eversense 365 - Indications for Use

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Eversense 365 CGM System Quick Reference Guide
The Eversense 365 Continuous Glucose Monitoring (CGM) System is indicated for continually
measuring glucose levels for upto 1 year in people (18 years or older) with diabetes. The system
is indicated for use to replace fingerstick blood glucose measurements for diabetes treatment
decisions.
The system is intended to:
• Provide real-time glucose readings.
• Provide glucose trend information.
• Provide alerts for the detection and prediction of episodes of low blood glucose (hypoglycemia)
and high blood glucose (hyperglycemia).
Historical data from the system can be interpreted to aid in providing therapy adjustments. These
adjustments should be based on patterns and trends seen over time.
The Eversense 365 CGM System is also intended to autonomously communicate with digitally
connected devices, including automated insulin dosing (AID) systems. The Eversense 365 CGM
System can be used alone or in conjunction with these digitally connected medical devices for the
purpose of managing diabetes.
The system is intended for single patient use and requires a prescription.
Refer to the Eversense 365 CGM System User Guide for more detailed information.
Indications for Use