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Comparison Evaluation of Blood Glucose Meter Systems

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ClinicalTrials.gov Identifier: NCT01548885
Recruitment Status : Completed
First Posted : March 8, 2012
Results First Posted : August 6, 2013
Last Update Posted : February 29, 2016
Sponsor:
Information provided by (Responsible Party):
Ascensia Diabetes Care

Brief Summary:
The purpose of this study was to evaluate the performance of one investigational Bayer Blood Glucose meter (with investigational Bayer test strips) and four Blood Glucose Monitoring Systems from other companies. All meter BG results were compared with plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer). Performance of the five systems was evaluated across the glucose range of the BGMSs using capillary blood. All testing and lancing were performed by study staff and some blood samples were glycolyzed to lower the glucose levels.

Condition or disease Intervention/treatment Phase
Diabetes Device: CONTOUR® NEXT EZ BGMS Device: FreeStyle Freedom Lite® BGMS Device: ACCU-CHEK® Aviva BGMS Device: TRUEtrack® BGMS Device: OneTouch® Ultra®2 BGMS Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 146 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of Blood Glucose Meter Systems - NACT Study
Study Start Date : March 2012
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 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.
Device: 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).
Device: 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).
Device: 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).
Device: 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).
Device: 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).



Primary Outcome Measures :
  1. MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) Across the Overall Tested Glucose Range [ Time Frame: 10 hours ]
    Using the overall Blood Glucose(BG) range (24 to 386mg/dL), the Mean Absolute Relative Differences (MARD) between the BGM System readings and the YSI laboratory reference values 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 five 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.


Secondary Outcome Measures :
  1. MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) Across the Low Glucose Range (<70mg/dL) [ Time Frame: 10 hours ]
    Using fresh and glycolyzed samples with Blood Glucose(BG) below 70 mg/dL, the Mean Absolute Relative Differences (MARD) between the BGM System readings and the YSI laboratory reference values 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 five 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Males and females
  • 18 years of age or older
  • Willing to complete all study procedures

Exclusion Criteria:

  • Blood Borne infections like hepatitis or HIV or infections such as tuberculosis
  • Hemophilia or any other bleeding disorder
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01548885


Locations
United States, Indiana
Bayer HealthCare LLC, Diabetes Care
Mishawaka, Indiana, United States, 46544
Sponsors and Collaborators
Ascensia Diabetes Care
Investigators
Principal Investigator: David Simmons, MD Ascensia Diabetes Care

Responsible Party: Ascensia Diabetes Care
ClinicalTrials.gov Identifier: NCT01548885     History of Changes
Other Study ID Numbers: CTD-PRO-2012-001-01
First Posted: March 8, 2012    Key Record Dates
Results First Posted: August 6, 2013
Last Update Posted: February 29, 2016
Last Verified: January 2016