Intranasal Insulin for Autism Spectrum Disorder in Children and Young Adults Aged 4 to 21 Years (IN-INS-AUT)

April 3, 2026 updated by: Healing Hope International

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.

Study Overview

Status

Enrolling by invitation

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

12

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Spring, Texas, United States, 77386
        • Healing Hope International

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

This study population includes approximately 12 children and young adults (ages 4 to 21 years) with a clinical diagnosis of autism spectrum disorder (ASD). Participants are individuals who are using or planning to use intranasal insulin as prescribed by their treating healthcare providers as part of routine clinical care. The population represents a real-world sample of individuals with ASD across a range of functional abilities and symptom severity. Caregivers are involved in reporting outcomes related to social communication, behavior, and adaptive functioning. Participants are followed prospectively for approximately 6 months in a non-interventional, observational setting.

Description

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:

  • 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
  • Use of investigational drugs or participation in an interventional clinical trial within 30 days prior to enrollment
  • Any condition that would prevent reliable participation in study assessments, including inability of caregiver to complete questionnaires

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intranasal Insulin Cohort

This single observational cohort includes approximately 12 children and young adults (ages 4 to 21 years) diagnosed with autism spectrum disorder (ASD) who are using or planning to use intranasal insulin as prescribed by their treating healthcare providers as part of routine clinical care.

Intranasal insulin in this study represents off label use of an FDA approved medication. The study does not assign, provide, or direct treatment, dosing, or route of administration. All clinical decisions are made independently by the participant's healthcare provider. Participants are followed prospectively for approximately 6 months in a real world clinical setting. The exposure of interest is the use of intranasal insulin.

Data collection includes assessments of safety and tolerability (including reported adverse events), as well as changes in autism-related outcomes such as social communication, behavior, adaptive functioning, and overall developmental status.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Social Responsiveness Scale, Second Edition (SRS-2) Total Score
Time Frame: Baseline to 6 months
The Social Responsiveness Scale, Second Edition (SRS-2) is a caregiver-reported measure of social communication and autism-related behaviors. Change in total score from baseline to approximately 6 months will be assessed to evaluate changes in social functioning over time in participants using intranasal insulin as part of routine clinical care.
Baseline to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Caregiver Global Impression of Change (CGI-C)
Time Frame: Up to 6 months
Caregivers will report perceived overall changes in the participant's condition over time using a standardized global impression scale.
Up to 6 months
Change in Vineland Adaptive Behavior Scales, Third Edition (Vineland-3)
Time Frame: Baseline to 6 months
The Vineland-3 assesses adaptive functioning across communication, daily living skills, and socialization domains. Changes in standard scores over time will be evaluated to assess functional development.
Baseline to 6 months
Incidence of Adverse Events and Tolerability
Time Frame: Baseline to 6 months
Safety will be assessed by collecting reported adverse events, including nasal irritation, hypoglycemia symptoms, and other clinically relevant observations during routine use of intranasal insulin.
Baseline to 6 months
Change in Repetitive Behaviors and Social Communication (Caregiver Reported)
Time Frame: Baseline to 6 months
Caregiver reported changes in repetitive behaviors, communication, and social interaction will be tracked using structured questionnaires or standardized reporting tools.
Baseline to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Healing Hope International

Collaborators

Kurve Technology Inc.

Investigators

  • Principal Investigator: Glen Cronett, PhD/MD, CMO Kurve Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

January 30, 2030

Study Registration Dates

First Submitted

April 1, 2026

First Submitted That Met QC Criteria

April 3, 2026

First Posted (Actual)

April 9, 2026

Study Record Updates

Last Update Posted (Actual)

April 9, 2026

Last Update Submitted That Met QC Criteria

April 3, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HHI-INS-AUT-OBS-2026-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Individual participant data (IPD) sharing is currently undecided. This observational study involves a small cohort and the collection of sensitive health information, including data from pediatric participants. Any future sharing of IPD will require strict de identification to protect participant privacy and will be subject to applicable regulatory requirements, institutional policies, and informed consent provisions.

There is an intention to share aggregated study results through publications, presentations, and public platforms to contribute to scientific understanding and support future research. Consideration of IPD sharing may occur at a later stage following study completion, data validation, and evaluation of appropriate data use agreements and governance frameworks.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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