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

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 Overview

• Status: Recruiting
• Conditions: Diabetes
• Intervention / Treatment: Other: Questionnar

• Study Type: Interventional
• Enrollment (Estimated): 900
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Quentin Perrier, PharmD, phD; Phone Number: +33 4 76 76 55 16; Email: qperrier@chu-grenoble.fr

Study Locations

• France
  • Grenoble, France
    • Recruiting
    • Chu Grenoble Alpes
    • Contact: Quentin Perrier, PharmD, phD; Phone Number: +33 4 76 76 55 16; Email: qperrier@chu-grenoble.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Only 1 arm = patient treated with AID systems	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction score	Part C, D and E of the questionnar	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Describe the perception of physical activity within the study population	Part A of the questionnar	Baseline
Describe the proportion of individuals using the physical activity mode in our study	Part B of the questionnar	Baseline
Describe satisfaction with the mode in relation to the physical activities performed by patients	Part F of the questionnar	Baseline
Describe overall satisfaction with the "physical activity" mode	Part G of the questionnar	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 (%)	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	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	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	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	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	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	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)	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	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)	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)	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 %)	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)	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)	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	Baseline

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: April 20, 2026
• First Submitted That Met QC Criteria: April 27, 2026
• First Posted (Actual): May 5, 2026

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: physical activity; automated insulin delivery; PROMs; Closed-loop
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Behavior; Nutritional and Metabolic Diseases; Diabetes Mellitus; Motor Activity
• Other Study ID Numbers: 38RC26.0046

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No