Actively Recruiting

Phase Not Applicable
Age: 5Years - 7Years
All Genders
Healthy Volunteers
NCT06461065

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

Age: 5Years - 7Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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