Comparing the Garmin Venu 3 for Non-Invasive Vital Sign Monitoring to a Hospital-Grade Monitor (GARMIN)

East Limburg Hospital

Status: Enrolling

Conditions: Validation of Vital Signs Measured by a Consumer-grade Smartwatch

Treatments: Other: Smartwatch rating scale questionnaire; Device: Garmin Venu 3 + Philips Intellivue X2

Study type: Interventional

Funder types: Other

Identifiers

NCT07360678

CIV-25-07-053536 (Other Identifier)

Z-2025082

Details and patient eligibility

About

This clinical trial evaluates the accuracy of the Garmin Venu 3 smartwatch in measuring vital signs (heart rate, respiratory rate, SpO₂) compared to the clinically validated Philips IntelliVue X2. The study aims to determine whether the consumer-grade smartwatch can provide reliable data for remote patient monitoring, early hospital discharge, and chronic disease management, offering a more accessible and affordable alternative to MDR-certified devices.

Full description

Wearable technology has rapidly evolved from fitness tracking tools to potential clinical-grade devices capable of non-invasive monitoring of vital signs. Among these, smartwatches equipped with optical sensors and accelerometers now offer continuous measurements of parameters such as heart rate, respiratory rate, and blood oxygen saturation (SpO2). The Garmin Venu 3 represents a new generation of commercially available smartwatches that provide vital sign monitoring outside of controlled medical environments.

Despite their growing popularity and technological advancements, the clinical validity of smartwatches remains unknown. Applying for medical device regulation (MDR) certification is a long and expensive process, something not all companies can or want to invest in. Besides, the devices that are MDR certified are often very expensive, something not possible to use in an average patient population without extensive funding. For the use of (non-MDR certified) smartwatches into clinical workflows or remote patient monitoring systems, these devices must demonstrate accuracy and reliability comparable to gold-standard hospital-grade monitors.

The Philips IntelliVue X2 is a widely used and clinically validated multi-parameter patient monitoring system employed in acute care setting. It provides high-fidelity, real-time monitoring of vital signs and serves as an appropriate benchmark for evaluating the performance of customer-grade devices.

Comparing measurements obtained with the Garmin Venu 3 against the IntelliVue X2 is essential to determine whether the smartwatch can serve as a reliable tool for continuous vital sign tracking in real-world clinical scenarios. This is particularly relevant for use cases such as early hospital discharge, remote patient monitoring and chronic disease management where accessibility, affordability, convenience and user compliance are critical.

This clinical trial seeks to assess the agreement and accuracy of the Garmin Venu 3 in measuring key physiological parameters such as heart rate, respiratory rate, and SpO2 compared to the Philips Intellivue X2 in a diverse patient population. Demonstrating clinical equivalence or acceptable accuracy margins would support the potential use of the Garmin Venu 3 in remote or supplemental monitoring roles within modern (hybrid) healthcare systems.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Provide signed and dated informed consent
• Adults older than 18 years of age
• Speak and understand the Dutch language
• Hospitalized for at least another 24 hours

Exclusion criteria

• Life expectancy is less than 30 days
• Patient is isolated due to infection control

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Patients admitted to the pulmonology ward

Experimental group

Description:

Patients admitted to the pulmonology ward of Ziekenhuis Oost-Limburg, Genk, Belgium.

Treatment:

Device: Garmin Venu 3 + Philips Intellivue X2

Other: Smartwatch rating scale questionnaire