Brain development in children with type 1 diabetes using an automated insulin system
Studies brain development in children with type 1 diabetes using an automated insulin system.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- Paris, FranceSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 5 and 8 years old?
Source: NCT06461065, who can take part
Where in France
- Hôpital Universitaire Necker Enfants MaladesParis, FranceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Assistance Publique - Hôpitaux de Paris
- Trial code
- NCT06461065
- Record updated
- 7 October 2026
- Original 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 translationRead full original descriptionShow less
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
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.
Inclusion: 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: History of neurological disease; History of child psychiatric disease; Severe skin disease preventing the use of an insulin pump sensor or catheter; Uncontrolled celiac disease; Uncontrolled autoimmune thyroiditis; Refusal to participate by a minor after information adapted to his/her age and abilities; Prematurity (birth before 37 SA); Wearing of internal metal parts contraindicating the performance of MRI; Participation in another interventional research study or in the exclusion period thereof.