Evaluation of Neurodevelopmental Trajectories in Children According to the Glycemic Profile Associated With Different Early Treatment Modalities in Children With Type 1 Diabetes (T1DM)

Summary

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

• Diabetes

Interventions

DEVICE

AIDS

mylife CamAPS application, marketed by CamDiab Ltd, in conjunction with YpsoPump, marketed by Ypsomed, Dexcom blood glucose sensor, Orbit Infusion sets and Orbit Infusion sets and Orbit inserter (used in their indications)

OTHER

Brain MRI

To evaluate the neuroanatomical damage to gray matter associated with type 1 diabetes in young children according to their glycemic profile (AIDS use or not) and compared with an age-matched control subject

Sponsors & Collaborators

• Fondation Francophone pour la Recherche sur le Diabete

  collaborator OTHER

• Ypsomed Diabetes Care AG

  collaborator INDUSTRY

• Assistance Publique - Hôpitaux de Paris

  lead OTHER

Principal Investigators

• Jacques Beltrand, PHD · APHP

• Nathalie Boddaert, PHD · APHP

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

5 Years

Max Age

7 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-02-20

Primary Completion

2028-03-20

Completion

2028-03-20

Countries

• France

Study Locations