RECRUITINGINTERVENTIONAL
ACCESS 2: AI for pediatriC diabetiC Eye examS Study 2
Implementing Digital Retinal Exams Into Comprehensive Pediatric Diabetes Care
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.
Who May Be Eligible (Plain English)
Who May Qualify:
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.
Who Should NOT Join This Trial:
- Known diabetic eye exam in the last 12 months
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DIAGNOSTIC_TEST
Point of Care Autonomous AI diabetic retinopathy exam
Participants will undergo point-of-care diabetic retinopathy screening using autonomous artificial intelligence software to interpret retinal images taken with a non-mydriatic fundus camera and providing an immediate result.
Locations (1)
Johns Hopkins Pediatric Diabetes Center
Baltimore, Maryland, United States