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

Completed
Conditions
Blood Glucose Measurement
Registration Number
NCT01795625
Lead Sponsor
Johnson & Johnson Medical, China
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
301
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
• 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 sample56days

August 20,2012\~October 14,2012

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (2)

Shanghai First People's Hospital

🇨🇳

Shanghai, China

Shanghai Jiaotong University, medical school affiliated Third People's Hospital

🇨🇳

Shanghai, China

Shanghai First People's Hospital
🇨🇳Shanghai, China
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