Study of accuracy assessment of the Gmate LIFE blood glucose monitoring system

BACKGROUND: Currently, diabetes mellitus is studied as an urgent social problem. This is due to the fact that the number of identified cases is constantly growing, the course of the disease often becomes chronic, various complications develop, which lead to a deterioration in the quality of life and a reduction in its duration. At the moment, there are many blood glucose monitoring systems that differ in measurement accuracy, which is important not only for daily monitoring, emergency measurement when health deteriorates, but also for selecting an adequate dose of insulin. With the advent of a new product on the consumer market, in particular the Gmate LIFE blood glucose monitoring system, many questions arise - is the device as reliable and accurate as the manufacturer claims? AIM: To evaluate whether the measurement accuracy of the domestic Gmate LIFE blood glucose monitoring system meets the requirements of GOST R ISO 15197-2015 «In vitro diagnostic test systems. Requirements for blood glucose monitoring systems for self-testing in managing diabetes mellitus» (identical to International ISO 15197:2013). MATERIALS AND METHODS: The design of experiments to study the measurement accuracy of the Gmate LIFE glucose monitoring system was guided by the requirements of GOST R ISO 15197-2015. The accuracy of the system was studied on capillary blood samples. Capillary blood samples were taken from healthy individuals, as well as from outpatients with hypoglycemic and hyperglycemic conditions in the endocrinology department of the Irkutsk Regional State Autonomous Healthcare Institution «Irkutsk City Clinical Hospital No. 10». The studies were conducted from 05.03.2025 to 06.03.2025 in the endocrinology department of the Irkutsk Regional State Autonomous Healthcare Institution «Irkutsk City Clinical Hospital No. 10». RESULTS: To evaluate the accuracy of the system, 600 capillary blood samples were tested, obtained from volunteers - mainly outpatients with diabetes mellitus or inpatients. The results met the minimum accuracy criteria of the GOST R ISO 15197-2015 standard. CONCLUSION: The result of tests for measuring blood glucose levels depends on the technology and quality of the glucometer and test strips. The system must meet the minimum requirements of the GOST R ISO 15197-2015 standard. Testing of the Gmate LIFE system showed that the results of accuracy of the Gmate LIFE glucose monitoring system fully comply with the standard, and according to the system accuracy criterion, they show a result better than specified in the requirements.