Healing Hope International
This observational study evaluates the real-world use of intranasal insulin in children and young adults with autism spectrum disorder (ASD) utilizing the ViaNase™ device developed by Kurve Therapeutics. Intranasal insulin represents an off label use of an FDA approved medication and is prescribed by participants' treating healthcare providers as part of routine clinical care. Insulin is a hormone involved in cerebral energy metabolism and may play a role in cognitive processes such as learning, memory, and behavior. Emerging research suggests that intranasal delivery using specialized delivery systems such as ViaNase™ may facilitate transport along olfactory and trigeminal pathways, potentially allowing insulin to reach central nervous system targets. This delivery approach has been associated in early studies with changes in social communication and functional outcomes in individuals with neurodevelopmental conditions. This study will follow approximately 12 participants between the ages of 4 and 21 years who are already receiving, or planning to receive, intranasal insulin as part of their standard clinical care using the ViaNase™ device. This is a non-interventional observational study; no treatment is assigned or provided by the study team. Participants will be monitored over an approximate 6-month period for changes in autism-related symptoms, including social interaction, communication, repetitive behaviors, and overall functional development. In addition, safety data will be collected, including tolerability and any reported adverse events. The primary objective of this study is to generate real-world evidence to better characterize the safety profile and potential functional effects of intranasal insulin delivered via ViaNase™ in individuals with ASD, and to inform the design of future controlled clinical investigations.
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 purpos…
Inclusion Criteria: * Age 4 to 21 years * Clinical diagnosis of autism spectrum disorder (ASD) documented by a qualified healthcare provider * Currently using or planning to use intranasal insulin as prescribed by a treating healthcare provider as part of routine clinical care * Stable medical and behavioral therapy regimen for at least 4 weeks prior to baseline (if applicable) * Caregiver or parent/guardian able to provide informed consent and complete study related assessments * Willingness to participate in observational data collection over approximately 6 months Exclusion Criteria: * K…