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Идёт набор NCT06876207

Real-world Study on the Effectiveness and Safety of Control-IQ Technology in Teenagers With Type 1 Diabetes Engaging in Regular Physical Activity

— Наблюдательное Type 1 Diabetes Mellitus

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: Tandem t:slim X2 with Control-IQ technology.
Кому может быть актуально
Состояния в реестре: Type 1 Diabetes Mellitus. Базовые параметры: до 20 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
Италия
Следующий шаг
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Обзор

We hypothesize that the use of the Control-IQ system positively influences glycemic control in teenagers with type 1 diabetes during physical activity. To test this hypothesis, we will evaluate the glucose profiles (based on CGM metrics) of adolescents engaging in different types, intensities, and durations of physical activity over a 14-day period, in real-life conditions. We will compare glucose control on exercise days with that on sedentary days. As a secondary objective, we will investigate the influence of factors such as anthropometric characteristics, type and duration of exercise, the use of the exercise mode and other management strategies used for physical activity, on glycemic outcomes. Regarding the safety, we will report any episodes of severe hypoglycemia or diabetic ketoacidosis (DKA). This is an observational, open-label, non-randomized, real-world study. Each participant will be provided with a diary to record detailed information about physical activity sessions over a 14-day period, including type, intensity, and duration of exercise, and timing and composition of pre-exercise meals. Clear instructions on how to complete the diary will be provided. CGM metrics will be analyzed throughout the 14-day observation period, including time in range, time in tight range, time above range, time below range, mean glucose level, and coefficient of variation. A daily comparison will be performed between metrics recorded on days of physical activity and sedentary days, assessing the entire day as well as daytime (07:00-23:00) and nighttime (23:00-07:00) periods. The influence of factors such as anthropometrics, type of physical activity, the use of the exercise mode and other specific management strategies, type and duration of exercise, and pre-exercise meals on CGM metrics will be evaluated. The frequency of severe hypoglycemia and DKA episodes, as defined by international guidelines, will be assessed.

Вмешательства

  • Устройство Tandem t:slim X2 with Control-IQ technology
    Control-IQ is one of the second-generation AID technologies currently available worldwide and is approved for people \> 6 years. Control-IQ can predict glucose levels 30 minutes in advance and automatically adjust basal insulin delivery, providing corrective boluses if needed. The system can prevent hypoglycemia by suspending insulin delivery if glucose is predicted to drop below 70 mg/dl (8). Additionally, the device offers specific settings for circumstances such as sleep or exercise. When the

Первичные конечные точки

  • Time in range (%) [Срок оценки: 14 days]
  • Time in tight range (%) [Срок оценки: 14 days]
  • Time above range level 1 (%) [Срок оценки: 14 days]
  • Time above range level 2 (%) [Срок оценки: 14 days]
  • Time below range level 1 (%) [Срок оценки: 14 days]
  • Time below range level 2 (%) [Срок оценки: 14 days]
  • Mean sensor glucose (mg/dl or mmol/L) [Срок оценки: 14 days]
  • Coefficient of variation (%) [Срок оценки: 14 days]
Вторичные конечные точки (2)
  • Daytime (h 07.00-23.00) Time in Range (%) [Срок оценки: 14 days]
  • Nighttime (h 23.00 - 07.00) Time in Range (%) [Срок оценки: 14 days]

Критерии участия

Критерии включения

  • Diagnosis of type 1 diabetes according to International Society for Pediatric and Adolescent Diabetes (ISPAD) guidelines
  • Duration of diabetes > 12 months
  • Age < 20 years
  • Pubertal development completed according to the Tanner stage
  • Use of Control-IQ technology for at least 3 months
  • Automatic mode use for at least 70% of the time during the 2 weeks preceding enrollment
  • CGM use for at least 70% of the time during the 2 weeks preceding enrollment
  • Regular physical activity (at least 2 sessions per week, each lasting at least 45 minutes)

Критерии исключения

  • Uncontrolled celiac disease or thyroid disease
  • Presence of other chronic illnesses
  • Psychiatric or neurological conditions, including eating disorders, that may interfere with the study
  • Chronic use of medications (other than insulin) that may affect glucose control
  • Chronic use of substances or drugs that could impact CGM accuracy

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Италия · 1 центр
  • University Hospital of Messina — Messina

Идентификаторы

NCT: NCT06876207 · PED#CIQACT1VE

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗