The U.S. FDA has approved a continuous glucose monitor, the Dexcom G6, for use without finger sticks for calibration or dosing decisions.<\/p>\n
The U.S. FDA has granted a De Novo request for the Dexcom G6\u00a0CGM System, Dexcom\u2019s newest generation of CGM for people with diabetes ages 2 and up.<\/p>\n
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\u00a0is the first CGM to receive this classification by the FDA.<\/p>\n
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.<\/p>\n
“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,\u201d said Daniel DeSalvo, MD, Pediatric Endocrinologist at Texas Children\u2019s 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.\u201d<\/p>\n
<\/p>\n
New with Dexcom G6:<\/strong>\u00a0<\/strong><\/p>\n \u00a0<\/strong><\/p>\n Dexcom G6 carries forward important features of Dexcom CGM systems:<\/strong><\/p>\n <\/p>\n “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,\u201d 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 \u2013 automated insulin delivery known as the \u2018artificial pancreas\u2019.\u201d<\/p>\n “We listen closely to people with diabetes and continuously look for ways to empower them to better manage their condition. The FDA\u2019s special controls set a rigorous, new standard in our industry and clearly define the process by which other CGM systems may be approved,\u201d said Kevin Sayer, Chief Executive Officer of Dexcom. “We believe the new Dexcom G6 is a significant step forward for Dexcom and our industry.\u201d<\/p>\n\n
\n