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Идёт набор NCT06567158

The Impact of a Moderate Carbohydrate Diet in Children With Type 1 Diabetes on Hybrid Closed-loop Therapy

Без фазы С лечением Diabetes Mellitus, Type 1

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Moderate carbohydrate diet, Traditional diet.
Кому может быть актуально
Состояния в реестре: Diabetes Mellitus, Type 1. Базовые параметры: 7 лет — 17 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Бельгия
Следующий шаг
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Официальное название

The Impact of Carbohydrate Restriction on Glycemic Control in Children and Adolescents With Type 1 Diabetes Using a Hybrid Closed-loop Insulin Delivery System: a Randomized Cross-over Study

Обзор

In the past, carbohydrate restriction was indicated as a treatment for people with type 1 diabetes when exogenous insulin was not available. Now it is mainly used as an added treatment for people with type 1 diabetes on top of standard insulin administration and glucose monitoring. Despite previous studies, the impact of carbohydrate restriction on glycemic control and quality of life is still not clear. Furthermore, few studies exist on carbohydrate restriction in children with type 1 diabetes and combined with the use of hybrid closed-loop insulin delivery. Therefore this study will determine the impact on glycemic control and the feasability of a moderate carbohydrate diet compared to a traditional diet in children (7-17 years) with type 1 diabetes on top of using a hybrid closed-loop system. In this randomized, crossover study, 28 children will follow a moderate carbohydrate diet (four weeks) and a traditional diet (four weeks) in randomized order. With a run-in period (two weeks) prior to the first diet and a wash-out period (six weeks) between the two diets, the children will participate in the study for a total of 16 weeks. The primary endpoint is the difference of time spent in target range (defined as a sensor glucose value between 70 and 180 mg/dL) between the four-week moderate carbohydrate diet and the four-week traditional diet.

Вмешательства

  • Другое Moderate carbohydrate diet
    During the moderate carbohydrate diet, participants will be asked to limit his/her carbohydrate intake to no more than 30% of their total energy intake.
  • Другое Traditional diet
    During the traditional diet, participants do not follow any diet, however their carbohydrate intake must be at least 50% of their total energy intake.

Первичные конечные точки

  • Time in range [Срок оценки: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet]
Вторичные конечные точки (12)
  • Time in tight range [Срок оценки: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet]
  • Time below range [Срок оценки: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet]
  • Time in level 2 hypoglycemia [Срок оценки: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet]
  • Time above range [Срок оценки: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet]
  • Time in level 2 hyperglycemia [Срок оценки: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet]
  • Hemoglobin A1c [Срок оценки: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet]
  • Mean blood glucose [Срок оценки: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet]
  • Glycemic variability: standard deviation and coefficient of variation [Срок оценки: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet]
  • Daily insulin dose [Срок оценки: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet]
  • Number of severe hypoglycemic events [Срок оценки: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet]
  • Number of diabetic ketoacidosis [Срок оценки: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet]
  • Body weight [Срок оценки: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet]

Критерии участия

Критерии включения

  • Signed informed consent (ICF) (both children/adolescents and parents)
  • ≥7 and ≤17 years old at moment of ICF signature
  • ≥6 months type 1 diabetes diagnosis at moment of ICF signature
  • ≥3 months use of the hybrid closed-loop system Medtronic MiniMedTM 780G, Tandem t:slim X2 Control-IQTM or Mylife Ypsopump with CamAPS algorithm at moment of ICF signature
  • Ability to understand, read, write and speak Dutch, French or English at moment of ICF signature

Критерии исключения

  • <7 or >17 years old at moment of ICF signature
  • <6 months type 1 diabetes diagnosis at moment of ICF signature
  • <3 months use of the advanced hybrid closed-loop system Medtronic MiniMedTM 780G, Tandem t:slim X2 Control-IQTM or Mylife Ypsopump with CamAPS algorithm at moment of ICF signature
  • Any other insulin therapy than advanced hybrid closed-loop system Medtronic MiniMedTM 780G , Tandem t:slim X2 Control-IQTM or Mylife Ypsopump with CamAPS algorithm at moment of ICF signature
  • Failure to understand, read, write or speak Dutch, French or English at moment of ICF signature

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Бельгия · 1 центр
  • UZ Leuven — Leuven

Идентификаторы

NCT: NCT06567158 · S68499

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗