The Need for Standardization of Continuous Glucose Monitoring Performance Evaluation: An Opinion by the International Federation of Clinical Chemistry and Laboratory Medicine Working Group on Continuous Glucose Monitoring

Stefan Pleus; Manuel Eichenlaub; Elisabet Eriksson Boija; Marion Fokkert; Rolf Hinzmann; Johan Jendle; David C Klonoff; Konstantinos Makris; James H Nichols; John Pemberton; Elizabeth Selvin; Robbert J Slingerland; Andreas Thomas; Nam K Tran; Lilian Witthauer; Guido Freckmann

doi:10.1177/19322968241296097

The Need for Standardization of Continuous Glucose Monitoring Performance Evaluation: An Opinion by the International Federation of Clinical Chemistry and Laboratory Medicine Working Group on Continuous Glucose Monitoring

J Diabetes Sci Technol. 2024 Nov 14:19322968241296097. doi: 10.1177/19322968241296097. Online ahead of print.

Authors

Stefan Pleus^{1

2}, Manuel Eichenlaub², Elisabet Eriksson Boija^{1

3}, Marion Fokkert^{1

4}, Rolf Hinzmann^{1

5}, Johan Jendle^{1

6}, David C Klonoff^{1

7}, Konstantinos Makris^{1

8}, James H Nichols^{1

9}, John Pemberton^{1

10}, Elizabeth Selvin^{1

11}, Robbert J Slingerland^{1

4}, Andreas Thomas^{1

12}, Nam K Tran^{1

13}, Lilian Witthauer^{1

14

15}, Guido Freckmann^{1

2}

Affiliations

¹ Working Group on Continuous Glucose Monitoring, Scientific Division, The International Federation of Clinical Chemistry and Laboratory Medicine, Milano, Italy.
² Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany.
³ Equalis AB, Uppsala, Sweden.
⁴ Department of Clinical Chemistry, Isala Clinics, Zwolle, The Netherlands.
⁵ Lampertheim, Germany.
⁶ School of Medical Sciences, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.
⁷ Diabetes Research Institute of Mills-Peninsula Medical Center, San Mateo, CA, USA.
⁸ Clinical Biochemistry Department, KAT General Hospital, Athens, Greece.
⁹ Vanderbilt University Medical Center, Nashville, TN, USA.
¹⁰ Birmingham Women's and Children's NHS Foundation Trust, Birmingham, UK.
¹¹ Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
¹² Independent Scientific Consulting, Pirna, Germany.
¹³ Department of Pathology and Laboratory Medicine, University of California Davis Health, Sacramento, CA, USA.
¹⁴ Diabetes Center Berne, Bern, Switzerland.
¹⁵ Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital Bern, University of Bern, Bern, Switzerland.

Abstract

Metrics derived from continuous glucose monitoring (CGM) systems are often discordant between systems. A major cause is that CGM systems are not standardized; they use various algorithms and calibration methods, leading to discordant CGM readings across systems. This discordance can be addressed by standardizing CGM performance assessments: If manufacturers aim their CGM systems at the same target, then CGM readings will align across systems. This standardization should include the comparator device, sample origin, and study procedures. With better aligned CGM readings, CGM-derived metrics will subsequently also align better between systems.

Keywords: IFCC; continuous glucose monitoring; standardization.