Clinical trial Recruiting at 1 site Interventional Ages 22 and up

Using AI to prevent vision loss from diabetes in underserved communities

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)

Run by University of Wisconsin, Madison · NCT06763952 · Data updated 2026-11-12

This study is testing a new AI program to see if it can help people with diabetes in underserved communities get better eye care and follow-up after screenings.

Quick facts

Study typeInterventional
Ages22 Years and up
SexAll
Enrollment6900 (estimated)
SponsorUniversity of Wisconsin, Madison
Academic / other
Drugs / interventionsradiation
Locations1 site (Madison, Wisconsin)
StatusRecruiting
StartedOctober 1, 2026
Main results expectedMay 2030
Study endsMay 2030
Registry record updatedOctober 22, 2026
Trial IDNCT06763952 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include adults over 21 years old with type 1 or 2 diabetes, no known diabetic eye disease, and who have not had an eye exam in the past year.

Probably not a fit

Patients who have already been diagnosed with diabetic eye disease or those who have had an eye exam in the previous year may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of an artificial intelligence-based screening strategy called AI-BRIDGE to improve screening and follow-up care for diabetic eye disease in primary care clinics. The study employs a stepped-wedge cluster randomized design, where clinics transition from usual care to the AI-BRIDGE program in four steps. The primary objective is to compare follow-up rates for eye care among patients of different racial and ethnic backgrounds after being screened with AI-BRIDGE versus standard care. The trial aims to reduce disparities in diabetic eye disease screening and care among socioeconomically disadvantaged communities.

Why it matters

Potential benefit: If successful, this approach could significantly improve early detection and treatment of diabetic eye disease, ultimately preventing vision loss in vulnerable populations.

How similar studies have gone: Other studies have shown promise in using AI for medical screening, suggesting that this approach could be effective, though this specific application is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
Clinics Inclusion Criteria:

* Clinic must be from a health system with at least two clinics that meet eligibility criteria and will agree to join.
* Number of unique patients with diabetes should be \>550 over any continuous 15-month period prior to the clinic providing a letter of support to participate in the trial.
* No point-of-care screening system in use for DR.
* Have an electronic health record to track patient data and agree to share limited data set as requested.
* Have a member of the clinical team who can commit to serving as the clinic champion for this study.
* Have the IT infrastructure to deploy an artificial-intelligence-based eye camera in the clinic.

Patient Inclusion Criteria:

* Diagnosis of type 1 or 2 diabetes
* No known diabetic retinopathy
* No diabetic retinopathy screening in the past 12 months

Patient Exclusion Criteria:

* Have a documented DR screening in the electronic health record within 12 months of the date of the primary care visit
* Contraindication includes diagnosed with macular edema, severe non-proliferative retinopathy, proliferative retinopathy, radiation retinopathy, or retinal vein occlusion
* Pregnant

Where it's running

  • UW School of Medicine and Public Health
    Madison, Wisconsin, United States
    Recruiting

Study contacts

  • Principal investigator: Roomasa Channa — UW School of Medicine and Public Health
  • Study coordinator: Mozhdeh Bahrainian
  • Email: bahrainian@wisc.edu
  • Phone: 608-262-9955

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.