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Leveraging Artificial Intelligence to Prevent Vision Loss From Diabetes

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)

Who can join

Ages 22 and older · All sexes

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

About the study

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.

What is being tested

• AI-BRIDGE (other)
• Educational Materials (other)

Sponsor: University of Wisconsin, Madison · Participants: 6,900 · Started: Oct 1, 2026

Contact the study team

• Mozhdeh Bahrainian · Phone: 608-262-9955

Official record on ClinicalTrials.gov — NCT06763952

Locations in the U.S.

Conditions

• Diabetic Eye Problems
• Diabetes

From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.