This review analyzes accuracy evaluation methods in continuous glucose monitoring systems, suggesting guidelines for clinical trials and performance standards.
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.
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Шестакова et al. (2025) studied this question.
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