The illusion of accuracy: a critical analysis of continuous glucose monitoring systems quality assessment methods
M. V. Shestakova,
V. A. Peterkova,
G. R. Galstyan,
L. I. Ibragimova,
V. V. Klimontov,
D. N. Laptev,
I. P. Malaya,
E. A. Shestakova https://doi.org/10.14341/DM13329
Abstract
Continuous glucose monitoring (CGM) has been established as a method for self-assessment glucose levels in individuals with diabetes mellitus in the Russian Federation for more than 15 years. The main characteristics of CGM sensors are its’ accuracy and performance that ensure their effectiveness and safety. Currently, there are no standardized guidelines that outline the minimum accuracy standards for CGM systems.
This review is aimed to codify the current methods for evaluating CGMs accuracy and performance across the different countries, as well as to propose local Russian guidelines on CGM device accuracy evaluation. This involves guidelines for the design of clinical trials to assess sensors accuracy and the minimum acceptable performance requirements for CGM devices to be utilized in clinical settings.
About the Authors
M. V. Shestakova
Endocrinology Research Centre
Russian Federation
Competing Interests:
Russian Federation
Marina V. Shestakova - MD, PhD, Professor, Academician of the RAS.
11 Dm. Ulyanova street, 117292 Moscow
Scopus Author ID 7004195530
Competing Interests:
None
V. A. Peterkova
Endocrinology Research Centre
Russian Federation
Competing Interests:
Russian Federation
Valentina A. Peterkova - PhD, Professor, Academician of the RAS.
Moscow
Competing Interests:
None
G. R. Galstyan
Endocrinology Research Centre
Russian Federation
Competing Interests:
Russian Federation
Gagik R. Galstyan - MD, PhD, Professor.
Moscow
Competing Interests:
None
L. I. Ibragimova
Endocrinology Research Centre
Russian Federation
Competing Interests:
Russian Federation
Liudmila I. Ibragimova - MD, PhD.
Moscow
Competing Interests:
None
V. V. Klimontov
Research Institute of Clinical and Experimental Lymphology — Branch of the Institute of Cytology and Genetics, Siberian Branch of Russian Academy of Sciences
Russian Federation
Competing Interests:
Russian Federation
Vadim V. Klimontov - MD, PhD, Professor.
Novosibirsk
Researcher ID R-7689-2017; Scopus Author ID 8295977000
Competing Interests:
None
D. N. Laptev
Endocrinology Research Centre
Russian Federation
Competing Interests:
Russian Federation
Dmitry N. Laptev - MD, PhD.
Moscow
Researcher ID O-1826-2013; Scopus Author ID 24341083800
Competing Interests:
None
I. P. Malaya
Endocrinology Research Centre; Pirogov Russian National Research Medical University
Russian Federation
Competing Interests:
Russian Federation
Irina P. Malaya - MD, PhD.
Moscow
Researcher ID AAO-8351-2021; Scopus Author ID 57218705086
Competing Interests:
None
E. A. Shestakova
Endocrinology Research Centre; Russian Medical Academy of Continuous Professional Education
Russian Federation
Competing Interests:
Russian Federation
Ekaterina A. Shestakova - MD, PhD.
Moscow
Competing Interests:
None
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Supplementary files
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1. Figure 1. Minimum accuracy requirements for continuous glucose monitoring systems proposed by the European Expert Panel [13]. | |
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| Type | Исследовательские инструменты | |
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Shestakova M.V., Peterkova V.A., Galstyan G.R., Ibragimova L.I., Klimontov V.V., Laptev D.N., Malaya I.P., Shestakova E.A. The illusion of accuracy: a critical analysis of continuous glucose monitoring systems quality assessment methods. Diabetes mellitus. 2025;28(3):231-239. (In Russ.) https://doi.org/10.14341/DM13329
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