Implementing Digital Retinal Exams Into Comprehensive Pediatric Diabetes Care
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Johns Hopkins University
- Enrollment
- 500
- Locations
- 2
- Primary Endpoint
- Proportion screened for diabetic retinopathy
Study Overview
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.
Detailed Description
This study will recruit up to 500 individuals ages 8-21 with type 1 or type 2 diabetes. In this study, participants will undergo a point-of-care diabetic eye exam using autonomous AI software on a non-mydriatic fundus camera. Participants will receive the diabetic eye exam results immediately from the autonomous AI system, and if abnormal will be referred to an eye care provider for a dilated eye exam.
In the AI for ChildrenS Diabetic Eye ExamS Study (ACCESS2), 398 participants will be enrolled to determine if point of care autonomous AI increases the proportion of minority and underserved youth screened for diabetic retinopathy. The autonomous AI interpretation will also be compared to consensus grading of retinal specialists to determine if there is agreement and to determine the diagnostic accuracy of the system in youth.
A cohort of youth with known diabetic retinopathy (true positives) will also be enrolled as an enriched population to determine the diagnostic accuracy of autonomous AI compared to the prognostic standard interpretation of a central reading center.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Screening
- Masking
- None
Masking Description
All participants will undergo point-of-care diabetic retinopathy screening. Participants will know that they will undergo point-of-care diabetic retinopathy screening at the time of consenting.
Eligibility Criteria
- Ages
- 8 Years to 21 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Diabetic Retinopathy Exam at the point of care
Participants will undergo a point of care diabetic retinopathy eye exam using autonomous AI. Those that test positive will be referred to Eye Care Provider for dilated eye exam.
Intervention: Point of Care Autonomous AI diabetic retinopathy exam (Diagnostic Test)
Outcomes
Primary Outcomes
Proportion screened for diabetic retinopathy
Time Frame: Day 1
Equivalence in proportion screened for diabetic retinopathy of white and non-white youth with autonomous AI
Secondary Outcomes
- Percentage of agreement in interpretation of retinal images(Day 1)
- Sensitivity of autonomous AI vs. prognostic standard(Day 1)
- Specificity of autonomous AI vs. prognostic standard(Day 1)
- Proportion with diabetic retinopathy(Day 1)