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

NCT07567170 | Recruiting

• 1 other identifier: 38RC26.0046
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes

Keywords

Closed-loop; automated insulin delivery; physical activity; PROMs

Outcome Measures

Primary Outcomes (1)

• Satisfaction score

  Part C, D and E of the questionnar

  Baseline

Secondary Outcomes (19)

• Describe the perception of physical activity within the study population

  Baseline

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

  Baseline

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

  Baseline

• Describe overall satisfaction with the "physical activity" mode

  Baseline

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

  Baseline

Study Arms (1)

Only 1 arm = patient treated with AID systems

OTHER

Other: Questionnar

Interventions

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.

Only 1 arm = patient treated with AID systems

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

CHU Grenoble Alpes

Grenoble, France

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus; Motor Activity

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Central Study Contacts

Quentin Perrier, PharmD, phD

CONTACT

+33 4 76 76 55 16; qperrier@chu-grenoble.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2026
• First Posted: May 5, 2026
• Study Start: April 21, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

FR (1)