NCT07425236

Argus 2.0 Adoption Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: KOS Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the usability of the KOS Argus Continuous Glucose Monitoring (CGM) System, a noninvasive, wrist-worn device that estimates blood glucose levels using light-based sensors and artificial intelligence algorithms. The Argus device does not puncture the skin or require sensor insertions. The study will enroll up to 100 adults with type 1 diabetes, type 2 diabetes, or prediabetes at a single site. Participants will complete a screening visit, followed by a Day 1 in-clinic baseline visit that includes serial venous blood draws approximately every 10 minutes over 6 hours to collect paired reference blood glucose measurements alongside Argus device readings. After the baseline visit, participants will wear the Argus device and a commercially available Dexcom Stelo CGM continuously for 15 days during normal daily activities. The primary objective is to collect paired glucose data to support device development and algorithm training. Participants will not receive glucose readings from the Argus device and will continue their usual diabetes management throughout the study. Secondary objectives include assessing device safety, tolerability, adherence, and operational lifespan over the 15-day wear period.

Detailed description

The KOS Argus CGM System is a noninvasive, wrist-worn device that uses multi-spectral photoplethysmography (PPG) sensors combined with AI-driven algorithms to estimate blood glucose levels. The device measures volumetric, optical, and vascular tone variations in peripheral blood flow using three different wavelengths of light to create a comprehensive picture of tissue dynamics. This is a prospective, open-label, single-center study. Participants will complete three visits: a screening visit (Day -8 to Day -7), an in-clinic baseline visit (Day 1), and a final visit (Day 15). At the screening visit, informed consent will be obtained, eligibility will be assessed, and screening procedures will be performed, including vital signs, electrocardiogram, and laboratory testing. Eligible participants will return for the Day 1 baseline visit, during which both the Argus device and a Dexcom Stelo CGM will be placed. Serial venous blood samples will be collected via intravenous line approximately every 10 minutes over a 6 hour period and analyzed at the site laboratory. Each participant is expected to contribute approximately 37 paired reference blood glucose measurements during this visit, yielding approximately 3,700 total paired measurements across the study population. Following the baseline visit, participants will wear both the Argus CGM and the Dexcom Stelo CGM continuously for 15 days during normal daily activities. Participants will perform a reference glucose measurement using a Contour Next One fingerstick glucose meter every 5 days and will log meals, medications, and activities in the Argus mobile application. Paired Argus and Dexcom Stelo CGM data are expected to yield approximately 350,000 to 432,000 matched data points across the study population based on a 5 minute sampling interval. The Argus device has been determined to be a non-significant risk device. Participants will be blinded to Argus glucose output and will not use Argus readings for any treatment decisions. All glucose management will continue according to each participant's usual standard of care. Primary endpoints include the quantity and quality of paired Argus and reference laboratory blood glucose measurement data collected during the Day 1 in-clinic visit, and paired Argus and Dexcom Stelo CGM data collected during the 15 day home-wear period. Secondary endpoints include device adherence measured as the number of hours of active device time, device lifespan measured as the number of hours before device failure, and user input via survey. Safety endpoints include adverse events, serious adverse events, and device-related events. No formal hypothesis testing is planned.

Conditions

• Diabetes
• Diabetes Mellitus, Type 1 Diabetes
• Diabetes Mellitus, Type 2
• Prediabetes

Interventions

Type	Name	Description
DEVICE	KOS Argus Continuous Glucose Monitoring System	The KOS Argus CGM is a noninvasive, wrist-worn device that uses multi-spectral photoplethysmography (PPG) sensors and AI-driven algorithms to estimate blood glucose levels. The device is worn continuously on the wrist and collects glucose measurements every 5 minutes. Participants are blinded to all Argus glucose readings throughout the study and will not use Argus data for any treatment decisions. A reference glucose measurement is performed every 5 days using a Contour Next One fingerstick glucose meter, and values are entered into the Argus mobile application. The device has been determined to be a non-significant risk (NSR) investigational device.

Timeline

• Start date: 2026-04-19
• Primary completion: 2026-08-19
• Completion: 2027-08-19
• First posted: 2026-02-20
• Last updated: 2026-02-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study