Back to resultsACCESS 2: AI for pediatriC diabetiC Eye examS Study 2 (ACCESS2)
Primary Purpose
Type 1 Diabetes, Type 2 Diabetes, Cystic Fibrosis-related Diabetes
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Point of Care Autonomous AI diabetic retinopathy exam
Sponsored by
About this trial
This is an interventional screening trial for Type 1 Diabetes focused on measuring Diabetic Retinopathy
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:
- Known diabetic eye exam in the last 12 months
Sites / Locations
- Johns Hopkins Pediatric Diabetes CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Diabetic Retinopathy Exam at the point of care
Arm Description
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.
Outcomes
Primary Outcome Measures
Proportion screened for diabetic retinopathy
Equivalence in proportion screened for diabetic retinopathy of white and non-white youth with autonomous AI
Secondary Outcome Measures
Percentage of agreement in interpretation of retinal images
Agreement in interpretation of retinal images between autonomous AI and consensus grading by ophthalmologists
Diagnostic Accuracy
Sensitivity, specificity and diagnosability of autonomous AI in detecting diabetic retinopathy in youth compared to the prognostic standard
Full Information
NCT ID
NCT05463289
First Posted
July 14, 2022
Last Updated
April 24, 2023
Sponsor
Johns Hopkins University
Collaborators
National Eye Institute (NEI), Juvenile Diabetes Research Foundation
1. Study Identification
Unique Protocol Identification Number
NCT05463289
Brief Title
ACCESS 2: AI for pediatriC diabetiC Eye examS Study 2
Acronym
ACCESS2
Official Title
Implementing Digital Retinal Exams Into Comprehensive Pediatric Diabetes Care
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 11, 2022 (Actual)
Primary Completion Date
May 15, 2024 (Anticipated)
Study Completion Date
May 15, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Eye Institute (NEI), Juvenile Diabetes Research Foundation
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 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.
Detailed Description
This study will recruit 500 individuals ages 8-21 with type 1 and type 2 diabetes. 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. The autonomous AI interpretation will also be compared to consensus grading of retinal specialists to determine if there is agreement.
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, Cystic Fibrosis-related Diabetes
Keywords
Diabetic Retinopathy
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
All participants will undergo point-of-care diabetic retinopathy screening. Participants will know that they will undergo point-of-care diabetic retinopathy screening at the time of consenting.
Allocation
N/A
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Diabetic Retinopathy Exam at the point of care
Arm Type
Other
Arm Description
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.
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 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.
Primary Outcome Measure Information:
Title
Proportion screened for diabetic retinopathy
Description
Equivalence in proportion screened for diabetic retinopathy of white and non-white youth with autonomous AI
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Percentage of agreement in interpretation of retinal images
Description
Agreement in interpretation of retinal images between autonomous AI and consensus grading by ophthalmologists
Time Frame
2 years
Title
Diagnostic Accuracy
Description
Sensitivity, specificity and diagnosability of autonomous AI in detecting diabetic retinopathy in youth compared to the prognostic standard
Time Frame
Day 1
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:
Known diabetic eye exam in the last 12 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Risa M Wolf, MD
Phone
4109556463
Email
RWolf@jhu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Alvin Liu, MD
Email
tliu25@jhmi.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Risa M 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
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Risa M Wolf, MD
Phone
410-955-6463
Email
rwolf@jhu.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32126819
Citation
Channa R, Wolf R, Abramoff MD. Autonomous Artificial Intelligence in Diabetic Retinopathy: From Algorithm to Clinical Application. J Diabetes Sci Technol. 2021 May;15(3):695-698. doi: 10.1177/1932296820909900. Epub 2020 Mar 4.
Results Reference
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PubMed Identifier
34042939
Citation
Thomas CG, Channa R, Prichett L, Liu TYA, Abramoff MD, Wolf RM. Racial/Ethnic Disparities and Barriers to Diabetic Retinopathy Screening in Youths. JAMA Ophthalmol. 2021 Jul 1;139(7):791-795. doi: 10.1001/jamaophthalmol.2021.1551.
Results Reference
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PubMed Identifier
32880616
Citation
Wolf RM, Channa R, Abramoff MD, Lehmann HP. Cost-effectiveness of Autonomous Point-of-Care Diabetic Retinopathy Screening for Pediatric Patients With Diabetes. JAMA Ophthalmol. 2020 Oct 1;138(10):1063-1069. doi: 10.1001/jamaophthalmol.2020.3190.
Results Reference
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PubMed Identifier
33479160
Citation
Wolf RM, Liu TYA, Thomas C, Prichett L, Zimmer-Galler I, Smith K, Abramoff MD, Channa R. The SEE Study: Safety, Efficacy, and Equity of Implementing Autonomous Artificial Intelligence for Diagnosing Diabetic Retinopathy in Youth. Diabetes Care. 2021 Mar;44(3):781-787. doi: 10.2337/dc20-1671. Epub 2021 Jan 21.
Results Reference
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PubMed Identifier
32410329
Citation
Porter M, Channa R, Wagner J, Prichett L, Liu TYA, Wolf RM. Prevalence of diabetic retinopathy in children and adolescents at an urban tertiary eye care center. Pediatr Diabetes. 2020 Aug;21(5):856-862. doi: 10.1111/pedi.13037. Epub 2020 May 31.
Results Reference
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Learn more about this trial
ACCESS 2: AI for pediatriC diabetiC Eye examS Study 2
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