WASHINGTON, March 27 (Xinhua) -- The U.S. Food and Drug Administration (FDA) gave a green light on Tuesday to an integrated continuous glucose monitoring (iCGM) system for determining blood glucose (sugar) levels in children aged two and older and adults with diabetes.
This is the first type of continuous glucose monitoring system permitted by the watchdog that can be used as part of an integrated system with other compatible medical devices and electronic interfaces.
The Dexcom G6 is a patch device, about the size of a quarter coin, which is applied to the skin of abdomen and contains a small sensor that continuously measures the amount of glucose in body fluid.
The device transmits 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 soars too high or drops too low.
Also, it may be integrated with automated insulin dosing systems, insulin pumps, blood glucose meters or other electronic devices for diabetes management.
If it is 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.
The authorization has classified 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.
"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," said 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."
CGMs were initially 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, intended for a more seamless integration with other diabetes devices, has been recognized 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.
The FDA evaluated data from two clinical studies of the Dexcom G6, which included 324 adults and children aged two years and older with diabetes.
Both studies included multiple clinical visits within a 10-day period where system readings were compared to a laboratory test method that measures blood glucose values. No serious adverse events were reported during the studies.
