Clinical Efficacy of Implementing an AI-SaMD for Funduscopy Analysis in Patients With Diabetes Mellitus (SAFE-DM)

April 8, 2026 updated by: VUNO Inc.

Clinical Efficacy of Implementing an AI-Driven Software as a Medical Device (SaMD) for Funduscopy Analysis in Patients With Diabetes Mellitus: A Randomized Controlled Trial Protocol

The objective of this study is to investigate the efficacy of implementing the AI-SaMD(VUNO Med®-Fundus AI™) alongside routine clinical practice for the detection of diabetic retinopathy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The primary objective of this study is to compare the true referral rate between patients with VUNO Med®-Fundus AI™-assisted screening (intervention group) and those receiving usual clinical care without AI assistance (control group) among patients with diabetes mellitus.

Study Type

Interventional

Enrollment (Estimated)

340

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • South Korea
    • Gyeonggi-do
      • Incheon, Gyeonggi-do, South Korea, 22332
        • Recruiting
        • Inha University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults aged 19 years or older.
  • A documented diagnosis of type 2 diabetes mellitus.
  • Ability to communicate adequately and provide written informed consent for participation in the study.

Exclusion Criteria:

  • A prior diagnosis of diabetic retinopathy at the time of screening.
  • A history of ophthalmic surgery within 6 months prior to the screening date.
  • A diagnosis of type 1 diabetes mellitus.
  • Pregnancy at the time of screening.
  • Any condition that, in the opinion of the investigator, would make participation in the study infeasible or inappropriate.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
For participants assigned to the intervention group, VUNO Med®-Fundus AI™ will be applied to the acquired fundus images, and the AI-generated outputs will be shown to clinicians during routine care.
Device: VUNO Med®-Fundus AI™
VUNO Med®-Fundus AI™ is an artificial intelligence-based fundus image detection and diagnostic support software. The software automatically identifies abnormal retinal findings and provides information on the type and location of detected abnormalities to aid clinical decision-making.
No Intervention: Control group
For participants assigned to the control group, fundus images will be interpreted according to usual clinical care without AI assistance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
True Referral Rate
Time Frame: within 6 months
The true referral rate is defined as the proportion of subjects who were diagnosed with diabetic retinopathy by an ophthalmologist among those referred to ophthalmology with suspected diabetic retinopathy. The true referral rate will be compared between the intervention and control groups.
within 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diabetic Retinopathy (DR) Diagnosis Rate
Time Frame: Within 6 months
Proportion of subjects diagnosed with diabetic retinopathy among all enrolled subjects will be compared between the intervention group and the control group.
Within 6 months
Odds Ratio
Time Frame: Within 6 months
Odds ratio between the diagnosis of diabetic retinopathy and the application of the AI system among subjects referred to ophthalmology will be calculated.
Within 6 months
Referral Rate
Time Frame: Within 6 months
Proportion of subjects referred to ophthalmology for suspected diabetic retinopathy among all enrolled subjects will be compared between the intervention group and the control group.
Within 6 months
Time to Diabetic Retinopathy Diagnosis
Time Frame: Within 6 months
Time interval from the diagnosis of diabetes mellitus to confirmed diagnosis of diabetic retinopathy based on ophthalmologic evaluation among referred subjects will be compared between the intervention group and the control group.
Within 6 months
Performance of the AI System in Detecting Diabetic Retinopathy
Time Frame: Within 6 months
Sensitivity, specificity, accuracy, positive predictive value (PPV), and negative predictive value (NPV) of the AI system will be calculated in comparison with ophthalmologist-confirmed diagnoses.
Within 6 months
Accuracy of Referral for Diabetic Retinopathy
Time Frame: Within 6 months
Proportion of subjects whose referral decisions (referral or non-referral) are concordant with ophthalmologist-confirmed DR status will be compared between the intervention group and the control group.
Within 6 months
Adherence Rate
Time Frame: Within 6 months
Proportion of referred subjects who attend an ophthalmology department will be compared between the intervention group and the control group.
Within 6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Interim Analysis
Time Frame: Within 6 months
One interim analysis will be conducted when 50% of subjects have completed all study visits. The purpose of this analysis is to review the status of subject dropouts and the reasons for dropout in each group. This procedure will be conducted by a statistician who is independent of the study conduct.
Within 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VUNO Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 7, 2026

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

August 31, 2027

Study Registration Dates

First Submitted

January 23, 2026

First Submitted That Met QC Criteria

January 23, 2026

First Posted (Actual)

January 30, 2026

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 8, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VN-M-03 PR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The institutional dataset used in this study, along with de-identified results, is available upon reasonable request for purposes such as systematic review or meta-analysis, only with approval from the corresponding author and the official approval of local IRB.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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