Performance Metrics for Continuous Interstitial Glucose Monitoring
|Publication Date:||1 November 2020|
This guideline provides recommendations for methods used to determine analytical and clinical metrics of continuous glucose monitoring (CGM) as an indicator of blood glucose values. It discusses use cases, point accuracy, trend accuracy, evaluation of threshold alerts, system stability and reliability, clinical studies for assessing CGM performance, calibration, traceability of measurement, cybersecurity, and device labeling.
The intended users of this guideline are in vitro diagnostic and medical device manufacturers, regulatory agencies, and health care professionals. This guideline is not intended for use by patients and does not discuss devices that do not meet the definitions of continuous, interstitial, and glucose monitoring.