DiabetesGLAMNCT05093569
Clinical Investigation of K'Watch - Lab & Home Study
An observational study of Diabetes, run by PKvitality at 1 site in United States.
Trial summary
This study categorized as a non significant risk trial is a monocentric, prospective, open-label comparative, paired-design trial aims to evaluate the performance and the tolerance of K'Watch CGM system in comparison with conventional reference (YSI system, BGM system and CGM systems ) . Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes
- What is being tested?
- K'watch
- Type of treatment
- Medical device
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2021to 30 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- Adult, Older adult
Study population: Patients with Type 1 and 2 of diabetes
Who may be able to join
- Female or male,
- Subject with Type 1 Diabetes, or subject with Type 2 Diabetes (depending on the study iteration), - Type 1 Diabetes subjects taking insulin need to be on their current insulin regimen for ≥ 3 months prior to study entry,
- Only patients using Dexcom device
- Adult subjects, age 18 or older and ≤80 years,
- Phototype: I to IV according to Fitzpatrick scale,
- BMI ≤40 kg/m²,
Show all 19Show fewer
- Subject free from analgesics, anti-inflammatory drugs, antihistamines and/or local anesthetics within 7 days before inclusion and for the duration of the study,
- Subject with a sufficient hand dexterity to apply the device,
- Not practice vigorous physical exercise (running, fast cycling, aerobics) during the study period,
- For subjects with Type 1 Diabetes, subjects must already be using a CGM (Abbott / Dexcom),
- Willing to comply with the requirements of the study:
- Self-administer Blood Glucose Measurements (BGM) in the frequency described in section 6.2.2 Blood Glucose Monitor (BGM),
- Avoid swimming or taking a bath for the Study Period,
- Use logbook to record adverse events and outcomes,
- Wrist size in the range 16 - 21 cm,
- Patients with hairiness grade between 1 to 3
- Sufficient cooperation and understanding to comply with the study requirements,
- Speak and read the English language,
- Signed informed consent form prior to study entry.
Who cannot join
- Subject with a known allergy to the components of the K'Watch CGM system (adhesive, disinfectants used during the study, ...),
- Subject implanted with Active Medical device (Pacemaker, Defibrillator, any kind of active implantable medical devices that require active sensing to performed it intended use)
- Subject suffering or having history of carpal tunnel syndrome,
- Woman of childbearing potential not using an effective contraceptive, pregnant or breastfeeding,
- Use of drugs that may interfere with glucose metabolism (such as steroids) unless they are chronic therapies whose dosage has remained stable over the past 3 months and is expected to remain stable during the study period,
- Subject presenting, at the proposed application site, significant skin fragility/alterations/diseases that could interfere with the placement of the K'Watch CGM system. These conditions include, but are not limited to, history of skin irritation following the use of bandages or skin adhesives, extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scars, dermatitis herpetiformis, skin lesions, redness, infections or swelling,
Show all 18Show fewer
- Subject exercising a professional or a daily recreational activity involving immersion in the water of the K'Watch CGM system (e.g. lifeguard, plumber, …),
- Subject with tattoos, piercings or implants at the proposed application site,
- History of alcoholism (consumption of more than 5 "drinks" per day. For example, 12 ounces (35.5 cl) of beer, 5 ounces (15 cl) of wine, or 1 oz (4.5 cl) of distilled spirits,
- Use of recreational drugs which would interfere with participation in the study, as determined by the PI,
- Hair removal or shaving in the area of application of the K'Watch CGM system over the month prior to inclusion and throughout the duration of the study,
- Application of cosmetics on the application area of the device the day before the Lab phase and during the Study Period,
- Intensive exposure to sunlight or UV-rays within the previous month and/or foreseen during the study,
- Subject with a scheduled radiographic, MRI, CT or diathermy appointment during the study participation period, and the appointment cannot be postponed,
- Subject has concomitant medical condition which, in the opinion of the investigator, could interfere with the study or present a risk to the safety or welfare of the subject or clinical staff,
- Subject currently is participating in another clinical trial,
- European citizen. (PK will not recruit european citizens for this trial, because the sponsor prefer not to implement the additional administrative steps as required by the GDPR).
- Prisoners or subjects who are involuntarily incarcerated
Trial locations and contacts
1 site in 1 country.
TOM TB BISHOP contact
United States1 site, 1 recruiting
- Recruiting
AMCR Institute
San Diego, California, 92025
Timothy Bailey, MD, 760-466-1530, tbailey@amcrinstitute.com
Laura Bedolla, 760.466.1523, lbedolla@amcrinstitute.com
About this study
This study categorized as a non significant risk trial is a monocentric, prospective, open-label comparative, paired-design trial aims to evaluate the performance and the tolerance of K'Watch CGM system in comparison with conventional reference (YSI system, BGM system and CGM systems ) . This trial will be conducted on patients with Type 1 and 2 of diabetes for 8 days.
Read the detailed description
The purpose of this prospective study is to establish the performance and the cutaneous tolerance of the K'Watch device, for a Study Period of 8 hours (Lab-only study) to 8 days. This prospective study is divided in two phases: a first Laboratory phase will evaluate for 8 hours the safety and performance of the device under test (DUT) in a clinical controlled environment, then if no safety or critical performance issue occurred, the second phase will aim to collect data over a longer time frame, with the subjects using the DUT at home, and to get usability feedback for 6 additional consecutive days. This protocol is to evaluate a series of design iterations to K'Watch CGM system and its use on various populations.
All patients included will be followed for 28 days for safety requirements. 35 patients will be included in this trial and distributed in 7 iterations. For each iteration, the device tested will be improved according to the results obtained in the previous iteration.
- Conditions
- Diabetes
- Being tested
- K'watch
- Keywords
- k'watch, diabetes,CGM
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
K'watchDevice
Patients
| Study group | Role | What they receive |
|---|---|---|
| Iteration | 35 patients will be included in 7 iterations. Receives: Device: K'watch |
What is being measured
The primary outcome is the main question the study is designed to answer.
to determine the accuracy of K'Watch Release 0.x CGM system glucose readings at day 1 as compared to standard references.
The Primary endpoint in this trial is the degree of compliance with the accuracy section of the FDA Class II Integrated continuous glucose monitoring (iCGM) requirements after one entire day.
Measured: 14 months
Secondary outcomes (4)
Accuracy of the investigational device compared to the standard reference CGM devices
Accuracy of the investigational device compared to the standard reference CGM devices by measuring the median absolute relative difference (MARD)
Measured: Between day1 and day 7
The number and duration of gaps in sensor data availability
This is intended to measure the time that the sensor was not able to measure glucose, even though the watch was connected. If the user removes the watch, then this time is not considered to be a "gap"
Measured: 14 months
Safety of the K'Watch system, characterizing device-related Adverse Events
Safety of the K'Watch system, characterizing device-related Adverse Events
Measured: 14 months
Safety of the K'Watch system characterizing device-related pain intensity (Visual Analogue Scale scores from 0-10) recorded during the study.
Safety of the K'Watch system characterizing device-related pain intensity (Visual Analogue Scale scores from 0-10) recorded during the study.
Measured: 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2021
- Study start15 Nov 2021
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Dec 2022 (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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PKvitality
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05093569
- Sponsor's protocol ID
- PRT00014
- Acronym
- GLAM
- Status last verified
- Apr 2022
- First submitted
- 29 Sep 2021
- Last updated
- 2 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation of K'Watch - Lab & Home Study
- ClinicalTrials.gov ID
- NCT05093569
- Acronym / sponsor ID
- GLAM / PRT00014
- Conditions
- Diabetes
- Keywords
- k'watch, diabetes,CGM
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- PKvitalityIndustry (pharma, biotech, devices)
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 26 Oct 2021 (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 categorized as a non significant risk trial is a monocentric, prospective, open-label comparative, paired-design trial aims to evaluate the performance and the tolerance of K'Watch CGM system in comparison with conventional reference (YSI system, BGM system and CGM systems ) . This trial will be conducted on patients with Type 1 and 2 of diabetes for 8 days.
Detailed description
The purpose of this prospective study is to establish the performance and the cutaneous tolerance of the K'Watch device, for a Study Period of 8 hours (Lab-only study) to 8 days. This prospective study is divided in two phases: a first Laboratory phase will evaluate for 8 hours the safety and performance of the device under test (DUT) in a clinical controlled environment, then if no safety or critical performance issue occurred, the second phase will aim to collect data over a longer time frame, with the subjects using the DUT at home, and to get usability feedback for 6 additional consecutive days. This protocol is to evaluate a series of design iterations to K'Watch CGM system and its use on various populations.
All patients included will be followed for 28 days for safety requirements. 35 patients will be included in this trial and distributed in 7 iterations. For each iteration, the device tested will be improved according to the results obtained in the previous iteration.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Iteration | – | Device: K'watch35 patients will be included in 7 iterations. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with Type 1 and 2 of diabetes
Key inclusion criteria (19 listed)
- Female or male,
- Subject with Type 1 Diabetes, or subject with Type 2 Diabetes (depending on the study iteration), - Type 1 Diabetes subjects taking insulin need to be on their current insulin regimen for ≥ 3 months prior to study entry,
- Only patients using Dexcom device
- Adult subjects, age 18 or older and ≤80 years,
- Phototype: I to IV according to Fitzpatrick scale,
Key exclusion criteria (18 listed)
- Subject with a known allergy to the components of the K'Watch CGM system (adhesive, disinfectants used during the study, ...),
- Subject implanted with Active Medical device (Pacemaker, Defibrillator, any kind of active implantable medical devices that require active sensing to performed it intended use)
- Subject suffering or having history of carpal tunnel syndrome,
- Woman of childbearing potential not using an effective contraceptive, pregnant or breastfeeding,
- Use of drugs that may interfere with glucose metabolism (such as steroids) unless they are chronic therapies whose dosage has remained stable over the past 3 months and is expected to remain stable during the study 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 |
|---|---|---|
| K'watchPatients | Device | Iteration |
Primary outcome
to determine the accuracy of K'Watch Release 0.x CGM system glucose readings at day 1 as compared to standard references.
Time frame: 14 months
The Primary endpoint in this trial is the degree of compliance with the accuracy section of the FDA Class II Integrated continuous glucose monitoring (iCGM) requirements after one entire day.
4 secondary outcomes
Accuracy of the investigational device compared to the standard reference CGM devices
Time frame: Between day1 and day 7
The number and duration of gaps in sensor data availability
Time frame: 14 months
Safety of the K'Watch system, characterizing device-related Adverse Events
Time frame: 14 months
Safety of the K'Watch system characterizing device-related pain intensity (Visual Analogue Scale scores from 0-10) recorded during the study.
Time frame: 14 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2022.
Related trials for Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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. This study is not recruiting at the moment.
TOM TB BISHOP contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes, run by PKvitality 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 19 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: status not confirmed, as of the sponsor's last update on 2 May 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Timothy TB Bailey, MD (877-567-2627, info@amcrinstitute.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to determine the accuracy of K'Watch Release 0.x CGM system glucose readings at day 1 as compared to standard references. (time frame: 14 months). 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 2 May 2022.