OneTouch® Verio™Pro+ Blood Glucose Monitoring System Clinical Accuracy Study in China

Overview

The evaluation will determine professional clinical accuracy comparing the OneTouch® Verio™Pro+ blood glucose results with the YSI 2300 analyzer. "Professional Clinical Accuracy" is defined as accuracy of the system when used by a trained healthcare professional.

Full Title of Study: “A Multi-centre, Open Clinical Evaluation to Determine Professional Clinical Accuracy Comparing the OneTouch® Verio™Pro+ Blood Glucose Results With the YSI 2300 Analyzer.”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: October 2012

Clinical Trial Outcome Measures

Primary Measures

  • • Obtain professional clinical accuracy data for the OneTouch® Verio™Pro+ blood glucose monitoring meter in comparison with a standard laboratory reference (YSI 2300 glucose analyzer) using a capillary blood sample and a venous sample
    • Time Frame: August 20,2012~October 14,2012

Participating in This Clinical Trial

Inclusion Criteria

  • Subject is at least 18 years of age.
  • Subject has been diagnosed with diabetes mellitus (type 1 or type 2 diabetes)
  • Subject agrees to sign two (2) copies each of the Subject Informed Consent Form and to follow the procedures of the study.
  • Subject agrees to allow the HCP to perform finger stick for blood glucose test by the meter and the YSI instrument. Up to one retry of finger stick will be needed in the event of insufficient blood collected or test failure.
  • Subject agrees to allow the HCP to perform venous puncture for blood glucose test by the meter and the YSI instrument, and for haematocrit (HCT) test. Up to one retry of venous puncture will be needed in the event of insufficient blood collected or test failure.
  • Subject agrees to provide demographic and medical history information and give access to medical records where appropriate.

Exclusion Criteria

  • Subject is currently working for, has previously worked for, or has an immediate family member working for a company manufacturing and/or marketing blood glucose monitoring products.
  • Subject has already participated in this study.
  • Subject is known pregnant

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Johnson & Johnson Medical, China
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Yongde Peng, Professor, Principal Investigator, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
    • Fengling Chen, Professor, Principal Investigator, Shanghai Jiaotong University, medical school affiliated Third People’s Hospital

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