Status:
COMPLETED
Evaluate the Safety and Efficacy of Sinocare CGM System Regarding Real Time Glucose Level Monitoring
Lead Sponsor:
Sinocare
Conditions:
Type 1 or Type 2 Diabetes
Eligibility:
All Genders
18+ years
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 wo...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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.
Key Trial Info
Start Date :
December 20 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2022
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT05995756
Start Date
December 20 2021
End Date
June 30 2022
Last Update
September 1 2023
Active Locations (3)
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1
Beijing Pinggu Hospital
Beijing, China
2
Peking University People's Hospital
Beijing, China
3
The Second Xiangya Hospital of Central South University
Changsha, China