Subcutaneous glucose sensor

Intended purpose

The subcutaneous glucose sensor is intended to be used as part of the Continuous Glucose Monitoring (CGM) System. The Dexcom Continuous Glucose Monitoring System (CGM System) is a glucose monitoring system indicated for continuously measuring glucose in the interstitial fluid in persons with diabetes mellitus age 2 years and older, where self-monitoring of blood glucose (SMBG) is indicated. The Dexcom CGM System is designed to replace fingerstick blood glucose (BG) testing for treatment decisions. Interpretation of the CGM System results should be based on glucose trends and several sequential sensor readings over time. The CGM System also aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. The CGM System is intended for use by patients at home and in healthcare facilities. The CGM System is also designed to reliably and securely transmit glucose management data to digitally connected devices, including automated insulin dosing (AID) systems, and is intended to be used alone or in conjunction with these digitally connected medical devices for the purpose of managing diabetes.