ACCESS: AI for pediatriC diabetiC Eye examS Study
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.
|Condition or Disease||Intervention/Treatment||Phase|
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.
Arms and Interventions
|No Intervention: Usual care with educational reinforcement
Standard of care referral to Eye Care Provider (ECP) for the diabetic eye exam with educational reinforcement
|Experimental: Diabetic Retinopathy Exam
Point of care (POC) Diabetic Retinopathy Exam using Autonomous AI on non-mydriatic fundus camera
Diagnostic Test: 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.
Primary Outcome Measures
- Proportion of participants who get screened with a diabetic eye exam [6 months]
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 [6 months]
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.
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
Diabetic eye exam within the last 6 months
Known diabetic retinopathy
Contacts and Locations
|1||Johns Hopkins Pediatric Diabetes Center||Baltimore||Maryland||United States||21287|
Sponsors and Collaborators
- Johns Hopkins University
- Principal Investigator: Risa Wolf, MD, Johns Hopkins University
Study Documents (Full-Text)None provided.