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)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 5 Years – 7 Years
• Healthy volunteers: Accepted

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.

Detailed description

The aim of the study was to evaluate the neuroanatomical damage to gray matter associated with type 1 diabetes in young children according to their glycemic profile (use of a AIDS or Insulin pump combined with a continuous glucose monitoring sensor with the option of activating predictive shut-off before hypoglycemia (SAP-AAH)) and compared with an age-matched control subject. Prospective case-control cohort study (T1DM or not) and exposed/non-exposed (CL or not), multicenter with 2 visits at 6 and 24 months of T1DM and 2 parallel visits for the control group. The AIDS system used is a "mylife CamAPS application", marketed by CamDiab Ltd. class III, (YpsoPump, marketed by Ypsomed, Dexcom blood glucose sensor, used in their respective indications). The experimental group will consist of patients treated with AIDS. The standard treatment (comparative) group will consist of patients with T1D treated with the gold standard treatment for this age group (SAP-AAH = insulin pump combined with a continuous glucose monitoring sensor with the option of activating predictive shut-off before hypoglycemia). In order to have a reference image, a second control group consisting of children aged 5 to 7 The expected benefits are early access to an automated insulin delivery system for study participants, as well as evidence of the neurocognitive benefit of early use of AIDs leading to changes in care practices.

Conditions

• Diabetes

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-02-20
• Primary completion: 2028-03-20
• Completion: 2028-03-20
• First posted: 2024-06-14
• Last updated: 2025-10-02

Locations

1 site across 1 country: France