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

NCT ID: NCT05418699

Last Updated: 2025-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

439 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-26

Study Completion Date

2025-03-31

Brief Summary

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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

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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.

Conditions

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Type 1 Diabetes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Type I diabetic patient

closed-loop insulin pump

Intervention Type DEVICE

Follow up of patients with real-time closed-loop insulin delivery systems

Interventions

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closed-loop insulin pump

Follow up of patients with real-time closed-loop insulin delivery systems

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Groupe Hospitalier de la Rochelle Ré Aunis

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Didier GOUET, MD

Role: STUDY_DIRECTOR

Groupe Hospitalier de la Rochelle Ré Aunis

Locations

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CH Béthune-Beuvry

Béthune, , France

Site Status

CH Boulogne-sur-Mer

Boulogne-sur-Mer, , France

Site Status

CH Dax

Dax, , France

Site Status

CHI Mont de Marsan et du Pays des Sources

Mont-de-Marsan, , France

Site Status

CH Périgueux

Périgueux, , France

Site Status

Countries

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France

Other Identifiers

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2022/P02/540

Identifier Type: -

Identifier Source: org_study_id

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