ACCESS 2: AI for pediatriC diabetiC Eye examS Study 2
Recruiting
N/A
Interventional Study
Type 1 Diabetes
Type 2 Diabetes
Cystic Fibrosis-related Diabetes
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 8 – 21
- Sex
- Any
- Study type
- Interventional
- Purpose
- Screening
- Participants needed
- 500 (estimated)
- Sponsor
- Johns Hopkins University · Other
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About This Trial
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.
Trial Locations
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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 kno…