Evaluation of Blood Glucose Monitoring Systems
Evaluation of Blood Glucose Meter Systems - Contour® NEXT LINK Study
1 other identifier
interventional
112
1 country
1
Brief Summary
The purpose of this study was to evaluate the performance of a Bayer Blood Glucose Monitoring System (BGMS) and two additional Blood Glucose Monitoring Systems (BGMS) from other companies. All meter BG results were compared with plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable diabetes
Started Oct 2012
1 active site
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
October 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 2, 2012
CompletedFirst Posted
Study publicly available on registry
October 4, 2012
CompletedResults Posted
Study results publicly available
November 28, 2013
CompletedFebruary 29, 2016
January 1, 2016
Same day
October 2, 2012
September 20, 2013
January 29, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) Across the Overall Tested Glucose Range
Using the overall Blood Glucose (BG) range (34 to 561 mg/dL according to YSI subject plasma results), the Mean Absolute Relative Differences (MARD) between the BGM System readings and the YSI plasma results (BG reference) were compared. MARD is calculated from the sum of all \|(BG meter)-(BG reference)\|/(BG reference) assessments, divided by the number of assessments, then multiplied by 100(%). Each evaluable sample was tested on all 3 BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MARD value indicates smaller difference between meter value and the reference value. Higher MARD value indicates larger difference between meter value and the reference value.
8 hours
Secondary Outcomes (2)
MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) in the Low Glucose Range (<=80 mg/dL)
8 hours
MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) in the High Glucose Range (>180 mg/dL)
8 hours
Study Arms (1)
Subjects with and without Diabetes
EXPERIMENTALAll 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.
Interventions
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).
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).
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
You may qualify if:
- Males and females, 18 years of age or older
- Willing to complete all study procedures
You may not qualify if:
- Blood Borne infections like hepatitis or HIV or infections such as tuberculosis
- Hemophilia or any other bleeding disorder
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bayer HealthCare LLC, Diabetes Care
Mishawaka, Indiana, 46544, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Carmine Greene
- Organization
- Ascensia Diabetes Care
Study Officials
- PRINCIPAL INVESTIGATOR
David Simmons, MD
Ascensia Diabetes Care
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 2, 2012
First Posted
October 4, 2012
Study Start
October 1, 2012
Primary Completion
October 1, 2012
Study Completion
October 1, 2012
Last Updated
February 29, 2016
Results First Posted
November 28, 2013
Record last verified: 2016-01