CLSI POCT5 P : 1ED 2008

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

Provides consensus guidelines for health care professionals, in vitro diagnostic (IVD) and medical device manufacturers, and regulatory agencies on how continuous glucose monitor (CGM) data should be: 1) presented; 2) compared between devices; and 3) compared between measurement technologies.

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.