Evaluation of Blood Glucose Monitoring Systems

Not Applicable

Completed

• Conditions: Diabetes
• Interventions: Device: Contour® NEXT LINK BGMS; Device: OneTouch® UltraLink® BGMS; Device: Nova Max Link® BGMS

• Registration Number: NCT01699763
• Lead Sponsor: Ascensia Diabetes Care

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).

Detailed Description

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.

Study Timeline

• Study Start: 2012-10
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Study First Submitted: 2012-10-02
• Study First Submitted QC: 2012-10-02
• Study First Posted: 2012-10-04
• Results First Submitted: 2013-09-20
• Results First Submitted QC: 2013-09-20
• Results First Posted: 2013-11-28
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-29
• Last Update Posted: 2016-02-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Subjects with and without Diabetes	Contour® NEXT LINK BGMS	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.
Subjects with and without Diabetes	OneTouch® UltraLink® BGMS	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.
Subjects with and without Diabetes	Nova Max Link® BGMS	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.

Primary Outcome Measures

Name	Time	Method
MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) Across the Overall Tested Glucose Range	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 Outcome Measures

Name	Time	Method
MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) in the High Glucose Range (>180 mg/dL)	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.
MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) in the Low Glucose Range (<=80 mg/dL)	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.

Trial Locations

Locations (1)

Bayer HealthCare LLC, Diabetes Care; 🇺🇸 Mishawaka, Indiana, United States