Invasive interstitial-fluid glucose monitoring system

Intended purpose

Continuous Glucose Monitoring System is intended for adults (18 and above) with diabetes mellitus who need to monitor their glucose levels. The system is indicated for measuring interstitial fluid glucose levels in intended adult users and can provide users with real-time glucose readings, glucose trend and fluctuation characteristics, and alert information such as high/low glucose alerts. It is intended to replace blood glucose testing for diabetes treatment decisions. The 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. The System can be used alone or in conjunction with digitally connected devices where the user manually controls actions for therapy decisions and intended for single patient use.