An interventional study of AI-BRIDGE and Educational Materials in Diabetic Retinopathy and Diabetes Mellitus, sponsored by University of Wisconsin, Madison. Not yet recruiting at 1 site in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-10-02.
Sponsored by University of Wisconsin, Madison · Not applicable, Interventional, and Health services research
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.
This study is a parallel cluster randomized clinical trial to determine whether AI-BRIDGE, an autonomous AI-based protocol of screening for DR, improves DR screening and follow-up rates compared to usual care. In this study, DR screening refers to the detection of DR either via referral of patients for an eye-care appointment with an eye-care provider in usual-care or via point-of-care AI-based DR screening for patients in AI-BRIDGE. The trial will be conducted across 8 clinics from four health systems that are Federally Qualified Health Centers. Each clinic will be randomly assigned to either usual care or the AI-BRIDGE intervention.
Randomization is done at the clinic level in this study. One of the two clinics within each of the four health systems will be randomly selected to be in the AI-BRIDGE arm (i.e., a total of four clinics will use AI-BRIDGE during the intervention period) and the other clinics will be in the control arm (i.e., a total of four clinics will be in usual care).
Primary Objective:
Compare the 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.
Secondary Objective:
Compare the proportion of patients who complete DR screening, defined as: (AI-BRIDGE) an AI-interpretable image obtained at the primary care visit; or, for patients who did not complete AI screening or did not start AI-screening, an in-person screening eye care visit completed within 6 months of the primary care visit; (Usual-care) an in-person screening eye care visit completed within 6 months of the primary care visit.
773 studies on the registry are indexed under Diabetic Retinopathy; 139 are open to participants now.
This study's planned enrollment of 6,900 is above the median of 78 across 480 interventional studies indexed under Diabetic Retinopathy.
Browse Diabetic Retinopathy studies →University of Wisconsin, Madison is the lead sponsor of 1,161 studies on the registry; 182 are open to participants now.
Of its 151 completed or terminated interventional studies of FDA-regulated products, 114 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Clinics Inclusion Criteria:
Patient Inclusion Criteria:
Patient Exclusion Criteria:
4 month period of usual care screening then randomized to a 15-month period of usual care. Participants in usual care will receive educational material about diabetic retinopathy.
Other: Educational Materials
4 month period of usual care screening then randomized to a 15-month period of AI-based eye screening program called AI-Based point of caRe, Incorporating Diagnosis, SchedulinG, and Education (AI-BRIDGE).
Other: AI-BRIDGE
4 month period of usual care screening then randomized to a 15-month period of usual care. Participants in usual care will receive educational material about diabetic retinopathy.
Other: Educational Materials
4 month period of usual care screening then randomized to a 15-month period of AI-based eye screening program called AI-Based point of caRe, Incorporating Diagnosis, SchedulinG, and Education (AI-BRIDGE).
Other: AI-BRIDGE
4 month period of usual care screening then randomized to a 15-month period of usual care. Participants in usual care will receive educational material about diabetic retinopathy.
Other: Educational Materials
4 month period of usual care screening then randomized to a 15-month period of AI-based eye screening program called AI-Based point of caRe, Incorporating Diagnosis, SchedulinG, and Education (AI-BRIDGE).
Other: AI-BRIDGE
4 month period of usual care screening then randomized to a 15-month period of usual care. Participants in usual care will receive educational material about diabetic retinopathy.
Other: Educational Materials
4 month period of usual care screening then randomized to a 15-month period of AI-based eye screening program called AI-Based point of caRe, Incorporating Diagnosis, SchedulinG, and Education (AI-BRIDGE).
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.
Also known as: Artificial Intelligence-Based point of caRe, Incorporating Diagnosis, SchedulinG, and Education
Participants in the Usual Care arm will receive educational materials about diabetic retinopathy during the intervention period.
Proportion of Participants Who Follow Up With Recommended Eye Care
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.
Time frame: up to 6 months
Proportion of patients who complete DR screening
Proportion of patients who complete DR screening, defined as: (AI-BRIDGE) an AI-interpretable image obtained at the primary care visit; or, for patients who did not complete AI screening or did not start AI-screening, an in-person screening eye care visit completed within 6 months of the primary care visit; (Usual-care) an in-person screening eye care visit completed within 6 months of the primary care visit.
Time frame: up to 6 months
Plan to share: Yes — The trial protocol and SAP will be publicly accessible through the Harvard Dataverse, where study protocols, analysis code, and related project documentation will be deposited and assigned DOIs. In addition, summary protocol information, and aggregate trial data, along with related metadata, will be available on ClinicalTrials.gov in accordance with clinical trial reporting requirements.
Supporting information: Study protocol, Sap, Icf
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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University of Wisconsin, Madison