Study Results
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View full resultsBasic Information
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COMPLETED
NA
146 participants
INTERVENTIONAL
2012-03-31
2012-03-31
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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Study Staff Test BGMSs
All testing and lancings were performed by the study staff; subjects did not perform any lancing or self-testing in this study. Study Staff lanced the fingers of subjects and tested the blood samples using five Blood Glucose Monitoring Systems(BGMS): FreeStyle Freedom Lite® BGMS; ACCU-CHEK® Aviva BGMS; TRUEtrack® BGMS; OneTouch® Ultra®2 BGMS; CONTOUR® NEXT EZ BGMS.
CONTOUR® NEXT EZ BGMS
Study staff performed Blood Glucose (BG) testing with capillary fingerstick blood collected from subjects with diabetes and without diabetes (up to 10% of subjects without diabetes were included). Performance of CONTOUR® NEXT EZ BGMS was evaluated across the glucose range of the BGMs. All meter BG results were compared with capillary plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).
FreeStyle Freedom Lite® BGMS
Study staff performed Blood Glucose (BG) testing with capillary fingerstick blood collected from subjects with diabetes and without diabetes (up to 10% of subjects without diabetes were included). Performance of FreeStyle Freedom Lite® BGMS was evaluated across the glucose range of the BGMs. All meter BG results were compared with capillary plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).
ACCU-CHEK® Aviva BGMS
Study staff performed Blood Glucose (BG) testing with capillary fingerstick blood collected from subjects with diabetes and without diabetes (up to 10% of subjects without diabetes were included). Performance of ACCU-CHEK® Aviva BGMS was evaluated across the glucose range of the BGMs. All meter BG results were compared with capillary plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).
TRUEtrack® BGMS
Study staff performed Blood Glucose (BG) testing with capillary fingerstick blood collected from subjects with diabetes and without diabetes (up to 10% of subjects without diabetes were included). Performance of TRUEtrack® BGMS was evaluated across the glucose range of the BGMs. All meter BG results were compared with capillary plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).
OneTouch® Ultra®2 BGMS
Study staff performed Blood Glucose (BG) testing with capillary fingerstick blood collected from subjects with diabetes and without diabetes (up to 10% of subjects without diabetes were included). Performance of OneTouch® Ultra®2 BGMS was evaluated across the glucose range of the BGMs. 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 EZ BGMS
Study staff performed Blood Glucose (BG) testing with capillary fingerstick blood collected from subjects with diabetes and without diabetes (up to 10% of subjects without diabetes were included). Performance of CONTOUR® NEXT EZ BGMS was evaluated across the glucose range of the BGMs. All meter BG results were compared with capillary plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).
FreeStyle Freedom Lite® BGMS
Study staff performed Blood Glucose (BG) testing with capillary fingerstick blood collected from subjects with diabetes and without diabetes (up to 10% of subjects without diabetes were included). Performance of FreeStyle Freedom Lite® BGMS was evaluated across the glucose range of the BGMs. All meter BG results were compared with capillary plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).
ACCU-CHEK® Aviva BGMS
Study staff performed Blood Glucose (BG) testing with capillary fingerstick blood collected from subjects with diabetes and without diabetes (up to 10% of subjects without diabetes were included). Performance of ACCU-CHEK® Aviva BGMS was evaluated across the glucose range of the BGMs. All meter BG results were compared with capillary plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).
TRUEtrack® BGMS
Study staff performed Blood Glucose (BG) testing with capillary fingerstick blood collected from subjects with diabetes and without diabetes (up to 10% of subjects without diabetes were included). Performance of TRUEtrack® BGMS was evaluated across the glucose range of the BGMs. All meter BG results were compared with capillary plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).
OneTouch® Ultra®2 BGMS
Study staff performed Blood Glucose (BG) testing with capillary fingerstick blood collected from subjects with diabetes and without diabetes (up to 10% of subjects without diabetes were included). Performance of OneTouch® Ultra®2 BGMS was evaluated across the glucose range of the BGMs. 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
* 18 years of age or older
* 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-PRO-2012-001-01
Identifier Type: -
Identifier Source: org_study_id
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