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.
1 other identifier
observational
301
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2012
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 31, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2012
CompletedFirst Submitted
Initial submission to the registry
February 18, 2013
CompletedFirst Posted
Study publicly available on registry
February 20, 2013
CompletedAugust 21, 2023
August 1, 2023
2 months
February 18, 2013
August 18, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
• 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
August 20,2012\~October 14,2012
56days
Eligibility Criteria
The study population will consist of at least 240 diabetic subjects (type 1 or type 2) study-wide at two clinical sites.
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Shanghai First People's Hospital
Shanghai, China
Shanghai Jiaotong University, medical school affiliated Third People's Hospital
Shanghai, China
Study Officials
- PRINCIPAL INVESTIGATOR
Yongde Peng, Professor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- PRINCIPAL INVESTIGATOR
Fengling Chen, Professor
Shanghai Jiaotong University, medical school affiliated Third People's Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 18, 2013
First Posted
February 20, 2013
Study Start
August 31, 2012
Primary Completion
October 31, 2012
Study Completion
October 31, 2012
Last Updated
August 21, 2023
Record last verified: 2023-08