P-109: Brainy-T1D: brain research alliance in youth with type 1 diabetes; developing a longitudinal study of glycemic exposure and neurocognitive/neuroimaging outcomes in very young children living with T1D
L Di Meglio, L Eberly, E Helgeson, S Ghetti, , BRAINY-T1D Study GroupAbstract
Introduction
Childhood T1D is associated with neurocognitive complications that may worsen with time. Complication risk may be pronounced during early childhood when the brain is especially vulnerable to dysglycemia and other T1D-associated disruptions. Understanding underlying mechanisms is vital.
Objectives
In 2024, the NIH funded 11 U.S. clinical centers and a Biostatistics Research Center to develop a harmonized protocol to: 1) longitudinally evaluate disease-related neurocognitive impact and 2) identify potential clinical, developmental, and environmental factors that exacerbate or protect against neurocognitive difficulties in children with T1D.
Methods
Experts in pediatric endocrinology, neuroimaging, psychology, and biostatistics formed working groups and, together with a Community Advisory Board, developed a scientifically rigorous protocol through collaborative decision-making on aims, outcomes, measures, sample size, and other aspects of the protocol’s design.
Results
The primary aim of the study is to determine if prepubertal children with T1D with greater time in target glucose range, compared to those with less time in target glucose range or no T1D diagnosis, are protected against neurocognitive difficulties. Children within 6 months of diagnosis of T1D (N=600) and a similar comparator group (N=200) will be enrolled along with a primary caregiver. Dyads will be followed for 18 months. The study (anticipated to open July 2026) will assess clinical and laboratory measures; sleep, activity, and glycemia; and medical, medication, and psychosocial factors that might impact neurocognitive and neuroimaging outcomes.
Conclusions
BRAINY-T1D will characterize neurocognitive and clinical aspects of pediatric T1D and elucidate mechanisms associated with neurocognitive perturbations, critical periods for prevention and intervention, and strategies to mitigate complication risk. Accumulated data will inform future interventions to decrease adverse neurodevelopmental outcomes and long-term neurocognitive sequelae of T1D.