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Completed

NCT Number: NCT01699763

Evaluation of Blood Glucose Monitoring Systems

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).

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bayer HealthCare LLC, Diabetes Care

Mishawaka, Indiana, 46544, United States

About this study

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). Performance of the three systems was evaluated across the glucose range of the BGMSs using capillary blood. All testing and lancing was performed by study staff and some samples were tested from subject fingertips. Additionally, some blood samples were glycolyzed to lower the glucose concentration levels and glucose solution was added to other samples to raise glucose concentration levels.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Contour® NEXT LINK BGMS

Device

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

Device

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

Device

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).

Primary outcomes

  1. MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) Across the Overall Tested Glucose Range

    Time frame: 8 hours

    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.

Secondary outcomes

  1. MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) in the Low Glucose Range (<=80 mg/dL)

    Time frame: 8 hours

    Using fresh and glycolyzed samples with YSI plasma Blood Glucose (BG) ≤80 mg/dL, the Mean Absolute Relative Differences (MARD) between the BGM System readings and the YSI subject 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.

  2. MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) in the High Glucose Range (>180 mg/dL)

    Time frame: 8 hours

    Using samples with YSI plasma Blood Glucose (BG) >180 mg/dL, the Mean Absolute Relative Differences (MARD) between the BGM System readings and the YSI subject 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.

Sponsors and collaborators

Lead sponsor

Ascensia Diabetes Care

Industry

Registry information

Official study title

Evaluation of Blood Glucose Meter Systems - Contour® NEXT LINK Study

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Oct 4, 2012
Registry last updated
Feb 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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