Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07567170

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Diabetes Behavior Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnar

Other

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 outcomes

  1. Satisfaction score

    Time frame: Baseline

    Part C, D and E of the questionnar

Secondary outcomes

  1. Describe the perception of physical activity within the study population

    Time frame: Baseline

    Part A of the questionnar

  2. Describe the proportion of individuals using the physical activity mode in our study

    Time frame: Baseline

    Part B of the questionnar

  3. Describe satisfaction with the mode in relation to the physical activities performed by patients

    Time frame: Baseline

    Part F of the questionnar

  4. Describe overall satisfaction with the "physical activity" mode

    Time frame: Baseline

    Part G of the questionnar

  5. Compare populations who use the physical activity mode with those who do not use it

    Time frame: Baseline

    Comparison based on several parameters to describe the two populations at the time of questionnaire completion:

    HbA1c (%)

  6. Compare populations who use the physical activity mode with those who do not use it

    Time frame: Baseline

    Comparison based on several parameters to describe the two populations at the time of questionnaire completion:

    Type of closed-loop system

  7. Compare populations who use the physical activity mode with those who do not use it

    Time frame: Baseline

    Comparison based on several parameters to describe the two populations at the time of questionnaire completion:

    Duration of use of the closed-loop system

  8. Compare populations who use the physical activity mode with those who do not use it

    Time frame: Baseline

    Comparison based on several parameters to describe the two populations at the time of questionnaire completion:

    Time spent in closed-loop mode

  9. Compare populations who use the physical activity mode with those who do not use it

    Time frame: Baseline

    Comparison based on several parameters to describe the two populations at the time of questionnaire completion:

    Duration of type 1 diabetes

  10. Compare populations who use the physical activity mode with those who do not use it

    Time frame: Baseline

    Comparison based on several parameters to describe the two populations at the time of questionnaire completion:

    Age

  11. Compare populations who use the physical activity mode with those who do not use it

    Time frame: Baseline

    Comparison based on several parameters to describe the two populations at the time of questionnaire completion:

    Sex

  12. Compare populations who use the physical activity mode with those who do not use it

    Time frame: Baseline

    Comparison based on several parameters to describe the two populations at the time of questionnaire completion:

    Body Mass Index (BMI)

  13. Compare populations who use the physical activity mode with those who do not use it

    Time frame: Baseline

    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

  14. Compare populations who use the physical activity mode with those who do not use it

    Time frame: Baseline

    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)

  15. Compare populations who use the physical activity mode with those who do not use it

    Time frame: Baseline

    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)

  16. Compare populations who use the physical activity mode with those who do not use it

    Time frame: Baseline

    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 %)

  17. Compare populations who use the physical activity mode with those who do not use it

    Time frame: Baseline

    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)

  18. Compare populations who use the physical activity mode with those who do not use it

    Time frame: Baseline

    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)

  19. Compare populations who use the physical activity mode with those who do not use it

    Time frame: Baseline

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Quentin Perrier, PharmD, phD

CONTACT

[email protected]

+33 4 76 76 55 16

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Acronym: BF-ACT

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 5, 2026
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.