DiabetesNCT07425236
Argus 2.0 Adoption Study
A study testing KOS Argus Continuous Glucose Monitoring System in people with Diabetes and Diabetes Mellitus, Type 1 Diabetes, run by KOS Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 1 Diabetes, Diabetes Mellitus, Type 2
- What is being tested?
- KOS Argus Continuous Glucose Monitoring System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Apr 2026to 19 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Mills-Peninsula Medical Center - San Mateo Campus
San Mateo, California, 94401
Irina Nayberg, 650-696-4261, irina.nayberg@sutterhealth.org
David Klonoff, PhD
About this study
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.
Read the detailed description
The KOS Argus CGM System is a noninvasive, wrist-worn device that uses multi-spectral photoplethysmography (PPG) sensors combined with AI-driven algorithms to estimate blood glucose levels. The device measures volumetric, optical, and vascular tone variations in peripheral blood flow using three different wavelengths of light to create a comprehensive picture of tissue dynamics.
This is a prospective, open-label, single-center study. Participants will complete three visits: a screening visit (Day -8 to Day -7), an in-clinic baseline visit (Day 1), and a final visit (Day 15).
At the screening visit, informed consent will be obtained, eligibility will be assessed, and screening procedures will be performed, including vital signs, electrocardiogram, and laboratory testing. Eligible participants will return for the Day 1 baseline visit, during which both the Argus device and a Dexcom Stelo CGM will be placed. Serial venous blood samples will be collected via intravenous line approximately every 10 minutes over a 6 hour period and analyzed at the site laboratory. Each participant is expected to contribute approximately 37 paired reference blood glucose measurements during this visit, yielding approximately 3,700 total paired measurements across the study population.
Following the baseline visit, participants will wear both the Argus CGM and the Dexcom Stelo CGM continuously for 15 days during normal daily activities. Participants will perform a reference glucose measurement using a Contour Next One fingerstick glucose meter every 5 days and will log meals, medications, and activities in the Argus mobile application. Paired Argus and Dexcom Stelo CGM data are expected to yield approximately 350,000 to 432,000 matched data points across the study population based on a 5 minute sampling interval.
The Argus device has been determined to be a non-significant risk device. Participants will be blinded to Argus glucose output and will not use Argus readings for any treatment decisions. All glucose management will continue according to each participant's usual standard of care.
Primary endpoints include the quantity and quality of paired Argus and reference laboratory blood glucose measurement data collected during the Day 1 in-clinic visit, and paired Argus and Dexcom Stelo CGM data collected during the 15 day home-wear period. Secondary endpoints include device adherence measured as the number of hours of active device time, device lifespan measured as the number of hours before device failure, and user input via survey. Safety endpoints include adverse events, serious adverse events, and device-related events. No formal hypothesis testing is planned.
- Being tested
- KOS Argus Continuous Glucose Monitoring System
- Keywords
- Continuous Glucose Monitoring, Noninvasive Glucose Monitoring, Photoplethysmography, Wearable Biosensor, CGM, Blood Glucose Monitoring, PPG, Artificial Intelligence, Machine Learning, Glucose Monitoring Device
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KOS Argus Continuous Glucose Monitoring SystemDevice
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: KOS Argus Continuous Glucose Monitoring System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Day 1 through Day 15 (15 days)
Secondary outcomes (4)
Device Adherence
Total number of hours of active Argus device wear time during the 15 day study period.
Measured: Day 1 through Day 15 (15 days)
Device Operational Lifespan
Total number of hours of continuous Argus device function before device failure, if applicable, during the 15 day study period.
Measured: Day 1 through Day 15 (15 days)
User Experience Survey
Participant reported feedback on device usability, comfort, and overall experience collected via survey at the final visit.
Measured: Day 15
Adverse Events and Device Related Events
Incidence and severity of adverse events, serious adverse events, and device related events reported throughout the study period.
Measured: Day 1 through Day 15 (15 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start19 Apr 2026 (estimated)
- Primary completion19 Aug 2026 (estimated)
- Study completion19 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KOS Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Klonoff, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07425236
- Sponsor's protocol ID
- 3
- Status last verified
- Feb 2026
- First submitted
- 16 Feb 2026
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Argus 2.0 Adoption Study
- ClinicalTrials.gov ID
- NCT07425236
- Acronym / sponsor ID
- 3
- Keywords
- Continuous Glucose Monitoring, Noninvasive Glucose Monitoring, Photoplethysmography, Wearable Biosensor, CGM, Blood Glucose Monitoring, PPG, Artificial Intelligence
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- KOS Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Apr 2026 (estimated)
- Primary completion
- 19 Aug 2026 (estimated)
- Study completion
- 19 Aug 2027 (estimated)
- First posted
- 20 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The KOS Argus CGM System is a noninvasive, wrist-worn device that uses multi-spectral photoplethysmography (PPG) sensors combined with AI-driven algorithms to estimate blood glucose levels. The device measures volumetric, optical, and vascular tone variations in peripheral blood flow using three different wavelengths of light to create a comprehensive picture of tissue dynamics.
This is a prospective, open-label, single-center study. Participants will complete three visits: a screening visit (Day -8 to Day -7), an in-clinic baseline visit (Day 1), and a final visit (Day 15).
At the screening visit, informed consent will be obtained, eligibility will be assessed, and screening procedures will be performed, including vital signs, electrocardiogram, and laboratory testing. Eligible participants will return for the Day 1 baseline visit, during which both the Argus device and a Dexcom Stelo CGM will be placed. Serial venous blood samples will be collected via intravenous line approximately every 10 minutes over a 6 hour period and analyzed at the site laboratory. Each participant is expected to contribute approximately 37 paired reference blood glucose measurements during this visit, yielding approximately 3,700 total paired measurements across the study population.
Following the baseline visit, participants will wear both the Argus CGM and the Dexcom Stelo CGM continuously for 15 days during normal daily activities. Participants will perform a reference glucose measurement using a Contour Next One fingerstick glucose meter every 5 days and will log meals, medications, and activities in the Argus mobile application. Paired Argus and Dexcom Stelo CGM data are expected to yield approximately 350,000 to 432,000 matched data points across the study population based on a 5 minute sampling interval.
The Argus device has been determined to be a non-significant risk device. Participants will be blinded to Argus glucose output and will not use Argus readings for any treatment decisions. All glucose management will continue according to each participant's usual standard of care.
Primary endpoints include the quantity and quality of paired Argus and reference laboratory blood glucose measurement data collected during the Day 1 in-clinic visit, and paired Argus and Dexcom Stelo CGM data collected during the 15 day home-wear period. Secondary endpoints include device adherence measured as the number of hours of active device time, device lifespan measured as the number of hours before device failure, and user input via survey. Safety endpoints include adverse events, serious adverse events, and device-related events. No formal hypothesis testing is planned.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Argus CGM Feasibility | Experimental | Device: KOS Argus Continuous Glucose Monitoring SystemAll 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KOS Argus Continuous Glucose Monitoring SystemThe 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. | Device | Argus CGM Feasibility |
Primary outcome
Quantity of Paired Argus and Reference Laboratory Blood Glucose Measurements During In-Clinic Visit
Time frame: Day 1 (approximately 6 hours)
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.
Quantity of Paired Argus and Dexcom Stelo CGM Data Points During Home-Wear Period
Time frame: Day 1 through Day 15 (15 days)
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.
4 secondary outcomes
Device Adherence
Time frame: Day 1 through Day 15 (15 days)
Device Operational Lifespan
Time frame: Day 1 through Day 15 (15 days)
User Experience Survey
Time frame: Day 15
Adverse Events and Device Related Events
Time frame: Day 1 through Day 15 (15 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- The SponsorLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Klonoff principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KOS Argus Continuous Glucose Monitoring System in people with Diabetes and Diabetes Mellitus, Type 1 Diabetes, run by KOS Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kai N Werner (6506669721, kw@kos-ai.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantity of Paired Argus and Reference Laboratory Blood Glucose Measurements During In-Clinic Visit (time frame: Day 1 (approximately 6 hours)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.