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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
900
Administration of 1 questionnar to investigate the satisfaction with the physical activity mode of closed-loop systems among people living with type 1 diabetes.
CHU Grenoble Alpes
Grenoble, France
RECRUITINGSatisfaction score
Part C, D and E of the questionnar
Time frame: Baseline
Describe the perception of physical activity within the study population
Part A of the questionnar
Time frame: Baseline
Describe the proportion of individuals using the physical activity mode in our study
Part B of the questionnar
Time frame: Baseline
Describe satisfaction with the mode in relation to the physical activities performed by patients
Part F of the questionnar
Time frame: Baseline
Describe overall satisfaction with the "physical activity" mode
Part G of the questionnar
Time frame: Baseline
Compare populations who use the physical activity mode with those who do not use it
Comparison based on several parameters to describe the two populations at the time of questionnaire completion: HbA1c (%)
Time frame: Baseline
Compare populations who use the physical activity mode with those who do not use it
Comparison based on several parameters to describe the two populations at the time of questionnaire completion: Type of closed-loop system
Time frame: Baseline
Compare populations who use the physical activity mode with those who do not use it
Comparison based on several parameters to describe the two populations at the time of questionnaire completion: Duration of use of the closed-loop system
Time frame: Baseline
Compare populations who use the physical activity mode with those who do not use it
Comparison based on several parameters to describe the two populations at the time of questionnaire completion: Time spent in closed-loop mode
Time frame: Baseline
Compare populations who use the physical activity mode with those who do not use it
Comparison based on several parameters to describe the two populations at the time of questionnaire completion: Duration of type 1 diabetes
Time frame: Baseline
Compare populations who use the physical activity mode with those who do not use it
Comparison based on several parameters to describe the two populations at the time of questionnaire completion: Age
Time frame: Baseline
Compare populations who use the physical activity mode with those who do not use it
Comparison based on several parameters to describe the two populations at the time of questionnaire completion: Sex
Time frame: Baseline
Compare populations who use the physical activity mode with those who do not use it
Comparison based on several parameters to describe the two populations at the time of questionnaire completion: Body Mass Index (BMI)
Time frame: Baseline
Compare populations who use the physical activity mode with those who do not use it
Comparison based on several parameters to describe the two populations at the time of questionnaire completion: CGM data over the 15 days prior to questionnaire completion: * Time in Range (TIR) 70-180 mg/dL * Time in Tight Range (TITR) 70-140 mg/dL * Time Above Range (TAR) \> 180 mg/dL and \> 250 mg/dL * Time Below Range (TBR) \< 70 mg/dL and \< 54 mg/dL
Time frame: Baseline
Compare populations who use the physical activity mode with those who do not use it
Comparison based on several parameters to describe the two populations at the time of questionnaire completion: CGM data over the 15 days prior to questionnaire completion: \- Mean glucose (mg/dL)
Time frame: Baseline
Compare populations who use the physical activity mode with those who do not use it
Comparison based on several parameters to describe the two populations at the time of questionnaire completion: CGM data over the 15 days prior to questionnaire completion: \- Glucose Management Index (GMI)
Time frame: Baseline
Compare populations who use the physical activity mode with those who do not use it
Comparison based on several parameters to describe the two populations at the time of questionnaire completion: CGM data over the 15 days prior to questionnaire completion: \- Coefficient of Variation (CV, in %)
Time frame: Baseline
Compare populations who use the physical activity mode with those who do not use it
Comparison based on several parameters to describe the two populations at the time of questionnaire completion: CGM data over the 15 days prior to questionnaire completion: \- Glycemia Risk Index (GRI)
Time frame: Baseline
Compare populations who use the physical activity mode with those who do not use it
Comparison based on several parameters to describe the two populations at the time of questionnaire completion: CGM data over the 15 days prior to questionnaire completion: \- Total daily insulin dose (IU/day)
Time frame: Baseline
Compare populations who use the physical activity mode with those who do not use it
Comparison based on several parameters to describe the two populations at the time of questionnaire completion: CGM data over the 15 days prior to questionnaire completion: \- Percentage of use of the physical activity mode
Time frame: Baseline
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