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临床试验/NCT07567170
NCT07567170招募中不适用

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

University Hospital, Grenoble1 个研究点 分布在 1 个国家目标入组 900 人开始时间: 2026年4月21日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
900
试验地点
1

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

研究者

发起方
University Hospital, Grenoble
申办方类型
Other
责任方
Sponsor

研究点 (1)

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