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OpenTrials
Completed

NCT Number: NCT05995756

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

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).

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Key information

Conditions

Type 1 or Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Pinggu Hospital, Beijing, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. overall mean absolute relative difference (MARD)

    Time frame: 8 or 15 days

Sponsors and collaborators

Lead sponsor

Sinocare

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 16, 2023
Registry last updated
Sep 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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