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A Multicenter, Self-Matched Positive Controlled Clinical Trial Protocol of Continuous Glucose Monitoring System for the Efficacy and Safety of Real-Time Monitoring of Glucose Concentration in Subcutaneous Tissue Fluid in Patients with Diabetes

A Multicenter, Self-Matched Positive Controlled Clinical Trial Protocol of Continuous Glucose Monitoring System for the Efficacy and Safety of Real-Time Monitoring of Glucose Concentration in Subcutaneous Tissue Fluid in Patients with Diabetes

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300070373
Enrollment
Unknown
Registered
2023-04-11
Start date
2022-03-24
Completion date
Unknown
Last updated
2023-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes

Interventions

Sponsors

Peking University People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: ?Patients diagnosed with type 1 or 2 diabetes. ?People aged 14 years or older, regardless of gender. ?The subjects had adequate venous access and were assessed by the researcher or appropriate staff. ?Those who sign informed consent to participate in this study voluntarily. ?The patient had good compliance and could complete the whole clinical trial.

Exclusion criteria

Exclusion criteria: ?The skin of body parts damaged, scarred, red, or infected. ?People who are allergic to disinfectants or medical tape, or susceptible to allergies. ?Patients who were using anticoagulants or had bleeding tendency within one week prior to enrollment. ?Pregnant and lactating women. ?People with mental disorders, cognitive and communication disorders, or high mental stress. ?The researcher considered that patients with poor compliance should not participate in this clinical trial. ?Subjects have received clinical study (drug or device) within the past 2 weeks.

Design outcomes

Primary

MeasureTime frame
Accuracy;

Secondary

MeasureTime frame
Alarm accuracy;Sensor stability;Repeatability of sensors;Product usability questionnaire;Sensor life;

Countries

China

Contacts

Public ContactLinong Ji

Peking University People's Hospital

jln@bjmu.edu.cn+86 10 826377

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026