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| Name | Class |
|---|---|
| National Eye Institute (NEI) | NIH |
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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 in a racially and ethnically diverse cohort of youth.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual care with educational reinforcement | No Intervention | Standard of care referral to Eye Care Provider (ECP) for the diabetic eye exam with educational reinforcement | |
| Diabetic Retinopathy Exam | Experimental | Point of care (POC) Diabetic Retinopathy Exam using Autonomous AI on non-mydriatic fundus camera |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Point of Care Autonomous AI diabetic retinopathy exam | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Get Screened With a Diabetic Eye Exam | The number 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). | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Follow-up Rates With an Eye Care Provider | The number of patients 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. | 6 months |
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Inclusion Criteria:
Meets American Diabetes Association (ADA) criteria for diabetic retinopathy screening:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Risa Wolf, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Pediatric Diabetes Center | Baltimore | Maryland | 21287 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38212308 | Derived | Wolf RM, Channa R, Liu TYA, Zehra A, Bromberger L, Patel D, Ananthakrishnan A, Brown EA, Prichett L, Lehmann HP, Abramoff MD. Autonomous artificial intelligence increases screening and follow-up for diabetic retinopathy in youth: the ACCESS randomized control trial. Nat Commun. 2024 Jan 11;15(1):421. doi: 10.1038/s41467-023-44676-z. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care With Educational Reinforcement | Standard of care referral to Eye Care Provider (ECP) for the diabetic eye exam with educational reinforcement |
| FG001 | Diabetic Retinopathy Exam | Point of care (POC) Diabetic Retinopathy Exam using Autonomous AI (artificial intelligence) on non-mydriatic fundus camera 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care With Educational Reinforcement | Standard of care referral to Eye Care Provider (ECP) for the diabetic eye exam with educational reinforcement |
| BG001 | Diabetic Retinopathy Exam |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Get Screened With a Diabetic Eye Exam | The number 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). | Posted | Count of Participants | Participants | 6 months |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care With Educational Reinforcement | Standard of care referral to Eye Care Provider (ECP) for the diabetic eye exam with educational reinforcement |
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Autonomous AI is not FDA cleared for use in ages 21 and under. Some participants were familiar with autonomous AI diabetic eye exams from a prior study and may have been more accepting of participation in the current study.
Although pharmacologic dilation is not necessary in the pediatric population to obtain sufficient fundus imaging, this may not be applicable to adults where real-world studies have demonstrated higher rates of insufficient images without pharmacologic dilation.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Risa Wolf | Johns Hopkins University | 4109556463 | rwolf@jhu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 5, 2023 | Sep 6, 2023 | Prot_SAP_000.pdf |
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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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Participants are masked to the study arms until after randomization
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Point of care (POC) Diabetic Retinopathy Exam using Autonomous AI on non-mydriatic fundus camera
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.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Secondary | Follow-up Rates With an Eye Care Provider | The number of patients 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. | The diabetic retinopathy exam group only includes those that had an abnormal AI exam and were referred to an eye care provider for a dilated eye exam. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| 0 |
| 83 |
| 0 |
| 83 |
| 0 |
| 83 |
| EG001 | Diabetic Retinopathy Exam | Point of care (POC) Diabetic Retinopathy Exam using Autonomous AI on non-mydriatic fundus camera 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. | 0 | 81 | 0 | 81 | 0 | 81 |
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| 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 |