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