RecruitingNot ApplicableNCT06461065

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

Enrollment

60 participants

Start Date

Feb 20, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 5 YearsMax Age: 7 Years

Inclusion Criteria9

  • 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

Exclusion Criteria9

  • 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

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Interventions

DEVICEAIDS

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)

OTHERBrain 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


Locations(1)

Hôpital Universitaire Necker Enfants Malades

Paris, France

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NCT06461065


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