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

Type 1 Diabetes Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05418699
• Other study ID #: 2022/P02/540
• Status: Recruiting
• Start date: September 26, 2022
• Est. completion date: January 31, 2025

Study information

• Verified date: January 2024
• Source: Groupe Hospitalier de la Rochelle Ré Aunis
• Contact: Caroline Allix-Béguec, PhD
• Phone: +33516494246
• Email: caroline.allix-beguec[@]ght-atlantique17.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: January 31, 2025
• Est. primary completion date: September 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Device:
• closed-loop insulin pump
Follow up of patients with real-time closed-loop insulin delivery systems

Locations

Country	Name	City	State
France	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

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier de la Rochelle Ré Aunis

Country where clinical trial is conducted

France, 

Outcome

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