ACCESS: AI for pediatriC diabetiC Eye examS Study

Study Overview
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Brief Summary
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The purpose of this study is to determine if providing in clinic point-of-care autonomous AI diabetic retinopathy exams improves screening rates compared to standard of care referral to an eye care provider, in a randomized control trial in a racially and ethnically diverse cohort of youth.

Detailed Description
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This study will recruit 164 individuals ages 8-21 with type 1 and type 2 diabetes. Participants will be randomized to usual care (referral to an eye care provider for a dilated eye exam) or the intervention arm and undergo a point-of-care diabetic eye exam using autonomous AI software on a non-mydriatic fundus camera. Participants in the intervention group will receive the diabetic eye exam results immediately from the autonomous AI system, and if abnormal will be referred to an eye care provider for a dilated eye exam. Participants in the standard of care group will have 6 months to complete the diabetic eye exam.

Official Title
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Autonomous AI for Diabetic Retinopathy Screening in Youth (AI-DR): A Randomized Control Trial

Conditions
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Type 1 Diabetes, Type 2 Diabetes

Intervention / Treatment
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* Diagnostic Test: Point of Care Autonomous AI diabetic retinopathy exam


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Meets American Diabetes Association (ADA) criteria for diabetic retinopathy screening: Diagnosis of Type 1 diabetes for ≥3 years, and age 11 or in puberty Diagnosis of Type 2 diabetes Exclusion Criteria: Diabetic eye exam within the last 6 months Known diabetic retinopathy

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Control Arm - Standard of care referral to an eye care provider + Educational Reinforcement Intervention Arm - Point of Care Diabetic Retinopathy screening using Autonomous artificial intelligence on a non-mydriatic fundus camera
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual care with educational reinforcement<br>Standard of care referral to Eye Care Provider (ECP) for the diabetic eye exam with educational reinforcement | |
| Experimental: Diabetic Retinopathy Exam<br>Point of care (POC) Diabetic Retinopathy Exam using Autonomous AI on non-mydriatic fundus camera | Diagnostic Test: Point of Care Autonomous AI diabetic retinopathy exam<br>* Participants will get a point of care diabetic retinopathy eye exam using autonomous AI. Those that test positive will be referred to Eye Care Provider for dilated eye exam.<br>* Other names: IDx-DR;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Get Screened With a Diabetic Eye Exam | The number of participants who get screened with a diabetic eye exam will be assessed for the AI group and the standard of care group referral to an eye care provider (ECP). | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Follow-up Rates With an Eye Care Provider | The number of patients that follow-up with an eye care provider (ECP), for participants in the standard of care group referred to ECP, and for participants in the AI group with an abnormal exam result that are then referred to the ECP for a dilated eye exam. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic Retinopathy