For children diagnosed between ages four and nine, the transition into constant glucose monitoring, insulin management, and emotional stress is immediate, yet the effects of these early challenges on cognition, learning, and long-term neurologic outcomes are still poorly understood. BRAINY-T1D seeks to address this critical gap.
The study aims to follow each child every three months, looking not only at diabetes management but at the entire ecosystem around them: family functioning, emotional well-being, and most of all, brain health. As Dr. Stephen Hooper, a pediatric neuropsychologist and one of UNC’s lead investigators on the project, explained, the team has built a comprehensive neurocognitive battery, a standardized set of tests of brain function, that evaluates everything from overall intellectual abilities to attention, executive function, memory, social cognition, and processing speed. Each child will complete this battery at enrollment and again eighteen months later, allowing researchers to track how their brains adapt over time. A similar timeframe will be followed for sophisticated brain imagining and various laboratory measures for tracking fluctuating glucose levels.
This study is one-of-a-kind because it goes beyond glucose numbers. Its purpose is to understand how fluctuations in blood sugar and early disease management shape the brain, not just the body.
With the coordinating center based at the University of Minnesota, the goal is ambitious—enrolling 800-900 children from families of all backgrounds. A study of this size naturally comes with challenges. Young children, for example, can be unpredictable, energetic, and sometimes unwilling to complete standardized testing or remain still for a brain scan. UNC and other sites are prepared for this, drawing on experience from infant imaging studies and staffing highly trained professionals who work patiently with children to guide them through assessments. Language can also present obstacles. To ensure Spanish-speaking families are fully included, the team selected tests available in both English and Spanish and has hired bilingual examiners. Despite careful planning, Hooper acknowledges that unexpected challenges are inevitable in a study of this size, and the team has structures in place to address these issues, ensuring that participation remains inclusive and supportive for families.
An important component of BRAINY-T1D at UNC is the Community Advisory Board (CAB), which includes parents of children newly diagnosed with Type 1 Diabetes. The CAB provides guidance on study design, communication, and procedures to ensure that the research addresses questions that matter most to families. Researchers like Jewell play a crucial role on the CAB, offering both professional expertise and personal perspective as a parent. Parents have influenced many aspects of the study, including its name, logo, and how key results from neurocognitive testing are shared with families. By involving families at every step, the study ensures that participation is meaningful, supportive, and responsive to the needs of both children and their caregivers.
Recruitment for BRAINY-T1D is expected to begin in the spring/early summer of 2026, after final IRB approvals across all sites. The study is planned for 5 years and will follow participants for approximately 18 months, capturing their progression of diabetes and the cognitive, neurologic, and psychosocial changes that accompany it over that time period. With a well-established sample across the 11 clinical sites, Hooper explained that once this grant cycle ends, the team aims to apply for follow-up funding to track these children into their adolescence.
Families interested in learning more about BRAINY-T1D at UNC or finding out if their child may be eligible are encouraged to visit the study’s website.