NCT06763952Recruiting
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)
Source: ClinicalTrials.gov · Last updated 22 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 6900 (estimated)
- First submitted
- 26 Dec 2024
- Start date
- 1 Oct 2026
- Primary completion date
- May 2030
- Lead sponsor
- University of Wisconsin, Madison
- Diseases
- Diabetic eye disease
- NCT number
- NCT06763952
What you commit to
- Study type: Interventional
- Planned participants: 6900
- From 1 Oct 2026 to the primary completion date, May 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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
Age in the registry: 22 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UW School of Medicine and Public Health Coordinator of this site? Confirm its status | Madison | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.