Diabetes
Conditions
Keywords
Closed-loop, automated insulin delivery, physical activity, PROMs
Brief summary
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
OTHERQuestionnar
Administration of 1 questionnar to investigate the satisfaction with the physical activity mode of closed-loop systems among people living with type 1 diabetes.
Sponsors
University Hospital, Grenoble
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction score | Baseline | Part C, D and E of the questionnar |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Describe the perception of physical activity within the study population | Baseline | Part A of the questionnar |
| Describe the proportion of individuals using the physical activity mode in our study | Baseline | Part B of the questionnar |
| Describe satisfaction with the mode in relation to the physical activities performed by patients | Baseline | Part F of the questionnar |
| Describe overall satisfaction with the "physical activity" mode | Baseline | Part G of the questionnar |
| Compare populations who use the physical activity mode with those who do not use it | Baseline | Comparison based on several parameters to describe the two populations at the time of questionnaire completion: HbA1c (%) |
Countries
France
Contacts
CONTACTQuentin Perrier, PharmD, phD
Outcome results
None listed