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Effectiveness and Safety Study of the GX-01 Continuous Glucose Monitoring System Used in Adult Subjects with Diabetes Mellitus

A Multicenter, Randomized, Open-Label, Self-Controlled Clinical Trial of Continuous Glucose Monitoring System Used in Adult Subjects with Diabetes Mellitus

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200064004
Enrollment
Unknown
Registered
2022-09-23
Start date
2022-09-23
Completion date
Unknown
Last updated
2025-03-17

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

Conditions

Diabetes

Interventions

A/B/C:Continuously wear the study medical device for 15 days

Sponsors

The First Medical Center of Chinese PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged > 18 years; 2. Diagnosis of diabetes mellitus; 3. Willing to continuously wear the study medical device for 15 days and allow medical personnel to take blood flow samples per the study protocol; 4. Voluntarily participating and signing a written informed consent before enrollment.

Exclusion criteria

Exclusion criteria: 1. Subject has MRI appointment scheduled during the period of study participation; 2. There are diffuse subcutaneous nodules on the arm; 3. Acute complications of diabetes; 4. Patients with coagulation disorders, the criteria to determine coagulation disorders are: (1) Activated partial prothrombin time (APTT) is exceeding the 1.5 times of the upper limit of normal range, or exceeding the lower limit of normal range; or (2) Prothrombin time (PT) is exceeding the 1.5 times of the upper limit of normal range, or exceeding the lower limit of normal range; 5. Subject has participated any other clinical trial(s) within the last one month; 6. Subjects that the investigator determined as not suitable to join this study.

Design outcomes

Primary

MeasureTime frame
Accuracy;

Countries

China

Contacts

Public ContactMu Yiming

Chinese PLA General Hospital

muyiming@301hospital.com.cn+86 13910580089

Outcome results

None listed

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