The illusion of accuracy: a critical analysis of continuous glucose monitoring systems quality assessment methods

Continuous glucose monitoring (CGM) has been used for over 15 years in the Russian Federation as a method of self-monitoring glucose levels in patients with diabetes. The main characteristic of CGM devices, ensuring their effective and safe use, is the accuracy of readings. Currently, there are no uniform regulatory documents defining the minimum acceptable accuracy indicators for CGM systems. The purpose of this review was to systematize existing approaches to assessing the accuracy of CGM systems in different countries, as well as proposals for the development of a Russian standard for assessing the accuracy of CGM devices, including requirements for the methodology of designing clinical trials to assess accuracy, as well as for the minimum acceptable indicators of the accuracy of CGM devices necessary for their use in clinical practice.