Recruiting

Artificial IntelligenceLeveraging Artificial Intelligence to Prevent Vision Loss From Diabetes

Sponsor:

University of Wisconsin, Madison

Code:

NCT06763952

Conditions

Diabetic Retinopathy

Diabetes Mellitus

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

AI-BRIDGE

Educational Materials

Study Details

Brief summary:

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.

Conditions

Diabetic Retinopathy

Diabetes Mellitus

Study ID

NCT06763952

Start date

Oct 1, 2026

Status verified date

Oct, 2026

Completion date

May, 2030

Anticipated

Primary completion date

May, 2030

Anticipated

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

6900 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

active comparator: Health System 1: Usual Care plus Education

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.

experimental: Health System 1: AI-BRIDGE Clinic

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).

active comparator: Health System 2: Usual Care plus Education

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.

experimental: Health System 2: AI-BRIDGE Clinic

active comparator: Health System 3: Usual Care plus Education

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.

experimental: Health System 3: AI-BRIDGE Clinic

active comparator: Health System 4: Usual Care plus Education

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.

experimental: Health System 4: AI-BRIDGE Clinic

Interventions

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.

Educational Materials

Participants in the Usual Care arm will receive educational materials about diabetic retinopathy during the intervention period.

Primary outcome measure

Proportion of Participants Who Follow Up With Recommended Eye Care [ Time Frame: up to 6 months ]

Central Contacts and Locations

Central contacts

Mozhdeh Bahrainian

608-262-9955 bahrainian@wisc.edu

Roomasa Channa

rchanna@wisc.edu

Locations

UW School of Medicine and Public Health

Recruiting

Madison, Wisconsin, United States, 53792

More Information

Sponsor

University of Wisconsin, Madison

Last update posted

Oct 22, 2026

Last verified

Oct, 2026

Keywords

Artificial Intelligence
AI
diabetic eye disease
cluster randomized trial
pragmatic trial
eye screening

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by University of Wisconsin, Madison on 2026-10-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.