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Набор скоро начнётся NCT07021690

The Steno Opti-Bolus-Timing Studies

Без фазы С лечением Type 1 Diabetes (T1D)

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: High glyceamic index meal, Low glyceamic index meal.
Кому может быть актуально
Состояния в реестре: Type 1 Diabetes (T1D). Базовые параметры: 18 лет — 70 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
Дания
Следующий шаг
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Официальное название

Timing Insulin for Meals Using AID Systems

Обзор

The project investigates the significance of the timing of insulin dosing for breakfast and lunch with an automated insulin pump and whether it matters if the meal primarily contains high or low glycemic index carbohydrates. We hypothesise that a bolus given 15 minutes before the meal will result in the best blood glucose levels after the meal, regardless of the type of carbohydrates. Participants will attend 6 experimental days over a maximum of 3 months, where they will be served either breakfast or lunch at the research site, depending on sub-study (breakfast or Lunch sub-study). Three different bolus timings will be tested, with either rapidly absorbed carbohydrates or slowly absorbed carbohydrates, in a randomized order for each participant. Participants will take insulin for the meal using the bolus calculator in the pump, either 15 minutes before, at the start of the meal, or 30 minutes after the meal. The development in sensor glucose will then be monitored for up to 4 hours after the meal.

Вмешательства

  • Другое High glyceamic index meal
    Meal sizes are standardized regarding the amount of carbohydrate, always 50 g. The composition of these meals focuses on selecting carbohydrates with high glycemic index.
  • Другое Low glyceamic index meal
    Meal sizes are standardized regarding the amount of carbohydrate, always 50 g. The composition of these meals focuses on selecting carbohydrates with low glycemic index.

Первичные конечные точки

  • Change in SG between three meal bolus delivery times for meals with two levels of glycemic index [Срок оценки: From -15 min before the meal to 270 min after meal intake]
Вторичные конечные точки (8)
  • Area under the post-meal CGM-curve [Срок оценки: From -15 min before the meal to 270 min after meal intake]
  • Difference in amount of insulin given for autocorrections during the post-meal period between the three bolus methods for each type of meal. [Срок оценки: From -15 min before the meal to 270 min after meal intake]
  • Distribution of Time Below Range (TBR) [Срок оценки: From -15 min before the meal to 270 min after meal intake]
  • Difference in the number of Time Below Range events (with SG< 3.9 mmol/l) [Срок оценки: From -15 min before the meal to 270 min after meal intake]
  • Distribution of Time In target Range (TIR) [Срок оценки: From -15 min before the meal to 270 min after meal intake]
  • Distribution of Time In Tight target Range (TITR) [Срок оценки: From -15 min before the meal to 270 min after meal intake]
  • Distribution of Time Above Range (TAR) [Срок оценки: From -15 min before the meal to 270 min after meal intake]
  • Number of hypoglycemia events (PG< 3.9 mmol/L ) [Срок оценки: From -15 min before the meal to 270 min after meal intake]

Критерии участия

Критерии включения

Type 1 diabetes ≥ 3 years Age 18-70 years User of the MiniMed 780G for at least 3 months Use of Novorapid insulin in the pump (for a minimum of two weeks) TIR > 70% for minimum of 14 days Use carbohydrate counting and bolus calculation Uploads insulin pump and CGM data to the Carelink Personal database Pump settings: carbohydrate ratio (300-500 rule), active insulin time of ≤ 3 hours and smartguard target glucose of 5.5 or 6.1 mmol/L

Критерии исключения

Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period or within 4 weeks prior to study start Diagnosed with gastroparesis Females who are pregnant, breast-feeding Food allergies related to standardized meals Alcohol or drug abuse Inability to understand the individual information and to give informed consent.

Current participation in another clinical trial that, in the judgment of the principal investigator, will compromise the study results

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

Дания · 1 центр
  • Steno Diabetes Center Copenhagen Clinical Translational Research, Diabetes Technology — Herlev

Идентификаторы

NCT: NCT07021690 · Copenhagen University Hospital

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗