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

Primary Purpose

Type 1 Diabetes, Type 2 Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Point of Care Autonomous AI diabetic retinopathy exam
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Type 1 Diabetes focused on measuring Diabetic Retinopathy

Eligibility Criteria

8 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Johns Hopkins Pediatric Diabetes Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual care with educational reinforcement

Diabetic Retinopathy Exam

Arm Description

Standard of care referral to Eye Care Provider (ECP) for the diabetic eye exam with educational reinforcement

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

Outcomes

Primary Outcome Measures

Proportion of participants who get screened with a diabetic eye exam
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

Follow-up rates with an eye care provider
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.

Full Information

First Posted
November 11, 2021
Last Updated
April 27, 2023
Sponsor
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT05131451
Brief Title
ACCESS: AI for pediatriC diabetiC Eye examS Study
Acronym
ACCESS
Official Title
Autonomous AI for Diabetic Retinopathy Screening in Youth (AI-DR): A Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
November 24, 2021 (Actual)
Primary Completion Date
December 6, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes, Type 2 Diabetes
Keywords
Diabetic Retinopathy

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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 camera
Masking
None (Open Label)
Masking Description
Participants are masked to the study arms until after randomization
Allocation
Randomized
Enrollment
164 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual care with educational reinforcement
Arm Type
No Intervention
Arm Description
Standard of care referral to Eye Care Provider (ECP) for the diabetic eye exam with educational reinforcement
Arm Title
Diabetic Retinopathy Exam
Arm Type
Experimental
Arm Description
Point of care (POC) Diabetic Retinopathy Exam using Autonomous AI on non-mydriatic fundus camera
Intervention Type
Diagnostic Test
Intervention Name(s)
Point of Care Autonomous AI diabetic retinopathy exam
Other Intervention Name(s)
IDx-DR
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of participants who get screened with a diabetic eye exam
Description
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).
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Follow-up rates with an eye care provider
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Risa Wolf, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Pediatric Diabetes Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

ACCESS: AI for pediatriC diabetiC Eye examS Study

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