Skip to main content
OpenTrials
Recruiting

NCT Number: 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)

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

5 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Universitaire Necker Enfants Malades

Paris, 75015, France

Location status: Recruiting

Location contact

Jacques Beltrand, PhD

CONTACT

[email protected]

+33 144381796

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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)

Other names: Brain MRI

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

Primary outcomes

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

    Time frame: at inclusion and at 18 months after inclusion

    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.

Secondary outcomes

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

    Time frame: at month 6 and 24 months after diagnosis of T1DM

    Variation in other morphometric measures (localized gray matter, total and localized white matter, measurement of anatomical connectivity) and resting brain function (measurement of cerebral blood flow by arterial label spin ALS) will be compared between the two groups of diabetic children between randomization and the end of the 18-month intervention

  2. Intelligence score

    Time frame: at month 6 and 24 months after diagnosis of T1DM

    Assessment of neurocognitive performance: Scale scores Wechsler Intelligence Scale for Children (WIPPSI-IV)

  3. glycemic variability indexes

    Time frame: at month 6 and 24 months after diagnosis of T1DM

    Glycemic variability measured from data from continuous measurement of interstitial glycemia though the sensor worn by the patient. The standard deviation (SD) of the glycemic mean, the coefficient of variation (CV), the continuous overall net glycemic action (CONGA) 1 hour - 2 hours - 4 hours will be calculated from the full 72 hours recording closest to the visit. Their changes will be compared between the two measurement times between the groups.

  4. Score of test "attention go/nogo" of KiTAP scale

    Time frame: at month 6 and 24 months after diagnosis of T1DM

    Behavioral control assessment and focused attention test

  5. Score on BRIEF ((behavioral assessment inventory) scale

    Time frame: at month 6 and 24 months after diagnosis of T1DM

    behavioral assessment inventory

  6. Score of Stroop big small et Stropp fruits scale

    Time frame: at month 6 and 24 months after diagnosis of T1DM

    Assessment of inhibitory control

  7. Score of Nepsy II scale

    Time frame: at month 6 and 24 months after diagnosis of T1DM

    Auditory attention test

Study contacts

Contact information is provided by the study sponsor or research team.

Jacques Beltrand, PHD

CONTACT

[email protected]

01 44 38 17 96

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Fondation Francophone pour la Recherche sur le Diabete
  • mylife Diabetes Care AG

Registry information

Acronym: PROCEDE

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jun 14, 2024
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.