The U.S. Food and Drug Administration approved DexCom Inc.'s integrated continuous glucose monitoring system, Dexcom G6, for diabetes patients over two years of age.
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.
In addition, the FDA's authorization classifies this new type of device in Class II and subjects it to certain criteria called special controls. This enables developers of future integrated continuous glucose monitoring systems to bring their products to market with less difficulty.
DexCom's G6 is approved for use as both a stand-alone continuous glucose monitoring system and for integration into automated insulin dosing systems.
The approval is based on evaluated data from two clinical studies, which included multiple clinical visits within a 10-day period where system readings were compared to a laboratory test method that measures blood glucose values. The studies included 324 adults and children aged two years and older with diabetes.
In 2016, the agency approved an earlier generation of the technology, the Dexcom G5 system; however, it was not designed as an integrated system to be used with compatible devices.
The device, which contains a small sensor, is applied to the skin of the abdomen and transmits real-time glucose readings every five 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 levels rise too high or drop too low.
If the device is integrated with an automated insulin dosing system, a rise in blood sugar would trigger the release of insulin from the pump.