Argus 2.0 Adoption Study
KOS Inc.
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.
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…
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Provision of signed and dated informed consent form * Male or female, aged 18 years and older * Clinical diagnosis of type 1 or type 2 diabetes and/or prediabetes for any duration * Sufficient venous access for one IV line * Stated willingness to comply with all study procedures and availability for the duration of the study * Willing to wear the required number of CGM systems for the total duration of the study (up to 15 days of total wear), including up to two Argus devices and at least one provided, commercially available, CGM device * Willing and able to use a compat…
Interventions
- DeviceKOS 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.
Location
- Mills-Peninsula Medical Center - San Mateo CampusSan Mateo, California