Actively Recruiting
Evaluation of Neurodevelopmental Trajectories in Children According to the Glycemic Profile Associated With Different Early Treatment Modalities in Children With Type 1 Diabetes (T1DM)
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-10-02
60
Participants Needed
1
Research Sites
160 weeks
Total Duration
On this page
Sponsors
A
Assistance Publique - Hôpitaux de Paris
Lead Sponsor
F
Fondation Francophone pour la Recherche sur le Diabete
Collaborating Sponsor
AI-Summary
What this Trial Is About
More than half of all new cases of type 1 diabetes (T1D) are diagnosed in the first decade of life. It has been reported that early onset T1D may be associated with deterioration in cognitive performance. It mainly affects working memory or the ability to perform complex tasks involving planning (executive functions) or decision-making. Brain magnetic resonance imaging (MRI) has reported alteration brain growth alteration related to impaired cognitive performance. Exposure to hypoglycemia, hyperglycemia and glycemic variability are thought to be responsible for these structural changes, especially in younger patients. Those changes can be detected early after diagnosis. Automatized insulin delivery systems (AIDS) can dramatically improve glycemic profile in children with T1D by reducing the occurrence of hypo and hyperglycemia. However, in France, market authorization are limited to children with unbalanced T1D who have failed to respond to other therapies and to the reinforcement of diabetes education. It therefore does not concern newly diagnosed patients. 60% of patients under 10 diagnosed with T1DM for less than 3 years are not treated in France by these systems. The aim of this study is therefore to determine whether early treatment of patients with AIDS would have a positive impact on cerebral growth and and on cognitive function in pediatric patients with T1DM.
CONDITIONS
Official Title
Evaluation of Neurodevelopmental Trajectories in Children According to the Glycemic Profile Associated With Different Early Treatment Modalities in Children With Type 1 Diabetes (T1DM)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 5 and 7 years
- Parental or guardian informed consent
- Parents able to speak, understand, and read French
- Social security affiliation
- For children with type 1 diabetes: currently using insulin pump and Dexcom sensor
- Type 1 diabetes diagnosed less than 6 months ago
- Insulin dose at least 0.5 IU/kg/day
- Agreement to use the Dexcom sensor during the study
You will not qualify if you...
- History of neurological disease
- History of child psychiatric disease
- Premature birth before 37 weeks of gestation
- Presence of internal metal parts that prevent MRI
- Severe skin disease preventing use of insulin pump sensor or catheter
- Uncontrolled celiac disease
- Uncontrolled autoimmune thyroiditis
- Participation in another interventional research study or within exclusion period
- Child refusal to participate after age-appropriate information
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Hôpital Universitaire Necker Enfants Malades
Paris, France, 75015
Actively Recruiting
Research Team
J
Jacques Beltrand, PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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