diaendoСахарный диабетDiabetes mellitus2072-03512072-0378Endocrinology research centre10.14341/DM12838diaendo-12838Research ArticleОригинальные исследованияOriginal StudiesСравнительная оценка гликемического контроля у детей с сахарным диабетом 1 типа после перевода на сверхбыстродействующий инсулин аспарт с использованием систем мониторирования глюкозы в условиях реальной клинической практикиComparative assessment of modern parameters of glycemic control in children with type 1 diabetes after switching to fast-acting insulin aspart using Flash Glucose Monitoring in real clinical practicehttps://orcid.org/0000-0003-0283-2428ГиршЯ. В.GirshY. V.

Гирш Яна Владимировна - доктор медицинских наук, профессор; Scopus Author ID: 57194569997; eLibrary SPIN: 6683-8810.

628412, Тюменская область, ХМАО-Югра, Сургут, пр. Ленина, д. 1

Yana V. Girsh - MD, PhD, Professor; Scopus Author ID: 57194569997; eLibrary SPIN: 6683-8810.

1, Lenina prospect, Surgut, 628412

prof.girsh@yandex.ruhttps://orcid.org/0000-0002-5578-5242КияевА. В.KiyaevA. V.

Кияев Алексей Васильевич - доктор медицинских наук; eLibrary SPIN: 7092-7894.

Alexey V. Kiyaev - MD, PhD; eLibrary SPIN: 7092-7894.

Yekaterinburg

thyroend@mail.ruhttps://orcid.org/0000-0003-3652-9531СловакМ. А.SlovakM. A.

Словак Мария Александровна - eLibrary SPIN: 3277-6940.

Maria A. Slovak - MD; eLibrary SPIN: 3277-6940.

Yekaterinburg

slovakmaria@yandex.ruhttps://orcid.org/0000-0001-8114-0512КорневаИ. В.KornevaI. V.

Корнева Ирина Владимировна - eLibrary SPIN: 7879-5342.

Irina V. Korneva - MD; eLibrary SPIN: 7879-5342.

Yekaterinburg

kira63@mail.ruhttps://orcid.org/0000-0003-1193-4856ПроминИ. А.ProminI. A.

Промин Иван Александрович - eLibrary SPIN: 4023-7975.

Ivan A. Promin - MD; eLibrary SPIN: 4023-7975.

Yekaterinburg

i-promin@yandex.ruЮсуповаН. А.YusupovaN. A.

Юсупова Наина Алимхановна - eLibrary SPIN: 4304-0070

Naina A. Yusupova - MD; eLibrary SPIN: 4304-0070.

Surgut

yusupova.naina08@mail.ruhttps://orcid.org/0000-0002-5180-6560СавельевЛ. И.SavelyevL. I.

Савельев Леонид Иосифович - кандидат медицинских наук; Scopus Author ID: 55535477300; eLibrary SPIN: 1427-5514

Leonid Y. Saveliev - MD, PhD; Scopus Author ID: 55535477300; eLibrary SPIN: 1427-5514

Yekaterinburg

sav7000@yandex.ruСургутский государственный университетРоссияSurgut State UniversityRussian FederationУральский государственный медицинский университет; Областная детская клиническая больницаРоссияUral State Medical University; Regional Children’s Clinical HospitalRussian FederationОбластная детская клиническая больницаРоссияRegional Children's Clinical HospitalRussian Federation202230112022255458467Copyright © Гирш Я.В., Кияев А.В., Словак М.А., Корнева И.В., Промин И.А., Юсупова Н.А., Савельев Л.И., 20222022Гирш Я.В., Кияев А.В., Словак М.А., Корнева И.В., Промин И.А., Юсупова Н.А., Савельев Л.И.Girsh Y.V., Kiyaev A.V., Slovak M.A., Korneva I.V., Promin I.A., Yusupova N.A., Savelyev L.I.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/12838ОБОСНОВАНИЕ

ОБОСНОВАНИЕ. Постпрандиальная гипергликемия вносит существенный вклад в недостижение гликемического контроля у пациентов с сахарным диабетом 1 типа (СД1). Не менее четверти пациентов забывают вводить инсулин перед едой 1 раз в неделю, а более 40% вводят болюсный инсулин непосредственно перед едой, что не соответствует фармакокинетическим эффектам инсулинов ультракороткого профиля и определяет необходимость использования инсулинов с лучшей имитацией физиологической секреции.

ЦЕЛЬ

ЦЕЛЬ. Дать оценку влияния сверхбыстродействующего инсулина аспарт (БДиАсп) на современные параметры гликемического контроля у детей с СД1 после перевода с инсулина аспарт (иАсп) с использованием систем мониторирования глюкозы.

МАТЕРИАЛЫ И МЕТОДЫ

МАТЕРИАЛЫ И МЕТОДЫ. Инициировано многоцентровое обсервационное 12-недельное проспективное открытое неконтролируемое сравнительное исследование, в которое вошли пациенты с неудовлетворительным контролем СД1 (n=44), разделенные на подгруппы терапии множественными инъекциями инсулина (МИИ) (инсулин деглудек и иАсп) и постоянной подкожной инфузии инсулина (ППИИ) на иАсп. Проведено три 14-дневных флеш-мониторинга глюкозы (ФМГ): до перевода пациентов на БДиАсп, через 2 и 12 нед после. Основные конечные показатели: динамика уровня HbA1c через 2 и 12 нед относительно исходного значения, анализ изменения параметров 5 диапазонов уровня глюкозы по данным ФМГ через 2 и 12 нед после перевода. Дополнительно исследовались: изменение суточной дозы инсулина, количество эпизодов нетяжелых и тяжелых гипогликемий, нежелательные явления, возникшие во время наблюдения.

РЕЗУЛЬТАТЫ

РЕЗУЛЬТАТЫ. Через 2 нед после перевода с иАсп на БДиАсп во всех группах пациентов увеличилось время нахождения в целевом диапазоне уровня глюкозы (TIR) с 53% [44,3; 66,5] до 57% [47,4; 71,0] (p-value=0,010) и уменьшился показатель времени нахождения выше целевого диапазона (TАR) с 38% [24,8; 50,2] до 30,5% [22,0; 45,0] (p-value=0,0124) при статистически недостоверном уменьшении показателя времени нахождения ниже целевого диапазона (TBR). Те же тенденции продолжили сохраняться и в показателях через 12 нед, хотя и не достигнув статистической значимости при достоверном уменьшении эпизодов гипогликемии <3,9 ммоль/л в неделю, что привело к улучшению контроля СД1: снижению HbA1c с 8,15 до 7,75% (p-value = 0,0224), более выраженному в группе пациентов на ППИИ — с 7,9 до 7,5% (p-value=0,028).

ЗАКЛЮЧЕНИЕ

ЗАКЛЮЧЕНИЕ. Перевод с иАсп на БДиАсп в рутинной клинической практике в режимах МИИ и ППИИ у детей и подростков с СД1 позволяет добиваться лучших показателей контроля гликемии по сравнению с прандиальным аналогом инсулина предыдущего поколения иАсп, что ассоциировано с увеличением или тенденцией к увеличению показателя TIR и снижением или тенденцией к снижению показателей TAR, а также достоверному снижению количества эпизодов гипогликемии.

BACKGROUND

BACKGROUND: Postprandial hyperglycaemia contributes significantly to the lack of glycaemic control in patients with type 1 diabetes mellitus (DM1). At least a quarter of patients forget to inject insulin before meals once a week, and more than 40% of them inject bolus insulin immediately before meals, which does not correspond to the pharmacokinetic effects of ultrashort insulins and determines the need to use insulins with better imitations of physiological insulin secretion.

AIM

AIM: To assess the effect of fast acting insulin aspart (FIAsp) on the current parameters of glycaemic control in children with DM1 after switching from insulin Asp (iAsp) using continuous glucose monitoring.

MATERIALS AND METHODS

MATERIALS AND METHODS: A multicenter observational 12-week prospective open-label uncontrolled comparative study was initiated. A group of insufficiently controlled patients were identified (n = 48) including a group on multiple insulin injections therapy (MII) (insulin degludec and IAsp) and a group on continuous subcutaneous insulin infusion (CSII) of iAsp. Three 14-day flash glucose monitoring (FMG) were performed: before transferring patients to FiAsp and after 2 and 12 weeks of the transfer. Key endpoints: HbA1c after 2 and 12 weeks on FiAsp relative to baseline, analysis of 5 FMG target glucose ranges, presented as an ambulatory glycemic profile. Additional indicators: dynamics of insulin daily dose, frequency of glucose self- monitoring, the number of severe hypoglycemia, adverse events that occurred during treatment.

RESULTS

RESULTS: 2 weeks after the transfer from IAsp to FIAsp, TIR increased in the entire group of patients: from 53% [44.3; 66.5] to 57% [47.4; 71.0] (p-value = 0.010) and TAR decreased from 38% [24.8; 50.2] to 30.5% [22.0; 45, 0] (p-value = 0.0124). Maintaining and increase time spent in the target glucose ranges during a 12-week observation period, in parallel with a significant decrease in hypoglycemic episodes <3.9 mmol / L per week, on FIAsp therapy naturally leads to an improvement in diabetes control: a decrease in HbA1c from 8.15% up to 7.75% (p-value = 0.0224), more pronounced in the group of patients on CSII — from 7.9% to 7.5% (p-value = 0.028).

CONCLUSION

CONCLUSION: Switching from IAsp to BDIAsp in routine clinical practice in the MII and CSII regimen in children and adolescents with type 1 diabetes allows achieving better glycemic control compared to the previous generation prandial insulin analog Iasp. The better diabetes control is associated with an increase or a trend towards an increase in TIR and a decrease or a trend towards a decrease in TAR and TBR, as well as a significant decrease in episodes of hypoglycemia.

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