Clinical Investigation of K'Watch - Lab & Home Study
NCT05093569 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 35
Last updated 2022-05-02
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
Interventions
- DEVICE
-
K'watch
Patients
Sponsors & Collaborators
-
PKvitality
lead INDUSTRY
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-11-15
- Primary Completion
- 2022-12-30
- Completion
- 2022-12-30
- FDA Device
- Yes
Countries
- United States
Study Locations
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