Clinical Investigation of K'Watch - Lab & Home 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.

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.