Which standards do we need for continuous glucose monitoring (CGM)?

Session Type
PARALLEL SESSION
Date
21.02.2020, Friday
Session Time
09:00 - 10:00
Channel
London
Lecture Time
09:00 - 09:20
Presenter
  • Guido Freckmann, Germany
Authors
  • Guido Freckmann, Germany

Abstract

Background and Aims

Continuous glucose monitoring (CGM) is increasingly used by in diabetes therapy and is partly replacing self-monitoring of blood glucose (SMBG). However, CGM and SMBG measure glucose in different compartments which are known to exhibit a time lag in glucose concentration. In addition, CGM systems use different calibration procedures and algorithms to calculate glucose values. Studies showed that there can be considerable systematic measurement differences between CGM systems.

Methods

While for SMBG systems an international standard describing test procedures and accuracy criteria is available, there is no international standard for CGM systems established. In addition, CGM glucose values currently cannot be traced to higher order materials or methods because a reference measurement in s.c. tissue is currently not feasible. The major metric, the mean absolute relative deviation (MARD), that is used to describe CGM accuracy, is highly dependent on many factors like study design and therefore only offers limited comparability between systems.

Results

The IFCC (International Federation of Clinical Chemistry and Laboratory Medicine) recently founded a new CGM working group. Objectives are the establishment of traceability for CGM glucose values, definition of procedures for assessment of the analytical performance of CGM system and definition of suitable metrics and acceptance criteria regarding analytical performance.

Conclusions

Considering the increasing importance of CGM in diabetes therapy, standards addressing traceability, testing procedures and acceptance criteria are needed.

Hide