Status:
RECRUITING
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
Lead Sponsor:
Fondation Lenval
Conditions:
Type 1 Diabetes
Closed Loop
Eligibility:
All Genders
2-6 years
Brief Summary
The incidence of type 1 diabetes is increasing, with an incidence of +4% per year in France today. The treatment for type 1 diabetes is insulin therapy. In recent years, new systems have emerged, so-...
Eligibility Criteria
Inclusion
- -Patients aged 2 to 6 years inclusive
- Presenting type 1 diabetes on insulin therapy
- Social security affiliates
- Patient initiating semi-closed loop treatment
- Family (at least one parent or representative of parental authority) agreeing to follow the training necessary for continuous measurement of glucose in real time.
- collection of non-opposition from one of the two parents or the representative of parental authority agreement
Exclusion
- Opposition to participation in research involving humans or opposition to the use of data or samples and associated data (withdrawal of non-opposition).
Key Trial Info
Start Date :
March 17 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06875167
Start Date
March 17 2025
End Date
December 1 2026
Last Update
April 20 2025
Active Locations (1)
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1
Fondation Lenval Hôpitaux pédiatrique Nice CHU Lenval
Nice, France, France, 06000