Performance Evaluation of an Investigational Blood Glucose Monitoring System

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer HealthCare, Diabetes Care
ClinicalTrials.gov Identifier:
NCT01598610
First received: May 13, 2012
Last updated: July 29, 2013
Last verified: July 2013
  Purpose

The purpose of this study is to demonstrate that untrained subjects who have diabetes can operate the Investigational Blood Glucose Monitoring System (BGMS) and obtain valid glucose results.


Condition Intervention
Diabetes
Device: CONTOUR® PLUS Investigational BG Monitoring System

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Performance of the CONTOUR® PLUS Blood Glucose Monitoring System With CONTOUR® PLUS Strip

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Percent of Self-Test Fingerstick Blood Glucose Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    Untrained subjects with diabetes self-test fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. BG results are used to calculate the number of BGMS results within +/- 15mg/dL (<75mg/dL YSI capillary plasma) or +/- 20% (>=75mg/dL YSI capillary plasma) of the reference method results.


Secondary Outcome Measures:
  • Percent of Glucose Results From Alternative Site Testing (AST) of the Palm Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    Untrained subjects with diabetes self-test Alternative Site (AST) Palm blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS AST results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. BG results are used to calculate the number of AST BGMS results within +/- 15mg/dL (<75mg/dL YSI capillary plasma) or +/- 20% (>=75mg/dL YSI capillary plasma) of the reference method results.

  • Percent of Venous Blood Glucose Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    Study staff tested subject venous blood using an investigational Blood Glucose Monitoring System (BGMS). Venous BGMS results are compared with venous plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. Venous plasma BG results are used to calculate the number of BGMS results within +/- 15mg/dL (<75mg/dL YSI venous plasma) or +/- 20% (>=75mg/dL YSI venous plasma) of the reference method results.

  • Percent of Self-Test Fingerstick Blood Glucose Results Within +/- 5to15mg/dL (<100mg/dL) or Within +/- 5to15% (>=100mg/dL) of Laboratory Glucose Method [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    Untrained subjects with diabetes self-test fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. BG results are used to calculate the number of BGMS results within +/- 5to15mg/dL (<100mg/dL YSI capillary plasma) or +/- 5to15% (>=100mg/dL YSI capillary plasma) of the reference method results.

  • Percent of Subject Fingerstick BG Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method When Tested by Study Staff [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    Study staff test subject fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. BG results are used to calculate the number of BGMS results within +/- 15mg/dL (<75mg/dL YSI capillary plasma) or +/- 20% (>=75mg/dL YSI capillary plasma) of the reference method results.

  • Number of Subject Responses 'Strongly Agree' 'Agree' or 'Neutral' With Questionnaire Statements [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    Subjects respond to statements read by study staff to provide feedback on the labeling materials and system ease of use. Subjects may respond 'Strongly Agree' 'Agree' 'Neutral' 'Disagree' or 'Strongly Disagree'.


Enrollment: 220
Study Start Date: May 2012
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intended Users of the Monitoring System
Untrained subjects with diabetes use CONTOUR® PLUS Investigational BG Monitoring System.
Device: CONTOUR® PLUS Investigational BG Monitoring System
Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the CONTOUR® PLUS Investigational BG Monitoring System. Study staff test subject venous blood. All Blood Glucose (BG) results are compared to a reference laboratory glucose method.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females, 18 years of age and older
  • Type 1 or type 2 diabetes
  • Able to speak, read, and understand English
  • Willing to complete all study procedures

Exclusion Criteria:

  • Pregnancy
  • Hemophilia or any other bleeding disorder
  • Previously participated in a study using the CONTOUR PLUS system
  • Working for a medical laboratory, hospital or other clinical setting that involves training on and clinical use of blood glucose monitors.
  • Working for a competitive medical device company, or having an immediate family member or someone who is not a family member but is living within the household of someone who works for such a company.
  • A condition, which in the opinion of the investigator, would put the person or study conduct at risk (reason for exclusion will be clearly documented by investigator or designee).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01598610

Locations
United States, Indiana
Midwest Institute For Clinical Research
Indianapolis, Indiana, United States, 46260
United States, New Jersey
Consumer Product Testing Co.
Fairfield, New Jersey, United States, 07004
Sponsors and Collaborators
Bayer HealthCare, Diabetes Care
Investigators
Principal Investigator: Phillip D Toth, MD, FACP Midwest Institute For Clinical Research
Principal Investigator: Michael Caswell, PhD Consumer Product Testing Co.
  More Information

No publications provided

Responsible Party: Bayer HealthCare, Diabetes Care
ClinicalTrials.gov Identifier: NCT01598610     History of Changes
Other Study ID Numbers: CTD-2012-002-01
Study First Received: May 13, 2012
Results First Received: May 30, 2013
Last Updated: July 29, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on July 28, 2014