The Food and Drug Administration (FDA) has authorized the marketing of the Dexcom G6 integrated continuous glucose monitoring (iCGM) system for determining glucose levels in patients aged ≥2 years with diabetes. This marks the first type of CGM system permitted for use as part of an integrated system with other compatible medical devices and electronic interfaces such as automated insulin dosing systems, insulin pumps, blood glucose meters or other electronic devices for managing diabetes.
The Dexcom G6 patch contains a small sensor which is applied to the abdomen. It continuously measures glucose levels and transmits readings every 5 minutes to a compatible display device (eg, mobile app). If the patient’s glucose level is too high or too low, it triggers an alarm to alert the patient. If integrated with an automated insulin dosing system, a glucose spike would trigger insulin release from the pump.
Dexcom G6 was evaluated in 2 clinical studies (N=324) that included adults and children aged ≥2 years with diabetes. During multiple clinical visits over a 10-day period, the system’s readings were compared against a lab test method to measure blood glucose. There were no serious adverse events reported during the trials.
Different from the earlier Dexcom G5 model, the G6 model already comes factory calibrated eliminating the need for a patient fingerstick to calibrate the sensor. Moreover, its updated sensor probe also minimizes interference with concomitant acetaminophen.
“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.
Formerly a class III medical device (“high risk”), the FDA has classified iCGMs as class II (“moderate risk”) devices with special controls. Special controls refer to the requirements for assuring accuracy, reliability, and clinical relevance of iCGM devices, as well as the type of studies and data required to demonstrate acceptable iCGM performance. This authorization serves to streamline and expedite the regulatory review process for developers of future iCGM systems who are seeking marketing authorization.
For more information visit FDA.gov.