Following children and young adults with autism who use intranasal insulin
Observes people with autism already using insulin nasal spray, tracking symptoms and side effects.
Plain-language title generated from the registry record
Registry title: Intranasal Insulin for Autism Spectrum Disorder in Children and Young Adults Aged 4 to 21 Years
Key facts
- Where
- Spring, United StatesSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 4 and 21 years old?
Source: NCT07521371, who can take part
Where in United States
- Healing Hope InternationalSpring, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Healing Hope International
- Trial code
- NCT07521371
- Record updated
- 9 April 2026
- Original description
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.Read full original descriptionShow less
Observational Study of Intranasal Insulin Delivery in Autism Spectrum Disorder Ages 4 to 21 Years (INS-AUT)
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.
Inclusion: 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: Use of investigational drugs or participation in an interventional clinical trial within 30 days prior to enrollment; Known diagnosis of diabetes mellitus requiring insulin for glycemic control; History of recurrent hypoglycemia or clinically significant risk of hypoglycemia; Known hypersensitivity or adverse reaction to insulin; Significant uncontrolled medical conditions that, in the opinion of the investigator, would interfere with participation or data interpretation; Any condition that would prevent reliable participation in study assessments, including inability of caregiver to complete questionnaires.