Evaluate the Safety and Efficacy of Sinocare CGM System Regarding Real Time Glucose Level Monitoring
1 other identifier
observational
120
1 country
3
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2021
Shorter than P25 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 20, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2022
CompletedFirst Submitted
Initial submission to the registry
August 9, 2023
CompletedFirst Posted
Study publicly available on registry
August 16, 2023
CompletedSeptember 1, 2023
August 1, 2023
6 months
August 9, 2023
August 29, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
overall mean absolute relative difference (MARD)
8 or 15 days
Study Arms (2)
In pateint
Out pateint
Eligibility Criteria
Adult (Aged ≥18) TD1 and TD2
You may qualify if:
- Aged ≥18 years, male or female;
- Clinically diagnosed with diabetes;
- Being willing to wear the investigational device for the duration set according to its service life, and conduct glucose monitoring;
- Consent to participate in this clinical study, and sign the Informed Consent Form (ICF).
You may not qualify if:
- Disagree to wear the investigational device continuously according to the requirements of the trial;
- Refuse venous blood collection for 7 consecutive hours (every 15 minutes) on a certain day during the trial;
- Plan to undergo magnetic resonance imaging (MRI) during the clinical trial;
- With diffuse subcutaneous nodules at the wearing site of the investigational device;
- Have a history of diabetic ketoacidosis or hyperosmolar hyperglycemic state within the 6 months prior to screening;
- With mental disorders, lack of self-control and inability to express clearly;
- Have participated in any other clinical trial within the past 1 month;
- Where the investigator thinks not suitable for being enrolled.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sinocarelead
Study Sites (3)
Beijing Pinggu Hospital
Beijing, China
Peking University People's Hospital
Beijing, China
The Second Xiangya Hospital of Central South University
Changsha, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 9, 2023
First Posted
August 16, 2023
Study Start
December 20, 2021
Primary Completion
June 30, 2022
Study Completion
June 30, 2022
Last Updated
September 1, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will not share