Trials / Completed
CompletedNCT05995756
Evaluate the Safety and Efficacy of Sinocare CGM System Regarding Real Time Glucose Level Monitoring
Evaluate the Safety and Efficacy of Sinocare CGM System Regarding Real Time Glucose
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 120 (actual)
- Sponsor
- Sinocare · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
From Jan 2022 to June 2022, 120 subjects (22-75 years of age, mean ±standard deviation \[SD\] of 53.20 ±14.49 years) with type 1 or type 2 diabetes participated in the study in P.R. China. Subjects wore two sensors in the abdomen which were paired with smart devices running a glucose monitoring mobile application (i3/H3 CGM APP). Subjects were asked to undergo one in-clinic visit (on one of the study days 2, 7-9, or 15) for 7-hour long YSI frequent sampling test (FST) periods, where intravenous (IV) blood samples were drawn every 15 min and analyzed using the YSI 2300 STAT Plus Glucose \& Lactate Analyzer (Yellow Springs Instrument, YSI Life Sciences, Yellow Springs, OH).
Conditions
Timeline
- Start date
- 2021-12-20
- Primary completion
- 2022-06-30
- Completion
- 2022-06-30
- First posted
- 2023-08-16
- Last updated
- 2023-09-01
Locations
3 sites across 1 country: China
Source: ClinicalTrials.gov record NCT05995756. Inclusion in this directory is not an endorsement.