Argus 2.0 Adoption Study
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorKOS Inc.
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Known or suspected hypersensitivity to any of the components of the investigational device
Known allergy to medical grade adhesives
Presence of any injury, infection, atypical skin condition (such as hyperkeratosis or hyperpigmentation) or tattoo on the wrists
Participation in any clinical trial investigation of a medical device or any medicinal product in clinical development within 30 days
Trial design
Design model
Single group
Treatments tested in this trial
KOS Argus Continuous Glucose Monitoring System
DeviceThe 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.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Argus CGM FeasibilityExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Quantity of Paired Argus and Reference Laboratory Blood Glucose Measurements During In-Clinic Visit
Total number of paired data points collected from simultaneous Argus CGM readings and venous blood glucose laboratory measurements obtained via serial blood sampling approximately every 10 minutes over a 6 hour in-clinic visit on Day 1.
Time frame
Day 1 (approximately 6 hours)2
Quantity of Paired Argus and Dexcom Stelo CGM Data Points During Home-Wear Period
Total number of matched data points collected from simultaneous Argus CGM and Dexcom Stelo CGM readings during the 15 day continuous home-wear period based on a 5 minute sampling interval.
Time frame
Day 1 through Day 15 (15 days)Secondary outcomes
1
Device Adherence
Total number of hours of active Argus device wear time during the 15 day study period.
Time frame
Day 1 through Day 15 (15 days)2
Device Operational Lifespan
Total number of hours of continuous Argus device function before device failure, if applicable, during the 15 day study period.
Time frame
Day 1 through Day 15 (15 days)3
User Experience Survey
Participant reported feedback on device usability, comfort, and overall experience collected via survey at the final visit.
Time frame
Day 154
Adverse Events and Device Related Events
Incidence and severity of adverse events, serious adverse events, and device related events reported throughout the study period.
Time frame
Day 1 through Day 15 (15 days) Source ClinicalTrials.gov
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