ACCESS 2: AI for pediatriC diabetiC Eye examS Study 2 (ACCESS2)

March 25, 2026 updated by: Johns Hopkins University

Implementing Digital Retinal Exams Into Comprehensive Pediatric Diabetes Care

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, and to determine the diagnostic accuracy of the autonomous AI system in detecting diabetic retinopathy from retinal images of youth with diabetes.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study will recruit up to 500 individuals ages 8-21 with type 1 or type 2 diabetes. In this study, 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.

In the AI for ChildrenS Diabetic Eye ExamS Study (ACCESS2), 398 participants will be enrolled to determine if point of care autonomous AI increases the proportion of minority and underserved youth screened for diabetic retinopathy. The autonomous AI interpretation will also be compared to consensus grading of retinal specialists to determine if there is agreement and to determine the diagnostic accuracy of the system in youth.

A cohort of youth with known diabetic retinopathy (true positives) will also be enrolled as an enriched population to determine the diagnostic accuracy of autonomous AI compared to the prognostic standard interpretation of a central reading center.

Study Type

Interventional

Enrollment (Estimated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Risa M Wolf, MD
  • Phone Number: 4109556463
  • Email: RWolf@jhu.edu

Study Contact Backup

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins Pediatric Diabetes Center
        • Contact:
          • Risa M Wolf, MD
          • Phone Number: 410-955-6463
          • Email: rwolf@jhu.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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

Enriched cohort:

  • Patients with Type 1 or Type 2 diabetes,
  • 8-21 years of age with known diabetic retinopathy (true positives).
  • No time limit on last diabetic eye exam.

Exclusion Criteria:

  • Known diabetic eye exam in the last 12 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Diabetic Retinopathy Exam at the point of care
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.
Diagnostic test: Point of Care Autonomous AI diabetic retinopathy exam
Participants will undergo point-of-care diabetic retinopathy screening using autonomous artificial intelligence software to interpret retinal images taken with a non-mydriatic fundus camera and providing an immediate result.
Other Names:
  • IDx-DR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion screened for diabetic retinopathy
Time Frame: Day 1
Equivalence in proportion screened for diabetic retinopathy of white and non-white youth with autonomous AI
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of agreement in interpretation of retinal images
Time Frame: Day 1
Agreement in interpretation of retinal images between autonomous AI and consensus grading by ophthalmologists
Day 1
Sensitivity of autonomous AI vs. prognostic standard
Time Frame: Day 1
Sensitivity of autonomous AI in detecting diabetic retinopathy in youth compared to the prognostic standard. This will be analyzed in the ACCESS2 trial cohort alone, and also in the ACCESS2 trial cohort with the enriched cohort of youth with known diabetic retinopathy.
Day 1
Specificity of autonomous AI vs. prognostic standard
Time Frame: Day 1
Specificity of autonomous AI in detecting diabetic retinopathy in youth compared to the prognostic standard. This will be analyzed in the ACCESS2 trial cohort alone, and also in the ACCESS2 trial cohort with the enriched cohort of youth with known diabetic retinopathy.
Day 1
Proportion with diabetic retinopathy
Time Frame: Day 1
Proportion of participants with diabetic retinopathy, including none, mild, moderate or severe DR.
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

Juvenile Diabetes Research Foundation
National Eye Institute (NEI)

Investigators

  • Principal Investigator: Risa M Wolf, MD, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 11, 2022

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

July 14, 2022

First Submitted That Met QC Criteria

July 14, 2022

First Posted (Actual)

July 18, 2022

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 25, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00180692
  • 1R01EY033233-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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