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

Condition(s) studied

Investigational drug(s) / intervention(s)

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)

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

Study 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.

Eligibility

Primary outcome measure(s)

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

Trial sites (1)

More Assistance Publique - Hôpitaux de Paris trials in France

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