Leveraging Artificial Intelligence to Prevent Vision Loss From Diabetes Among Socioeconomically Disadvantaged Communities

University of Wisconsin (UW)

Status: Enrolling

Conditions: Diabetes; Vision

Treatments: Other: AI-BRIDGE

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06763952

Version 8/9/24 (Other Identifier)

1R01EY035994 (U.S. NIH Grant/Contract)

2024-0030

A536000 (Other Identifier)

Details and patient eligibility

About

This study aims to investigate whether a novel artificial intelligence based screening strategy (AI-Based point of caRe, Incorporating Diagnosis, SchedulinG, and Education or AI-BRIDGE), which allows primary care providers to screen patients for vision-threatening diabetic eye disease in the primary care clinic, improves screening and follow-up care rates across race/ethnicity groups and reduces racial/ethnic disparities in screening.

Full description

This is a multicenter clinical trial and University of Wisconsin is the coordinating center of the study.

A stepped-wedge cluster randomized clinical trial will be conducted. The investigators will evaluate the effectiveness of two standard diabetic retinopathy screening strategies at primary care clinics; (1) AI-based eye screening program called AI-BRIDGE, eye photos of the patients will be obtained in the primary care clinic by trained clinic staff. Images will be reviewed using autonomous artificial-intelligence (AI) algorithm (Digital Diagnostics). Patients with referrable diabetic retinopathy are detected within minutes and patients with referrable disease will be assisted with scheduling an in-person follow-up eye care visit (2) usual care screening, primary care providers refer patients with diabetes to an eye care provider for an in-person dilated eye exam.

After adapting AI-BRIDGE protocols to clinics and training of clinic personnel, stepped wedge randomized clinical trial begins with sites transitioning from usual-care to AI-BRIDGE in 4 steps.

Primary Objective:

• Compare the proportion of patients, by race and ethnicity, who follow-up with recommended eye care in the AI-BRIDGE and usual-care arms within 6 months of the recommendation.

Secondary Objectives:

• Compare the difference in proportion of White vs Hispanic and White vs Black patients who get screening in the AI-BRIDGE and usual-care arms within 6 months of the recommendation.
• Compare proportion of patients, by race and ethnicity, who receive eye screening in the AI-BRIDGE and usual-care arms within 6 months of the recommendation.

Enrollment: 4,000 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Eligible patients include patients older than 21 years
• Diagnosed with type 1 or 2 diabetes
• No known diabetic eye disease
• Medicaid as their primary insurance
• Not had an eye exam in the prior year

Exclusion criteria

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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4,000 participants in 2 patient groups

Usual Care Screening

No Intervention group

Description:

Primary care providers refer patients with diabetes to an eye care provider for a dilated eye exam. Patients are provided with culturally adapted diabetic eye disease educational materials similar to that provided to patients in the AI-BRIDGE group.

AI-BRIDGE

Experimental group

Description:

AI-based eye screening program called AI-Based point of caRe, Incorporating Diagnosis, SchedulinG, and Education (AI-BRIDGE). Eye photos of the patients will be obtained in the primary care clinic during a patient's regular primary care visit by a trained technician. Images will be reviewed using autonomous artificial-intelligence (AI) algorithm (Digital Diagnostics). Patients with referrable diabetic retinopathy are detected, and assisted with scheduling an in-person follow-up eye care visits. All patients irrespective of diabetic retinopathy status are also provided culturally adapted educational material on diabetic eye disease.

Treatment:

Other: AI-BRIDGE