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

September 29, 2025 updated by: Assistance Publique - Hôpitaux de Paris
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Paris, France, 75015
        • Recruiting
        • Hôpital Universitaire Necker Enfants Malades
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AIDS group
patients with T1DM with automatized insulin delivery systems (AIDS)
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
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 Names:
  • Brain MRI
Other: Control group
age-matched control subjects without T1DM
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
Other: TS group
patients with T1D treated with insulin pumps + blood glucose sensors with the option of activating predictive hypoglycemia shutdown (SAP-AAH)
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at inclusion and at 18 months after inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at month 6 and 24 months after diagnosis of T1DM
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)
at month 6 and 24 months after diagnosis of T1DM
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.
at month 6 and 24 months after diagnosis of T1DM
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
at month 6 and 24 months after diagnosis of T1DM
Score on BRIEF ((behavioral assessment inventory) scale
Time Frame: at month 6 and 24 months after diagnosis of T1DM
behavioral assessment inventory
at month 6 and 24 months after diagnosis of T1DM
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
at month 6 and 24 months after diagnosis of T1DM
Score of Nepsy II scale
Time Frame: at month 6 and 24 months after diagnosis of T1DM
Auditory attention test
at month 6 and 24 months after diagnosis of T1DM

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Fondation Francophone pour la Recherche sur le Diabete
Ypsomed Diabetes Care AG

Investigators

  • Principal Investigator: Jacques Beltrand, PHD, APHP
  • Study Chair: Nathalie Boddaert, PHD, APHP

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2025

Primary Completion (Estimated)

March 20, 2028

Study Completion (Estimated)

March 20, 2028

Study Registration Dates

First Submitted

May 31, 2024

First Submitted That Met QC Criteria

June 11, 2024

First Posted (Actual)

June 14, 2024

Study Record Updates

Last Update Posted (Estimated)

October 2, 2025

Last Update Submitted That Met QC Criteria

September 29, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP230422

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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