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Evaluation of Neurodevelopmental Trajectories in Children According to the Glycemic Profile Associated With Early Treatment Using an Automated Delivery System in Children With Type 1 Diabetes

Sponsor: Assistance Publique - Hôpitaux de Paris • ClinicalTrials.gov ID: NCT06461065

Registry updated: 2026-10-07

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Description

ore than half of all new cases of type 1 diabetes (T1D) are diagnosed within the first decade of life. It has been reported that early onset of this disease may be associated with a decline in cognitive performance in adulthood, primarily affecting memory or the ability to perform complex tasks that require planning (executive functions) or decision-making. Magnetic resonance imaging (MRI) of the brain has revealed alterations in the brain's neural network that parallel the decline in cognitive performance. It has been suggested that hypoglycemia, hyperglycemia, and glycemic variability could explain this phenomenon, as they lead to early structural changes in cortical gray and white matter in young patients after disease onset and in the months that follow. New automated closed-loop insulin delivery systems (SADI) have proven effective in drastically reducing the number of hypoglycemic and hyperglycemic episodes and glycemic variability in children with type 1 diabetes as young as 2 years old.English translation Although these treatments can be used from 2 years of age in patients who do not achieve their glycemic targets, their use from the time of diagnosis is not yet widely endorsed by scientific societies. Consequently, the use of these treatments in the weeks following diagnosis varies from one center to another and is often left to the prescribing physician's discretion. However, changes in recommendations from scientific societies, the current organization of healthcare in France, and the expertise developed by most pediatric teams are enabling patients to access these treatments increasingly soon after diagnosis, sometimes within days of diagnosis.

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)
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

Eligibility criteria

Inclusion Criteria: * 5 to 8 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

Conditions

Diabetes

Locations

Hôpital Universitaire Necker Enfants Malades — Paris, France

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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