Argus 2.0 Adoption Study

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.