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Clinical Trials/NCT05418699
NCT05418699CompletedNot Applicable

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

Groupe Hospitalier de la Rochelle Ré Aunis5 sites in 1 country410 target enrollmentStarted: September 26, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
410
Locations
5
Primary Endpoint
HbA1c Level

Study Overview

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 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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
7 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Type I diabetic patient

Intervention: closed-loop insulin pump (Device)

Outcomes

Primary Outcomes

HbA1c Level

Time Frame: 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 Outcomes

  • HbA1c Level(At 6 months)
  • HbA1c Level(At 12 months)
  • Time in Range(At 3 months)
  • Time in Range(At 6 months)
  • Time in Range(At 12 months)
  • Time Below Range(At 3 months)
  • Time Below Range(At 6 months)
  • Time Below Range(At 12 months)
  • Time Above Range(At 3 months)
  • Time Above Range(At 6 months)
  • Time Above Range(At 12 months)
  • Coefficient of Variation(At 3 months)
  • Coefficient of Variation(At 6 months)
  • Coefficient of Variation(At 12 months)
  • HbA1c Level(at 18 months)
  • Time in Range(at 18 months)
  • Time Below Range(at 18 months)
  • Time Above Range(at 18 months)
  • Coefficient of Variation(at 18 months)

Investigators

Sponsor
Groupe Hospitalier de la Rochelle Ré Aunis
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (5)

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