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

Recruiting now · Not applicable

Conditions studied: Diabetes

In brief

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.

Key facts

Study ID

NCT06461065

Run by

Assistance Publique - Hôpitaux de Paris

People needed

60

Starts

2025-02-20

Expected to finish

2028-03-20

Last updated by the study team

2025-10-02

Who can join

Age: 5 and older, up to 7. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 5 to 7 years old
• Informed consent of parental guardians
• Parents able to speak, understand and read French (verified by investigator)
• Social security affiliation
• Only for subjects with T1DM:
• Insulin pump treatment and Dexcom sensor wear
• Type 1 diabetes diagnosed less than 6 months ago
• Insulin dose ≥ 0.5 IU/k/day
• Patients agree to use the DEXCOM sensor

You may not qualify if…

• History of neurological disease
• History of child psychiatric disease
• Prematurity (birth before 37 SA)
• Wearing of internal metal parts contraindicating the performance of MRI
• Severe skin disease preventing the use of an insulin pump sensor or catheter
• Uncontrolled celiac disease
• Uncontrolled autoimmune thyroiditis
• Participation in another interventional research study or in the exclusion period thereof
• Refusal to participate by a minor after information adapted to his/her age and abilities

Where it is running

• Hôpital Universitaire Necker Enfants Malades — Paris, France (enrolling)

Full record on ClinicalTrials.gov

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