scope:

This guideline specifies requirements/recommendations for methods for determining analytical and clinical metrics of continuous interstitial glucose monitoring. It defines the following aspects of continuous glucose monitoring: point accuracy, trend accuracy, sensitivity and specificity, device stability, calibration, lag time, sampling rate, reporting rate, reference material, and reference device traceability.

The intended users of this guideline are health care professionals, in vitro diagnostic (IVD) and medical device manufacturers, and regulatory agencies.

This guideline is not intended for use by the patient.

This guideline does not address devices that do not meet the definitions of continuous, interstitial, and glucose monitoring.