Using AI for diabetic eye exams in underserved youth
Implementing Digital Retinal Exams Into Comprehensive Pediatric Diabetes Care
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 8 Years to 21 Years |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT05463289 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are youth aged 8-21 with a diagnosis of type 1 or type 2 diabetes who meet specific screening criteria.
Not a fit: Patients who have had a diabetic eye exam in the last 12 months will not benefit from this study.
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 performed: Other studies have shown promise in using AI for diabetic retinopathy screening, indicating potential success for this approach.
Eligibility criteria
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 this trial is running
Baltimore, Maryland
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.