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Comparison Evaluation of Blood Glucose Meter Systems

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer HealthCare, Diabetes Care
ClinicalTrials.gov Identifier:
NCT01548885
First received: March 6, 2012
Last updated: April 5, 2012
Last verified: April 2012
History of Changes
  Purpose

The purpose of this study is 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 are compared with plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer). Performance of the five systems will be evaluated across the glucose range of the BGMSs using capillary blood with emphasis on low Blood Glucose samples. All testing and lancing will be performed by study staff and some blood samples will be glycolyzed to lower the glucose levels.


Condition Intervention
Diabetes
 Device: Five Blood Glucose Monitoring Systems

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 - NACT Study

Resource links provided by NLM:

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 EZ BGMS and BGMSs from other companies across the overall tested glucose range. [ Time Frame: 10 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluate differences in accuracy between the Bayer Contour Next EZ BGMS and BGMSs from other companies across the low glucose range (<70mg/dL) [ Time Frame: 10 hours ] [ Designated as safety issue: No ]

Enrollment: 146
Study Start Date: March 2012
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Study Staff Test BGMSs
Study Staff will lance the fingers of subjects and test the blood samples using five Blood Glucose Monitoring Systems (BGMS). All testing and lancing will be performed by the study staff; subjects will not perform any lancing or self-testing in this study.
 Device: Five 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 five Blood Glucose Monitoring Systems (BGMS) will be evaluated across the glucose range of the BGMs with emphasis on low glucose samples. All meter BG results are compared with plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).

  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: NCT01548885

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: NCT01548885     History of Changes
Other Study ID Numbers: CTD-PRO-2012-001-01
Study First Received: March 6, 2012
Last Updated: April 5, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on June 18, 2013