Evaluation of Blood Glucose Monitoring Systems - Full Text View

Purpose

The purpose of this study is 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 are compared with plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).

Condition	Intervention
Diabetes	Device: Three Blood Glucose Monitoring Systems Device: Contour® NEXT LINK BGMS Device: OneTouch® UltraLink® BGMS Device: Nova Max Link® BGMS

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	Evaluation of Blood Glucose Meter Systems - Contour® NEXT LINK Study

Resource links provided by NLM:

MedlinePlus related topics: Blood Sugar Diabetes

Drug Information available for: Dextrose

U.S. FDA Resources

Further study details as provided by Bayer HealthCare, Diabetes Care:

Primary Outcome Measures:

Evaluate differences in accuracy between the Bayer Contour NEXT LINK BGMS and BGMSs from other companies across the overall tested glucose range. [ Time Frame: 8 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Evaluate differences in accuracy between the Bayer Contour NEXT LINK BGMS and BGMSs from other companies across the low glucose range (<=80 mg/dL) [ Time Frame: 8 hours ] [ Designated as safety issue: No ]
Evaluate differences in accuracy between the Bayer Contour NEXT LINK BGMS and BGMSs from other companies in the high glucose range (>180 mg/dL) [ Time Frame: 8 hours ] [ Designated as safety issue: No ]

Enrollment:	112
Study Start Date:	October 2012
Study Completion Date:	October 2012
Primary Completion Date:	October 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Study Staff Test BGMSs All testing and lancing will be performed by the study staff; subjects will not perform any lancing or self-testing in this study. Study Staff will lance the fingers of subjects and test the blood samples using three Blood Glucose Monitoring Systems (BGMS): Contour® NEXT LINK BGMS; OneTouch® UltraLink® BGMS; Nova Max Link® BGMS.	Device: Three Blood Glucose Monitoring Systems Study staff performs Blood Glucose (BG) tests with capillary fingerstick blood collected from subjects with diabetes and without diabetes (up to 10% of subjects without diabetes may be included). Performance of three Blood Glucose Monitoring Systems (BGMS) will be evaluated across the glucose range of the BGM. All meter BG results are compared with capillary plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer). Device: Contour® NEXT LINK BGMS Study staff performs Blood Glucose (BG) tests with capillary fingerstick blood collected from subjects with diabetes and without diabetes (up to 10% of subjects without diabetes may be included). All meter BG results are compared with capillary plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer). Device: OneTouch® UltraLink® BGMS Study staff performs Blood Glucose (BG) tests with capillary fingerstick blood collected from subjects with diabetes and without diabetes (up to 10% of subjects without diabetes may be included). All meter BG results are compared with capillary plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer). Device: Nova Max Link® BGMS Study staff performs Blood Glucose (BG) tests with capillary fingerstick blood collected from subjects with diabetes and without diabetes (up to 10% of subjects without diabetes may be included). All meter BG results are compared with capillary plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).

Arms

Assigned Interventions

Experimental: Study Staff Test BGMSs

All testing and lancing will be performed by the study staff; subjects will not perform any lancing or self-testing in this study. Study Staff will lance the fingers of subjects and test the blood samples using three Blood Glucose Monitoring Systems (BGMS): Contour® NEXT LINK BGMS; OneTouch® UltraLink® BGMS; Nova Max Link® BGMS.

Device: Three Blood Glucose Monitoring Systems

Study staff performs Blood Glucose (BG) tests with capillary fingerstick blood collected from subjects with diabetes and without diabetes (up to 10% of subjects without diabetes may be included). Performance of three Blood Glucose Monitoring Systems (BGMS) will be evaluated across the glucose range of the BGM. All meter BG results are compared with capillary plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).

Device: Contour® NEXT LINK BGMS

Study staff performs Blood Glucose (BG) tests with capillary fingerstick blood collected from subjects with diabetes and without diabetes (up to 10% of subjects without diabetes may be included). All meter BG results are compared with capillary plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).

Device: OneTouch® UltraLink® BGMS

Study staff performs Blood Glucose (BG) tests with capillary fingerstick blood collected from subjects with diabetes and without diabetes (up to 10% of subjects without diabetes may be included). All meter BG results are compared with capillary plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).

Device: Nova Max Link® BGMS

Study staff performs Blood Glucose (BG) tests with capillary fingerstick blood collected from subjects with diabetes and without diabetes (up to 10% of subjects without diabetes may be included). All meter BG results are compared with capillary plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).

Detailed Description:

The purpose of this study is 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 are compared with plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer). Performance of the three systems will be evaluated across the glucose range of the BGMSs using capillary blood. All testing and lancing will be performed by study staff and some samples will be tested from subject fingertips. Additionally, some blood samples will be glycolyzed to lower the glucose concentration levels and glucose solution will be added to other samples to raise glucose concentration levels.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01699763

Locations

United States, Indiana
Bayer HealthCare LLC, Diabetes Care
Mishawaka, Indiana, United States, 46544

Sponsors and Collaborators

Bayer HealthCare, Diabetes Care

Investigators

Principal Investigator:

David Simmons, MD

Bayer HealthCare, Diabetes Care

More Information

No publications provided

Responsible Party:	Bayer HealthCare, Diabetes Care
ClinicalTrials.gov Identifier:	NCT01699763 History of Changes
Other Study ID Numbers:	CTD-2012-007-01
Study First Received:	October 2, 2012
Last Updated:	October 19, 2012
Health Authority:	United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 23, 2013