FDA approves first ‘integrated’ CGM system
The Dexcom G6 continuous glucose monitoring (CGM) system received FDA marketing approval March 27, the agency announced.
This is the first system permitted by the FDA to be used in an “integrated” fashion alongside other diabetes management devices, including automatic insulin dosing systems, insulin pumps and blood glucose meters. The FDA said such systems would be classified as moderate risk class II medical devices, paving the way for similar integrated products to make it to market in “the least burdensome manner possible.” Previously, continuous glucose monitoring systems were reviewed based on more rigorous criteria for the highest risk, class III medical devices.
“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,” 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, said in a statement. “In addition, the FDA has taken steps to expedite the review process for similar, integrated CGMs and make these types of systems available to patients as quickly as possible while also helping to ensure their safety and reliability.”
The Dexcom 6 is a patch about the size of the quarter that is placed on the abdomen so a sensor can measure the amount of glucose in body fluid. Real-time glucose readings are transmitted every five minutes to a compatible display device, which can signal when blood sugars are dangerously high or low. If the system is integrated with an insulin dosing system, a low blood sugar level would automatically trigger insulin to be released from the pump, according to the press release.
A previous iteration of the device, the Dexcom G5, received FDA approval in 2016, but it wasn’t designed to be used as part of an integrated system like the G6.
Daniel joined TriMed’s Chicago editorial team in 2017 as a Cardiovascular Business writer. He previously worked as a writer for daily newspapers in North Dakota and Indiana.