Clinical Research Directory

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

Sponsor: Assistance Publique - Hôpitaux de Paris

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.

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