Satisfaction of Specific Modes Related to Physical Activity in People Living With Type 1 Diabetes and Using an Hybrid Closed-loop System
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Questionnar.
- Who it may be relevant to
- Registry conditions: Diabetes. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other 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.
Primary outcome measures
- Satisfaction score [Time frame: Baseline]
Secondary outcome measures (12)
- Describe the perception of physical activity within the study population [Time frame: Baseline]
- Describe the proportion of individuals using the physical activity mode in our study [Time frame: Baseline]
- Describe satisfaction with the mode in relation to the physical activities performed by patients [Time frame: Baseline]
- Describe overall satisfaction with the "physical activity" mode [Time frame: Baseline]
- Compare populations who use the physical activity mode with those who do not use it [Time frame: Baseline]
- Compare populations who use the physical activity mode with those who do not use it [Time frame: Baseline]
- Compare populations who use the physical activity mode with those who do not use it [Time frame: Baseline]
- Compare populations who use the physical activity mode with those who do not use it [Time frame: Baseline]
- Compare populations who use the physical activity mode with those who do not use it [Time frame: Baseline]
- Compare populations who use the physical activity mode with those who do not use it [Time frame: Baseline]
- Compare populations who use the physical activity mode with those who do not use it [Time frame: Baseline]
- Compare populations who use the physical activity mode with those who do not use it [Time frame: Baseline]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- People opposed to the research
- People protected by the law
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 1 center
- CHU Grenoble Alpes — Grenoble
Identifiers
NCT: NCT07567170 · 38RC26.0046