display device that could be on a mobile app or a smartphone. An alarm will sound if glucose levels are getting too high or too low. The patch is replaced every 10 days.
Dexcom G6 is to be used in an integrated system with compatible medical devices such as automated insulin dosing systems, insulin pumps, blood glucose meters and other devices used to manage diabetes. This is an upgrade as earlier versions of the product were standalone and did not integrate with other devices.
FDA has classified Dexcom G6 as a class II device subject to certain controls. With approval of Dexcom G6, FDA believes it can speed subsequent review processes for similar products, getting the products out to patients quicker.
FDA’s evaluation of two clinical studies on Dexcom G6 prior to approval included data from 324 participating adults and children, with no serious adverse events reported.
The agency acknowledges there is a risk that in some cases information provided by the device may be inaccurate and used to make treatment decisions, or there could be hardware or set-up issues that disable alarms.
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