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.

1. Who.int/news-room [Internet]. World Health Organization [updated 2025 April 11]. Available from: https://www.who.int/news-room/fact-sheets/detail/diabetes.

2. Ametov AS, Sayamov YuN. Bioetika saharnogo diabeta kak global’naya problema sovremennogo mira. Doktor.Ru. 2022;21(2):56-58 (In Russ.) doi: https://doi.org/10.31550/1727-2378-2022-21-2-56-58

3. Kudencova LA, Davydov DV, Chernavskij SV. i dr. Klassifikaciya saharnogo diabeta: novyj vzglyad na problemu. Lechashchij vrach. 2022;5-6(25):84-90 (In Russ.) doi: https://doi.org/10.51793/OS.2022.25.6.015

4. Mohort TV, Shepel’kevich AP, Shishko EI, i dr. Saharnyj diabet: obnovlenie klassifikacii i osobennosti diagnostiki razlichnyh tipov: uchebno-metodicheskoe posobie. — Minsk: BGMU, 2021. – 31 s. (In Russ.)

5. Dedov II, Shestakova MV, Vikulova OK, et al. Epidemiology and key clinical and therapeutic indicators of diabetes mellitus in Russian Federation according to the World Health Organization’s strategy goals. Diabetes mellitus. 2025;28(1):4-17. (In Russ.) doi: https://doi.org/10.14341/DM13292

6. Nechaeva Yu. Chto iz nelekarstvennogo assortimenta luchshe vsego prodavalos’ v aptekah v 2022 godu. Farmacevticheskij vestnik. — 2022. Dostupno po: https://pharmvestnik.ru/content/articles/Chto-iz-nelekarstvennogo-assortimenta-luchshe-vsego-prodavalos-v-aptekah-v-2022-godu.html. Ssylka aktivna na 11.04.2025. (In Russ.)

7. Shestakova MV, Vikulova OK, Zheleznyakova AV, i dr. Saharnyj diabet 2-go tipa: klinicheskie rekomendacii protiv real’noj klinicheskoj praktiki. Terapevticheskij arhiv. 2023;95(10):833-838 (In Russ.) doi: https://doi.org/10.26442/00403660.2023.10.202424

8. Suplotova LA, Alieva OO. Evolution of blood glucose self-monitoring technology. Diabetes mellitus. 2023;26(6):566-574. (In Russ.) doi: https://doi.org/10.14341/DM13063

9. Huang Q, Chen J, Zhao Y, et al. Advancements in electrochemical glucose sensors. Talanta. 2025;281:126897. doi: https://doi.org/10.1016/j.talanta.2024.126897

10. Pullano SA, Greco M, Bianco MG, et al. Glucose biosensors in clinical practice: principles, limits and perspectives of currently used devices. Theranostics. 2022;12(2),493-511. doi: https://doi.org/10.7150/thno.64035

11. Setford S, Phillips S, Cameron H, et al. Clinical Accuracy of a Glucose Oxidase-Based Blood Glucose Test-Strip Across Extremes of Oxygen Partial Pressure. J Diabetes Sci Technol. 2024;18(6):1445-1451. doi: https://doi.org/10.1177/19322968231158663

12. Xu NY, Nguyen KT, Mehta C, et al. Antioxidant-Induced Pseudohyperglycemia Due to Interference of Measurements by Blood Glucose Monitors. J Diabetes Sci Technol. 2021;15(6):1404-1405. doi: https://doi.org/10.1177/19322968211041328

13. Wijewickrama P, Williams J, Bain S, et al; Association of British Clinical Diabetologists (ABCD) and UK Kidney Association (UKKA) Diabetic Kidney Disease Clinical Speciality Group. Narrative Review of Glycemic Management in People with Diabetes on Peritoneal Dialysis. Kidney Int Rep. 2023;8(4):700-714. doi: https://doi.org/10.1016/j.ekir.2023.01.040

14. Stolarczyk K, Rogalski J, Bilewicz R. NAD (P)-dependent glucose dehydrogenase: Applications for biosensors, bioelectrodes, and biofuel cells. Bioelectrochemistry. 2020; 135:107574. doi: https://doi.org/10.1016/j.bioelechem.2020.107574

15. Cohen R, Cohen Y, Mukha D, et al. Oxygen insensitive amperometric glucose biosensor based on FAD dependent glucose dehydrogenase co-entrapped with DCPIP or DCNQ in a polydopamine layer. Electrochimica Acta. 2021. doi: https://doi.org/10.1016/j.electacta.2020.137477

16. Pleus S, Baumstark A, Schauer S, et al. User Performance Evaluation and System Accuracy Assessment of Four Blood Glucose Monitoring Systems With Color Coding of Measurement Results. J Diabetes Sci Technol. 2024;18(3):644-652. doi: https://doi.org/10.1177/19322968221141926

17. Dzhimejt Lajf. Instrukciya po ekspluatacii. Versiya 1.6. Dzhimejt Lajf, 2025. — 60 s. (In Russ.)

18. Parkes JL, Slatin SL, Pardos, et al. A new consensus error grid to evaluate the clinical significance of in accuracies in the measurement of blood glucose. Diabetes Care. 2000; 23(8):1143–1148. doi: https://doi.org/10.2337/diacare.23.8.1143

19. Dianov OA, Majorov RV, Gorshkova MA, i dr. Tochnost’ izmereniya i interferenciya pri samokontrole glikemii s pomoshch’yu glyukometra SATELLIT® ONLINE u bol’nyh saharnym diabetom. Effektivnaya farmakoterapiya. 2023;19(34):24-30 (In Russ.) doi: https://doi.org/10.33978/2307-3586-2023-19-34-24-30