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NOT YET RECRUITING
NCT06763952
NA

Leveraging Artificial Intelligence to Prevent Vision Loss From Diabetes

Sponsor: University of Wisconsin, Madison

View on ClinicalTrials.gov

Summary

This pragmatic clinical trial is being conducted to test the effectiveness of AI-BRIDGE (Artificial Intelligence-Based point of caRe, Incorporating Diagnosis, SchedulinG, and Education), in improving screening and follow-up eye care compared to usual-care among patients with diabetes across 8 primary care clinics. AI-BRIDGE is an implementation program which includes an autonomous AI-based protocol that provides screening for diabetic retinopathy (DR) disease at primary care visits, as well as patient education on disease and, if a patient screens positive for referable DR or has insufficient quality image, or image unobtainable due to other technical issues, or does not get AI-screening for any reason, assistance with scheduling an in-person, follow-up eye-care visit.

Official title: Multicenter National Parallel Cluster Randomized Controlled Superiority Trial Comparing an Artificial Intelligence-Based Screening Strategy to Usual Care for Improving Eye-Care Follow-Up Among Patients With Diabetes (AI-BRIDGE Trial)

Key Details

Gender

All

Age Range

22 Years - Any

Study Type

INTERVENTIONAL

Enrollment

6900

Start Date

2026-10-01

Completion Date

2030-05

Last Updated

2026-10-02

Healthy Volunteers

No

Interventions

OTHER

AI-BRIDGE

AI-BRIDGE intervention includes (1) acquisition of eye photos and autonomous (i.e. without human oversight) AI-based identification of referable or non-referable DR or insufficient image at the primary care clinic, (2) provision of patient educational material identical to that provided to the usual-care group, and (3) clinic champion-led assistance with scheduling eye-care follow-up visits for patients with referable DR or has insufficient quality image, or image unobtainable due to other technical issues, or does not get AI-screening for any reason.

OTHER

Educational Materials

Participants in the Usual Care arm will receive educational materials about diabetic retinopathy during the intervention period.

Locations (1)

UW School of Medicine and Public Health

Madison, Wisconsin, United States