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RECRUITING
NCT06461065
NA

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

View on ClinicalTrials.gov

Summary

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.

Official title: Assessment of Children's Neurodevelopmental Trajectories Based on Glycemic Profile Associated With Early Treatment Using an Automated Insulin Delivery System in Children With Type 1 Diabetes (T1D) - PROCEDE: A Pilot Study

Key Details

Gender

All

Age Range

5 Years - 8 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2025-02-20

Completion Date

2030-03-20

Last Updated

2026-10-07

Healthy Volunteers

Yes

Conditions

Interventions

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

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

Locations (1)

Hôpital Universitaire Necker Enfants Malades

Paris, France