FDA Approves Dexcom G6 CGM

(The Dexcom G6 family with applicator. Image courtesy of Dexcom, Inc.)

The U.S. Food and Drug Administration (FDA) has approved the Dexcom G6, a continuous glucose monitor (CGM) that removes the need for fingerstick calibration and is the first type of continuous glucose monitoring system allowed to be used as part of an integrated system with other compatible electronic interfaces and medical devices. Such devices include automated insulin dosing systems, insulin pumps, blood glucose meters, and other tools used in diabetes care. 

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Made by Dexcom, Inc., a California-based technology company that specializes in continuous glucose monitoring systems, the Dexcom G6, which is about the size of a quarter, is worn on the stomach and has a small sensor that the user inserts just beneath the skin by using an auto-applicator. It wirelessly transmits blood sugar readings every five minutes to a small touch screen receiver or to a compatible smart device, such as a smartphone, a smartwatch, or medical device app. It sounds an alarm when the user’s blood sugar is high or too low. The G6 improves on Dexcom’s already popular G5 mobile monitoring system in several ways: it eliminates the need for fingerstick calibration; can be worn for ten days instead of seven; and has a one-touch applicator and low-profile transmitter, acetaminophen-blocking abilities, and a new “Urgent Low Soon” alert.

The FDA endorsement was based on two clinical studies involving 324 adults and children with diabetes. The G6 was approved for adults and for children as young as two. According to Donald St. Pierre, acting director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, “The ability of this device to work with different types of compatible devices gives patients the flexibility to tailor their diabetes management tools to best meet personal preferences.” According to the manufacturer, most insurance plans cover the Dexcom G6.

Want to learn more about CGM? Watch our video, “Continuous Glucose Monitoring,” and read “Sensing the Big Picture With Continuous Glucose Monitoring.”

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