NCT05463289Recruiting
ACCESS 2: AI for pediatriC diabetiC Eye examS Study 2
Implementing Digital Retinal Exams Into Comprehensive Pediatric Diabetes Care
Source: ClinicalTrials.gov · Last updated 23 Sept 2026
Brief summary (registry, in English)
The purpose of this study is to determine if use of a nonmydriatic fundus camera using autonomous artificial intelligence software at the point of care increases the proportion of underserved youth with diabetes screened for diabetic retinopathy, and to determine the diagnostic accuracy of the autonomous AI system in detecting diabetic retinopathy from retinal images of youth with diabetes.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 500 (estimated)
- First submitted
- 14 Jul 2022
- Start date
- Jul 2022
- Primary completion date
- Dec 2026
- Lead sponsor
- Johns Hopkins University
- NCT number
- NCT05463289
What you commit to
- Study type: Interventional
- Planned participants: 500
- From Jul 2022 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Known diabetic eye exam in the last 12 months
Who the study is looking for
- 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.
Age in the registry: 8 years to 21 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Johns Hopkins Pediatric Diabetes Center Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.