Actively Recruiting
Semi-closed Loop Automated Insulin Therapy in Children Aged 2-6 Years With Type 1 Diabetes: Impact on Quality of Life and Glycemic Control
Led by Fondation Lenval · Updated on 2025-04-20
20
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying children aged 2 to 6 years with type 1 diabetes to compare the quality of life and diabetes control when using a semi-closed loop automated insulin pump versus other insulin therapies such as open loop pumps or injections. This study focuses on the pediatric population where the semi-closed loop system is newly recognized and reimbursed for this age group in France. The goal is to assess improvements in quality of life and glycemic balance using validated questionnaires and blood sugar control measures. The study observes children who start treatment with the semi-closed loop insulin pump and compares their outcomes to their previous insulin therapies. Each child serves as their own control, allowing evaluation before and after switching to the semi-closed loop system. Quality of life is measured using the PedsQL 4.0 questionnaire at baseline, then at 1 month and 6 months post-implementation. Secondary measures include time in range, HbA1c levels, frequency of hypoglycemic episodes, and time spent in hyperglycemia. Participants will be assessed at three time points: before starting the semi-closed loop treatment, at 1 month, and at 6 months after. These evaluations include questionnaires on quality of life and clinical measures of blood sugar control to monitor diabetes balance. The study tracks changes over time to understand how the new system affects daily life and glucose management in young children with type 1 diabetes. Participation lasts at least 6 months, with ongoing observation of both quality of life and glycemic outcomes.
CONDITIONS
Brief Title
Semi-closed Loop Automated Insulin Therapy in the Pediatric Population Aged 2-6 Years With Type 1 Diabetes: Impact on Quality of Life and Glycemic Control
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 2 to 6 years inclusive
- Diagnosed with type 1 diabetes and currently on insulin therapy
- Affiliated with social security
- Starting semi-closed loop insulin therapy
- Family agrees to participate in training for continuous real-time glucose monitoring
- Consent obtained from at least one parent or legal guardian
You will not qualify if you...
- Opposed to participation in human research or use of their data and samples (withdrawal of consent)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Initial phase before 1 month assessment
Participants start semi-closed loop automated insulin therapy and receive training for continuous real-time glucose monitoring.
1 baseline visit (in-person)
Duration - 6 months
Participants are monitored to assess quality of life and glycemic control at 1 month and 6 months after therapy implementation.
2 visits (at 1 month and 6 months, in-person or remote)
Trial Site Locations
Total: 1 location
1
Fondation Lenval Hôpitaux pédiatrique Nice CHU Lenval
Nice, France, France, 06000
Actively Recruiting
Research Team
A
Aline JOULIE, PHD
V
Valentine FOURNY-SARGHAT, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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