medsovetМедицинский СоветMeditsinskiy sovet = Medical Council2079-701X2658-5790REMEDIUM GROUP Ltd.10.21518/ms2026-026medsovet-9890Research ArticleЭНДОКРИНОЛОГИЯENDOCRINOLOGYПоказатели метаболического контроля при физических нагрузках у детей с сахарным диабетом 1-го типа, получающих терапию отечественными биосимилярами инсулина аспарт в условиях работы системы замкнутого циклаGlycemic control metrics during exercise in children with type 1 diabetes treated with domestic insulin aspart biosimilars using a hybrid closed-loop systemhttps://orcid.org/0000-0003-0923-6223ПлатоновВ. В.PlatonovV. V.

Платонов Вадим Валерьевич - к.м.н., заведующий 3-м эндокринологическим отделением, врач – детский эндокринолог, ДГМКЦ ВМТ им. К.А. Раухфуса; доцент кафедры эндокринологии имени академика В.Г. Баранова, СЗГМУ им. И.И. Мечникова; главный детский эндокринолог, Клиника Фомина. Дети.

191036, Санкт-Петербург, Лиговский проспект, д. 8; 195067, Санкт-Петербург, Пискаревский проспект, д. 47; 191014, Санкт-Петербург, Басков пер., д. 2

Vadim V. Platonov - Cand. Sci. (Med.), Head of the 3rd Endocrinology Department, Pediatric Endocrinologist, St Petersburg Children’s Municipal Multi-Specialty Clinical Center of High Medical Technologies named after K.A. Rauhfus; Associate Professor of the Department of Endocrinology named after Academician V.G. Baranov, North-Western State Medical University named after I.I. Mechnikov; Chief Pediatric Endocrinologist, Fomin Clinic. Children.

8, Ligovsky Ave., St Petersburg, 191036; 47, Piskarevsky Ave., St Petersburg, 195067; 2, Baskov Lane, St Petersburg, 191014

v_platonov@mail.ruhttps://orcid.org/0009-0002-5166-7166НосковаЕ. Д.NоskovaE. D.

Носкова Елизавета Дмитриевна - врач – детский эндокринолог эндокринологического отделения.

620085, Екатеринбург, ул. Серафимы Дерябиной, д. 32

Elizaveta D. Noskova - Pediatric Endocrinologist of the Endocrinology Department, Sverdlovsk Region Regional Children’s Clinical Hospital.

32, Serafima Deryabina St., Ekaterinburg, 620085

lutsevich.liza@mail.ruhttps://orcid.org/0000-0002-5578-5242КияевА. В.KiyaevA. V.

Кияев Алексей Васильевич - д.м.н., главный внештатный детский специалист-эндокринолог Минздрава России по Уральскому федеральному округу, главный внештатный специалист – детский эндокринолог Минздрава Свердловской области, профессор кафедры госпитальной педиатрии, УГМУ; заведующий Областным центром детской эндокринологии, Областная ДКБ.

620028, Екатеринбург, ул. Репина, д. 3; 620085, Екатеринбург, ул. Серафимы Дерябиной, д. 32

Alexey V. Kiyaev - Dr. Sci. (Med.), Chief Freelance Pediatric Endocrinologist of the Ministry of Health of Russia for the Ural Federal District, Chief Freelance Pediatric Endocrinologist of the Ministry of Health of the Sverdlovsk Region, Professor of the Department of Hospital Pediatrics, Ural State Medical University; Head of the Regional Center for Pediatric Endocrinology, Sverdlovsk Region Regional Children’s Clinical Hospital.

3, Repin St., Ekaterinburg, 620028; 32, Serafima Deryabina St., Ekaterinburg, 620085

thyroend@mail.ruДетковВ. Ю.DetkovV. Yu.

Детков Вячеслав Юрьевич - д.м.н., заслуженный врач РФ, главный врач.

191036, Санкт-Петербург, Лиговский проспект, д. 8

Vyacheslav Yu. Detkov - Dr. Sci. (Med.), Honored Doctor of the Russian Federation, Chief Physician, St Petersburg Children’s Municipal Multi-Specialty Clinical Center of High Medical Technologies named after K.A. Rauhfus.

8, Ligovsky Ave., St Petersburg, 191036

rauhfus@zdrav.spb.ruДетский городской многопрофильный клинический центр высоких медицинских технологий имени К.А. Раухфуса; Северо-западный государственный медицинский университет имени И.И. Мечникова; Клиника Фомина. ДетиРоссияSt Petersburg Children’s Municipal Multi-Specialty Clinical Center of High Medical Technologies named after K.A. Rauhfus; North-Western State Medical University named after I.I. Mechnikov; Fomin Clinic. ChildrenRussian FederationОбластная детская клиническая больницаРоссияSverdlovsk Region Regional Children’s Clinical HospitalRussian FederationОбластная детская клиническая больница; Уральский государственный медицинский университетРоссияSverdlovsk Region Regional Children’s Clinical Hospital; Ural State Medical UniversityRussian FederationДетский городской многопрофильный клинический центр высоких медицинских технологий имени К.А. РаухфусаРоссияSt Petersburg Children’s Municipal Multi-Specialty Clinical Center of High Medical Technologies named after K.A. RauhfusRussian Federation20262403202601116122Copyright © Платонов В.В., Носкова Е.Д., Кияев А.В., Детков В.Ю., 20262026Платонов В.В., Носкова Е.Д., Кияев А.В., Детков В.Ю.Platonov V.V., Nоskova E.D., Kiyaev A.V., Detkov V.Y.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.med-sovet.pro/jour/article/view/9890Введение

Введение. Достижение и поддержание целевых показателей гликемии у детей и подростков с сахарным диабетом 1-го типа (СД1) остается сложной задачей, особенно на фоне физических нагрузок, которые существенно повышают риск развития острых осложнений. В исследовании оценены показатели метаболического контроля у детей и подростков, вовлеченных в регулярные занятия спортом и получающих терапию отечественными биосимилярами инсулина аспарт в условиях работы системы замкнутого цикла (СЗЦ).

Цель

Цель. Оценить эффективность и безопасность отечественных биосимиляров инсулина аспарт в условиях работы гибридных СЗЦ у физически активных детей с СД1.

Материалы и методы

Материалы и методы. Проведено ретроспективное сравнительное исследование с участием 36 детей и подростков с СД1, получавших терапию с использованием СЗЦ и регулярно занимавшихся спортом. Участники исследования получали терапию биосимилярами инсулина аспарт РинФастНик (n = 17) и РинФаст (n = 19). Период наблюдения составил 12 нед. Ключевые показатели гликемического контроля (TIR, TAR, TBR, CV, HbA1c) оценивались на основе данных непрерывного мониторинга глюкозы.

Результаты

Результаты. В группе РинФастНик зафиксированы статистически лучшие показатели метаболического контроля по сравнению с группой РинФаст: время в целевом диапазоне (TIR) составило 81,41% против 67,74% (p < 0,05), время выше диапазона (TAR) – 13,18% против 28,53% (p < 0,05). Показатели гипогликемий (TBR) были сопоставимы. Коэффициент вариации (33,01% против 38,46%, p < 0,05) и уровень HbA1c (6,4% против 6,8%, p < 0,05) также были лучше в основной группе.

Выводы

Выводы. Применение биосимиляра инсулина аспарт РинФастНик в гибридных СЗЦ ассоциировано с достоверным улучшением гликемического контроля у физически активных детей с СД1, преимущественно за счет увеличения TIR и снижения гипергликемии, без повышения риска гипогликемий. Результаты указывают на важность учета фармакокинетических свойств инсулина для оптимизации работы СЗЦ в условиях физических нагрузок.

Introduction

Introduction. Achieving and maintaining target glycemic levels in children and adolescents with type 1 diabetes (T1D) remains a challenging task, especially during physical activity, which significantly increases the risk of acute complications. This study evaluated metabolic control parameters in children and adolescents engaged in regular sports activities and receiving therapy with domestic biosimilars of insulin aspart under the conditions of a hybrid closed-loop (HCL) systems.

Aim

Aim. To evaluate the efficacy and safety of domestic insulin aspart biosimilars in HCL systems in physically active children with T1D.

Materials and methods

Materials and methods. A retrospective comparative study was conducted involving 36 children and adolescents with T1D treated using HCL systems and regularly engaged in sports. Study participants received therapy with the insulin aspart biosimilars RinFastNic (n = 17) and RinFast (n = 19). The observation period was 12 weeks. Key glycemic control metrics (TIR, TAR, TBR, CV, HbA1c) were assessed based on continuous glucose monitoring data.

Results

Results. The RinFastNic group demonstrated statistically superior metabolic control metrics compared to the RinFast group: Time in Range (TIR) was 81.41% vs. 67.74% (p < 0.05), Time Above Range (TAR) – 13.18% vs. 28.53% (p < 0.05). Hypoglycemia metrics (TBR) were comparable. Сoefficient of variation (33.01% vs. 38.46%, p < 0.05) and HbA1c level (6.4% vs. 6.8%, p < 0.05) were also better in the main group.

Conclusions

Conclusions. The use of the insulin aspart biosimilar RinFastNic in HCL systems is associated with a significant improvement in glycemic control in physically active children with T1D, primarily due to increased TIR and reduced hyperglycemia, without an increased risk of hypoglycemia. The results indicate the importance of considering the pharmacokinetic properties of insulin for optimizing HCL system performance under conditions of physical activity.

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