Diabetic Retinopathy (DR)SAFE-DMNCT07378956
Clinical Efficacy of Implementing an AI-SaMD for Funduscopy Analysis in Patients With Diabetes Mellitus
A study testing VUNO Med®-Fundus AI™ in people with Diabetic Retinopathy (DR) and Diabete Mellitus, run by VUNO Inc. at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Diabetic Retinopathy (DR), Diabete Mellitus, Fundus Photography
- What is being tested?
- VUNO Med®-Fundus AI™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 340 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Apr 2026to 31 Aug 2027
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Inha University Hospital
Incheon, Gyeonggi-do, 22332
About this study
Official title: 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.
Read the 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.
- Being tested
- VUNO Med®-Fundus AI™
- 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.
VUNO Med®-Fundus AI™Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 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. Receives: Device: VUNO Med®-Fundus AI™ |
| Control group | No intervention | For participants assigned to the control group, fundus images will be interpreted according to usual clinical care without AI assistance. |
What is being measured
The primary outcome is the main question the study is designed to answer.
True Referral Rate
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.
Measured: within 6 months
Secondary outcomes (7)
Diabetic Retinopathy (DR) Diagnosis Rate
Proportion of subjects diagnosed with diabetic retinopathy among all enrolled subjects will be compared between the intervention group and the control group.
Measured: Within 6 months
Odds Ratio
Odds ratio between the diagnosis of diabetic retinopathy and the application of the AI system among subjects referred to ophthalmology will be calculated.
Measured: Within 6 months
Referral Rate
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.
Measured: Within 6 months
Time to Diabetic Retinopathy Diagnosis
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.
Measured: Within 6 months
Performance of the AI System in Detecting Diabetic Retinopathy
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.
Measured: Within 6 months
Accuracy of Referral for Diabetic Retinopathy
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.
Measured: Within 6 months
Adherence Rate
Proportion of referred subjects who attend an ophthalmology department will be compared between the intervention group and the control group.
Measured: Within 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start7 Apr 2026
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Retinopathy (DR)Studies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VUNO Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07378956
- Sponsor's protocol ID
- VN-M-03 PR
- Acronym
- SAFE-DM
- Status last verified
- Apr 2026
- First submitted
- 23 Jan 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07378956
- Acronym / sponsor ID
- SAFE-DM / VN-M-03 PR
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- VUNO Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Apr 2026 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 30 Jan 2026 (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.
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.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: VUNO Med®-Fundus AI™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. |
| Control group | No intervention | –For participants assigned to the control group, fundus images will be interpreted according to usual clinical care without AI assistance. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| 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. | Device | Intervention group |
Primary outcome
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.
7 secondary outcomes
Diabetic Retinopathy (DR) Diagnosis Rate
Time frame: Within 6 months
Odds Ratio
Time frame: Within 6 months
Referral Rate
Time frame: Within 6 months
Time to Diabetic Retinopathy Diagnosis
Time frame: Within 6 months
Performance of the AI System in Detecting Diabetic Retinopathy
Time frame: Within 6 months
Accuracy of Referral for Diabetic Retinopathy
Time frame: Within 6 months
Adherence Rate
Time frame: Within 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 13 Apr 2026.
- Individual participant dataSharing planned: Yes. 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.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VUNO Med®-Fundus AI™ in people with Diabetic Retinopathy (DR) and Diabete Mellitus, run by VUNO Inc. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. 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 13 Apr 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 South Korea. 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 Hee Jun Park (82-10-7101-2844, heejun.park@vuno.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
True Referral Rate (time frame: within 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 13 Apr 2026.