NCT05418699

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 410 (actual)
• Sponsor: Groupe Hospitalier de la Rochelle Ré Aunis · Academic / Other
• Sex: All
• Age: 7 Years
• Healthy volunteers: Not accepted

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 mellitus (T1DM). 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

• Type 1 Diabetes

Interventions

Type	Name	Description
DEVICE	closed-loop insulin pump	Follow up of patients with real-time closed-loop insulin delivery systems

Timeline

• Start date: 2022-09-26
• Primary completion: 2023-10-10
• Completion: 2025-03-31
• First posted: 2022-06-14
• Last updated: 2026-03-12
• Results posted: 2026-03-12

Locations

5 sites across 1 country: France