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ACCESS: AI for pediatriC diabetiC Eye examS Study

Sponsor
Johns Hopkins University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05131451
Collaborator
(none)
164
Enrollment
1
Location
2
Arms
13.2
Anticipated Duration (Months)
12.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Point of Care Autonomous AI diabetic retinopathy exam
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
164 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Control Arm - Standard of care referral to an eye care provider + Educational Reinforcement Intervention Arm - Point of Care Diabetic Retinopathy screening using Autonomous artificial intelligence on a non-mydriatic fundus cameraControl Arm - Standard of care referral to an eye care provider + Educational Reinforcement Intervention Arm - Point of Care Diabetic Retinopathy screening using Autonomous artificial intelligence on a non-mydriatic fundus camera
Masking:
None (Open Label)
Masking Description:
Participants are masked to the study arms until after randomization
Primary Purpose:
Screening
Official Title:
Autonomous AI for Diabetic Retinopathy Screening in Youth (AI-DR): A Randomized Control Trial
Actual Study Start Date :
Nov 24, 2021
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Usual care with educational reinforcement

Standard of care referral to Eye Care Provider (ECP) for the diabetic eye exam with educational reinforcement
Experimental: Diabetic Retinopathy Exam

Point of care (POC) Diabetic Retinopathy Exam using Autonomous AI on non-mydriatic fundus camera

Diagnostic Test: Point of Care Autonomous AI diabetic retinopathy exam
Participants will get 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.
Other Names:
  • IDx-DR

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of participants who get screened with a diabetic eye exam [6 months]

      The proportion 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).

    Secondary Outcome Measures

    1. Follow-up rates with an eye care provider [6 months]

      The proportion that follow-up with an eye care provider (ECP), for participants in the standard of care group referred to ECP, and for participants in the AI group with an abnormal exam result that are then referred to the ECP for a dilated eye exam.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    8 Years to 21 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Johns Hopkins Pediatric Diabetes Center Baltimore Maryland United States 21287

    Sponsors and Collaborators

    • Johns Hopkins University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Johns Hopkins University
    ClinicalTrials.gov Identifier:
    NCT05131451
    Other Study ID Numbers:
    • IRB00288043
    First Posted:
    Nov 23, 2021
    Last Update Posted:
    Aug 2, 2022
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Johns Hopkins University
    Diabetic Retinopathy
    Additional relevant MeSH terms:
    Diabetic Retinopathy
    Diabetes Mellitus

    Study Results

    No Results Posted as of Aug 2, 2022