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Performance Evaluation of an Investigational Blood Glucose Monitoring System

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ClinicalTrials.gov Identifier: NCT01598610
Recruitment Status : Completed
First Posted : May 15, 2012
Results First Posted : July 30, 2013
Last Update Posted : February 29, 2016
Sponsor:
Information provided by (Responsible Party):
Ascensia Diabetes Care

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Device: CONTOUR® PLUS Investigational BG Monitoring System Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 220 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Performance of the CONTOUR® PLUS Blood Glucose Monitoring System With CONTOUR® PLUS Strip
Study Start Date : May 2012
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    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 :
  1. 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 ]
    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.

  2. Percent of Venous Blood Glucose Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method [ Time Frame: 1 hour ]
    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.

  3. 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 ]
    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.

  4. 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 ]
    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.

  5. Number of Subject Responses 'Strongly Agree' 'Agree' or 'Neutral' With Questionnaire Statements [ Time Frame: 1 hour ]
    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'.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01598610


Locations
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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
Ascensia Diabetes Care
Investigators
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Principal Investigator: Phillip D Toth, MD, FACP Midwest Institute For Clinical Research
Principal Investigator: Michael Caswell, PhD Consumer Product Testing Co.
More Information
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Responsible Party: Ascensia Diabetes Care
ClinicalTrials.gov Identifier: NCT01598610    
Other Study ID Numbers: CTD-2012-002-01
First Posted: May 15, 2012    Key Record Dates
Results First Posted: July 30, 2013
Last Update Posted: February 29, 2016
Last Verified: January 2016