Evaluation of Blood Glucose Meter Systems

Ascensia Diabetes Care

Status: Completed

Conditions: Diabetes

Treatments: Device: Contour® PLUS BGMS; Device: Accu-Chek® Performa BGMS; Device: Freestyle Freedom® BGMS; Device: Accu-Chek® Active BGMS; Device: OneTouch® SelectSimple™ BGMS

Study type: Interventional

Funder types: Industry

Identifiers

NCT01714232

CTD-2012-008-01

Details and patient eligibility

About

The purpose of this study was to evaluate the performance of a Bayer Blood Glucose Monitoring System (BGMS) and four additional Blood Glucose Monitoring Systems (BGMS) from other manufacturers. All meter BG results were compared with plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).

Full description

The purpose of this study was to evaluate the performance of a Bayer Blood Glucose Monitoring System (BGMS) and four additional Blood Glucose Monitoring Systems (BGMS) from other manufacturers. All meter BG results were compared with plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer). Performance of the five systems were evaluated across the glucose range of the BGMSs using capillary blood. All testing and lancing were 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.

Enrollment: 106 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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106 participants in 1 patient group

Study Staff Test BGMSs

Experimental group

Description:

All testing and lancing 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): Contour® PLUS BGMS; OneTouch® SelectSimple™ BGMS; Accu-Chek® Performa BGMS; Accu-Chek® Active BGMS; Freestyle Freedom® BGMS.

Treatment:

Device: Accu-Chek® Active BGMS

Device: Freestyle Freedom® BGMS

Device: Contour® PLUS BGMS

Device: Accu-Chek® Performa BGMS

Device: OneTouch® SelectSimple™ BGMS