Automated insulin therapy for young children with type 1 diabetes
Official 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
Run by Fondation Lenval · NCT06875167 · Data updated 2026-11-12
This study tests if a new automated insulin delivery system can improve the quality of life and blood sugar control for young children with type 1 diabetes compared to traditional methods.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 2 Years to 6 Years |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Fondation Lenval Academic / other |
| Locations | 1 site (Nice, France) |
| Status | Recruiting |
| Started | March 17, 2025 |
| Main results expected | June 2026 |
| Study ends | December 2026 |
| Registry record updated | April 20, 2025 |
| Trial ID | NCT06875167 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children aged 2 to 6 years who have been diagnosed with type 1 diabetes and are starting semi-closed loop insulin therapy.
✕Probably not a fit
Patients who are older than 6 years or those not initiating semi-closed loop treatment may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study investigates the impact of semi-closed loop automated insulin therapy on the quality of life and glycemic control in children aged 2 to 6 years with type 1 diabetes. It aims to compare the experiences of children using this new insulin delivery system against traditional methods such as open-loop systems or injections. The study is particularly significant as it is the first to evaluate the quality of life benefits for this younger age group following the recent approval of the YPSOPUMP model in France. Participants will be required to have parental consent and undergo training for continuous glucose monitoring.
Why it matters
Potential benefit: If successful, this study could enhance the quality of life and glycemic control for young children with type 1 diabetes.
How similar studies have gone: While there have been studies on older children and adults, this specific approach for the 2-6 year age group is novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * -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 Criteria: * Opposition to participation in research involving humans or opposition to the use of data or samples and associated data (withdrawal of non-opposition).
Where it's running
-
Fondation Lenval Hôpitaux pédiatrique Nice CHU Lenval
Nice, France, France Recruiting
Study contacts
- Principal investigator: Céline Gouillard-Darnaud, MD — Fondation Lenval
- Study coordinator: Aline JOULIE, PHD
- Email: joulie.a@chu-nice.fr
- Phone: +33492030520
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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This study tests whether teaching mealtime insulin dosing using CGM data helps adults with Type 1 diabetes who don’t usually count carbs.
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This registry will see if adding GLP-1RA or SGLTi therapies to insulin helps adults with type 1 diabetes over one year.
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Near-sensor insulin delivery with CGM in people with type 1 diabetes
A small early-feasibility study tests a dual-port insulin patch pump that includes a CGM sensor to see if delivering insulin near the sensor affects glucose readings and whether an automated control algorithm can manage glucose.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.