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NCT06461065Recruiting

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

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

Source: ClinicalTrials.gov · Last updated 7 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
50 (estimated)
First submitted
31 May 2024
Start date
20 Feb 2025
Primary completion date
20 Mar 2030
Lead sponsor
Assistance Publique - Hôpitaux de Paris
NCT number
NCT06461065

What you commit to

  • Study type: Interventional
  • Planned participants: 50
  • From 20 Feb 2025 to the primary completion date, 20 Mar 2030
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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

Age

  • Refusal to participate by a minor after information adapted to his/her age and abilities

Other

  • 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

Who the study is looking for

  • 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

Age in the registry: 5 years to 8 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hôpital Universitaire Necker Enfants Malades
Coordinator of this site? Confirm its status
ParisFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.