March 27, 2018 02:00 PM PDT
Dexcom is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted a De Novo request for the Dexcom G6® CGM System, the newest generation of CGM for people with diabetes ages 2 and up. The Dexcom G6 is indicated by the FDA for use as both a standalone CGM and for integration into automated insulin dosing (AID) systems. The powerful and revolutionary new Dexcom G6® is the first CGM to receive this classification by the FDA.
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,” said Daniel DeSalvo, MD, 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.”
New with Dexcom G6®:
- 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.
Dexcom G6® carries forward important features of Dexcom CGM systems:
- Continuous Glucose Readings – Automatically sends glucose readings to a Dexcom receiver or compatible smart device every five minutes.
- Mobile App and Sharing – Compatibility with smart device apps allows for sharing glucose information with up to five people for added support.
- Customizable Alarms and Alerts – Personalized alert schedule immediately warns the wearer of pending dangerous high and low blood sugars.
“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,” said 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’.”
"We listen closely to people with diabetes and continuously look for ways to empower them to better manage their condition. The FDA’s special controls set a rigorous, new standard in our industry and clearly define the process by which other CGM systems may be approved.,” said Kevin Sayer, Chief Executive Officer of Dexcom. “We believe the new Dexcom G6® is a significant step forward for Dexcom and our industry.”
The company expects to launch later this year. For more information, visit www.dexcom.com/G6.
Read the full FDA press release here.