Real-life Data From Diabetic Patients on Closed-loop Pumps (BLOOM)

February 20, 2026 updated by: Groupe Hospitalier de la Rochelle Ré Aunis
To evaluate, in real life, the effect of closed-loop devices on the improvement of glycemic control in diabetic patients managed in the endocrinology departments of secondary care hospitals.

Study Overview

Status

Status

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

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.

Detailed Description

In recent years, closed-loop insulin delivery have been developed to deliver real-time glucose-responsive insulin to people with type 1 diabetes mellitus (T1DM). Their use has been validated in clinical trials, but international investigative centers participating in clinical trials are not always representative of secondary care centers, and the patients they manage are also different. The eligibility criteria for participants in clinical trials are more stringent and restrictive than those of the usual patient population of diabetes/endocrinology centers. The socio-demographic characteristics of patients in clinical trials, in particular the ratio of males to females, age or ethnicity, do not necessarily reflect those observed in patients actually using the device.

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.
Observational

Enrollment (Actual)

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.
410

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
      • Boulogne-sur-Mer, France
        • Ch Boulogne-Sur-Mer
      • Béthune, France
        • CH Béthune-Beuvry
      • Dax, France
        • CH Dax
      • Mont-de-Marsan, France
        • CHI Mont de Marsan et du Pays des Sources
      • Périgueux, France
        • CH Périgueux

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

7 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Type I diabetic patients with a closed-loop insulin pump between April 2020 and August 2023

Description

Inclusion Criteria:

  • type I diabetic
  • with a closed-loop insulin pump

Exclusion Criteria:

  • under legal protection order
  • patient or legal guardian objecting to the use of the data in the research

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
Type I diabetic patient
Device: closed-loop insulin pump
Follow up of patients with real-time closed-loop insulin delivery systems

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
HbA1c Level
Time Frame: At 3 months
Hemoglobin A1c is an indicator of your long-term glucose levels. Normal range for the hemoglobin A1c level is between 4% and 5.6%
At 3 months

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
HbA1c Level
Time Frame: At 6 months
Hemoglobin A1c is an indicator of your long-term glucose levels. Normal range for the hemoglobin A1c level is between 4% and 5.6%
At 6 months
HbA1c Level
Time Frame: At 12 months
Hemoglobin A1c is an indicator of your long-term glucose levels. Normal range for the hemoglobin A1c level is between 4% and 5.6%
At 12 months
Time in Range
Time Frame: At 3 months
Percentage of time spent in the target range between 70 and 180 mg/dL in the last 14 days
At 3 months
Time in Range
Time Frame: At 6 months
Percentage of time spent in the target range between 70 and 180 mg/dL in the last 14 days
At 6 months
Time in Range
Time Frame: At 12 months
Percentage of time spent in the target range between 70 and 180 mg/dL in the last 14 days
At 12 months
Time Below Range
Time Frame: At 3 months
Percentage of time with glucose values below 70 mg/dL in the last 14 days
At 3 months
Time Below Range
Time Frame: At 6 months
Percentage of time with glucose values below 70 mg/dL in the last 14 days
At 6 months
Time Below Range
Time Frame: At 12 months
Percentage of time with glucose values below 70 mg/dL in the last 14 days
At 12 months
Time Above Range
Time Frame: At 3 months
Percentage of time with glucose values above 180 mg/dL in the last 14 days
At 3 months
Time Above Range
Time Frame: At 6 months
Percentage of time with glucose values above 180 mg/dL in the last 14 days
At 6 months
Time Above Range
Time Frame: At 12 months
Percentage of time with glucose values above 180 mg/dL in the last 14 days
At 12 months
Coefficient of Variation
Time Frame: At 3 months
Ratio of the standard deviation divided by the mean glucose and multiplying by 100 (percentage)
At 3 months
Coefficient of Variation
Time Frame: At 6 months
Ratio of the standard deviation divided by the mean glucose and multiplying by 100 (percentage)
At 6 months
Coefficient of Variation
Time Frame: At 12 months
Ratio of the standard deviation divided by the mean glucose and multiplying by 100 (percentage)
At 12 months
HbA1c Level
Time Frame: at 18 months
Hemoglobin A1c is an indicator of your long-term glucose levels. Normal range for the hemoglobin A1c level is between 4% and 5.6%
at 18 months
Time in Range
Time Frame: at 18 months
Percentage of time spent in the target range between 70 and 180 mg/dL in the last 14 days
at 18 months
Time Below Range
Time Frame: at 18 months
Percentage of time with glucose values below 70 mg/dL in the last 14 days
at 18 months
Time Above Range
Time Frame: at 18 months
Percentage of time with glucose values above 180 mg/dL in the last 14 days
at 18 months
Coefficient of Variation
Time Frame: at 18 months
Ratio of the standard deviation divided by the mean glucose and multiplying by 100 (percentage)
at 18 months

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.
Groupe Hospitalier de la Rochelle Ré Aunis

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Didier GOUET, MD, Groupe Hospitalier de La Rochelle Ré Aunis

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.
September 26, 2022

Primary Completion (Actual)

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.
October 10, 2023

Study Completion (Actual)

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.
March 31, 2025

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).
June 10, 2022

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.
June 10, 2022

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.
June 14, 2022

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.
March 12, 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.
February 20, 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.
February 1, 2026

More Information

Terms related to this study

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.
  • 2022/P02/540

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The database will be made available on a general-purpose open repository. Medical Subject Headings (MESH) terms will be used to describe clinical data. International standard unit will be used. Keyword are type I diabetes, Insulin Infusion Systems, Patient Outcome Assessment

IPD Sharing Time Frame

Data will be made available with publication. A Digital Object Identifier will be used.

IPD Sharing Access Criteria

The only available version will be the locked database. With the exception of dates, all data will be made available. Dates will only be collected to verify the quality of the clinical trial execution. They do not add to the clinical question, and may be a means of indirectly identifying patients.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

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