Clinical Investigation of K'Watch - Lab & Home Study (GLAM)
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|ClinicalTrials.gov Identifier: NCT05093569|
Recruitment Status : Recruiting
First Posted : October 26, 2021
Last Update Posted : December 16, 2021
|Condition or disease||Intervention/treatment|
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 7 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 4 iterations. For each iteration, the device tested will be improved according to the results obtained in the previous iteration.
|Study Type :||Observational|
|Estimated Enrollment :||35 participants|
|Official Title:||Clinical Investigation of K'Watch - Lab & Home Study|
|Actual Study Start Date :||November 15, 2021|
|Estimated Primary Completion Date :||April 30, 2022|
|Estimated Study Completion Date :||June 30, 2022|
35 patients will be included in 4 iterations.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05093569
|Contact: Timothy TB Bailey, MDfirstname.lastname@example.org|
|Contact: TOM TB BISHOP|