diaendoСахарный диабетDiabetes mellitus2072-03512072-0378Endocrinology research centre10.14341/DM13385diaendo-13385Research ArticleОригинальные исследованияOriginal StudiesFlash-мониторинг глюкозы у детей младше 4 лет: проспективная оценка системы Freestyle Libre 2 в популяции детей с сахарным диабетом 1 типаFlash glucose monitoring in children under 4 years of age: a prospective evaluation of the Freestyle Libre 2 in a pediatric type 1 diabetes populationhttps://orcid.org/0000-0002-4316-8546ЛаптевД. Н.LaptevD. N.

Лаптев Дмитрий Никитич, д.м.н., профессор 

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

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

Dmitry N. Laptev, MD, PhD, Professor 

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

11 Dm. Ulyanova street, Moscow 117292 

laptevdn@ya.ruhttps://orcid.org/0000-0003-2891-0906ГалдаО. Г.GaldaO. G.

Галда Ольга Геннадьевна, клинический ординатор 

Москва 

Olga G. Galda, clinical resident 

Moscow 

o.docgalda@yandex.ruhttps://orcid.org/0000-0002-1990-7310БессоноваА. В.BessonovaA. V.

Бессонова Анна Владимировна 

Москва 

Anna V. Bessonova, MD 

Moscow 

bessonova-ann@mail.ruhttps://orcid.org/0000-0001-5964-5725МалаяИ. П.MalayaI. P.

Малая Ирина Павловна, к.м.н. 

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

Москва 

Irina P. Malaya, MD, PhD 

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

Moscow 

malaya.irina@endocrincentr.ruhttps://orcid.org/0000-0001-9896-4681КокшароваЕ. О.KoksharovaE. O.

Кокшарова Екатерина Олеговна, н.с. 

Москва 

Ekaterina O. Koksharova, MD, research associate 

Moscow 

katekoksharova@gmail.comhttps://orcid.org/0000-0001-6178-2016КолтаковаМ. П.KoltakovaM. P.

Колтакова Мария Павловна, аспирант 

Москва 

Mariya P. Koltakova, MD, PhD student 

Moscow 

koltakova.mariya@endocrincentr.ruhttps://orcid.org/0000-0002-3612-0974ФедорининА. А.FedorininA. A.

Федоринин Артем Альбертович, клинический ординатор  

Research ID: rid97643; Scopus ID: 57224524155 

Москва 

Artem A. Fedorinin, clinical resident 

Research ID: rid97643; Scopus ID: 57224524155 

Moscow 

artem_fedor@mail.ruhttps://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.comГНЦ РФ ФГБУ «Национальный медицинский исследовательский центр эндокринологии им. академика И.И. Дедова»РоссияEndocrinology Research CentreRussian FederationГНЦ РФ ФГБУ «Национальный медицинский исследовательский центр эндокринологии им. академика И.И. Дедова» ; Российский национальный исследовательский медицинский университет им. Н.И. Пирогова (Пироговский Университет), Российский геронтологический научно-клинический центрРоссияEndocrinology Research Centre ; Russian Gerontology Research and Clinical Centre, Pirogov National Research Medical UniversityRussian Federation2026110220262912028Copyright © Лаптев Д.Н., Галда О.Г., Бессонова А.В., Малая И.П., Кокшарова Е.О., Колтакова М.П., Федоринин А.А., Петеркова В.А., 20262026Лаптев Д.Н., Галда О.Г., Бессонова А.В., Малая И.П., Кокшарова Е.О., Колтакова М.П., Федоринин А.А., Петеркова В.А.Laptev D.N., Galda O.G., Bessonova A.V., Malaya I.P., Koksharova E.O., Koltakova M.P., Fedorinin A.A., Peterkova V.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/13385ОБОСНОВАНИЕ

ОБОСНОВАНИЕ. Непрерывный мониторинг глюкозы (НМГ) становится стандартом лечения детей с сахарным диабетом 1 типа (СД1), однако данные о применении у детей младше 4 лет ограничены. FreeStyle Libre 2 (FSL2) одобрен для использования с 4 лет, однако имеется клиническая потребность и в более младшей возрастной группе.

ЦЕЛЬ

ЦЕЛЬ. Оценить показатели точности и безопасности системы FSL2 при применении вне зарегистрированных показаний у детей в возрасте 1–4 лет с СД1.

МАТЕРИАЛЫ И МЕТОДЫ

МАТЕРИАЛЫ И МЕТОДЫ. В исследование было включено 20 детей с СД1 (средний возраст 2,8±0,7 года, длительность диабета 1,2±0,8 года, гликированный гемоглобин (HbA1c) 7,1±1,4%). Участники последовательно использовали два сенсора FSL2 в течение 28 дней. Точность оценивалась путем сравнения данных FSL2 с референсными измерениями глюкозы капиллярной крови глюкометром (≥6 раз в день). Анализировались средняя абсолютная относительная погрешность (MARD), показатели согласованности и распределение по зонам консенсусной сетки ошибок Паркса.

РЕЗУЛЬТАТЫ

РЕЗУЛЬТАТЫ. Для анализа получено 2554 парных измерения. Общий MARD составил 11,5% (95% ДИ: 10,6–12,3%). Показатели согласованности: 74,6% измерений находились в пределах ±15%/15 мг/дл, 84,2% — в пределах ±20%/20 мг/дл. В зонах A+B консенсусной сетки ошибок находилось 99,9% измерений. MARD оставался стабильным на протяжении 14 дней использования (11,9%, 11,1%, 11,7% в начальный, средний и завершающий периоды использования соответственно). Средняя продолжительность работы сенсора составила 285,7±95,9 часа. Серьезных нежелательных явлений не зарегистрировано; местные кожные реакции были легкими и самостоятельно разрешились.

ЗАКЛЮЧЕНИЕ

ЗАКЛЮЧЕНИЕ. FSL2 продемонстрировал клинически приемлемую точность и высокий профиль безопасности у детей 1–4 лет с СД1. Полученные данные поддерживают возможность расширения применения FSL2 в этой возрастной группе для улучшения гликемического контроля и качества жизни семей.

BACKGROUND

BACKGROUND. Continuous glucose monitoring (CGM) is becoming the standard of care for children with type 1 diabetes (T1D), yet data on its use in children under 4 years old remain limited. FreeStyle Libre 2 (FSL2) is approved for use from the age of 4, but there is a clinical need for use in younger age groups.

OBJECTIVE

OBJECTIVE. To evaluate the accuracy and safety of the FSL2 system when used off-label in children aged 1–4 years with T1D.

MATERIALS AND METHODS

MATERIALS AND METHODS. The study included 20 children with T1D (mean age 2.8±0.7 years, diabetes duration 1.2±0.8 years, HbA1c 7.1±1.4%). Participants consecutively used two FSL2 sensors over a 28-day period. Accuracy was assessed by comparing FSL2 data to reference capillary blood glucose measurements (≥6 times daily). Analyses included mean absolute relative difference (MARD), agreement rates, and distribution across zones of the Parkes consensus error grid.

RESULTS

RESULTS. A total of 2,554 paired measurements were analyzed. Overall MARD was 11.5% (95% CI: 10.6–12.3%). Agreement rates: 74.6% of readings were within ±15%/15 mg/dL, and 84.2% within ±20%/20 mg/dL. A total of 99.9% of readings fell within Zones A+B of the consensus error grid. MARD remained stable over the 14-day sensor wear period (11.9%, 11.1%, 11.7% in the initial, middle and final periods of use). The average sensor wear time was 285.7±95.9 hours. No serious adverse events were reported; local skin reactions were mild and resolved fully without any treatment.

CONCLUSION

CONCLUSION. FSL2 demonstrated clinically acceptable accuracy and a high safety profile in children aged 1–4 years with T1D. The findings support potential extension of FSL2 use in this age group to improve glycemic control and family quality of life.

непрерывный мониторинг глюкозыFreeStyle Libre 2дети раннего возрастасахарный диабет 1 типаточностьбезопасностьcontinuous glucose monitoringFreeStyle Libre 2young childrentype 1 diabetesaccuracysafetyИсследование выполнено в рамках исполнения государственного задания № 123021000040-9.ReferencesCardona-Hernandez R, Schwandt A, Alkandari H, et al. Glycemic Outcome Associated With Insulin Pump and Glucose Sensor Use in Children and Adolescents With Type 1 Diabetes. Data From the International Pediatric Registry SWEET. Diabetes Care. 2021;44(5):1176-1184. doi: https://doi.org/10.2337/dc20-1674Cardona-Hernandez R, Schwandt A, Alkandari H, et al. Glycemic Outcome Associated With Insulin Pump and Glucose Sensor Use in Children and Adolescents With Type 1 Diabetes. Data From the International Pediatric Registry SWEET. Diabetes Care. 2021;44(5):1176-1184. doi: https://doi.org/10.2337/dc20-1674Kandemir N, Vuralli D, Ozon A, et al. Epidemiology of type 1 diabetes mellitus in children and adolescents: A 50-year, single-center experience. J Diabetes. 2024;16(5):e13562. doi: https://doi.org/10.1111/1753-0407.13562Kandemir N, Vuralli D, Ozon A, et al. Epidemiology of type 1 diabetes mellitus in children and adolescents: A 50-year, single-center experience. J Diabetes. 2024;16(5):e13562. doi: https://doi.org/10.1111/1753-0407.13562Jones TW, Davis EA. Hypoglycemia in children with type 1 diabetes: current issues and controversies. Pediatr Diabetes. 2003;4(3):143-150. doi: https://doi.org/10.1034/j.1399-5448.2003.00025.xJones TW, Davis EA. Hypoglycemia in children with type 1 diabetes: current issues and controversies. Pediatr Diabetes. 2003;4(3):143-150. doi: https://doi.org/10.1034/j.1399-5448.2003.00025.xCampbell 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.12735Strategies to Enhance New CGM Use in Early Childhood (SENCE) Study Group. A Randomized Clinical Trial Assessing Continuous Glucose Monitoring (CGM) Use With Standardized Education With or Without a Family Behavioral Intervention Compared With Fingerstick Blood Glucose Monitoring in Very Young Children With Type 1 Diabetes. Diabetes Care. 2021;44(2):464-472. doi: https://doi.org/10.2337/dc20-1060Strategies to Enhance New CGM Use in Early Childhood (SENCE) Study Group. A Randomized Clinical Trial Assessing Continuous Glucose Monitoring (CGM) Use With Standardized Education With or Without a Family Behavioral Intervention Compared With Fingerstick Blood Glucose Monitoring in Very Young Children With Type 1 Diabetes. Diabetes Care. 2021;44(2):464-472. doi: https://doi.org/10.2337/dc20-1060Ng SM, Moore HS, Clemente MF, et al. Continuous Glucose Monitoring in Children with Type 1 Diabetes Improves Well-Being, Alleviates Worry and Fear of Hypoglycemia. Diabetes Technol Ther. 2019;21(3):133-137. doi: https://doi.org/10.1089/dia.2018.0347Ng SM, Moore HS, Clemente MF, et al. Continuous Glucose Monitoring in Children with Type 1 Diabetes Improves Well-Being, Alleviates Worry and Fear of Hypoglycemia. Diabetes Technol Ther. 2019;21(3):133-137. doi: https://doi.org/10.1089/dia.2018.0347Parkes JL, Slatin SL, Pardo S, Ginsberg BH. A new consensus error grid to evaluate the clinical significance of inaccuracies in the measurement of blood glucose. Diabetes Care. 2000;23(8):1143-1148. doi: https://doi.org/10.2337/diacare.23.8.1143Parkes JL, Slatin SL, Pardo S, Ginsberg BH. A new consensus error grid to evaluate the clinical significance of inaccuracies in the measurement of blood glucose. Diabetes Care. 2000;23(8):1143-1148. doi: https://doi.org/10.2337/diacare.23.8.1143Johnson SR, Holmes-Walker DJ, Chee M, et al. Universal Subsidized Continuous Glucose Monitoring Funding for Young People With Type 1 Diabetes: Uptake and Outcomes Over 2 Years, a Population-Based Study. Diabetes Care. 2022;45(2):391-397. doi: https://doi.org/10.2337/dc21-1666Johnson SR, Holmes-Walker DJ, Chee M, et al. Universal Subsidized Continuous Glucose Monitoring Funding for Young People With Type 1 Diabetes: Uptake and Outcomes Over 2 Years, a Population-Based Study. Diabetes Care. 2022;45(2):391-397. doi: https://doi.org/10.2337/dc21-1666Dovc K, Cargnelutti K, Sturm A, Selb J, Bratina N, Battelino T. Continuous glucose monitoring use and glucose variability in pre-school children with type 1 diabetes. Diabetes Res Clin Pract. 2019;147:76-80. doi: https://doi.org/10.1016/j.diabres.2018.10.005Dovc K, Cargnelutti K, Sturm A, Selb J, Bratina N, Battelino T. Continuous glucose monitoring use and glucose variability in pre-school children with type 1 diabetes. Diabetes Res Clin Pract. 2019;147:76-80. doi: https://doi.org/10.1016/j.diabres.2018.10.005Tauschmann M, Cardona-Hernandez R, DeSalvo DJ, et al. International Society for Pediatric and Adolescent Diabetes Clinical Practice Consensus Guidelines 2024 Diabetes Technologies: Glucose Monitoring. Horm Res Paediatr. 2024;97(6):615-635. doi: https://doi.org/10.1159/000543156Tauschmann M, Cardona-Hernandez R, DeSalvo DJ, et al. International Society for Pediatric and Adolescent Diabetes Clinical Practice Consensus Guidelines 2024 Diabetes Technologies: Glucose Monitoring. Horm Res Paediatr. 2024;97(6):615-635. doi: https://doi.org/10.1159/000543156Fokkert MJ, van Dijk PR, Edens MA, et al. Performance of the FreeStyle Libre Flash glucose monitoring system in patients with type 1 and 2 diabetes mellitus. BMJ Open Diabetes Res Care. 2017;5(1):e000320. doi: https://doi.org/10.1136/bmjdrc-2016-000320Fokkert MJ, van Dijk PR, Edens MA, et al. Performance of the FreeStyle Libre Flash glucose monitoring system in patients with type 1 and 2 diabetes mellitus. BMJ Open Diabetes Res Care. 2017;5(1):e000320. doi: https://doi.org/10.1136/bmjdrc-2016-000320Genève P, Adam T, Delawoevre A, et al. High incidence of skin reactions secondary to the use of adhesives in glucose sensors or insulin pumps for the treatment of children with type 1 diabetes. Diabetes Res Clin Pract. 2023;204:110922. doi: https://doi.org/10.1016/j.diabres.2023.110922Genève P, Adam T, Delawoevre A, et al. High incidence of skin reactions secondary to the use of adhesives in glucose sensors or insulin pumps for the treatment of children with type 1 diabetes. Diabetes Res Clin Pract. 2023;204:110922. doi: https://doi.org/10.1016/j.diabres.2023.110922Sundberg F, deBeaufort C, Krogvold L, et al. ISPAD Clinical Practice Consensus Guidelines 2022: Managing diabetes in preschoolers. Pediatr Diabetes. 2022;23(8):1496-1511. doi: https://doi.org/10.1111/pedi.13427Sundberg F, deBeaufort C, Krogvold L, et al. ISPAD Clinical Practice Consensus Guidelines 2022: Managing diabetes in preschoolers. Pediatr Diabetes. 2022;23(8):1496-1511. doi: https://doi.org/10.1111/pedi.13427Jendrike N, Baumstark A, Kamecke U, et al. ISO 15197: 2013 Evaluation of a Blood Glucose Monitoring System's Measurement Accuracy. J Diabetes Sci Technol. 2017;11(6):1275-1276. doi: https://doi.org/10.1177/1932296817727550Jendrike N, Baumstark A, Kamecke U, et al. ISO 15197: 2013 Evaluation of a Blood Glucose Monitoring System's Measurement Accuracy. J Diabetes Sci Technol. 2017;11(6):1275-1276. doi: https://doi.org/10.1177/1932296817727550ГОСТ Р ИСО 15197–2015. Тест-системы для диагностики in vitro. Требования к системам мониторинга глюкозы в крови для самоконтроля при лечении сахарного диабета. — Введ. 2016-01-01. — М.: Стандартинформ, 2016.GOST R ISO 15197–2015. In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus. Moscow: Standartinform; 2016. (In Russ.)Stephan P, Eichenlaub M, Waldenmaier D, et al. A Statistical Approach for Assessing the Compliance of Integrated Continuous Glucose Monitoring Systems with Food and Drug Administration Accuracy Requirements. Diabetes Technol Ther. 2023;25(3):212-216. doi: https://doi.org/10.1089/dia.2022.0331Stephan P, Eichenlaub M, Waldenmaier D, et al. A Statistical Approach for Assessing the Compliance of Integrated Continuous Glucose Monitoring Systems with Food and Drug Administration Accuracy Requirements. Diabetes Technol Ther. 2023;25(3):212-216. doi: https://doi.org/10.1089/dia.2022.0331Alva S, Bailey T, Brazg R, et al. Accuracy of a 14-Day Factory-Calibrated Continuous Glucose Monitoring System With Advanced Algorithm in Pediatric and Adult Population With Diabetes. J Diabetes Sci Technol. 2022;16(1):70-77. doi: https://doi.org/10.1177/1932296820958754Alva S, Bailey T, Brazg R, et al. Accuracy of a 14-Day Factory-Calibrated Continuous Glucose Monitoring System With Advanced Algorithm in Pediatric and Adult Population With Diabetes. J Diabetes Sci Technol. 2022;16(1):70-77. doi: https://doi.org/10.1177/1932296820958754Alva S, Brazg R, Castorino K, et al. Accuracy of the Third Generation of a 14-Day Continuous Glucose Monitoring System. Diabetes Ther. 2023;14(4):767-776. doi: https://doi.org/10.1007/s13300-023-01385-6Alva S, Brazg R, Castorino K, et al. Accuracy of the Third Generation of a 14-Day Continuous Glucose Monitoring System. Diabetes Ther. 2023;14(4):767-776. doi: https://doi.org/10.1007/s13300-023-01385-6Alva S, Bhargava A, Bode B, et al. Accuracy of a 15-day Factory-Calibrated Continuous Glucose Monitoring System With Improved Sensor Design. J Diabetes Sci Technol. 2025. doi: https://doi.org/10.1177/19322968251329364Alva S, Bhargava A, Bode B, et al. Accuracy of a 15-day Factory-Calibrated Continuous Glucose Monitoring System With Improved Sensor Design. J Diabetes Sci Technol. 2025. doi: https://doi.org/10.1177/19322968251329364Sundberg F, Nåtman J, Franzen S, et al. A decade of improved glycemic control in young children with type 1 diabetes: A population-based cohort study. Pediatr Diabetes. 2021;22(5):742-748. doi: https://doi.org/10.1111/pedi.13211Sundberg F, Nåtman J, Franzen S, et al. A decade of improved glycemic control in young children with type 1 diabetes: A population-based cohort study. Pediatr Diabetes. 2021;22(5):742-748. doi: https://doi.org/10.1111/pedi.13211

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