CLSI POCT5 P : 1ED 2008
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
PERFORMANCE METRICS FOR CONTINUOUS INTERSTITIAL GLUCOSE MONITORING
15-12-2008
25-08-2018
Abstract
Committee Membership
Foreword
1 Scope
2 Introduction
3 Standard Precautions
4 Definitions
5 Point Accuracy
6 Trend Accuracy
6.1 General Physiologic Principles - Rate of Blood Glucose
Fluctuation
6.2 Testing Protocol
6.3 Data Analysis
6.4 Presentation of the Results
6.5 Display of Current Glucose Rate of Change
6.6 Combining Clinical Point and Trend Accuracy
7 Sensitivity and Specificity
7.1 Testing Protocol
7.2 Presentation of Results
7.3 Device User Considerations
8 Device Stability
8.1 CGM Sensor Function In Vivo: Stability Issues
8.2 Clinical Trial Required to Demonstrate Safe and
Effective Function of CGM Sensor Control Algorithm
8.3 Stability Metrics
9 Calibration
9.1 Factors That Should Be Considered When Establishing
the Calibration Process
9.2 Calibration Metrics
9.3 Considerations for Pivotal Clinical Accuracy Trials
9.4 Human Factors Considerations
9.5 Other Comments
10 Lag Time
10.1 Sources of Lag and Factors Influencing Lag Time
10.2 Accounting for Lag in Accuracy Assessments
11 Establishing Trueness of Measurement and Device Traceability
References
Appendix A. Clinical Trials
Appendix B. R-Deviation - Numerical Accuracy Metric for Rate
of Change in Process Measurement
Appendix C. Rate Error-Grid Analysis (R-EGA) - Clinical Accuracy
Metric for (Instantaneous) Rate of Change in Process
Measurement
Appendix D. Continuous Glucose Error-Grid Analysis (CG-EGA)
The Quality Management System Approach
Related CLSI Reference Materials
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