番茄社区

The Dexcom G6 integrated continuous glucose monitoring system (iCGM) received marketing approval, the Tuesday.

This is the first "integrated" system that allows use along with other types of diabetes management devices, such as insulin pumps, blood glucose meters, automatic insulin dosing systems, and other electronic devices.

Along with this marketing approval, the FDA also determined that such products could henceforth be classified as "moderate risk" class II medical devices with special controls. This designation allows for future iCGM's to hit the market in a more streamlined review process, according to the agency.

The wearable device is authorized for use in patients, including children age 2 and older as well as adults, with type 1 and type 2 diabetes. Replaced every 10 days, the device is applied to the abdomen and transmits real-time glucose levels, via a small sensor that continuously measures the amount of glucose in body fluid, to a mobile medical app.

Risks associated with use of the system include hypoglycemia or hyperglycemia when the data provided by the device is inaccurate but still used to make treatment decisions. Patients may also experience skin irritation or redness around the device's adhesive patch.

"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 a statement.

He added, "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 G5 system, an earlier generation of the device, received FDA approval in 2016, but was not designed as an integrated system to be used with compatible devices, according to the agency.

Comment