ACCESS: AI for pediatriC diabetiC Eye examS Study

Not Applicable

Completed

• Conditions: Type 2 Diabetes; Type 1 Diabetes
• Interventions: Diagnostic Test: Point of Care Autonomous AI diabetic retinopathy exam

• Registration Number: NCT05131451
• Lead Sponsor: Johns Hopkins University

Brief Summary

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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-11-11
• Study First Submitted QC: 2021-11-11
• Study First Posted: 2021-11-23
• Study Start: 2021-11-24
• Primary Completion: 2022-12-06
• Study Completion: 2022-12-31
• Status Verified: 2023-10
• Results First Submitted: 2023-10-09
• Results First Submitted QC: 2023-10-09
• Last Update Submitted: 2023-10-09
• Results First Posted: 2023-11-02
• Last Update Posted: 2023-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 164

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diabetic Retinopathy Exam	Point of Care Autonomous AI diabetic retinopathy exam	Point of care (POC) Diabetic Retinopathy Exam using Autonomous AI on non-mydriatic fundus camera

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Get Screened With a Diabetic Eye Exam	6 months	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).

Secondary Outcome Measures

Name	Time	Method
Follow-up Rates With an Eye Care Provider	6 months	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.

Trial Locations

Locations (1)

Johns Hopkins Pediatric Diabetes Center; 🇺🇸 Baltimore, Maryland, United States