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

April 27, 2026 updated by: University Hospital, Grenoble

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
900

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Grenoble, France
        • Recruiting
        • Chu Grenoble Alpes
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Satisfaction score
Time Frame: Baseline
Part C, D and E of the questionnar
Baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Describe the perception of physical activity within the study population
Time Frame: Baseline
Part A of the questionnar
Baseline
Describe the proportion of individuals using the physical activity mode in our study
Time Frame: Baseline
Part B of the questionnar
Baseline
Describe satisfaction with the mode in relation to the physical activities performed by patients
Time Frame: Baseline
Part F of the questionnar
Baseline
Describe overall satisfaction with the "physical activity" mode
Time Frame: Baseline
Part G of the questionnar
Baseline
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 (%)
Baseline
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
Baseline
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
Baseline
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
Baseline
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
Baseline
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
Baseline
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
Baseline
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)
Baseline
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
Baseline
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)
Baseline
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)
Baseline
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 %)
Baseline
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)
Baseline
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)
Baseline
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
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Grenoble

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 21, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 20, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 5, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings