Study Results
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View full resultsBasic Information
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COMPLETED
NA
164 participants
INTERVENTIONAL
2021-11-24
2022-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
2. Intervention Arm - Point of Care Diabetic Retinopathy screening using Autonomous artificial intelligence on a non-mydriatic fundus camera
SCREENING
NONE
Study Groups
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Usual care with educational reinforcement
Standard of care referral to Eye Care Provider (ECP) for the diabetic eye exam with educational reinforcement
No interventions assigned to this group
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of Type 1 diabetes for ≥3 years, and age 11 or in puberty
* Diagnosis of Type 2 diabetes
Exclusion Criteria
* Known diabetic retinopathy
8 Years
21 Years
ALL
No
Sponsors
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National Eye Institute (NEI)
NIH
Johns Hopkins University
OTHER
Responsible Party
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Principal Investigators
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Risa Wolf, MD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Locations
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Johns Hopkins Pediatric Diabetes Center
Baltimore, Maryland, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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IRB00288043
Identifier Type: -
Identifier Source: org_study_id
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