Leveraging Artificial Intelligence to Prevent Vision Loss From Diabetes

Last updated: April 27, 2026
Sponsor: University of Wisconsin, Madison
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Diabetic Neuropathy

Diabetic Macular Edema

Diabetic Foot Ulcers

Treatment

AI

AI-BRIDGE

Clinical Study ID

NCT06763952
2026-0446
A536000
2024-0030
Version 8/9/24
1R01EY035994
Protocol Version 2/20/26
  • Ages > 22
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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

Exclusion Criteria:

Study Design

Total Participants: 4000
Treatment Group(s): 2
Primary Treatment: AI
Phase:
Study Start date:
August 01, 2026
Estimated Completion Date:
May 31, 2030

Study 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.

Connect with a study center

  • UW School of Medicine and Public Health

    Madison, Wisconsin 53792
    United States

    Site Not Available

  • UW School of Medicine and Public Health

    Madison 5261457, Wisconsin 5279468 53792
    United States

    Site Not Available

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