Autonomous AI for Diabetic Retinopathy Screening in Youth (AI-DR): A Randomized Control Trial

Johns Hopkins University1 site in 1 country164 target enrollmentNovember 24, 2021

ConditionsType 1 Diabetes Type 2 Diabetes

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Type 1 Diabetes
Sponsor: Johns Hopkins University
Enrollment: 164
Locations: 1
Primary Endpoint: Number of Participants Who Get Screened With a Diabetic Eye Exam
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to determine if providing in clinic point-of-care autonomous AI diabetic retinopathy exams improves screening rates compared to standard of care referral to an eye care provider, in a randomized control trial in a racially and ethnically diverse cohort of youth.

Detailed Description

This study will recruit 164 individuals ages 8-21 with type 1 and type 2 diabetes. Participants will be randomized to usual care (referral to an eye care provider for a dilated eye exam) or the intervention arm and undergo a point-of-care diabetic eye exam using autonomous AI software on a non-mydriatic fundus camera. Participants in the intervention group 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. Participants in the standard of care group will have 6 months to complete the diabetic eye exam.

Registry

clinicaltrials.gov

Start Date

November 24, 2021

End Date

December 31, 2022

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Johns Hopkins University

Responsible Party

Sponsor

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

Exclusion Criteria

•Diabetic eye exam within the last 6 months
•Known diabetic retinopathy

Outcomes

Primary Outcomes

Number of Participants Who Get Screened With a Diabetic Eye Exam

Time Frame: 6 months

The number of participants who get screened with a diabetic eye exam will be assessed for the AI group and the standard of care group referral to an eye care provider (ECP).