The U.S. Food and Drug Administration (FDA) has granted a De Novo request for the Dexcom G6® CGM System. The Dexcom G6 is indicated by the FDA for use as both a standalone CGM and for integration into automated insulin dosing (AID) systems.
Along with this authorization, the FDA is establishing criteria, called special controls, which outline requirements for assuring CGM accuracy, reliability, and clinical relevance as well as describe the type of studies and data required to demonstrate acceptable CGM performance.
“As a factory-calibrated, real-time CGM system with exceptional accuracy, the Dexcom G6® will be transformative for people with diabetes, who will no longer be required to prick their fingers for diabetes management,” says Daniel DeSalvo, MD, a pediatric endocrinologist at Texas Children’s Hospital in Houston, Texas. “I can tell you as someone who has type 1 diabetes myself, with all of its features and benefits, the Dexcom G6® is the CGM device I have been anticipating for the last twenty years. This CGM system will help to alleviate the burden of diabetes management while improving the lives of people with diabetes.”
The new device features:
- Fingerstick Elimination– No fingersticks are needed for calibration or diabetes treatment decisions.
- Easy Sensor Applicator – Complete redesign of the sensor applicator allows for one-touch, simple insertion.
- Discreet and Low Profile– A redesigned transmitter with a 28% lower profile than previous generation Dexcom CGMs makes the device comfortable and easy to wear under clothing.
- Acetaminophen Blocking– New feature allows for more accurate glucose readings with no medication interference.
- Predictive Low Alert – New alert feature predicts hypoglycemia before it hits to help avoid dangerous low blood sugar events.
- Extended 10-Day Sensor– 10-day sensor allows for 43% longer wear than previous generation Dexcom CGMs.
“Contemporary diabetes technology relies on accuracy and performance, which Dexcom has proven over time. Once again, Dexcom has earned the trust of the research community all over the world,” says Boris Kovatchev, PhD and founding director of the UVA Center for Diabetes Technology. “Innovations like the Dexcom G6® are critical to closing the loop – automated insulin delivery known as the ‘artificial pancreas’.”
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