Comparison Evaluation of Blood Glucose Meter Systems

Not Applicable

Completed

Conditions: Diabetes

Interventions: Device: CONTOUR® NEXT EZ BGMS
Device: FreeStyle Freedom Lite® BGMS
Device: ACCU-CHEK® Aviva BGMS
Device: TRUEtrack® BGMS
Device: OneTouch® Ultra®2 BGMS

Registration Number: NCT01548885

Lead Sponsor: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 146

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
Study Staff Test BGMSs	ACCU-CHEK® Aviva BGMS	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.
Study Staff Test BGMSs	CONTOUR® NEXT EZ BGMS	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.
Study Staff Test BGMSs	OneTouch® Ultra®2 BGMS	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.
Study Staff Test BGMSs	FreeStyle Freedom Lite® BGMS	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.
Study Staff Test BGMSs	TRUEtrack® BGMS	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.

Primary Outcome Measures

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

Name	Time	Method
MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) Across the Low Glucose Range (<70mg/dL)	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.