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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01795625

Enrollment

301

Registered

2013-02-20

Start date

2012-08-31

Completion date

2012-10-31

Last updated

2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Glucose Measurement

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
• 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	56days	August 20,2012\ October 14,2012

Countries

China

Outcome results