ACCESS: AI for pediatriC diabetiC Eye examS Study

Johns Hopkins University

Status: Completed

Conditions: Type 1 Diabetes; Type 2 Diabetes

Treatments: Diagnostic Test: Point of Care Autonomous AI diabetic retinopathy exam

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05131451

IRB00288043

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 164 patients

Sex: All

Ages: 8 to 21 years old

Volunteers: No Healthy Volunteers

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

• Diabetic eye exam within the last 6 months
• Known diabetic retinopathy

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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164 participants in 2 patient groups

Usual care with educational reinforcement

No Intervention group

Description:

Standard of care referral to Eye Care Provider (ECP) for the diabetic eye exam with educational reinforcement

Diabetic Retinopathy Exam

Experimental group

Description:

Point of care (POC) Diabetic Retinopathy Exam using Autonomous AI on non-mydriatic fundus camera

Treatment:

Diagnostic Test: Point of Care Autonomous AI diabetic retinopathy exam