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NCT05463289
ACCESS 2: AI for pediatriC diabetiC Eye examS Study 2
Conditions: Type 1 Diabetes, Type 2 Diabetes, Cystic Fibrosis-related Diabetes
Sex: All
Ages: 8 Years – 21 Years
Healthy volunteers: No
Phase: NA
Enrollment: 500
Sponsor: Johns Hopkins University
Location: Johns Hopkins Pediatric Diabetes Center Baltimore Maryland
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
Source: ClinicalTrials.gov (NCT05463289). StuddyBuddy aggregates publicly available trial information.
