OneTouch® Verio™Pro+ Blood Glucose Monitoring System Clinical Accuracy Study in China
NCT ID: NCT01795625
Last Updated: 2023-08-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
301 participants
OBSERVATIONAL
2012-08-31
2012-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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 has already participated in this study.
* Subject is known pregnant
18 Years
ALL
No
Sponsors
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Johnson & Johnson Medical, China
INDUSTRY
Responsible Party
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Principal Investigators
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Yongde Peng, Professor
Role: PRINCIPAL_INVESTIGATOR
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Fengling Chen, Professor
Role: PRINCIPAL_INVESTIGATOR
Shanghai Jiaotong University, medical school affiliated Third People's Hospital
Locations
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Shanghai First People's Hospital
Shanghai, , China
Shanghai Jiaotong University, medical school affiliated Third People's Hospital
Shanghai, , China
Countries
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Other Identifiers
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LFS-201201
Identifier Type: -
Identifier Source: org_study_id
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