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AI-Powered Eye Exam for Diabetes (ACCESS2 Trial)

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
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group

ACCESS2 Trial 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.Check my eligibility
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.See study design
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.

ACCESS2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
I have had Type 1 diabetes for 3+ years and am at least 11 years old or in puberty.
I have been diagnosed with Type 2 diabetes.

ACCESS2 Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion screened for diabetic retinopathy
Secondary outcome measures
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.

ACCESS2 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.
First Studied
Drug Approval Stage
How many patients have taken this drug
Point of Care Autonomous AI diabetic retinopathy exam

Find a Location

Who is running the clinical trial?

Juvenile Diabetes Research FoundationOTHER
227 Previous Clinical Trials
110,190 Total Patients Enrolled
Johns Hopkins UniversityLead Sponsor
2,225 Previous Clinical Trials
14,811,299 Total Patients Enrolled
National Eye Institute (NEI)NIH
542 Previous Clinical Trials
1,299,823 Total Patients Enrolled

Media Library

Diabetic Retinopathy Exam at the point of care Clinical Trial Eligibility Overview. Trial Name: NCT05463289 — N/A
Type 2 Diabetes Research Study Groups: Diabetic Retinopathy Exam at the point of care
Type 2 Diabetes Clinical Trial 2023: Diabetic Retinopathy Exam at the point of care Highlights & Side Effects. Trial Name: NCT05463289 — N/A
Diabetic Retinopathy Exam at the point of care 2023 Treatment Timeline for Medical Study. Trial Name: NCT05463289 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies still remaining for this particular experiment?

"According to clinicaltrials.gov, this medical trial has been open for recruitment since July 11th of 2022 and was recently updated on the 14th."

Answered by AI

Does your research protocol incorporate participants who are 25 and older?

"Patients aged 8 to 21 are eligible for inclusion in this trial, as outlined by the predetermined eligibility criteria."

Answered by AI

To whom is eligibility for this clinical research extended?

"This investigation is enrolling 500 patients aged 8 to 21 with type 2 diabetes mellitus. The main requirements for participants are a diagnosis of Type 1 diabetes lasting at least 3 years and age 11 or beyond, as well as being diagnosed with Type 2 Diabetes."

Answered by AI

How many participants are currently being accepted into this research program?

"Affirmative. According to clinicaltrials.gov, the trial posted on July 11th 2022 is actively recruiting participants. 500 patients are expected at a single medical facility for the duration of this research study."

Answered by AI
Recent research and studies
~45 spots leftby May 2024