Real-life Data From Diabetic Patients on Closed-loop Pumps
BLOOM
1 other identifier
observational
410
1 country
5
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2022
Typical duration for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 10, 2022
CompletedFirst Posted
Study publicly available on registry
June 14, 2022
CompletedStudy Start
First participant enrolled
September 26, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 10, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2025
CompletedResults Posted
Study results publicly available
March 12, 2026
CompletedMarch 12, 2026
February 1, 2026
1 year
June 10, 2022
February 20, 2026
February 20, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
HbA1c Level
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 Outcomes (19)
HbA1c Level
At 6 months
HbA1c Level
At 12 months
Time in Range
At 3 months
Time in Range
At 6 months
Time in Range
At 12 months
- +14 more secondary outcomes
Study Arms (1)
Type I diabetic patient
Interventions
Follow up of patients with real-time closed-loop insulin delivery systems
Eligibility Criteria
Type I diabetic patients with a closed-loop insulin pump between April 2020 and August 2023
You may qualify if:
- type I diabetic
- with a closed-loop insulin pump
You may not qualify if:
- under legal protection order
- patient or legal guardian objecting to the use of the data in the research
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
CH Béthune-Beuvry
Béthune, France
CH Boulogne-sur-Mer
Boulogne-sur-Mer, France
CH Dax
Dax, France
CHI Mont de Marsan et du Pays des Sources
Mont-de-Marsan, France
CH Périgueux
Périgueux, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Didier Gouet
- Organization
- Groupe Hospitalier de la Rochelle Ré Aunis
Study Officials
- STUDY DIRECTOR
Didier GOUET, MD
Groupe Hospitalier de la Rochelle Ré Aunis
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2022
First Posted
June 14, 2022
Study Start
September 26, 2022
Primary Completion
October 10, 2023
Study Completion
March 31, 2025
Last Updated
March 12, 2026
Results First Posted
March 12, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data will be made available with publication. A Digital Object Identifier will be used.
- 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.
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