diaendoСахарный диабетDiabetes mellitus2072-03512072-0378Endocrinology research centre10.14341/DM13329diaendo-13329Research ArticleОБЗОРЫREVIEWSИллюзия точности: критический анализ методов оценки качества систем непрерывного мониторирования глюкозыThe illusion of accuracy: a critical analysis of continuous glucose monitoring systems quality assessment methodshttps://orcid.org/0000-0002-5057-127XШестаковаМ. В.ShestakovaM. V.

Шестакова Марина Владимировна - д.м.н., профессор, академик РАН.

117292, Москва, ул. Дм. Ульянова, д. 11

Scopus Author ID 7004195530

Marina V. Shestakova - MD, PhD, Professor, Academician of the RAS.

11 Dm. Ulyanova street, 117292 Moscow

Scopus Author ID 7004195530

shestakova.mv@gmail.comhttps://orcid.org/0000-0002-5507-4627ПетерковаВ. А.PeterkovaV. A.

Петеркова Валентина Александровна - д.м.н., профессор, академик РАН.

Москва

Valentina A. Peterkova - PhD, Professor, Academician of the RAS.

Moscow

peterkovava@hotmail.comhttps://orcid.org/0000-0001-6581-4521ГалстянГ. Р.GalstyanG. R.

Галстян Гагик Радикович - д.м.н., профессор.

Москва

Gagik R. Galstyan - MD, PhD, Professor.

Moscow

galstyangagik964@gmail.comhttps://orcid.org/0000-0003-3535-520XИбрагимоваЛ. И.IbragimovaL. I.

Ибрагимова Людмила Ибрагимовна - к.м.н.

Москва

Liudmila I. Ibragimova - MD, PhD.

Moscow

ibragimovaliudmila@gmail.comhttps://orcid.org/0000-0002-5407-8722КлимонтовВ. В.KlimontovV. V.

Климонтов Вадим Валерьевич - д.м.н., профессор.

Новосибирск

Researcher ID R-7689-2017; Scopus Author ID 8295977000

Vadim V. Klimontov - MD, PhD, Professor.

Novosibirsk

Researcher ID R-7689-2017; Scopus Author ID 8295977000

klimontov@mail.ruhttps://orcid.org/0000-0002-4316-8546ЛаптевД. Н.LaptevD. N.

Лаптев Дмитрий Никитич - д.м.н.

Москва

Researcher ID O-1826-2013; Scopus Author ID 24341083800

Dmitry N. Laptev - MD, PhD.

Moscow

Researcher ID O-1826-2013; Scopus Author ID 24341083800

laptevdn@ya.ruhttps://orcid.org/0000-0001-5964-5725МалаяИ. П.MalayaI. P.

Малая Ирина Павловна - к.м.н.

Москва

Researcher ID AAO-8351-2021; Scopus Author ID 57218705086

Irina P. Malaya - MD, PhD.

Moscow

Researcher ID AAO-8351-2021; Scopus Author ID 57218705086

malaya.irina@endocrincentr.ruhttps://orcid.org/0000-0001-6612-6851ШестаковаЕ. А.ShestakovaE. A.

Шестакова Екатерина Алексеевна - д.м.н.

Москва

Ekaterina A. Shestakova - MD, PhD.

Moscow

katiashestakova@mail.ruГНЦ РФ ФГБУ «Национальный медицинский исследовательский центр эндокринологии им. академика И.И. Дедова»РоссияEndocrinology Research CentreRussian FederationНаучно-исследовательский институт клинической и экспериментальной лимфологии — филиал ФГБНУ «Федеральный исследовательский центр Институт цитологии и генетики Сибирского отделения Российской академии наук»РоссияResearch Institute of Clinical and Experimental Lymphology — Branch of the Institute of Cytology and Genetics, Siberian Branch of Russian Academy of SciencesRussian FederationГНЦ РФ ФГБУ «Национальный медицинский исследовательский центр эндокринологии им. академика И.И. Дедова»; Российский национальный исследовательский медицинский университет им. Н.И. ПироговаРоссияEndocrinology Research Centre; Pirogov Russian National Research Medical UniversityRussian FederationГНЦ РФ ФГБУ «Национальный медицинский исследовательский центр эндокринологии им. академика И.И. Дедова»; Российская медицинская академия непрерывного профессионального образованияРоссияEndocrinology Research Centre; Russian Medical Academy of Continuous Professional EducationRussian Federation202524072025283231239Copyright © Шестакова М.В., Петеркова В.А., Галстян Г.Р., Ибрагимова Л.И., Климонтов В.В., Лаптев Д.Н., Малая И.П., Шестакова Е.А., 20252025Шестакова М.В., Петеркова В.А., Галстян Г.Р., Ибрагимова Л.И., Климонтов В.В., Лаптев Д.Н., Малая И.П., Шестакова Е.А.Shestakova M.V., Peterkova V.A., Galstyan G.R., Ibragimova L.I., Klimontov V.V., Laptev D.N., Malaya I.P., Shestakova E.A.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.dia-endojournals.ru/jour/article/view/13329

Непрерывное мониторирование глюкозы (НМГ) применяется более 15 лет в Российской Федерации как метод самоконтроля уровня глюкозы у пациентов с сахарным диабетом. Основной характеристикой устройств НМГ, обеспечивающей их эффективное и безопасное применение, является точность показаний. В настоящий момент отсутствуют единые регламентирующие документы, определяющие минимально приемлемые показатели точности для систем НМГ.

Целью настоящего обзора являлась систематизация существующих подходов к оценке точности систем НМГ в различных странах, а также предложения по разработке российского стандарта оценки точности устройств НМГ, включая требования к методологии дизайна клинических исследований оценки точности, а также к минимально приемлемым показателям точности устройств НМГ, необходимым для возможности их применения в клинической практике.

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.

непрерывный мониторинг глюкозыточностьстандартыминимальные требования к точностиcontinues glucose monitoringaccuracyguidelinesminimum acceptable accuracy requirementsReferencesLeelarathna L, Evans ML, Neupane S, et al. Intermittently Scanned Continuous Glucose Monitoring for Type 1 Diabetes. N Engl J Med. 2022;387(16):1477-1487 doi: https://doi.org/10.1056/NEJMoa2205650Leelarathna L, Evans ML, Neupane S, et al. Intermittently Scanned Continuous Glucose Monitoring for Type 1 Diabetes. N Engl J Med. 2022;387(16):1477-1487 doi: https://doi.org/10.1056/NEJMoa2205650Bolinder J, Antuna R, Geelhoed-Duijvestijn P, et al. Novel glucose-sensing technology and hypoglycaemia in type 1 diabetes: a multicentre, non-masked, randomized controlled trial. Lancet. 2016;388(10057):2254-2263 doi: https://doi.org/10.1016/S0140-6736(16)31535-5Bolinder J, Antuna R, Geelhoed-Duijvestijn P, et al. Novel glucose-sensing technology and hypoglycaemia in type 1 diabetes: a multicentre, non-masked, randomized controlled trial. Lancet. 2016;388(10057):2254-2263 doi: https://doi.org/10.1016/S0140-6736(16)31535-5Campbell FM, Murphy NP, Stewart C, et al. Outcomes of using flash glucose monitoring technology by children and young people with type 1 diabetes in a single arm study. Pediatr Diabetes. 2018;19(7):1294-1301 doi: https://doi.org/10.1111/pedi.12735Campbell FM, Murphy NP, Stewart C, et al. Outcomes of using flash glucose monitoring technology by children and young people with type 1 diabetes in a single arm study. Pediatr Diabetes. 2018;19(7):1294-1301 doi: https://doi.org/10.1111/pedi.12735Evans M, Welsh Z, Ells S, Seibold A. The Impact of Flash Glucose Monitoring on Glycaemic Control as Measured by HbA1c: A Meta-analysis of Clinical Trials and Real-World Observational Studies. Diabetes Ther. 2020;11(1):83-95. doi: https://doi.org/10.1007/s13300-019-00720-0Evans M, Welsh Z, Ells S, Seibold A. The Impact of Flash Glucose Monitoring on Glycaemic Control as Measured by HbA1c: A Meta-analysis of Clinical Trials and Real-World Observational Studies. Diabetes Ther. 2020;11(1):83-95. doi: https://doi.org/10.1007/s13300-019-00720-0Evans M, Welsh Z, Seibold A. Reductions in HbA1c with Flash Glucose Monitoring Are Sustained for up to 24 Months: A Meta-Analysis of 75 Real-World Observational Studies. Diabetes Ther. 2022;13(6):1175-1185. doi: https://doi.org/10.1007/s13300-022-01253-9Evans M, Welsh Z, Seibold A. Reductions in HbA1c with Flash Glucose Monitoring Are Sustained for up to 24 Months: A Meta-Analysis of 75 Real-World Observational Studies. Diabetes Ther. 2022;13(6):1175-1185. doi: https://doi.org/10.1007/s13300-022-01253-9Fokkert M, van Dijk P, Edens M, et al. Improved well-being and decreased disease burden after 1-year use of flash glucose monitoring (FLARE-NL4). BMJ Open Diabetes Res Care. 2019;7(1):e000809 doi: https://doi.org/10.1136/bmjdrc-2019-000809Fokkert M, van Dijk P, Edens M, et al. Improved well-being and decreased disease burden after 1-year use of flash glucose monitoring (FLARE-NL4). BMJ Open Diabetes Res Care. 2019;7(1):e000809 doi: https://doi.org/10.1136/bmjdrc-2019-000809Wright EE, Jr., Kerr MSD, Reyes IJ, et al. Use of Flash Continuous Glucose Monitoring Is Associated With A1C Reduction in People With Type 2 Diabetes Treated With Basal Insulin or Noninsulin Therapy. Diabetes Spectr. 2021;34(2):184-189 doi: https://doi.org/10.2337/ds20-0069Wright EE, Jr., Kerr MSD, Reyes IJ, et al. Use of Flash Continuous Glucose Monitoring Is Associated With A1C Reduction in People With Type 2 Diabetes Treated With Basal Insulin or Noninsulin Therapy. Diabetes Spectr. 2021;34(2):184-189 doi: https://doi.org/10.2337/ds20-0069Wright EE, Roberts GJ, Chuang JS, et al. Initiating GLP-1 Therapy in Combination with FreeStyle Libre Provides Greater Benefit Compared with GLP-1 Therapy Alone. Diabetes Technol Ther. 2024;26(10):754-762. doi: https://doi.org/10.1089/dia.2024.0015Wright EE, Roberts GJ, Chuang JS, et al. Initiating GLP-1 Therapy in Combination with FreeStyle Libre Provides Greater Benefit Compared with GLP-1 Therapy Alone. Diabetes Technol Ther. 2024;26(10):754-762. doi: https://doi.org/10.1089/dia.2024.0015Yaron M, Roitman E, Aharon-Hananel G, et al. Effect of Flash Glucose Monitoring Technology on Glycemic Control and Treatment Satisfaction in Patients With Type 2 Diabetes. Diabetes Care. 2019;42(7):1178-1184. doi: https://doi.org/10.2337/dc18-0166Yaron M, Roitman E, Aharon-Hananel G, et al. Effect of Flash Glucose Monitoring Technology on Glycemic Control and Treatment Satisfaction in Patients With Type 2 Diabetes. Diabetes Care. 2019;42(7):1178-1184. doi: https://doi.org/10.2337/dc18-0166Лаптев Д.Н., Безлепкина О.Б., Демина Е.С., и соавт. Результаты клинической апробации системы FreeStyle Libre у детей с сахарным диабетом 1 типа: улучшение гликемического контроля в сочетании со снижением риска тяжелой гипогликемии и диабетического кетоацидоза // Проблемы эндокринологии. — 2022. — Т. 68. — №3 — С. 86-92. doi: https://doi.org/10.14341/probl12877Laptev DN, Bezlepkina OB, Demina ES, et al. Evaluation of FreeStyle Libre in pediatric t1dm: improved glycemic control, reduction in diabetic ketoacidosis and severe hypoglycemia. Problems of Endocrinology. 2022;68(3):86-92. (In Russ.) doi: https://doi.org/10.14341/probl12877Danne T, Nimri R, Battelino T, et al. International Consensus on Use of Continuous Glucose Monitoring. Diabetes Care. 2017;40(12):1631-1640. doi: https://doi.org/10.2337/dc17-1600Danne T, Nimri R, Battelino T, et al. International Consensus on Use of Continuous Glucose Monitoring. Diabetes Care. 2017;40(12):1631-1640. doi: https://doi.org/10.2337/dc17-1600Bailey TS, Alva S. Landscape of Continuous Glucose Monitoring (CGM) and Integrated CGM: Accuracy Considerations. Diabetes Technol Ther. 2021;23(S3):S5-S11. doi: https://doi.org/10.1089/dia.2021.0236Bailey TS, Alva S. Landscape of Continuous Glucose Monitoring (CGM) and Integrated CGM: Accuracy Considerations. Diabetes Technol Ther. 2021;23(S3):S5-S11. doi: https://doi.org/10.1089/dia.2021.0236Mathieu C, Irace C, Wilmot EG, et al. Minimum expectations for market authorization of continuous glucose monitoring devices in Europe-’eCGM’ compliance status. Diabetes Obes Metab. 2025;27(3):1025-1031. doi: https://doi.org/10.1111/dom.16153Mathieu C, Irace C, Wilmot EG, et al. Minimum expectations for market authorization of continuous glucose monitoring devices in Europe-’eCGM’ compliance status. Diabetes Obes Metab. 2025;27(3):1025-1031. doi: https://doi.org/10.1111/dom.16153Pemberton JS, Wilmot EG, Barnard-Kelly K, et al. CGM accuracy: Contrasting CE marking with the governmental controls of the USA (FDA) and Australia (TGA): A narrative review. Diabetes Obes Metab. 2023;25(4):916-939. doi: https://doi.org/10.1111/dom.14962Pemberton JS, Wilmot EG, Barnard-Kelly K, et al. CGM accuracy: Contrasting CE marking with the governmental controls of the USA (FDA) and Australia (TGA): A narrative review. Diabetes Obes Metab. 2023;25(4):916-939. doi: https://doi.org/10.1111/dom.14962Петеркова В.А., Аметов А.С., Майоров А.Ю., и соавт. Резолюция научно-консультативного совета «Применение технологии непрерывного мониторинга глюкозы с периодическим сканированием в достижении гликемического контроля» // Сахарный диабет. — 2021. — Т. 24. — № 2. — С. 185-192. doi: https://doi.org/10.14341/DM12753Peterkova VA, Ametov AS, Mayorov AY, et al. The Scientific Advisory board resolution: Implementation of intermittently scanned Continuous Glucose monitoring in clinical practice to improve glycemic control. Diabetes mellitus. 2021;24(2):185-192. (In Russ.) doi: https://doi.org/10.14341/DM12753Clinical and Laboratory Standards Institute (CLSI). Performance Metrics for Continuous Interstitial Glucose Monitoring (CLSI Guideline POCT05). 2nd ed. Wayne, PA: CLSI; 2020Clinical and Laboratory Standards Institute (CLSI). Performance Metrics for Continuous Interstitial Glucose Monitoring (CLSI Guideline POCT05). 2nd ed. Wayne, PA: CLSI; 2020Момыналиев К.Т., Прокопьев М.В., Иванов И.В. О стандартизации и оценке систем непрерывного мониторинга уровня глюкозы. Эталоны // Стандартные образцы. — 2023. — Т. 19. — № 5. — С. 113-125. doi: https://doi.org/10.20915/2077-1177-2023-19-5-113-125Momynaliev KT, Prokopyev MV, Ivanov IV. On Standardization and Evaluation of Continuous Glucose Monitoring Systems. Measurement Standards. Reference Materials. 2023;19(5):113-125. (In Russ.) doi: https://doi.org/10.20915/2077-1177-2023-19-5-113-125Ajjan RA, Cummings MH, Jennings P, et al. Accuracy of flash glucose monitoring and continuous glucose monitoring technologies: Implications for clinical practice. Diab Vasc Dis Res. 2018;15(3):175-184 doi: https://doi.org/10.1177/1479164118756240Ajjan RA, Cummings MH, Jennings P, et al. Accuracy of flash glucose monitoring and continuous glucose monitoring technologies: Implications for clinical practice. Diab Vasc Dis Res. 2018;15(3):175-184 doi: https://doi.org/10.1177/1479164118756240Vigersky RA, Shin J. The Myth of MARD (Mean Absolute Relative Difference): Limitations of MARD in the Clinical Assessment of Continuous Glucose Monitoring Data. Diabetes Technol Ther. 2024;26(S3):38-44. doi: https://doi.org/10.1089/dia.2023.0435Vigersky RA, Shin J. The Myth of MARD (Mean Absolute Relative Difference): Limitations of MARD in the Clinical Assessment of Continuous Glucose Monitoring Data. Diabetes Technol Ther. 2024;26(S3):38-44. doi: https://doi.org/10.1089/dia.2023.0435Zhu J, Volkening LK, Laffel LM. Distinct Patterns of Daily Glucose Variability by Pubertal Status in Youth With Type 1 Diabetes. Diabetes Care. 2020;43(1):22-28 doi: https://doi.org/10.2337/dc19-0083Zhu J, Volkening LK, Laffel LM. Distinct Patterns of Daily Glucose Variability by Pubertal Status in Youth With Type 1 Diabetes. Diabetes Care. 2020;43(1):22-28 doi: https://doi.org/10.2337/dc19-0083Heinemann L, Schoemaker M, Schmelzeisen-Redecker G, et al. Benefits and Limitations of MARD as a Performance Parameter for Continuous Glucose Monitoring in the Interstitial Space. J Diabetes Sci Technol. 2020;14(1):135-150 doi: https://doi.org/10.1177/1932296819855670Heinemann L, Schoemaker M, Schmelzeisen-Redecker G, et al. Benefits and Limitations of MARD as a Performance Parameter for Continuous Glucose Monitoring in the Interstitial Space. J Diabetes Sci Technol. 2020;14(1):135-150 doi: https://doi.org/10.1177/1932296819855670Klonoff DC, Gabbay M, Moon SJ, Wilmot EG. Importance of FDA-Integrated Continuous Glucose Monitors to Ensure Accuracy of Continuous Glucose Monitoring. J Diabetes Sci Technol. 2024:19322968241250357 doi: https://doi.org/10.1177/19322968241250357Klonoff DC, Gabbay M, Moon SJ, Wilmot EG. Importance of FDA-Integrated Continuous Glucose Monitors to Ensure Accuracy of Continuous Glucose Monitoring. J Diabetes Sci Technol. 2024:19322968241250357 doi: https://doi.org/10.1177/19322968241250357Freckmann G, Eichenlaub M, Waldenmaier D, et al. Clinical Performance Evaluation of Continuous Glucose Monitoring Systems: A Scoping Review and Recommendations for Reporting. J Diabetes Sci Technol. 2023;17(6):1506-1526 doi: https://doi.org/10.1177/19322968231190941Freckmann G, Eichenlaub M, Waldenmaier D, et al. Clinical Performance Evaluation of Continuous Glucose Monitoring Systems: A Scoping Review and Recommendations for Reporting. J Diabetes Sci Technol. 2023;17(6):1506-1526 doi: https://doi.org/10.1177/19322968231190941Дедов И.И., Шестакова М.В., Майоров А.Ю., и др. Клинические рекомендации. Сахарный диабет 1 типа у взрослых (2022 г). Доступно по ссылке: https://cr.minzdrav.gov.ru/preview-cr/286_2Dedov II, Shestakova MV, Maiorov AY, et al. Klinicheskie rekomendatsii. Sakharnyi diabet 1 tipa u vzroslykh (2022 g). Available from: https://cr.minzdrav.gov.ru/preview-cr/286_2 (In Russ.)Дедов И.И., Шестакова М.В., Майоров А.Ю., и др. Клинические рекомендации. Сахарный диабет 2 типа у взрослых (2022 г). Доступно по ссылке: https://cr.minzdrav.gov.ru/preview-cr/290_2Dedov II, Shestakova MV, Maiorov AY, et al. Klinicheskie rekomendatsii. Sakharnyi diabet 2 tipa u vzroslykh (2022 g). Available from: https://cr.minzdrav.gov.ru/preview-cr/290_2 (In Russ.)Петеркова В.А., Шестакова М.В., Безлепкина О.Б., и др. Клинические рекомендации. Сахарный диабет 1 типа у детей (2022). Доступно по ссылке: https://cr.minzdrav.gov.ru/preview-cr/287_3Peterkova VA, Shestakova MV, Bezlepkina OB, et al. Klinicheskie rekomendatsii. Sakharnyi diabet 1 tipa u detei (2022). Available from: https://cr.minzdrav.gov.ru/preview-cr/287_3 (In Russ.)Food and Drug Administration (FDA) [Internet]. Classification of the integrated continuous glucose monitoring system. Federal register February 18. 2022 [accessed 28 Feb 2025]. Available from: https://www.federalregister.gov/documents/2022/02/18/2022-03504/medical-devices-clinicalchemistry-and-clinical-toxicology-devices-classification-ofthe-integratedFood and Drug Administration (FDA) [Internet]. Classification of the integrated continuous glucose monitoring system. Federal register February 18. 2022 [accessed 28 Feb 2025]. Available from: https://www.federalregister.gov/documents/2022/02/18/2022-03504/medical-devices-clinicalchemistry-and-clinical-toxicology-devices-classification-ofthe-integrated

The authors declare that there are no conflicts of interest present.