Clinical Investigation of K'Watch - Lab & Home Study (GLAM)

• ClinicalTrials.gov Identifier: NCT05093569
• Recruitment Status: Recruiting
• First Posted: October 26, 2021
• Last Update Posted: May 2, 2022
• Sponsor: PKvitality
• Information provided by (Responsible Party): PKvitality

Tracking Information

• First Submitted Date: September 29, 2021
• First Posted Date: October 26, 2021
• Last Update Posted Date: May 2, 2022
• Actual Study Start Date: November 15, 2021
• Estimated Primary Completion Date: December 30, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 25, 2022)

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.

Original Primary Outcome Measures (submitted: October 25, 2021)

to determine the accuracy of K'Watch Release 0.x CGM system glucose readings at day 1 as compared to standard references. [ Time Frame: 9 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.

Current Secondary Outcome Measures (submitted: April 25, 2022)

• Accuracy of the investigational device compared to the standard reference CGM devices [ Time Frame: Between day1 and day 7 ]
  Accuracy of the investigational device compared to the standard reference CGM devices by measuring the median absolute relative difference (MARD)
• The number and duration of gaps in sensor data availability [ Time Frame: 14 months ]
  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"
• Safety of the K'Watch system, characterizing device-related Adverse Events [ Time Frame: 14 months ]
  Safety of the K'Watch system, characterizing device-related Adverse Events
• 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 ]
  Safety of the K'Watch system characterizing device-related pain intensity (Visual Analogue Scale scores from 0-10) recorded during the study.

Original Secondary Outcome Measures (submitted: October 25, 2021)

• Accuracy of the investigational device compared to the standard reference CGM devices [ Time Frame: Between day1 and day 7 ]
  Accuracy of the investigational device compared to the standard reference CGM devices by measuring the median absolute relative difference (MARD)
• The number and duration of gaps in sensor data availability [ Time Frame: 9 months ]
  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"
• Safety of the K'Watch system, characterizing device-related Adverse Events [ Time Frame: 9 months ]
  Safety of the K'Watch system, characterizing device-related Adverse Events
• Safety of the K'Watch system characterizing device-related pain intensity (Visual Analogue Scale scores from 0-10) recorded during the study. [ Time Frame: 9 months ]
  Safety of the K'Watch system characterizing device-related pain intensity (Visual Analogue Scale scores from 0-10) recorded during the study.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Clinical Investigation of K'Watch - Lab & Home Study
• Official Title: Clinical Investigation of K'Watch - Lab & Home Study
• Brief 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 ) . 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 Type: Observational
• Study Design: Observational Model: Other; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Patients with Type 1 and 2 of diabetes
• Condition: Diabetes

Intervention

Device: K'watch

Patients

Study Groups/Cohorts

Iteration

35 patients will be included in 7 iterations.

Intervention: Device: K'watch

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: October 25, 2021): 35
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 30, 2022
• Estimated Primary Completion Date: December 30, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. Female or male,
2. 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,
3. Only patients using Dexcom device
4. Adult subjects, age 18 or older and ≤80 years,
5. Phototype: I to IV according to Fitzpatrick scale,
6. BMI ≤40 kg/m²,
7. Subject free from analgesics, anti-inflammatory drugs, antihistamines and/or local anesthetics within 7 days before inclusion and for the duration of the study,
8. Subject with a sufficient hand dexterity to apply the device,
9. Not practice vigorous physical exercise (running, fast cycling, aerobics) during the study period,
10. For subjects with Type 1 Diabetes, subjects must already be using a CGM (Abbott / Dexcom),

11. 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,
12. Wrist size in the range 16 - 21 cm,
13. Patients with hairiness grade between 1 to 3
14. Sufficient cooperation and understanding to comply with the study requirements,
15. Speak and read the English language,
16. Signed informed consent form prior to study entry.

Exclusion Criteria:

1. Subject with a known allergy to the components of the K'Watch CGM system (adhesive, disinfectants used during the study, ...),
2. Subject implanted with Active Medical device (Pacemaker, Defibrillator, any kind of active implantable medical devices that require active sensing to performed it intended use)
3. Subject suffering or having history of carpal tunnel syndrome,
4. Woman of childbearing potential not using an effective contraceptive, pregnant or breastfeeding,
5. 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,
6. 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,
7. Subject exercising a professional or a daily recreational activity involving immersion in the water of the K'Watch CGM system (e.g. lifeguard, plumber, …),
8. Subject with tattoos, piercings or implants at the proposed application site,
9. 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,
10. Use of recreational drugs which would interfere with participation in the study, as determined by the PI,
11. 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,
12. Application of cosmetics on the application area of the device the day before the Lab phase and during the Study Period,
13. Intensive exposure to sunlight or UV-rays within the previous month and/or foreseen during the study,
14. Subject with a scheduled radiographic, MRI, CT or diathermy appointment during the study participation period, and the appointment cannot be postponed,
15. 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,
16. Subject currently is participating in another clinical trial,
17. 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).
18. Prisoners or subjects who are involuntarily incarcerated

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Not Provided

Contacts

Contact: Timothy TB Bailey, MD; 877-567-2627; info@amcrinstitute.com

Contact: TOM TB BISHOP

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05093569
• Other Study ID Numbers: PRT00014
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes
• Product Manufactured in and Exported from the U.S.: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: PKvitality
• Original Responsible Party: Same as current
• Current Study Sponsor: PKvitality
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: PKvitality
• Verification Date: April 2022