NCT06763952

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 4,000 (estimated)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	AI-BRIDGE	AI-based eye screening program

Timeline

• Start date: 2026-02-01
• Primary completion: 2029-05-01
• Completion: 2029-05-01
• First posted: 2025-01-08
• Last updated: 2025-08-26

Locations

1 site across 1 country: United States