Study Results
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View full resultsBasic Information
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COMPLETED
NA
112 participants
INTERVENTIONAL
2012-10-31
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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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Subjects with and without Diabetes
All testing and lancing were performed by the study staff; Subjects with and without Diabetes did not perform any lancing or self-testing in this study. Study Staff lanced the fingers of subjects and tested the blood samples using three Blood Glucose Monitoring Systems (BGMS): Contour® NEXT LINK BGMS; OneTouch® UltraLink® BGMS; Nova Max Link® BGMS.
Contour® NEXT LINK BGMS
Study staff performed Blood Glucose (BG) tests with capillary fingerstick blood collected from subjects with and without diabetes (up to 10% of subjects without diabetes were included). Performance of Contour® NEXT LINK BGMS was evaluated across the glucose range of the BGMSs. All meter BG results were compared with capillary plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).
OneTouch® UltraLink® BGMS
Study staff performed Blood Glucose (BG) tests with capillary fingerstick blood collected from subjects with and without diabetes (up to 10% of subjects without diabetes were included). Performance of OneTouch® UltraLink® BGMS was evaluated across the glucose range of the BGMSs. All meter BG results were compared with capillary plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).
Nova Max Link® BGMS
Study staff performed Blood Glucose (BG) tests with capillary fingerstick blood collected from subjects with and without diabetes (up to 10% of subjects without diabetes were included). Performance of Nova Max Link® BGMS was evaluated across the glucose range of the BGMSs. All meter BG results were compared with capillary plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).
Interventions
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Contour® NEXT LINK BGMS
Study staff performed Blood Glucose (BG) tests with capillary fingerstick blood collected from subjects with and without diabetes (up to 10% of subjects without diabetes were included). Performance of Contour® NEXT LINK BGMS was evaluated across the glucose range of the BGMSs. All meter BG results were compared with capillary plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).
OneTouch® UltraLink® BGMS
Study staff performed Blood Glucose (BG) tests with capillary fingerstick blood collected from subjects with and without diabetes (up to 10% of subjects without diabetes were included). Performance of OneTouch® UltraLink® BGMS was evaluated across the glucose range of the BGMSs. All meter BG results were compared with capillary plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).
Nova Max Link® BGMS
Study staff performed Blood Glucose (BG) tests with capillary fingerstick blood collected from subjects with and without diabetes (up to 10% of subjects without diabetes were included). Performance of Nova Max Link® BGMS was evaluated across the glucose range of the BGMSs. All meter BG results were compared with capillary plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).
Eligibility Criteria
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Inclusion Criteria
* Willing to complete all study procedures
Exclusion Criteria
* Hemophilia or any other bleeding disorder
* Pregnancy
18 Years
ALL
Yes
Sponsors
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Ascensia Diabetes Care
INDUSTRY
Responsible Party
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Principal Investigators
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David Simmons, MD
Role: PRINCIPAL_INVESTIGATOR
Ascensia Diabetes Care
Locations
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Bayer HealthCare LLC, Diabetes Care
Mishawaka, Indiana, United States
Countries
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Other Identifiers
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CTD-2012-007-01
Identifier Type: -
Identifier Source: org_study_id
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