Continuous Glucose Monitor Accuracy and Safety in Adults with Type 1 Diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with type 1 diabetes will wear two CGM sensors to compare interstitial glucose readings with venous plasma glucose reference tests. The study plans at least 36 participants, each undergoing four clinic visits with blood draws and sensor wear. Data will focus on the accuracy and safety of the CGM system during real-time use. The trial is conducted at Zibo Central Hospital under SiBionics, Co., Ltd.

Why it matters

Who can join: the full rules

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

Where it's running

• Zibo Central Hospital
  Zibo, Shandong, China Recruiting

Study contacts

• Study coordinator: Xiaodong Zhao
• Email: xd.zhao26@outlook.com
• Phone: 0533-3570000

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.