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

NCT ID: NCT05995756

Last Updated: 2023-09-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-12-20
• Study Completion Date: 2022-06-30

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).

Conditions

Type 1 or Type 2 Diabetes

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

In pateint

No interventions assigned to this group

Out pateint

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Aged ≥18 years, male or female;

2. Clinically diagnosed with diabetes;

3. Being willing to wear the investigational device for the duration set according to its service life, and conduct glucose monitoring;

4. Consent to participate in this clinical study, and sign the Informed Consent Form (ICF).

Exclusion Criteria

1. Disagree to wear the investigational device continuously according to the requirements of the trial;

2. Refuse venous blood collection for 7 consecutive hours (every 15 minutes) on a certain day during the trial;

3. Plan to undergo magnetic resonance imaging (MRI) during the clinical trial;

4. With diffuse subcutaneous nodules at the wearing site of the investigational device;

5. Have a history of diabetic ketoacidosis or hyperosmolar hyperglycemic state within the 6 months prior to screening;

6. With mental disorders, lack of self-control and inability to express clearly;

7. Have participated in any other clinical trial within the past 1 month;

8. Where the investigator thinks not suitable for being enrolled.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sinocare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing Pinggu Hospital

Beijing, , China

Peking University People's Hospital

Beijing, , China

The Second Xiangya Hospital of Central South University

Changsha, , China

Countries

China

Other Identifiers

NPI031-CIP-001

Identifier Type: -

Identifier Source: org_study_id