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CLSI POCT05

Performance Metrics for Continuous Interstitial Glucose Monitoring; Approved Guideline

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Organization: CLSI
Publication Date: 1 December 2008
Status: inactive
Page Count: 72
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.

Document History

November 1, 2020
Performance Metrics for Continuous Interstitial Glucose Monitoring
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...
CLSI POCT05
December 1, 2008
Performance Metrics for Continuous Interstitial Glucose Monitoring; Approved Guideline
This guideline specifies requirements/recommendations for methods for determining analytical and clinical metrics of continuous interstitial glucose monitoring. It defines the following aspects of...

References

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