Not yet recruitingNot applicable

Argus 2.0 Adoption Study

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 75 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 3 visits, 1 visit
  • Time periods mentioned: 15 days
  • Procedures mentioned: Blood draws, Heart tracing (ECG), Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "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."
Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how easy and safe it is to use Argus, a wrist device that uses light and artificial intelligence to estimate blood sugar without piercing the skin. It is for adults with type 1 diabetes, type 2 diabetes, or prediabetes (blood sugar above normal). Participants have blood draws about every 10 minutes for 6 hours, then wear Argus and another glucose monitor for 15 days; they will not see Argus readings and will keep their usual diabetes care.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older.
  • Have a diagnosis of type 1 diabetes, type 2 diabetes, or prediabetes.
  • Sign and date a form agreeing to join the study.
  • Have a vein that can hold one IV line, a small tube used for blood draws.
  • Be willing to follow all study steps and be available for the whole study.
  • Agree to wear up to two Argus devices and at least one provided glucose monitor for up to 15 days.
  • Be able and willing to use your own compatible iPhone or Android phone with the study app.
  • Have reliable access to your phone and keep Bluetooth and the study app running as instructed.

Who can't join

  • Allergy or suspected allergy to device parts or medical adhesives; wrist injuries, infections, tattoos, or unusual skin changes, such as thickened or darkened skin.
  • A study of a device or drug in development within the past 30 days; planned MRI, CT, or diathermy (a heat treatment) during device wear; blood donation or loss over 500 mL in 3 months; or anemia, with red blood cell levels below 36% for males or 33% for females.
  • An active implanted device, such as a pacemaker; current or past heart or blood vessel disease, including heart attack, stroke, mini-stroke, heart-related chest pain, heart failure, or serious heartbeat problems; or cancer other than basal cell or squamous cell skin cancer.
  • Signs of a sudden illness, a weak immune system, a serious body-wide infection in the past 4 weeks, past hepatitis B, hepatitis C, or HIV, or important abnormal blood tests or heart electrical tests at screening.
  • Past serious alcohol or drug misuse; current drinking above about two standard drinks daily for males or one for females; or inability or unwillingness to avoid smoking during visits.
  • Another health problem that could make the study unsafe or affect results, including kidney failure needing dialysis now or during the study; use of hydroxyurea; or substantial acetaminophen use above 1 gram every 6 hours. Pregnancy or breastfeeding also rules out joining.
  • Difficulty understanding or following study steps because of mental ability, language barriers, or unwillingness; inability or unwillingness to use the required phone, app, and Bluetooth; or the study doctor deciding the study is not suitable.
  • Current or past ties to the study site, sponsor, or staff, including work, contract work, or close family ties; or current work, contract work, or major financial interests in glucose-monitoring or diabetes-product companies that could affect study fairness.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Study sites (1)

CA