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Testing AI-based eye screening for diabetes complications in primary care

Tests an AI eye screening program for diabetic retinopathy in adults with diabetes.

Plain-language title generated from the registry record
Registry title: Leveraging Artificial Intelligence to Prevent Vision Loss From Diabetes

Key facts

Where
Madison, United StatesSee the site

Where in United States

  • UW School of Medicine and Public HealthMadison, United StatesTaking people

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Trial details

Who runs it
University of Wisconsin, Madison
Trial code
NCT06763952
Record updated
22 October 2026
Original description
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.Read full original descriptionShow less

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)

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.

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.

ClinicalTrials.gov NCT06763952