Intranasal Insulin for Autism Spectrum Disorder in Children and Young Adults Aged 4 to 21 Years

This is a prospective, single arm observational cohort study designed to evaluate the real world use of intranasal insulin in children and young adults diagnosed with autism spectrum disorder (ASD). Intranasal insulin represents an off label route of administration of an FDA approved medication. In this study, insulin is prescribed and managed independently by participants' treating healthcare providers as part of routine clinical care. The study does not assign, provide, or direct treatment, dosing, or route of administration. All clinical decisions are made outside of the study. The purpose of this study is to collect real world evidence (RWE) on the safety, tolerability, and potential clinical associations of intranasal insulin use in individuals with ASD. Insulin signaling in the central nervous system has been associated with neurodevelopment, synaptic plasticity, and cognitive function. Intranasal delivery may facilitate transport to the brain via olfactory and trigeminal pathways, and early studies suggest possible associations with changes in social communication and behavioral outcomes. Approximately 12 participants ages 4 to 21 years who are receiving or planning to receive intranasal insulin as part of their clinical care will be enrolled and followed prospectively for approximately 6 months. Data will be collected at baseline, during ongoing use, and at follow-up intervals. Outcome measures will include caregiver reported assessments of social communication, behavior, adaptive functioning, and overall developmental progress. Safety monitoring will include documentation of adverse events, tolerability, and any clinically relevant observations reported by caregivers or healthcare providers. This study is observational in nature and does not involve the prospective assignment of any intervention. The study team does not provide insulin or any delivery device. Participation in this study does not influence clinical care. The goal of this study is to generate real world data to better understand the safety profile and potential clinical associations of intranasal insulin use in ASD and to inform future clinical research.