CLSI POCT05
Performance Metrics for Continuous Interstitial Glucose Monitoring
This document offers expert approved guidance for healthcare professionals, medical device manufacturers, regulatory agencies and in-vitro diagnositc personnel on the use of continuous glucose monitoring (CGM) systems and the data they obtain. CLSI POCT05 Ed2 guides personnel through assessing CGM data for accuracy, evaluating CGM systems for factors that can decrease accuracy, and operating CGMs for optimal performance.
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{{FormatPrice(nonMemberPrice)}} List PriceClinical and Laboratory Standards Institute guideline POCT05—Performance Metrics for Continuous Interstitial Glucose Monitoring provides consensus information for health care professionals, in vitro diagnostic and medical device manufacturers, and regulatory agencies regarding how continuous glucose monitoring (CGM) data should be assessed for accuracy, how CGM systems should be assessed for factors that can decrease accuracy, and how CGMs should be operated for optimal performance. This guideline defines and explores multiple aspects of CGM performance, including use cases, point and trend accuracy, evaluation of threshold alerts, system stability and reliability, clinical studies for assessing CGM performance, calibration, measurement traceability, and special considerations such as shelf life, cybersecurity, and product labeling.
This guideline replaces the previous edition of the approved guideline, POCT05-A, published in 2008. Several changes were made in this edition, including:
- Extensively revising every chapter
- Adding new chapters that discuss:
- CGM device use cases
- Cybersecurity for CGM devices
- CGM device labeling
- Rearranging subchapters and appendixes, including:
- Changing stand-alone chapter on lag time to become part of Chapter 8
- Including text describing establishing measurement traceability in Chapter 4
- Replacing appendix on clinical studies with Chapter 9
- Replacing appendix on rate deviation with Subchapters 6.3.1, 6.3.2, and 6.4
- Eliminating appendix covering continuous glucose-error grid analysis
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.
The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.
Clinical and Laboratory Standards Institute guideline POCT05—Performance Metrics for Continuous Interstitial Glucose Monitoring provides consensus information for health care professionals, in vitro diagnostic and medical device manufacturers, and regulatory agencies regarding how continuous glucose monitoring (CGM) data should be assessed for accuracy, how CGM systems should be assessed for factors that can decrease accuracy, and how CGMs should be operated for optimal performance. This guideline defines and explores multiple aspects of CGM performance, including use cases, point and trend accuracy, evaluation of threshold alerts, system stability and reliability, clinical studies for assessing CGM performance, calibration, measurement traceability, and special considerations such as shelf life, cybersecurity, and product labeling.
This guideline replaces the previous edition of the approved guideline, POCT05-A, published in 2008. Several changes were made in this edition, including:
- Extensively revising every chapter
- Adding new chapters that discuss:
- CGM device use cases
- Cybersecurity for CGM devices
- CGM device labeling
- Rearranging subchapters and appendixes, including:
- Changing stand-alone chapter on lag time to become part of Chapter 8
- Including text describing establishing measurement traceability in Chapter 4
- Replacing appendix on clinical studies with Chapter 9
- Replacing appendix on rate deviation with Subchapters 6.3.1, 6.3.2, and 6.4
- Eliminating appendix covering continuous glucose-error grid analysis
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.
The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.