Evaluation of Blood Glucose Monitoring Systems

Ascensia Diabetes Care

Status: Completed

Conditions: Diabetes

Treatments: Device: Contour® NEXT LINK BGMS; Device: OneTouch® UltraLink® BGMS; Device: Nova Max Link® BGMS

Study type: Interventional

Funder types: Industry

Identifiers

NCT01699763

CTD-2012-007-01

Details and patient eligibility

About

The purpose of this study was to evaluate the performance of a Bayer Blood Glucose Monitoring System (BGMS) and 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).

Full 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.

Enrollment: 112 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)

---

112 participants in 1 patient group

Subjects with and without Diabetes

Experimental group

Description:

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.

Treatment:

Device: OneTouch® UltraLink® BGMS

Device: Nova Max Link® BGMS

Device: Contour® NEXT LINK BGMS