Argus CGM for Diabetes
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
David Klonoff
Principal Investigator
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline
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
Home-Wear Period
Participants wear the Argus CGM and Dexcom Stelo CGM continuously for 15 days during normal daily activities, performing reference glucose measurements every 5 days
Follow-up
Participants are monitored for safety and effectiveness after the home-wear period
What Are the Treatments Tested in This Trial?
Interventions
- KOS Argus Continuous Glucose Monitoring System
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
KOS Inc.
Lead Sponsor
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