Evaluation of the Accuracy and Safety of a Continuous Glucose Monitoring System
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: GS3 CGM.
- Who it may be relevant to
- Registry conditions: type1diabetes, CGM, T1D. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Evaluation of the Accuracy and Safety of a Continuous Glucose Monitoring System Across Varying Blood Glucose Ranges
Overview
The study is to evaluate the accuracy and safety of a real-time CGM system among adult patients with type 1 diabetes with respect to reference venous plasma sample measurements.
Detailed description
The study is to evaluate the accuracy and safety of a novel real-time CGM system among adult patients with type 1 diabetes mellitus with respect to YSI reference venous plasma sample measurements. No less than 36 patients will be enrolled. Each patient will wear two sensors. Interstitial glucose readings from each sensor will be obtained immediatedly following each venous blood sample test. Each participant will make 4 visits to the clinical study site, including the screening visit.
Interventions
- Device GS3 CGM
Wearing CGM for a consecutive 14 days
Primary outcome measures
- System performance [Time frame: 15 days]
- System-related Safety [Time frame: 15 days]
Eligibility criteria
Inclusion criteria
- Age ≥ 18 years
- Diagonsed with T1D
- Venous blood sampling access can be established in the forearm
- Capable of independently reading instructions and complying with the clinical trial requirements
- Willing to sign the Informed Consent Form (ICF)
Exclusion criteria
- Severe hypoglycemia within the past 6 month
- Heart failure or hemiplegic sequelae due to prior cerebrovascular disease
- Severe skin conditions at the sensor wear site
- Extensive systemic skin disorders
- Coagulation disorders confirmed by the investigator
- Anemia or abnormal hematocrit
- Blood donation within the past 6 months
- Pregnancy (defined as positive urine test in women ≤55 years), lactation, or plans for pregnancy within ≤30 days
- Current or recent (≤1 month) participation in other clinical trials
- Planned MRI/CT scans during sensor wear
- Allergy to medical adhesives or alcohol
- Conditions impairing comprehension of informed consent or study procedures
- Other exclusionary conditions per investigator's discretion
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
China · 1 center
- Zibo Central Hospital — Zibo
Identifiers
NCT: NCT07745244 · SS-KY-iCGM-0002