Argus 2.0 Adoption Study

Starting soon · Not applicable

Conditions studied: Diabetes, Diabetes Mellitus, Type 1 Diabetes, Diabetes Mellitus, Type 2, Prediabetes

In brief

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 facts

Study ID: NCT07425236
Run by: KOS Inc.
People needed: 100
Starts: 2026-04-19
Expected to finish: 2027-08-19
Last updated by the study team: 2026-02-20

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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 compatible personal iOS or Android smartphone with - Bluetooth capability to install and use the study application, and to pair and maintain continuous Bluetooth communication between the smartphone and the investigational device for the required wear period
Has reliable access to their personal smartphone for the duration of participation and agrees to keep Bluetooth enabled and the study app running as instructed

You may not qualify if…

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
Required or scheduled to have a Magnetic Resonance Imaging (MRI) scan, Computed Tomography (CT) scan, or diathermy during the study wear period
Blood donation or blood loss of more than 500 mL within the last 3 months
Presence of anemia as demonstrated by hematocrit measurements below 36.0% for males or 33.0% for females
Presence of an active implantable medical device such as a pacemaker
Presence or history of a cardiovascular disease including stable and unstable angina pectoris, myocardial infarction, transient ischemic attack, stroke, cardiac decompensation, clinically significant arrhythmias, or clinically significant conduction disorders
Any history or presence of cancer except basal cell skin cancer or squamous cell skin cancer
Presence of signs of acute illness or immunodeficiency Presence of any serious systemic infectious disease during four weeks prior to the intervention
Presence of clinically significant abnormal screening laboratory tests or standard 12 lead electrocardiogram after 5 minutes resting in supine position at screening
History of significant alcohol or drug abuse, or current alcohol consumption exceeding approximately two standard drinks per day for males or one standard drink per day for females
Inability or unwillingness to refrain from smoking for the duration of visits History of diagnosis for hepatitis B, hepatitis C, HIV 1, or HIV 2
Clinically relevant comorbidity capable of constituting a risk for the participant or interfering with interpretation of data as judged by the investigator, including but not limited to end stage renal disease currently managed by dialysis or anticipating initiating dialysis during the study wear period, current usage of hydroxyurea medications, or significant usage of acetaminophen over 1 g every 6 hours
Mental incapacity, unwillingness, or language barriers precluding adequate understanding or cooperation Pregnancy or current breastfeeding
Current or past affiliation with the investigational site, sponsor, or study personnel, including being an employee, contractor, or immediate family member of any individual directly involved in the trial, or current employment with, contractor relationship with, or significant financial interest in companies involved in glucose monitoring or diabetes related products that could create a conflict of interest or bias study results
Consideration of unsuitability for inclusion by investigator Inability or unwillingness to use a compatible personal smartphone to install and operate the study app and maintain Bluetooth connectivity as required

Where it is running

Mills-Peninsula Medical Center - San Mateo Campus — San Mateo, California, United States

Full record on ClinicalTrials.gov

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