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
- Diseases
- Type 1 diabetes
- 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
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hôpital Universitaire Necker Enfants Malades Coordinator of this site? Confirm its status | Paris | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.