Satisfaction of Specific Modes Related to Physical Activity in People Living With Type 1 Diabetes and Using an Hybrid Closed-loop System

Обзор

The BF-ACT study is a single-center, non-interventional (RIPH3) descriptive study conducted at CHU Grenoble Alpes. It aims to evaluate the satisfaction of adults with type 1 diabetes using closed-loop insulin delivery systems, specifically regarding the "physical activity mode" designed to adapt insulin delivery during exercise. Although physical activity is essential for managing type 1 diabetes, it remains challenging due to the risk of hypoglycemia. Closed-loop systems have improved glucose control, but their effectiveness during exercise depends on multiple factors, and their real-life use can be complex. Currently, little is known about patient satisfaction and experience with these specific modes. The study will collect data through a self-administered questionnaire, distributed to eligible patients (≥18 years old, with type 1 diabetes, using a closed-loop system for at least 4 months). The primary outcome is the satisfaction score based on the questionnaire. Secondary objectives include describing physical activity perception, usage of the activity mode, and comparing users versus non-users. Approximately up to 900 patients may be included over a 4-month recruitment period. Clinical and glucose monitoring data will also be collected from medical records. The results are expected to improve patient education, device usability, and support for physical activity in people living with type 1 diabetes.

Вмешательства

• Другое Questionnar
  Administration of 1 questionnar to investigate the satisfaction with the physical activity mode of closed-loop systems among people living with type 1 diabetes.

Первичные конечные точки

• Satisfaction score [Срок оценки: Baseline]

Вторичные конечные точки (12)

• Describe the perception of physical activity within the study population [Срок оценки: Baseline]
• Describe the proportion of individuals using the physical activity mode in our study [Срок оценки: Baseline]
• Describe satisfaction with the mode in relation to the physical activities performed by patients [Срок оценки: Baseline]
• Describe overall satisfaction with the "physical activity" mode [Срок оценки: Baseline]
• Compare populations who use the physical activity mode with those who do not use it [Срок оценки: Baseline]
• Compare populations who use the physical activity mode with those who do not use it [Срок оценки: Baseline]
• Compare populations who use the physical activity mode with those who do not use it [Срок оценки: Baseline]
• Compare populations who use the physical activity mode with those who do not use it [Срок оценки: Baseline]
• Compare populations who use the physical activity mode with those who do not use it [Срок оценки: Baseline]
• Compare populations who use the physical activity mode with those who do not use it [Срок оценки: Baseline]
• Compare populations who use the physical activity mode with those who do not use it [Срок оценки: Baseline]
• Compare populations who use the physical activity mode with those who do not use it [Срок оценки: Baseline]

Критерии участия

Критерии включения

• Age ≥ 18 years
• Patient living with type 1 diabetes
• Patient using a closed-loop system for at least 4 months
• Patient followed by a diabetologist in our center

Критерии исключения

• People opposed to the research
• People protected by the law

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Франция · 1 центр

• CHU Grenoble Alpes — Grenoble

Идентификаторы

NCT: NCT07567170 · 38RC26.0046

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗