Diabetic RetinopathyNCT06763952
Leveraging Artificial Intelligence to Prevent Vision Loss From Diabetes
A study testing AI-BRIDGE and Educational Materials in people with Diabetic Retinopathy and Diabetes Mellitus, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Diabetic Retinopathy, Diabetes Mellitus
- What is being tested?
- AI-BRIDGE and Educational Materials
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,900 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to May 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Roomasa Channa contact
United States1 site, 1 recruiting
- Recruiting
UW School of Medicine and Public Health
Madison, Wisconsin, 53792
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Diabetic Retinopathy, Diabetes Mellitus
- Being tested
- AI-BRIDGE, Educational Materials
- Keywords
- Artificial Intelligence, AI, diabetic eye disease, cluster randomized trial, pragmatic trial, eye screening
- Medical subject headings
- Diabetic Retinopathy, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-BRIDGEOther
Also called Artificial Intelligence-Based point of caRe, Incorporating Diagnosis, SchedulinG, and Education
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 MaterialsOther
Participants in the Usual Care arm will receive educational materials about diabetic retinopathy during the intervention period.
| Study group | Role | What they receive |
|---|---|---|
| Health System 1: Usual Care plus Education | Active comparator | 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. Receives: Other: Educational Materials |
| Health System 1: AI-BRIDGE Clinic | Experimental | 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). Receives: Other: AI-BRIDGE |
| Health System 2: Usual Care plus Education | Active comparator | 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. Receives: Other: Educational Materials |
| Health System 2: AI-BRIDGE Clinic | Experimental | 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). Receives: Other: AI-BRIDGE |
| Health System 3: Usual Care plus Education | Active comparator | 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. Receives: Other: Educational Materials |
| Health System 3: AI-BRIDGE Clinic | Experimental | 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). Receives: Other: AI-BRIDGE |
| Health System 4: Usual Care plus Education | Active comparator | 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. Receives: Other: Educational Materials |
| Health System 4: AI-BRIDGE Clinic | Experimental | 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). Receives: Other: AI-BRIDGE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 6 months
Secondary outcomes (1)
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.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2025
- Study start1 Oct 2026
- Primary completionMay 2030 (estimated)
- Study completionMay 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic RetinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Parallel cluster randomized controlled trial. Clinics will be recruited and randomized to either usual care or the AI-BRIDGE intervention. A 4-month baseline period (usual-care screening across all eight clinics) followed by up to 15-month intervention period in which four clinics (one from each health system) are randomized to AI-BRIDGE and four clinics (one from each health system) are randomized to usual-care. Total study duration is 5 years.
- Masking
- None (open label)
- Enrolment
- 6,900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Responsible party
- Sponsor
- Investigators
- Roomasa Channa, Principal investigator, UW School of Medicine and Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06763952
- Sponsor's protocol ID
- 2026-0446
- Other IDs
- Protocol Version 9/21/26, A536000, 2024-0030, 1R01EY035994
- Status last verified
- Oct 2026
- First submitted
- 26 Dec 2024
- Last updated
- 22 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06763952
- Acronym / sponsor ID
- 2026-0446
- Conditions
- Diabetic Retinopathy, Diabetes Mellitus
- Keywords
- Artificial Intelligence, AI, diabetic eye disease, cluster randomized trial, pragmatic trial, eye screening
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 6,900 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Study start
- 1 Oct 2026 (actual)
- Primary completion
- May 2030 (estimated)
- Study completion
- May 2030 (estimated)
- First posted
- 8 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 8
- Model description
- Parallel cluster randomized controlled trial. Clinics will be recruited and randomized to either usual care or the AI-BRIDGE intervention. A 4-month baseline period (usual-care screening across all eight clinics) followed by up to 15-month intervention period in which four clinics (one from each health system) are randomized to AI-BRIDGE and four clinics (one from each health system) are randomized to usual-care. Total study duration is 5 years.
| Arm | Type | Receives |
|---|---|---|
| Health System 1: Usual Care plus Education | Active comparator | Other: Educational Materials4 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. |
| Health System 1: AI-BRIDGE Clinic | Experimental | Other: AI-BRIDGE4 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). |
| Health System 2: Usual Care plus Education | Active comparator | Other: Educational Materials4 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. |
| Health System 2: AI-BRIDGE Clinic | Experimental | Other: AI-BRIDGE4 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). |
| Health System 3: Usual Care plus Education | Active comparator | Other: Educational Materials4 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. |
| Health System 3: AI-BRIDGE Clinic | Experimental | Other: AI-BRIDGE4 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). |
| Health System 4: Usual Care plus Education | Active comparator | Other: Educational Materials4 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. |
| Health System 4: AI-BRIDGE Clinic | Experimental | Other: AI-BRIDGE4 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). |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI-BRIDGEAlso: Artificial Intelligence-Based point of caRe, Incorporating Diagnosis, SchedulinG, and EducationAI-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 | Health System 1: AI-BRIDGE Clinic, Health System 2: AI-BRIDGE Clinic, Health System 3: AI-BRIDGE Clinic, Health System 4: AI-BRIDGE Clinic |
| Educational MaterialsParticipants in the Usual Care arm will receive educational materials about diabetic retinopathy during the intervention period. | Other | Health System 1: Usual Care plus Education, Health System 2: Usual Care plus Education, Health System 3: Usual Care plus Education, Health System 4: Usual Care plus Education |
Primary outcome
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.
1 secondary outcome
Proportion of patients who complete DR screening
Time frame: up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Roomasa Channa contact
Roomasa Channa principal investigator
UW School of Medicine and Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-BRIDGE and Educational Materials in people with Diabetic Retinopathy and Diabetes Mellitus, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mozhdeh Bahrainian (608-262-9955, bahrainian@wisc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants Who Follow Up With Recommended Eye Care (time frame: up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.