An integrated continuous glucose monitoring (iCGM) system for measuring sugar levels in children and diabetic adults has been given approval by the FDA.
Diabetes
Compatible with certain medical devices and electronic interfaces, it is the first type of integrated system for continuous glucose monitoring to be permitted by the watchdog.
The Dexcom G6 device is applied to the skin of the abdomen and contains a small sensor that continuously measures glucose levels.
Readings are transmitted from the device every five minutes to a mobile app which alerts the patient if their blood sugar drops or goes too high. The device can also be integrated with other devices for diabetes management and insulin dosing and measurement systems.
When integrated with an automated insulin dosing system, a rise in blood sugar will trigger the release of insulin from the pump.
The FDA hopes that the authorisation of this device will enable developers of future iCGM systems to bring their products to market in an efficient manner. Prior to this, continuous glucose monitoring systems were evaluated through the FDA’s premarket approval pathway designed for the highest risk class III medical devices.
The Dexcom G6 however established criteria that would classify these systems as moderate risk class II medical devices with special controls, easing the regulatory process.
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: “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.”
"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."
To gain classification, 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. Patients visited clinics multiple times over 10 days to have their readings compared with a laboratory test method for blood glucose levels.