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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01EY033233-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Eye Institute (NEI) | NIH |
| Juvenile Diabetes Research Foundation | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diabetic Retinopathy Exam at the point of care | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Point of Care Autonomous AI diabetic retinopathy exam | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion screened for diabetic retinopathy | Equivalence in proportion screened for diabetic retinopathy of white and non-white youth with autonomous AI | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of agreement in interpretation of retinal images | Agreement in interpretation of retinal images between autonomous AI and consensus grading by ophthalmologists | Day 1 |
| Sensitivity of autonomous AI vs. prognostic standard |
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Inclusion Criteria:
Meets American Diabetes Association (ADA) criteria for diabetic retinopathy screening:
Enriched cohort:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Risa M Wolf, MD | Contact | 4109556463 | RWolf@jhu.edu | |
| Alvin Liu, MD | Contact | tliu25@jhmi.edu |
| Name | Affiliation | Role |
|---|---|---|
| Risa M Wolf, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Pediatric Diabetes Center | Recruiting | Baltimore | Maryland | 21287 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32126819 | Background | 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. | |
| 34042939 | Background | 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. |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003924 | Diabetes Mellitus, Type 2 |
| D003930 | Diabetic Retinopathy |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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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.
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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 | 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 | Proportion of participants with diabetic retinopathy, including none, mild, moderate or severe DR. | Day 1 |
| 32880616 | Background | 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. |
| 33479160 | Background | 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. |
| 32410329 | Background | 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. |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |