CLSI POCT05

Performance Metrics for Continuous Interstitial Glucose Monitoring, 2nd Edition

This guideline provides consensus guidelines for health care professionals, in vitro diagnostic and medical device manufacturers, and regulatory agencies regarding the use of continuous glucose monitoring (CGM) systems and data obtained from CGM systems. This guideline covers how 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.

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Chairholder: David C. Klonoff, MD, FACP, FRCP (Edin), Fellow AIMBE

Date of Publication: November 9, 2020

Order Code PDF: CLSI POCT05Ed2E
ISBN Number: 978-1-68440-101-7

Order Code Print: CLSI POCT05Ed2
ISBN Number: 978-1-68440-100-0

Edition: Second

Pages: 82

CLSI POCT05 Additional Details

A guideline for global application developed through the Clinical and Laboratory Standards Institute consensus process.

CLSI POCT05 Abstract

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.