FDA approves marketing for ‘no finger-stick’ Dexcom G6 CGM
The FDA recently approved marketing of the Dexcom G6 integrated CGM system, which requires no finger-stick calibration, for use in patients with diabetes aged 2 years and older to determine blood glucose levels, according to a company press release.
The Dexcom G6 is a patch device applied to the abdomen and continuously monitors the amount of glucose in body fluid through a small sensor. Real-time glucose readings are transmitted every 5 minutes to a compatible display device and trigger an alarm when blood glucose is not at the correct level. The device should be replaced every 10 days.
As previously reported by Endocrine Today, Abbott’s FreeStyle Libre Flash Glucose Monitoring System was approved last fall as the first CGM to require no finger-stick testing.
According to the Dexcom release, the G6 will be the first device that is approved for use as part of an integrated system with compatible devices and electronic interfaces, including dosing systems, insulin pumps, blood glucose meters or other diabetes management electronic devices. The approval also grants the device de novo classification putting it in a category called special controls, which enables future integrated CGM system developers to bring their products to market. The FDA is currently developing criteria for future special controls outlining requirements for ensuring integrated CGM accuracy, reliability and clinical relevance.
“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 the release. “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.”
According to the release, hypoglycemia and hyperglycemia are possible adverse events; however, during two clinical studies that included 324 adults and children aged 2 years and older, no serious adverse events were reported. Skin irritation or redness around the device’s adhesive patch were also reported.