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

NCT06461065 | Recruiting

• 1 other identifier: APHP230422
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes

Keywords

Diabetes; Children; insulin therapy; cognitive development

Outcome Measures

Primary Outcomes (1)

• volume of total gray matter measured with high-resolution morphometric MRI

  The primary endpoint will be changes in total gray matter volume measured with high-resolution morphometric MRI (vox based morphometry method). It will be measured at randomization (within 6 months of diagnosis) and 18 months after randomization in the intervention group (treatment of T1DM with SADI), in a control group of T1DM patients (treatment of T1DM with insulin pump and blood glucose sensor) and in a group of non-diabetic control subjects in the same age range.

  at inclusion and at 18 months after inclusion

Secondary Outcomes (7)

• volume of total gray matter measured with high-resolution morphometric MRI

  at month 6 and 24 months after diagnosis of T1DM

• Intelligence score

  at month 6 and 24 months after diagnosis of T1DM

• glycemic variability indexes

  at month 6 and 24 months after diagnosis of T1DM

• Score of test "attention go/nogo" of KiTAP scale

  at month 6 and 24 months after diagnosis of T1DM

• Score on BRIEF ((behavioral assessment inventory) scale

  at month 6 and 24 months after diagnosis of T1DM

Study Arms (3)

AIDS group

EXPERIMENTAL

patients with T1DM with automatized insulin delivery systems (AIDS)

Device: AIDS; Other: Brain MRI

TS group

OTHER

patients with T1D treated with insulin pumps + blood glucose sensors with the option of activating predictive hypoglycemia shutdown (SAP-AAH)

Other: Brain MRI

Control group

OTHER

age-matched control subjects without T1DM

Other: Brain MRI

Interventions

AIDS DEVICE

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)

Also known as: Brain MRI

AIDS group

Brain MRI OTHER

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

AIDS group; Control group; TS group

Eligibility Criteria

• Age: 5 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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
• Refusal to participate by a minor after information adapted to his/her age and abilities

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Fondation Francophone pour la Recherche sur le Diabete: collaborator
• mylife Diabetes Care AG: collaborator

Study Sites (1)

Hôpital Universitaire Necker Enfants Malades

Paris, 75015, France

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Jacques Beltrand, PHD

  APHP

  PRINCIPAL INVESTIGATOR

• Nathalie Boddaert, PHD

  APHP

  STUDY CHAIR

Central Study Contacts

Jacques Beltrand, PHD

CONTACT

01 44 38 17 96; jacques.beltrand@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2024
• First Posted: June 14, 2024
• Study Start: February 20, 2025
• Primary Completion (Estimated): March 20, 2028
• Study Completion (Estimated): March 20, 2028
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)