Status:
COMPLETED
OneTouch® Verio™Pro+ Blood Glucose Monitoring System Clinical Accuracy Study in China
Lead Sponsor:
Johnson & Johnson Medical, China
Conditions:
Blood Glucose Measurement
Eligibility:
All Genders
18+ years
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 accurac...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 31 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 31 2012
Estimated Enrollment :
301 Patients enrolled
Trial Details
Trial ID
NCT01795625
Start Date
August 31 2012
End Date
October 31 2012
Last Update
August 21 2023
Active Locations (2)
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1
Shanghai First People's Hospital
Shanghai, China
2
Shanghai Jiaotong University, medical school affiliated Third People's Hospital
Shanghai, China