Comparison Evaluation of Blood Glucose Meter Systems

Ascensia Diabetes Care

Status: Completed

Conditions: Diabetes

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01548885

CTD-PRO-2012-001-01

Details and patient eligibility

About

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.

Enrollment: 146 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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146 participants in 1 patient group

Study Staff Test BGMSs

Experimental group

Description:

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.

Treatment:

Device: OneTouch® Ultra®2 BGMS

Device: TRUEtrack® BGMS

Device: ACCU-CHEK® Aviva BGMS

Device: FreeStyle Freedom Lite® BGMS

Device: CONTOUR® NEXT EZ BGMS