Argus 2.0 Adoption Study

NCT07425236 | Not Yet Recruiting FDA Device

• 1 other identifier: 3
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes; Diabetes Mellitus, Type 2; Prediabetes; Diabetes Mellitus, Type 1 Diabetes

Keywords

Continuous Glucose Monitoring; Noninvasive Glucose Monitoring; Photoplethysmography; Wearable Biosensor; CGM; Blood Glucose Monitoring; PPG; Artificial Intelligence; Machine Learning; Glucose Monitoring Device

Outcome Measures

Primary Outcomes (2)

• 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.

  Day 1 (approximately 6 hours)

• 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.

  Day 1 through Day 15 (15 days)

Secondary Outcomes (4)

• Device Adherence

  Day 1 through Day 15 (15 days)

• Device Operational Lifespan

  Day 1 through Day 15 (15 days)

• User Experience Survey

  Day 15

• Adverse Events and Device Related Events

  Day 1 through Day 15 (15 days)

Study Arms (1)

Argus CGM Feasibility

EXPERIMENTAL

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.

Device: KOS Argus Continuous Glucose Monitoring System

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.

Argus CGM Feasibility

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• KOS Inc.: lead

Study Sites (1)

Mills-Peninsula Medical Center - San Mateo Campus

San Mateo, California, 94401, United States

Location

Related Links

• The Sponsor

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Prediabetic State

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• David Klonoff

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kai N Werner

CONTACT

6506669721; kw@kos-ai.com

Schalal Habib

CONTACT

6509126451; sh@kos-ai.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Participants are blinded to Argus CGM glucose output throughout the study. Glucose readings from the Argus device are not displayed to participants or used for treatment decisions. However, participants and study staff are aware of device placement and study procedures.
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All enrolled participants will complete the same study procedures, including an in-clinic baseline visit with serial venous blood sampling and a 15-day home-wear period with the Argus CGM and Dexcom Stelo CGM. There are no comparator or control groups.

Study Record Dates

• First Submitted: February 16, 2026
• First Posted: February 20, 2026
• Study Start: April 19, 2026
• Primary Completion (Estimated): August 19, 2026
• Study Completion (Estimated): August 19, 2027
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)