ACCESS 2: AI for pediatriC diabetiC Eye examS Study 2

Not Applicable

Recruiting

• Conditions: Type 1 Diabetes; Type 2 Diabetes; Cystic Fibrosis-related Diabetes
• Interventions: Diagnostic Test: Point of Care Autonomous AI diabetic retinopathy exam

• Registration Number: NCT05463289
• Lead Sponsor: Johns Hopkins University

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.

Detailed Description

This study will recruit 500 individuals ages 8-21 with type 1 and type 2 diabetes. 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. The autonomous AI interpretation will also be compared to consensus grading of retinal specialists to determine if there is agreement.

Study Timeline

• Study Start: 2022-07-11
• Study First Submitted: 2022-07-14
• Study First Submitted QC: 2022-07-14
• Study First Posted: 2022-07-18
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-13
• Last Update Posted: 2025-02-14
• Primary Completion: 2025-05-28
• Study Completion: 2025-05-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

Exclusion Criteria

• Known diabetic eye exam in the last 12 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diabetic Retinopathy Exam at the point of care	Point of Care Autonomous AI diabetic retinopathy exam	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.

Primary Outcome Measures

Name	Time	Method
Proportion screened for diabetic retinopathy	2 years	Equivalence in proportion screened for diabetic retinopathy of white and non-white youth with autonomous AI

Secondary Outcome Measures

Name	Time	Method
Diagnostic Accuracy	Day 1	Sensitivity, specificity and diagnosability of autonomous AI in detecting diabetic retinopathy in youth compared to the prognostic standard
Percentage of agreement in interpretation of retinal images	2 years	Agreement in interpretation of retinal images between autonomous AI and consensus grading by ophthalmologists

Trial Locations

Locations (1)

Johns Hopkins Pediatric Diabetes Center; 🇺🇸 Baltimore, Maryland, United States