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

Groupe Hospitalier de la Rochelle Ré Aunis

Status: Active, not recruiting

Conditions: Type 1 Diabetes

Treatments: Device: closed-loop insulin pump

Study type: Observational

Funder types: Other

Identifiers

NCT05418699

2022/P02/540

Details and patient eligibility

About

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.

Full 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.

Enrollment: 439 patients

Sex: All

Ages: 7+ years old

Volunteers: No Healthy Volunteers

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

Trial design

439 participants in 1 patient group

Type I diabetic patient

Treatment:

Device: closed-loop insulin pump