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

VUNO Inc.

Status: Begins enrollment this month

Conditions: Fundus Photography; Diabetic Retinopathy (DR); Diabete Mellitus

Treatments: Device: VUNO Med®-Fundus AI™

Study type: Interventional

Funder types: Industry

Identifiers

NCT07378956

VN-M-03 PR

Details and patient eligibility

About

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.

Full 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.

Enrollment: 340 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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340 participants in 2 patient groups

Intervention group

Experimental group

Description:

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.

Treatment:

Device: VUNO Med®-Fundus AI™

Control group

No Intervention group

Description:

For participants assigned to the control group, fundus images will be interpreted according to usual clinical care without AI assistance.