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

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: Active, not recruiting
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Device: closed-loop insulin pump

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. 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: Observational
• Enrollment (Actual): 439

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 6 months
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 12 months
Time in range	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	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	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	Percentage of time with glucose values below 70 mg/dL in the last 14 days	At 3 months
Time below range	Percentage of time with glucose values below 70 mg/dL in the last 14 days	At 6 months
Time below range	Percentage of time with glucose values below 70 mg/dL in the last 14 days	At 12 months
Time above range	Percentage of time with glucose values above 180 mg/dL in the last 14 days	At 3 months
Time above range	Percentage of time with glucose values above 180 mg/dL in the last 14 days	At 6 months
Time above range	Percentage of time with glucose values above 180 mg/dL in the last 14 days	At 12 months
Coefficient of variation	Ratio of the standard deviation divided by the mean glucose and multiplying by 100 (percentage)	At 3 months
Coefficient of variation	Ratio of the standard deviation divided by the mean glucose and multiplying by 100 (percentage)	At 6 months
Coefficient of variation	Ratio of the standard deviation divided by the mean glucose and multiplying by 100 (percentage)	At 12 months

Collaborators and Investigators

• Sponsor: Groupe Hospitalier de la Rochelle Ré Aunis
• Investigators: Study Director: Didier GOUET, MD, Groupe Hospitalier de la Rochelle Ré Aunis

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2022
• Primary Completion (Actual): September 26, 2023
• Study Completion (Estimated): January 31, 2025

Study Registration Dates

• First Submitted: June 10, 2022
• First Submitted That Met QC Criteria: June 10, 2022
• First Posted (Actual): June 14, 2022

Study Record Updates

• Last Update Posted (Actual): May 17, 2024
• Last Update Submitted That Met QC Criteria: May 17, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin
• Other Study ID 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