Leveraging Artificial Intelligence to Prevent Vision Loss From Diabetes Among Socioeconomically Disadvantaged Communities

NCT ID: NCT06763952

Last Updated: 2025-08-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 4000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-28
• Study Completion Date: 2029-05-31

Brief Summary

This study aims to investigate whether a novel artificial intelligence based screening strategy (AI-Based point of caRe, Incorporating Diagnosis, SchedulinG, and Education or AI-BRIDGE), which allows primary care providers to screen patients for vision-threatening diabetic eye disease in the primary care clinic, improves screening and follow-up care rates across race/ethnicity groups and reduces racial/ethnic disparities in screening.

Detailed Description

This is a multicenter clinical trial and University of Wisconsin is the coordinating center of the study.

A stepped-wedge cluster randomized clinical trial will be conducted. The investigators will evaluate the effectiveness of two standard diabetic retinopathy screening strategies at primary care clinics; (1) AI-based eye screening program called AI-BRIDGE, eye photos of the patients will be obtained in the primary care clinic by trained clinic staff. Images will be reviewed using autonomous artificial-intelligence (AI) algorithm (Digital Diagnostics). Patients with referrable diabetic retinopathy are detected within minutes and patients with referrable disease will be assisted with scheduling an in-person follow-up eye care visit (2) usual care screening, primary care providers refer patients with diabetes to an eye care provider for an in-person dilated eye exam.

After adapting AI-BRIDGE protocols to clinics and training of clinic personnel, stepped wedge randomized clinical trial begins with sites transitioning from usual-care to AI-BRIDGE in 4 steps.

Primary Objective:

• Compare the proportion of patients, by race and ethnicity, who follow-up with recommended eye care in the AI-BRIDGE and usual-care arms within 6 months of the recommendation.

Secondary Objectives:

• Compare the difference in proportion of White vs Hispanic and White vs Black patients who get screening in the AI-BRIDGE and usual-care arms within 6 months of the recommendation.
• Compare proportion of patients, by race and ethnicity, who receive eye screening in the AI-BRIDGE and usual-care arms within 6 months of the recommendation.

Conditions

Vision; Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Usual Care Screening

Primary care providers refer patients with diabetes to an eye care provider for a dilated eye exam. Patients are provided with culturally adapted diabetic eye disease educational materials similar to that provided to patients in the AI-BRIDGE group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

AI-BRIDGE

AI-based eye screening program called AI-Based point of caRe, Incorporating Diagnosis, SchedulinG, and Education (AI-BRIDGE). Eye photos of the patients will be obtained in the primary care clinic during a patient's regular primary care visit by a trained technician. Images will be reviewed using autonomous artificial-intelligence (AI) algorithm (Digital Diagnostics). Patients with referrable diabetic retinopathy are detected, and assisted with scheduling an in-person follow-up eye care visits. All patients irrespective of diabetic retinopathy status are also provided culturally adapted educational material on diabetic eye disease.

Group Type: EXPERIMENTAL

AI-BRIDGE

Intervention Type: OTHER

AI-based eye screening program

Interventions

AI-BRIDGE

AI-based eye screening program

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Eligible patients include patients older than 21 years
• Diagnosed with type 1 or 2 diabetes
• No known diabetic eye disease
• Medicaid as their primary insurance
• Not had an eye exam in the prior year

Exclusion Criteria

-

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Eye Institute (NEI)

NIH

Sponsor Role: collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roomasa Channa

Role: PRINCIPAL_INVESTIGATOR

UW School of Medicine and Public Health

Locations

UW School of Medicine and Public Health

Madison, Wisconsin, United States

Countries

United States

Central Contacts

Mozhdeh Bahrainian

Role: CONTACT

bahrainian@wisc.edu

608-262-9955

Roomasa Channa

Role: CONTACT

rchanna@wisc.edu

Other Identifiers

Version 8/9/24

Identifier Type: OTHER

Identifier Source: secondary_id

A536000

Identifier Type: OTHER

Identifier Source: secondary_id

1R01EY035994

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2024-0030

Identifier Type: -

Identifier Source: org_study_id