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AI-Powered Eye Exam for Diabetes (ACCESS2 Trial)

N/A

Recruiting

Led By Risa M Wolf, MD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if a nonmydriatic fundus camera, which uses autonomous artificial intelligence software, can increase screening for diabetic retinopathy in underserved youth with diabetes.

Who is the study for?

This trial is for young people with Type 1 diabetes for at least 3 years, aged 11 or older and in puberty, or those diagnosed with Type 2 diabetes. It's aimed at helping underserved youth who haven't had a diabetic eye exam in the past year.

What is being tested?

The study tests if an AI-powered camera can help screen more kids with diabetes for eye problems caused by their condition (diabetic retinopathy) when used during regular care visits.

What are the potential side effects?

Since this intervention involves a non-invasive imaging test using a camera, there are no direct side effects associated with medications or invasive procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have had Type 1 diabetes for 3+ years and am at least 11 years old or in puberty.

Select...

I have been diagnosed with Type 2 diabetes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion screened for diabetic retinopathy

Secondary study objectives

Diagnostic Accuracy

Percentage of agreement in interpretation of retinal images

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Diabetic Retinopathy Exam at the point of careExperimental Treatment1 Intervention

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

First Studied

Drug Approval Stage

How many patients have taken this drug

Point of Care Autonomous AI diabetic retinopathy exam

2021

N/A

~170

0 / 2Eligibility criteria met