In a 2-pronged move, the FDA approved the sale of the Dexcom G6 integrated continuous glucose monitoring system for determining blood glucose levels and also classified the unit as a class II medical device, enabling a speedier review for similar future systems.
In a 2-pronged move, the FDA approved the sale of the Dexcom G6 integrated continuous glucose monitoring (iCGM) system for determining blood glucose levels and also classified the unit as a less-stringent class II medical device, enabling a speedier review for similar future systems.
The FDA said other developers of future iCGM systems could “bring their products to market in the least burdensome manner possible.” It is the FDA’s first approval for this type of device.
The Dexcom G6 is cleared for use in children 2 years and older and adults with diabetes. Nearly 10% of Americans have diabetes.
The Dexcom G6 is 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, including mobile health apps.
“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.”
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.
The FDA said it recognized the Dexcom G6 is as an opportunity to reduce regulatory burdens. Future iCGMs that meet the special controls criteria can go through a more streamlined premarket review known as 510(k) clearance.
The Dexcom G6 is a patch device, about the size of a quarter, 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 5 minutes to a compatible display device, such as a mobile medical app on a cell phone, and it will trigger an alarm when a patient’s blood sugar enters a danger zone, soaring too high or dropping too low.
If it’s integrated with an automated insulin dosing system, a rise in blood sugar would trigger the release of insulin from the pump. The patch device should be replaced every 10 days.
An earlier version, the Dexcom G5, won FDA approval in 2016 but was not designed as an integrated system to be used with compatible devices. Unlike the earlier model, the Dexcom G6 version is factory calibrated and does not require users to calibrate the sensor with fingerstick blood glucose measurements. In addition, it has an updated sensor probe that minimizes interference with the pain reliever acetaminophen.
The FDA evaluated data from 2 clinical studies of the Dexcom G6, which included 324 adults and children aged 2 years and older. Both studies included multiple clinical visits within a 10-day period. System readings were compared to a laboratory test method that measures blood glucose values. No serious adverse events were reported.