Leveraging Artificial Intelligence to Prevent Vision Loss From Diabetes
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22+
SponsorUniversity of Wisconsin, Madison
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 design
Design model
Sequential
Treatments tested in this trial
AI-BRIDGE
Other interventionAI-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
Other interventionParticipants in the Usual Care arm will receive educational materials about diabetic retinopathy during the intervention period.
Treatment groups
6,900 Participants
are divided into 8 treatment groups8
Treatment groupsSee each treatment group below.
Group A: Health System 1: Usual Care plus EducationActive comparator 1 intervention
Group B: Health System 1: AI-BRIDGE ClinicExperimental treatment 1 intervention
Group C: Health System 2: Usual Care plus EducationActive comparator 1 intervention
Group D: Health System 2: AI-BRIDGE ClinicExperimental treatment 1 intervention
Group E: Health System 3: Usual Care plus EducationActive comparator 1 intervention
Group F: Health System 3: AI-BRIDGE ClinicExperimental treatment 1 intervention
Group G: Health System 4: Usual Care plus EducationActive comparator 1 intervention
Group H: Health System 4: AI-BRIDGE ClinicExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 monthsSecondary 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.
Time frame
up to 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Wisconsin, Madison
Lead sponsor
National Eye Institute (NEI)
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: