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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 belowSelect...
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
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
Find a Location
Who is running the clinical trial?
Juvenile Diabetes Research FoundationOTHER
234 Previous Clinical Trials
141,576 Total Patients Enrolled
Johns Hopkins UniversityLead Sponsor
2,323 Previous Clinical Trials
14,873,800 Total Patients Enrolled
National Eye Institute (NEI)NIH
554 Previous Clinical Trials
1,406,832 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had Type 1 diabetes for 3+ years and am at least 11 years old or in puberty.You had an eye exam for diabetes in the past year.I have been diagnosed with Type 2 diabetes.
Research Study Groups:
This trial has the following groups:- Group 1: Diabetic Retinopathy Exam at the point of care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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