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

Johnson & Johnson (J&J)

Status: Completed

Conditions: Blood Glucose Measurement

Study type: Observational

Funder types: Industry

Identifiers

NCT01795625

LFS-201201

Details and patient eligibility

About

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.

Enrollment: 301 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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