Using AI for diabetic eye exams in underserved youth
Official title: Implementing Digital Retinal Exams Into Comprehensive Pediatric Diabetes Care
Run by Johns Hopkins University · NCT05463289 · Data updated 2026-11-12
This study is testing if a new AI tool can quickly and accurately check the eyes of young people with diabetes for problems, so they can get the right care if needed.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 8 Years to 21 Years |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Status | Recruiting |
| Started | July 11, 2022 |
| Main results expected | December 30, 2026 |
| Study ends | December 30, 2026 |
| Registry record updated | September 23, 2026 |
| Trial ID | NCT05463289 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are youth aged 8-21 with a diagnosis of type 1 or type 2 diabetes who meet specific screening criteria.
✕Probably not a fit
Patients who have had a diabetic eye exam in the last 12 months will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to evaluate the effectiveness of a non-mydriatic fundus camera equipped with autonomous artificial intelligence software to screen underserved youth aged 8-21 for diabetic retinopathy. By recruiting 500 participants with type 1 and type 2 diabetes, the study will provide immediate results from the AI system and refer those with abnormal findings to eye care providers for further evaluation. The AI's interpretations will be compared to assessments made by retinal specialists to assess accuracy and agreement.
Why it matters
Potential benefit: If successful, this approach could significantly increase screening rates for diabetic retinopathy among underserved youth with diabetes.
How similar studies have gone: Other studies have shown promise in using AI for diabetic retinopathy screening, indicating potential success for this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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 Enriched cohort: * Patients with Type 1 or Type 2 diabetes, * 8-21 years of age with known diabetic retinopathy (true positives). * No time limit on last diabetic eye exam. Exclusion Criteria: * Known diabetic eye exam in the last 12 months
Where it's running
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Johns Hopkins Pediatric Diabetes Center
Baltimore, Maryland, United States Recruiting
Study contacts
- Principal investigator: Risa M Wolf, MD — Johns Hopkins University
- Study coordinator: Risa M Wolf, MD
- Email: RWolf@jhu.edu
- Phone: 4109556463
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.