The U.S. FDA has permitted marketing of the Dexcom G6 integrated continuous glucose monitoring (iCGM) system for determining blood glucose levels in children aged 2 and older and adults with diabetes. This is the first type of continuous glucose monitoring system permitted by the agency to be used as part of an integrated system with other compatible medical devices and electronic interfaces, which may include automated insulin dosing systems, insulin pumps, blood glucose meters or other electronic devices used for diabetes management.
The authorization also classifies this new type of device in class II and subjects it to certain criteria called “special controls.” This enables developers of future iCGM systems to bring their products to market in the least burdensome manner possible, according to FDA officials.
“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,” says 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. “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.”
Continuous glucose monitoring systems that were first marketed had a different intended use and were evaluated through the FDA’s premarket approval pathway, the most rigorous review designed for the “highest risk” class III medical devices. However, the Dexcom G6 system is intended for a more seamless integration with other diabetes devices, and the FDA recognized this as an opportunity to reduce the regulatory burden for this type of device by establishing criteria that would classify these as “moderate risk” class II medical devices with special controls.
With the authorization of the Dexcom G6, future iCGMs that meet the special controls criteria can go through a more streamlined premarket review: 510(k) clearance.
The Dexcom G6 is a patch device that is applied to the skin of the abdomen and contains a small sensor that continuously measures the amount of glucose in body fluid. The device transmits real-time glucose readings every five minutes to a compatible display device, such as a mobile medical app on a cell phone, and will trigger an alarm when a patient’s blood sugar enters a danger zone soaring too high or dropping too low.