NCT05463289 ACCESS 2: AI for pediatriC diabetiC Eye examS Study 2
| NCT ID | NCT05463289 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Johns Hopkins University |
| Condition | Type 1 Diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 500 participants |
| Start Date | 2022-07-11 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 500 participants in total. It began in 2022-07-11 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Risa M Wolf, MD
PRINCIPAL INVESTIGATOR
Johns Hopkins University
Frequently Asked Questions
Who can join the NCT05463289 clinical trial?
This trial is open to participants of all sexes, aged 8 Years or older, up to 21 Years, studying Type 1 Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05463289 currently recruiting?
Yes, NCT05463289 is actively recruiting participants. Contact the research team at RWolf@jhu.edu for enrollment information.
Where is the NCT05463289 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT05463289 clinical trial?
NCT05463289 is sponsored by Johns Hopkins University. The principal investigator is Risa M Wolf, MD at Johns Hopkins University. The trial plans to enroll 500 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.