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Evaluate the Safety and Efficacy of Sinocare CGM System Regarding Real Time Glucose Level Monitoring

NCT05995756 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2023-09-01

No results posted yet for this study

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

  • Type 1 or Type 2 Diabetes

Sponsors & Collaborators

  • Sinocare

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-20
Primary Completion
2022-06-30
Completion
2022-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05995756 on ClinicalTrials.gov