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

Study acronym: PROCEDE
StatusRecruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 2 years later Mar 20, 2028 → Mar 20, 2030
Enrollment reduced 17% 60 → 50 participants
See other at-risk trials from Assistance Publique - Hôpitaux de Paris

Record History

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  1. Notable Primary and study completion pushed from Mar 20, 2028 to Mar 20, 2030 Show 6 more changesShow less
    • Enrollment reduced: 60 → 50 participants
    • Trial arms changed: 3 → 2
    • Eligibility criteria expanded, about 18 words
    • Secondary endpoints: details revised at 2 of 7 entries
    • Study description shortened, about 40 words
    • Study title expanded, about 2 words
  2. Notable Trial status: Not Yet Recruiting to Recruitingv2 Show 5 more changesShow less
    • Primary and study completion dates: Sep 15, 2027 to Mar 20, 2028
    • Start date changed from estimate of Sep 15, 2024 to Feb 20, 2025
    • Study sites: 0 to 1
    • Eligibility criteria expanded, about 7 words
    • Study description expanded, about 52 words
  3. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
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.
Trial Details
NCT Number NCT06461065
Lead Sponsor Assistance Publique - Hôpitaux de Paris
Collaborators: Fondation Francophone pour la Recherche sur le Diabete, mylife Diabetes Care AG
Conditions
(from sponsor)
Diabetes
Related terms Diabetes Mellitus
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov