Abstract
Background
Type 1 diabetes mellitus (T1D) is increasingly recognised to affect neurodevelopmental, cognitive and psychological functioning in children and young adults. Existing studies have largely evaluated biological, cognitive and psychological domains separately, and neuropsychological approaches suitable for multilingual and resource-constrained settings remain limited. This paper describes the MIND-T1D protocol, a culturally sensitive, clinically feasible, family-centred assessment framework for Indian children and young adults with T1D. The protocol addresses language-related barriers and educational variability by incorporating neuropsychological assessments and integrating child, parent and biological assessments within a single framework.
Methods and analysis
MIND-T1D is a cross-sectional analytical study conducted at a tertiary diabetes centre in Western India. Individuals aged 10–21 years with T1D (n=264) and healthy sibling controls (n=132) frequency matched by age group will be recruited. The protocol integrates neuropsychological assessment, behavioural and emotional evaluation, health-related quality of life, parental psychological assessment, glycated haemoglobin (HbA1c) and brain-derived neurotrophic factor (BDNF) estimation. Neuropsychological measures are organised in a structured sequence to maintain participant engagement and minimise assessment burden. The primary objective is to compare neurocognitive functioning between participants with T1D and healthy sibling controls. Secondary objectives include evaluation of behavioural and emotional functioning, health-related quality of life and parental psychological characteristics. Exploratory objectives include examining associations of HbA1c and serum BDNF levels with neurocognitive and psychological outcomes. Sample size provides approximately 80% power to detect small-to-moderate group differences at a two-sided significance level of 0.05. Statistical analyses will include group comparisons and multivariable regression models adjusting for relevant covariates.
Trial registration number
NCT07164768
.