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

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).

Study Overview

• Status: Completed
• Conditions: Type 1 or Type 2 Diabetes

• Study Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Peking University People's Hospital
  • Beijing, China
    • Beijing Pinggu Hospital
  • Changsha, China
    • The Second Xiangya Hospital of Central South University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult (Aged ≥18) TD1 and TD2

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
In pateint
Out pateint

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
overall mean absolute relative difference (MARD)	8 or 15 days

Collaborators and Investigators

• Sponsor: Sinocare

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2021
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: August 9, 2023
• First Submitted That Met QC Criteria: August 9, 2023
• First Posted (Actual): August 16, 2023

Study Record Updates

• Last Update Posted (Actual): September 1, 2023
• Last Update Submitted That Met QC Criteria: August 29, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: NPI031-CIP-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No