Argus 2.0 Adoption Study

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• KOS Argus Continuous Glucose Monitoring System — DEVICE
  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.

Study Details

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.

Key Dates

Start date

Apr 19, 2026

Status verified

Feb 2026

Primary completion

Aug 19, 2026

Completion

Aug 19, 2027

Study Design

Enrollment

100 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

DEVICE_FEASIBILITY

Arms

• Experimental: Argus CGM Feasibility
  All participants will wear the investigational KOS Argus CGM device and a commercially available Dexcom Stelo CGM for 15 days. On Day 1, participants will complete an in-clinic baseline visit with serial venous blood sampling approximately every 10 minutes over 6 hours to collect paired reference glucose measurements alongside Argus readings. From Day 1 through Day 15, participants will wear both devices continuously during normal daily activities. Participants will provide a fingerstick blood glucose reference measurement every 5 days using a Contour Next One meter and log meals, medications, and activities in the Argus mobile application.

Primary Outcome Measure

Quantity of Paired Argus and Reference Laboratory Blood Glucose Measurements During In-Clinic Visit [ Time Frame: Day 1 (approximately 6 hours) ]

Central Contacts

• Kai N Werner
  6506669721
  [email protected]
• Schalal Habib
  6509126451
  [email protected]

Locations (1)

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