Real-life Data from Diabetic Patients on Closed-loop Pumps

Active, not recruiting

• Conditions: Type 1 Diabetes

• Registration Number: NCT05418699
• Lead Sponsor: Groupe Hospitalier de la Rochelle Ré Aunis

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.

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 Timeline

• Study First Submitted: 2022-06-10
• Study First Submitted QC: 2022-06-10
• Study First Posted: 2022-06-14
• Study Start: 2022-09-26
• Primary Completion: 2023-10-10
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-13
• Last Update Posted: 2025-03-17
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 439

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
HbA1c level	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%

Secondary Outcome Measures

Name	Time	Method
Time below range	At 12 months	Percentage of time with glucose values below 70 mg/dL in the last 14 days
Time above range	At 12 months	Percentage of time with glucose values above 180 mg/dL in the last 14 days
HbA1c level	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%
Time in range	At 12 months	Percentage of time spent in the target range between 70 and 180 mg/dL in the last 14 days
Coefficient of variation	At 12 months	Ratio of the standard deviation divided by the mean glucose and multiplying by 100 (percentage)

Trial Locations

Locations (5)

CH Boulogne-sur-Mer; 🇫🇷 Boulogne-sur-Mer, France

CH Béthune-Beuvry; 🇫🇷 Béthune, France

CH Dax; 🇫🇷 Dax, France

CHI Mont de Marsan et du Pays des Sources; 🇫🇷 Mont-de-Marsan, France

CH Périgueux; 🇫🇷 Périgueux, France