iCan Continuous Glucose Monitoring System - Invasive interstitial-fluid glucose monitoring system

Intended purpose

Continuous Glucose Monitoring System (CGM System) is a real time, continuous glucose monitoring device indicated for the measurement of glucose in interstitial fluids for people 2 years and older. It is intended to replace fingerstick blood glucose testing for diabetes treatment decisions. The CGM System also detects trends and tracks patterns, and aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Interpretation of the CGM System results should be based on the glucose trends and several sequential readings over time. The CGM System can be used in conjunction with smart devices with corresponding application where the user manually controls actions for therapy decisions.