rmjournalЭталоны. Стандартные образцыMeasurement Standards. Reference Materials2687-0886D. I. Mendeleyev Institute for Metrology10.20915/2077-1177-2023-19-5-113-125rmjournal-448Research ArticleСовременные методы анализа веществ и материаловModern methods of analysis of substances and materialsО стандартизации и оценке систем непрерывного мониторинга уровня глюкозыOn Standardization and Evaluation of Continuous Glucose Monitoring Systemshttps://orcid.org/0000-0003-4656-1025МомыналиевК. Т.MomynalievK. T.

Куват Темиргалиеви Момыналиев, д-р биол. наук, доцент, помощник генерального директора

115478

Каширское ш., д. 24 стр. 16

Москва

Kuvat T. Momynaliev,  Doctor of Biological Sciences, Associate Professor, Assistant General Director

115478

24 building 16, Kashirskoye shosse

Moscow

kmomynaliev@vniiimt.orgПрокопьевМ. В.ProkopyevM. V.

Максим Владимирович Прокопьев, канд. мед. наук, заместитель руководителя по экспертизе медицинских изделий

Центр экспертизы, мониторинга и инспекции производства медицинских изделий

115478

Каширское ш., д. 24 стр. 16

Москва

Maxim V. Prokopyev, Candidate of Medical Sciences, Deputy Head for Expertise of Medical Devices

Center for Expertise, Monitoring and Inspection of the Production of MedicalDevices

115478

24 building 16, Kashirskoye shosse

Moscow

mprokopev@vniiimt.orghttps://orcid.org/0000-0003-0971-853XИвановИ. В.IvanovI. V.

Игорь Владимирович Иванов, д-р мед. наук, генеральный директор

Москва

Igor V. Ivanov, Doctor of Medical Sciences, General Director

Moscow

ivanov@vniiimt.orgФГБУ «Всероссийский научно-исследовательский и испытательный институт медицинской техники» Федеральной службы по надзору в сфере здравоохраненияРоссияRussian Scientific and Research Institute for Medical Engineering of Federal Service for Supervision in the sphere of public healthRussian Federation202307012024195113125Copyright © Момыналиев К.Т., Прокопьев М.В., Иванов И.В., 20242024Момыналиев К.Т., Прокопьев М.В., Иванов И.В.Momynaliev K.T., Prokopyev M.V., Ivanov I.V.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.rmjournal.ru/jour/article/view/448

   Контроль уровня глюкозы в крови осуществляется с помощью систем непрерывного мониторинга глюкозы (НМГ). Среди всех коммерчески доступных систем НМГ превалируют системы, непрерывно измеряющие концентрацию глюкозы в интерстициальной жидкости подкожной жировой ткани. Однако сегодня не существует международно признанной референтной методики измерения глюкозы в интерстициальной жидкости, – значит, не соблюдается необходимое условие для обеспечения метрологической прослеживаемости результатов измерений глюкозы, полученных с применением НМГ. К тому же производители не предоставляют информацию о цепочке прослеживаемости и неопределенности измерений их систем, следовательно, полученные с помощью НМГ значения глюкозы не могут быть отслежены до эталонов или референтных методик измерений более высокого порядка. Кроме того, часто используемый для описания аналитической эффективности систем НМГ показатель – средняя абсолютная относительная разница (МАRD) – зависит от многих факторов. Например, на МАRD может существенно влиять «время задержки» между изменением уровня глюкозы в крови и интерстициальной глюкозой, особенно при высоких скоростях изменения уровня глюкозы. Наконец, современные системы автоматизированной доставки инсулина (АДИ) со встроенным НМГ могут автоматически приостанавливать или увеличивать инфузию инсулина в ответ на текущие и/или прогнозируемые гипогликемические и гипергликемические явления у детей и взрослых с сахарным диабетом 1 типа (СД1).

   Целью обзора является обоснование необходимости установления метрологической прослеживаемости измерений глюкозы системами НМГ, а также обсуждение аналитических и клинических характеристик систем НМГ, предложенных различными профессиональными сообществами.

   По результатам обзора сделаны выводы о необходимости, первое – развития метрологического обеспечения измерений глюкозы, выполняемых с применением систем НМГ, и второе – решения проблем обеспечения пациентам доступности и удобства пользования системами НМГ в реальных условиях.

   Continuous glucose monitoring (CGM) systems are often used to monitor blood glucose levels. Most commercially available CGM systems continuously measure glucose concentrations in the interstitial fluid of subcutaneous adipose tissue. However, there is currently no internationally accepted reference method for measuring interstitial fluid glucose, which is a prerequisite for metrological traceability of glucose measurements obtained using CGM. Since manufacturers do not provide information about the traceability chain and measurement uncertainty of their systems, CGM-derived glucose values cannot currently be adequately traced to standards or higher order reference measurement procedures. Additionally, the «mean absolute relative difference» (MARD) often used to describe the analytical performance of CGM systems is dependent on many factors. For example, the MARD can be significantly affected by the «lag time» between the change in blood glucose and interstitial glucose, especially at high rates of change in glucose. Finally, modern automated insulin delivery (ADI) systems with integrated CGM can automatically suspend or increase insulin infusion in response to current and/or predicted hypoglycemic and hyperglycemic phenomenon in children and adults with type 1 diabetes mellitus (T1DM).

   The purpose of the review is justification of the necessity to establish metrological traceability of glucose measurements with CGM systems, as well as a discussion of the analytical and clinical characteristics of CGM systems proposed by various professional communities.

   Based on the results of the review, it was concluded that it is necessary to 1) develop metrological support for glucose measurements performed using CGM systems, 2) solve the problems of ensuring the accessibility and usability of CGM systems by patients in real conditions.

сахарный диабетнепрерывный мониторинг глюкозыавтоматизированная доставка инсулинасредняя абсолютная относительная разностьметрологическая прослеживаемостьdiabetes mellituscontinuous glucose monitoringautomated insulin deliverymean absolute relative differencemetrological traceabilityЭто исследование не получало финансовой поддержки в виде гранта от какой-либо организации государственного, коммерческого или некоммерческого сектораThis research did not receive financial support in the form of a grant from any governmental, for-profit, or non-profit organizationsReferencesAvari P., Reddy M., Oliver N. Is it possible to constantly and accurately monitor blood sugar levels, in people with Type 1 diabetes, with a discrete device (non-invasive or invasive)? // Diabetic Medicine. 2020. Vol. 37, № 4. P. 532–544. doi: 10.1111/dme.13942Avari P., Reddy M., Oliver N. Is it possible to constantly and accurately monitor blood sugar levels, in people with Type 1 diabetes, with a discrete device (non-invasive or invasive)? Diabetic Medicine. 2020;37(4):532–544. doi: 10.1111/dme.13942Health equity and diabetes technology: A study of access to continuous glucose monitors by payer, geography and race executive summary // American Diabetes Association [websiete]. URL: https://diabetes.org/sites/default/files/2022–10/ADA-CGM-Utilization-White-Paper-Oct-2022.pdf (date of access: 08. 06. 2023).Health equity and diabetes technology: A study of access to continuous glucose monitors by payer, geography and race executive summary. Accessed June 8, 2023. https://diabetes.org/sites/default/files/2022–10/ADA-CGM-Utilization-White-Paper-Oct-2022.pdfTime lag of glucose from intravascular to interstitial compartment in type 1 diabetes / A. Basu [et al.] // Journal of Diabetes Science and Technology. 2015. Vol. 9, № 1. P. 63–68. doi: 10.1177/1932296814554797Basu A., Dube S., Veettil S. et al. Time lag of glucose from intravascular to interstitial compartment in type 1 diabetes. Journal of Diabetes Science and Technology. 2015;9(1):63–68. doi: 10.1177/1932296814554797Standardization process of continuous glucose monitoring: Traceability and performance / G. Freckmann [et al.] // Clinica Chimica Acta. 2021. Vol. 515. P. 5–12. doi: 10.1016/j.cca.2020.12.025Freckmann G., Nichols J. H., Hinzmann R. et al. Standardization process of continuous glucose monitoring: Traceability and performance. Clinica Chimica Acta. 2021;515:5–12. doi: 10.1016/j.cca.2020.12.025The performance and usability of a factory-calibrated flash glucose monitoring system / T. Bailey [et al.] // Diabetes Technology & Therapeutics. 2015. Vol. 17, № 11. P. 787–794. doi: 10.1089/dia.2014.0378Bailey T., Bode B. W., Christiansen M. P. et al. The performance and usability of a factory-calibrated flash glucose monitoring system. Diabetes Technology & Therapeutics. 2015;17(11):787–794. doi: 10.1089/dia.2014.0378Bailey T. S., Chang A., Christiansen M. Clinical accuracy of a continuous glucose monitoring system with an advanced algorithm // Journal of Diabetes Science and Technology. 2015. Vol. 9, № 2. P. 209–214. doi: 10.1177/1932296814559746Bailey T. S., Chang A., Christiansen M. Clinical accuracy of a continuous glucose monitoring system with an advanced algorithm. Journal of Diabetes Science and Technology. 2015;9(2):209–214. doi: 10.1177/1932296814559746Freckmann G. Basics and use of continuous glucose monitoring (CGM) in diabetes therapy // Journal of Laboratory Medicine. 2020. Vol. 44, № 2. P. 71–79. doi: 10.1515/labmed-2019–0189Freckmann G. Basics and use of continuous glucose monitoring (CGM) in diabetes therapy. Journal of Laboratory Medicine. 2020;44(2):71–79. doi: 10.1515/labmed-2019–0189Effect of continuous glucose monitoring on glycemic control in adults with type 1 diabetes using insulin injections: The DIAMOND randomized clinical trial / R. W. Beck [et al.] // JAMA. 2017. Vol. 317, № 4. P. 371–378. doi: 10.1001/jama.2016.19975Beck R. W., Riddlesworth T., Ruedy K. et al. Effect of continuous glucose monitoring on glycemic control in adults with type 1 diabetes using insulin injections: The DIAMOND randomized clinical tria. JAMA. 2017;317(4):371–378. doi: 10.1001/jama.2016.19975Flash glucose-sensing technology as a replacement for blood glucose monitoring for the management of insulin-treated type 2 diabetes: a multicenter, open-label randomized controlled trial / T. Haak [et al.] // Diabetes Ther. 2017. Vol. 8, № 1. P. 55–73. doi: 10.1007/s13300-016-0223-6Haak T., Hanaire H., Ajjan R. et al. Flash glucose-sensing technology as a replacement for blood glucose monitoring for the management of insulin-treated type 2 diabetes: a multicenter, open-label randomized controlled trial. Diabetes Ther. 2017;8(1):55–73. doi: 10.1007/s13300-016-0223-6Continuous glucose monitoring vs conventional therapy for glycemic control in adults with type 1 diabetes treated with multiple daily insulin injections: The GOLD randomized clinical trial [published correction appears in JAMA. 2017. Vol. 317, № 18. P. 1912] / M. Lind [et al.] // JAMA. 2017. Vol. 317, № 4. P. 379–387. doi: 10.1001/jama.2016.19976Continuous glucose monitoring vs conventional therapy for glycemic control in adults with type 1 diabetes treated with multiple daily insulin injections: The GOLD randomized clinical trial [published correction appears in JAMA. 2017. Vol. 317, № 18. P. 1912] / M. Lind [et al.] // JAMA. 2017. Vol. 317, № 4. P. 379–387. doi: 10.1001/jama.2016.19976Switching from flash glucose monitoring to continuous glucose monitoring on hypoglycemia in adults with type 1 diabetes at high hypoglycemia risk: The extension phase of the I HART CGM Study / M. Reddy [et al.] // Diabetes Technol Ther. 2018. Vol. 20, № 11. P. 751–757. doi: 10.1089/dia.2018.0252Reddy M., Jugnee N., Anantharaja S. et al. Switching from flash glucose monitoring to continuous glucose monitoring on hypoglycemia in adults with type 1 diabetes at high hypoglycemia risk: The extension phase of the I HART CGM Study. Diabetes Technol Ther. 2018;20(11):751–757. doi: 10.1089/dia.2018.0252Kovatchev B. P. Metrics for glycaemic control – from HbA1c to continuous glucose monitoring // Nat Rev Endocrinol. 2017. Vol. 13, № 7. P. 425–436. doi: 10.1038/nrendo.2017.3Kovatchev B. P. Metrics for glycaemic control – from HbA1c to continuous glucose monitoring. Nat Rev Endocrinol. 2017;13(7):425–436. doi: 10.1038/nrendo.2017.3International consensus on use of continuous glucose monitoring / T. Danne [et al.] // Diabetes Care. 2017. Vol. 40, № 12. P. 1631–1640. doi: 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: 10.2337/dc17–1600Standardizing clinically meaningful outcome measures beyond HbA1c for type 1 diabetes: A consensus report of the american association of clinical endocrinologists, the american association of diabetes educators, the american diabetes association, the endocrine society, JDRF International, the Leona M. and Harry B. helmsley charitable trust, the pediatric endocrine society, and the T1D Exchange / G. Agiostratidou [et al.] // Diabetes Care. 2017. Vol. 40, № 12. P. 1622–1630. doi: 10.2337/dc17–1624Agiostratidou G., Anhalt H., Ball D. et al. Standardizing clinically meaningful outcome measures beyond HbA1c for type 1 diabetes: A consensus report of the american association of clinical endocrinologists, the american association of diabetes educators, the american diabetes association, the endocrine society, JDRF International, the Leona M. and Harry B. helmsley charitable trust, the pediatric endocrine society, and the T1D Exchange. Diabetes Care. 2017;40(12):1622–1630. doi: 10.2337/dc17–1624Time in range: a new parameter to evaluate blood glucose control in patients with diabetes / M. A. L. Gabbay [et al.] // Diabetology & Metabolic Syndrome. 2020. Vol. 12. P. 22. doi: 10.1186/s13098–020–00529-zGabbay M. A. L., Rodacki M., Calliari L. E. et al. Time in range: a new parameter to evaluate blood glucose control in patients with diabetes. Diabetology & Metabolic Syndrome. 2020;12:22. doi: 10.1186/s13098–020–00529-zGlucose management indicator (GMI): A New term for estimating A1C from continuous glucose monitoring / R. M. Bergenstal [et al.] // Diabetes Care. 2018. Vol. 41, № 11. P. 2275–2280. doi: 10.2337/dc18–1581Bergenstal R. M., Beck R. W., Close K. L. et al. Glucose management indicator (GMI): A New term for estimating A1C from continuous glucose monitoring. Diabetes Care. 2018;41(11):2275–2280. doi: 10.2337/dc18–1581Сахарный диабет 1 типа у взрослых : клинические рекомендации Министерства здравоохранения Российской Федерации; Разработчик Российская ассоциация эндокринологов; Одобрено Научно-практическим Советом Минздрава РФ. 2022 // Официальный интернет-портал правовой информации [сайт]. URL: https://base.garant.ru/406534305/ (дата обращения: 08. 06. 2023).Type 1 diabetes mellitus in adults: clinical recommendations of the Ministry of Health of the Russian Federation. Clinical research rubricator; 2022. (In Russ.). Accessed June 8, 2023. https://base.garant.ru/406534305/Сахарный диабет 2 типа у взрослых : клинические рекомендации Министерства здравоохранения Российской Федерации; Разработчик Российская ассоциация эндокринологов; Одобрено Научно-практическим Советом Минздрава РФ. 2022 // Рубрикатор клинических исследований [сайт]. URL: https://cr.minzdrav.gov.ru/schema/290_2 (дата обращения: 08. 06. 2023).Type 2 diabetes mellitus in adults: clinical recommendations of the Ministry of Health of the Russian Federation. Clinical research rubricator; 2022. (In Russ.). Accessed June 8, 2023. https://cr.minzdrav.gov.ru/schema/290_2Сахарный диабет 1 типа у детей : клинические рекомендации Министерства здравоохранения Российской Федерации; Разработчик Российская ассоциация эндокринологов; Одобрено Научно-практическим Советом Минздрава РФ. 2022 // Рубрикатор клинических исследований [сайт]. URL: https://cr.minzdrav.gov.ru/recomend/287_1 (дата обращения: 08. 06. 2023).Type 1 diabetes mellitus in children: clinical recommendations of the Ministry of Health of the Russian Federation. Clinical research rubricator; 2022. (In Russ.). Accessed June 8, 2023. https://cr.minzdrav.gov.ru/recomend/287_1Head-to-head comparison of the accuracy of abbott freestyle libre and dexcom G5 mobile / F. Boscari [et al.] // Nutrition, Metabolism and Cardiovascular Diseases. 2018. Vol. 28, № 4. P. 425–427. doi: 10.1016/j.numecd.2018.01.003Boscari F., Galasso S., Acciaroli G. et al. Head-to-head comparison of the accuracy of abbott freestyle libre and dexcom G5 mobile. Nutrition, Metabolism and Cardiovascular Diseases. 2018;28(4):425–427. doi: 10.1016/j.numecd.2018.01.003A three-way accuracy comparison of the dexcom G5, abbott freestyle libre pro, and senseonics eversense continuous glucose monitoring devices in a home-use study of subjects with type 1 diabetes / R. Z. Jafri [et al.] // Diabetes Technology & Therapeutics. 2020. Vol. 2, № 11. P. 846–852. doi: 10.1089/dia.2019.0449Jafri R. Z., Balliro C. A., El-Khatib F. et al. A three-way accuracy comparison of the dexcom G5, abbott freestyle libre pro, and senseonics eversense continuous glucose monitoring devices in a home-use study of subjects with type 1 diabetes. Diabetes Technology & Therapeutics. 2020;22(11):846–852. doi: 10.1089/dia.2019.0449Measurement performance of two continuous tissue glucose monitoring systems intended for replacement of blood glucose monitoring / G. Freckmann [et al.] // Diabetes Technology & Therapeutics. 2018. Vol. 20, № 8. P. 541–549. doi: 10.1089/dia.2018.0105Freckmann G., Link M., Pleus S. et al. Measurement performance of two continuous tissue glucose monitoring systems intended for replacement of blood glucose monitoring. Diabetes Technology & Therapeutics. 2018;20(8):541–549. doi: 10.1089/dia.2018.0105FreeStyle Libre and Dexcom G4 Platinum sensors: Accuracy comparisons during two weeks of home use and use during experimentally induced glucose excursions / F. Boscari [et al.] // Nutrition, Metabolism and Cardiovascular Diseases. 2018. Vol. 28, № 2. P. 180–186. doi: 10.1016/j.numecd.2017.10.023Boscari F., Galasso S., Facchinetti A. et al. FreeStyle Libre and Dexcom G4 Platinum sensors: Accuracy comparisons during two weeks of home use and use during experimentally induced glucose excursions. Nutrition, Metabolism and Cardiovascular Diseases. 2018;28(2):180–186. doi: 10.1016/j.numecd.2017.10.023Discrepancies between methods of continuous glucose monitoring in key metrics of glucose control in children with type 1 diabetes / A. Michalak [et al.] // Pediatric Diabetes. 2019. Vol. 20, № 5. P. 604–612. doi: 10.1111/pedi.12854Michalak A., Pagacz K., Młynarski W. Discrepancies between methods of continuous glucose monitoring in key metrics of glucose control in children with type 1 diabetes. Pediatric Diabetes. 2019;20(5):604–612. doi: 10.1111/pedi.12854Time in specific glucose ranges, glucose management indicator, and glycemic variability: impact of continuous glucose monitoring (CGM) system model and sensor on cgm metrics / S. Pleus [et al.] // Journal of Diabetes Science and Technology. 2021. Vol. 15, № 5. P. 1104–1110. doi: 10.1177/1932296820931825Pleus S., Kamecke U., Waldenmaier D. et al. Time in specific glucose ranges, glucose management indicator, and glycemic variability: impact of continuous glucose monitoring (CGM) system model and sensor on cgm metrics. Journal of Diabetes Science and Technology. 2021;15(5):1104–1110. doi: 10.1177/1932296820931825ГОСТ Р ИСО 17511–2022. Изделия медицинские для диагностики in vitro. Требования к установлению метрологической прослеживаемости значений, приписанных калибраторам, контрольным материалам правильности и образцам биологического материала человека. М.: Российский институт стандартизации, 2022.GOST R ISO 17511–2022 Invitro diagnostic medical devices. Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human biological samples. Moscow: Russian Institute of Standardization; 2022. (In Russ.).Samant P. P., Prausnitz M. R. Mechanisms of sampling interstitial fluid from skin using a microneedle patch // Proceedings of the National Academy of Sciences. 2018. Vol. 115, № 18. P. 4583–4588. doi: 10.1073/pnas.1716772115Samant P. P., Prausnitz M. R. Mechanisms of sampling interstitial fluid from skin using a microneedle patch. Proceedings of the National Academy of Sciences. 2018;115(18): 4583–4588. doi: 10.1073/pnas.1716772115Improving the bias of comparator methods in analytical performance assessments through recalibration / S. Pleus [et al.] // Journal of Diabetes Science and Technology. 2022. doi: 10.1177/19322968221133107Pleus S., Eichenlaub M., Gerber T. et al. Improving the bias of comparator methods in analytical performance assessments through recalibration. Journal of Diabetes Science and Technology. 2022;19322968221133107. doi: 10.1177/19322968221133107Seibold A., Brines R. Comment on Grino et al: Suitability of flash glucose monitoring for detection of hypoglycemia // Journal of Diabetes Science and Technology. 2019. Vol. 13, № 3. P. 607–608. doi: 10.1177/1932296819838534Seibold A., Brines R. Comment on Grino et al: Suitability of flash glucose monitoring for detection of hypoglycemia. Journal of Diabetes Science and Technology. 2019;13(3):607–608. doi: 10.1177/1932296819838534Results of a near continuous glucose monitoring technology in surgical intensive care and trauma / E. Nohra [et al.] // Contemp Clin Trials. 2016. Vol. 50. P. 1–4. doi: 10.1016/j.cct.2016.07.007Nohra E., Buckman S., Bochicchio K. et al. Results of a near continuous glucose monitoring technology in surgical intensive care and trauma. Contemp Clin Trials. 2016;50:1–4. doi: 10.1016/j.cct.2016.07.007Significance and reliability of MARD for the accuracy of CGM Systems / F. Reiterer [et al.] // Journal of Diabetes Science and Technology. 2017. Vol. 11, № 1. P. 59–67. doi: 10.1177/1932296816662047Reiterer F., Polterauer P., Schoemaker M. et al. Significance and reliability of MARD for the accuracy of CGM Systems. Journal of Diabetes Science and Technology. 2017;11(1):59–67. doi: 10.1177/1932296816662047Bailey T. S., Alva S. Landscape of continuous glucose monitoring (CGM) and integrated CGM: Accuracy considerations // Diabetes Technology & Therapeutics. 2021. Vol. 23. S5–S11. doi: 10.1089/dia.2021.0236Bailey T. S., Alva S. Landscape of continuous glucose monitoring (CGM) and integrated CGM: Accuracy considerations. Diabetes Technology & Therapeutics. 2021;23: S5–S11. doi: 10.1089/dia.2021.0236Measures of accuracy for continuous glucose monitoring and blood glucose monitoring devices / G. Freckmann [et al.] // Journal of Diabetes Science and Technology. 2019. Vol.13, № 3. P. 575–583. doi: 10.1177/1932296818812062Freckmann G., Pleus S., Grady M., Setford S., Levy B. Measures of accuracy for continuous glucose monitoring and blood glucose monitoring devices. Journal of Diabetes Science and Technology. 2019;13(3):575–583. doi: 10.1177/1932296818812062Benefits and limitations of MARD as a performance parameter for continuous glucose monitoring in the interstitial space / L. Heinemann [et al.] // Journal of Diabetes Science and Technology. 2020. Vol. 14, № 1. P. 135–150. doi: 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. Journal of Diabetes Science and Technology. 2020;14(1):135–150. doi: 10.1177/1932296819855670Performance comparison of CGM systems: MARD values are not always a reliable indicator of CGM system accuracy / H. Kirchsteiger [et al.] // Journal of Diabetes Science and Technology. 2015. Vol. 9, № 5. P. 1030–1040. doi: 10.1177/1932296815586013Kirchsteiger H., Heinemann L., Freckmann G. et al. Performance comparison of CGM systems: MARD values are not always a reliable indicator of CGM system accuracy. Journal of Diabetes Science and Technology. 2015;9(5):1030–1040. doi: 10.1177/1932296815586013Venous, arterialized-venous, or capillary glucose reference measurements for the accuracy assessment of a continuous glucose monitoring system / J. Kropff [et al.] // Journal of Diabetes Science and Technology. 2017. Vol. 19, № 11. P. 609–617. doi: 10.1089/dia.2017.0189Kropff J., van Steen S. C., deGraaff P., Chan M. W., van Amstel R. B.E., DeVries J. H. Venous, arterialized-venous, or capillary glucose reference measurements for the accuracy assessment of a continuous glucose monitoring system. Journal of Diabetes Science and Technology. 2017;19(11):609–617. doi: 10.1089/dia.2017.0189Macleod K., Katz L. B., Cameron H. Capillary and venous blood glucose accuracy in blood glucose meters versus reference standards: The impact of study design on accuracy evaluations // Journal of Diabetes Science and Technology. 2019. Vol. 13, № 3. P. 546–552. doi: 10.1177/1932296818790228Macleod K., Katz L. B., Cameron H. Capillary and venous blood glucose accuracy in blood glucose meters versus reference standards: The impact of study design on accuracy evaluations. Journal of Diabetes Science and Technology. 2019;13(3):546–552. doi: 10.1177/1932296818790228Continuous glucose deviation interval and variability analysis (CG-DIVA): A novel approach for the statistical accuracy assessment of continuous glucose monitoring systems / M. Eichenlaub [et al.] // Journal of Diabetes Science and Technology. 2022. P. 19322968221134639. doi: 10.1177/19322968221134639Eichenlaub M., Stephan P., Waldenmaier D. et al. Continuous glucose deviation interval and variability analysis (CG-DIVA): A novel approach for the statistical accuracy assessment of continuous glucose monitoring systems. Journal of Diabetes Science and Technology. 2022: 19322968221134639. doi: 10.1177/19322968221134639POCT05 Performance metrics for continuous interstitial glucose monitoring / eds. D. C. Klonoff [et al.]. 2<sup>nd</sup> ed. / CLSI [websiete]. URL: https://clsi.org/standards/products/new-products/documents/poct05/ (date of access: 08. 06. 2023).Klonoff D. C. et al. eds. POCT05 Performance metrics for continuous interstitial glucose monitoring. 2<sup>nd</sup> ed. CLSI. Accessed June 8, 2023. https://clsi.org/standards/products/new-products/documents/poct05/Continuous glucose monitoring and other wearable devices to assess hypoglycemia among older adult outpatients with diabetes mellitus / M. Weiner [et al.] // Applied Clinical Informatics. 2023. Vol. 14, № 1. P. 37–44. doi: 10.1055/a-1975–4136Weiner M., Adeoye P., Boeh M. J. et al. Continuous glucose monitoring and other wearable devices to assess hypoglycemia among older adult outpatients with diabetes mellitus. Applied Clinical Informatics. 2023;14(1):37–44. doi: 10.1055/a-1975–4136Clinical targets for continuous glucose monitoring data interpretation: recommendations from the international consensus on time in range / T. Battelino [et al.] // Diabetes Care. 2019. Vol. 42, № 8. P. 1593–1603. doi: 10.2337/dci19–0028Battelino T., Danne T., Bergenstal R. M. et al. Clinical targets for continuous glucose monitoring data interpretation: recommendations from the international consensus on time in range. Diabetes Care. 2019;42(8):1593–1603. doi: 10.2337/dci19–0028CFR – Code of Federal regulations title 21 // U. S. Food and Drug Administration [websiete]. URL: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr = 862.1355 (date of access: 08. 06. 2023).CFR – Code of Federal regulations title 21. U. S. Food and Drug Administration. Accessed June 8, 2023. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr = 862.1355

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