ACCESS 2: AI for pediatriC diabetiC Eye examS Study 2 (ACCESS2)

Johns Hopkins University

Status: Enrolling

Conditions: Cystic Fibrosis-related Diabetes; Type 1 Diabetes; Type 2 Diabetes

Treatments: Diagnostic Test: Point of Care Autonomous AI diabetic retinopathy exam

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05463289

IRB00180692

1R01EY033233-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 8 to 21 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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500 participants in 1 patient group

Diabetic Retinopathy Exam at the point of care

Other group

Description:

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.

Treatment:

Diagnostic Test: Point of Care Autonomous AI diabetic retinopathy exam