Clinical Investigation of K'Watch - Lab & Home Study

NCT05093569 | Unknown FDA Device

• 1 other identifier: PRT00014
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes

Keywords

k'watch, diabetes,CGM

Outcome Measures

Primary Outcomes (1)

• 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.

  14 months

Secondary Outcomes (4)

• Accuracy of the investigational device compared to the standard reference CGM devices

  Between day1 and day 7

• The number and duration of gaps in sensor data availability

  14 months

• Safety of the K'Watch system, characterizing device-related Adverse Events

  14 months

• Safety of the K'Watch system characterizing device-related pain intensity (Visual Analogue Scale scores from 0-10) recorded during the study.

  14 months

Study Arms (1)

Iteration

35 patients will be included in 7 iterations.

Device: K'watch

Interventions

K'watch DEVICE

Patients

Iteration

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Type 1 and 2 of diabetes

You may qualify if:

• 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,
• 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

You may not qualify if:

• 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,
• 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,
• 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,

Sponsors & Collaborators

• PKvitality: lead

Study Sites (1)

AMCR Institute

San Diego, California, 92025, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Timothy TB Bailey, MD

CONTACT

877-567-2627; info@amcrinstitute.com

TOM TB BISHOP

CONTACT

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2021
• First Posted: October 26, 2021
• Study Start: November 15, 2021
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: May 2, 2022

Record last verified: 2022-04

Locations

US (1)