NCT06763952 · University of Wisconsin, Madison
Leveraging Artificial Intelligence to Prevent Vision Loss From Diabetes
What this study is about
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.
View original scientific 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.
Interventions
OTHER
AI-BRIDGE
AI-BRIDGE intervention includes (1) acquisition of eye photos and autonomous (i.e. without human oversight) AI-based identification of referable or non-referable DR or insufficient image at the primary care clinic, (2) provision of patient educational material identical to that provided to the usual-care group, and (3) clinic champion-led assistance with scheduling eye-care follow-up visits for patients with referable DR or has insufficient quality image, or image unobtainable due to other technical issues, or does not get AI-screening for any reason.
OTHER
Educational Materials
Participants in the Usual Care arm will receive educational materials about diabetic retinopathy during the intervention period.
Primary outcome measures
Proportion of Participants Who Follow Up With Recommended Eye Care
Time frame: up to 6 months
Proportion of patients who follow-up with recommended eye care in the AI-BRIDGE and usual-care arms within 6 months of primary care visit.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Madison, Wisconsin
Collaborators
National Eye Institute (NEI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 22, 2026 · Source of record for eligibility and locations