Subcutaneous glucose sensor

Intended purpose

The subcutaneous glucose sensor is intended to be used as part of the Continuous Glucose Monitoring (CGM) System. The CGM is a glucose monitoring system indicated for persons with diabetes mellitus age 2 years and older where self-monitoring of blood glucose (SMBG) is indicated. The device is designed to replace fingerstick blood glucose (BG) testing for treatment decisions. Interpretation of the device results should be based on the glucose trends and several sequential readings over time. The device also aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. It is intended for use by patients athome and in healthcare facilities.