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
Location: See location...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 5
Maximum Age: 7
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
France
Hôpital Universitaire Necker Enfants Malades
RECRUITING
Paris
Contact Information
Primary
Jacques Beltrand, PHD
jacques.beltrand@aphp.fr
01 44 38 17 96
Time Frame
Start Date: 2025-02-20
Estimated Completion Date: 2028-03-20
Participants
Target number of participants: 60
Treatments
Experimental: AIDS group
patients with T1DM with automatized insulin delivery systems (AIDS)
Other: TS group
patients with T1D treated with insulin pumps + blood glucose sensors with the option of activating predictive hypoglycemia shutdown (SAP-AAH)
Other: Control group
age-matched control subjects without T1DM
Sponsors
Collaborators: Fondation Francophone pour la Recherche sur le Diabete, Ypsomed Diabetes Care AG
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov