FDA Approves First Interoperable CGM System
The device is the first of its class and will be designated as a class II device, subjecting it to special controls that will serve as criteria for future devices.
The US Food and Drug Administration (FDA) has announced its approval of the marketing of the first interoperable continuous glucose monitoring (iCGM) system, the Dexcom G6, for monitoring blood glucose levels in patients with diabetes aged 2 years and older.
The device is the first of its class and will be designated as a class II device, subjecting it to special controls that will allow future iCGM developers to easily bring products to market if they meet the now-set criteria, according to the FDA.
“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, the 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.”
Dexcom’s previous model, the G5 CGM system, was approved in 2016 but was not compatible with other devices. This newest model comes factory calibrated, meaning patients will not need to use fingerstick blood measurements to adjust the sensor.
The FDA’s decision was made based on 2 clinical trials of the device, including 324 adults and pediatric patients with diabetes. During the trials, no serious adverse events were reported, and the patients underwent multiple clinic visits in the 10-day study period to compare blood glucose measurements.
The device, a patch, is applied to the abdomen and reports readings every 5 minutes, compatible to be displayed with mobile phone apps which can trigger an alarm when the readings reach levels of alarm.
Almost 10% of the US, more than 30 million patients, have diabetes, and while the number of new diagnoses has slowed in recent years, it remains on the uptick, making any additional therapeutic options a positive sign.
Earlier this month, the FDA approved another CGM system, the Guardian Connect system, from Medtronic.
