ACCESS 2: AI for pediatriC diabetiC Eye examS Study 2

Recruiting now · Not applicable

Conditions studied: Type 1 Diabetes, Type 2 Diabetes, Cystic Fibrosis-related Diabetes

In brief

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.

Key facts

Study ID

NCT05463289

Run by

Johns Hopkins University

People needed

500

Starts

2022-07-11

Expected to finish

2026-09-30

Last updated by the study team

2026-07-02

Who can join

Age: 8 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Known diabetic eye exam in the last 12 months

Where it is running

• Johns Hopkins Pediatric Diabetes Center — Baltimore, Maryland, United States (enrolling)

Full record on ClinicalTrials.gov

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