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Evaluation of an Karajishi Contour Investigational Blood Glucose Monitoring System (ISO/FDA Study)

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ClinicalTrials.gov Identifier: NCT02150109
Recruitment Status : Completed
First Posted : May 29, 2014
Results First Posted : July 21, 2015
Last Update Posted : February 29, 2016
Sponsor:
Information provided by (Responsible Party):
Ascensia Diabetes Care

Brief Summary:
The purpose of this study was to determine if untrained persons with diabetes and without diabetes could operate the Investigational Blood Glucose Monitoring System (BGMS) and obtain valid blood glucose results.

Condition or disease Intervention/treatment Phase
Diabetes Device: Subjects WITH/WITHOUT Diabetes Use Karajishi Contour BGMS Device: Subjects WITH Diabetes Use Karajishi Contour BGMS Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 372 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: User Performance of the Karajishi Contour Blood Glucose Monitoring System (ISO/FDA Study)
Study Start Date : June 2014
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar

Arm Intervention/treatment
Experimental: Persons With Diabetes
Untrained subjects WITH Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System).
Device: Subjects WITH Diabetes Use Karajishi Contour BGMS
Untrained subjects WITH diabetes use the Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood (and study staff tested subject fingerstick blood) using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma. Also, study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma.

Experimental: Persons With and Without Diabetes
Untrained subjects WITH/WITHOUT Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System).
Device: Subjects WITH/WITHOUT Diabetes Use Karajishi Contour BGMS
Untrained subjects WITH and WITHOUT diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood (and study staff tested subject fingerstick blood) using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma. Also, study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma.




Primary Outcome Measures :
  1. Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method [ Time Frame: 1 hour ]
    Untrained subjects WITH diabetes (329) self-tested fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the number of BGMS results within +/-15 mg/dL (<100 mg/dL YSI capillary plasma) and +/-15% (>=100 mg/dL YSI capillary plasma).


Secondary Outcome Measures :
  1. Number of Venous Blood Glucose (BG) Results Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method [ Time Frame: 1 hour ]
    Study staff tested venous blood of subjects WITH diabetes (329) using an investigational Blood Glucose Monitoring System (BGMS). Venous BGMS results were compared with subject venous plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer venous plasma BG results were used to calculate the number of BGMS results within +/-15 mg/dL (<100 mg/dL YSI venous plasma) and +/-15% (>=100 mg/dL YSI venous plasma).

  2. Number of Fingerstick Blood Glucose (BG) Results Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method When Obtained and Tested by Study Staff [ Time Frame: 1 hour ]
    Study staff obtained and tested subject (329 WITH diabetes) fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI capillary plasma results were used to calculate the number of BGMS results within +/-15 mg/dL (<100 mg/dL YSI capillary plasma) and +/-15% (>=100 mg/dL YSI capillary plasma).

  3. Number of Responses From Persons With Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements [ Time Frame: 1 hour ]
    Staff obtained responses from persons WITH diabetes (329) using short questionnaires to provide feedback on instructions for use and the basic operation of the BGMS. Subjects could respond 'Strongly Agree' or 'Agree' or 'Neutral' or 'Disagree' or 'Strongly Disagree.'

  4. Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 15% of Laboratory Glucose Method Across the Tested Glucose Range [ Time Frame: 1 hour ]
    Untrained subjects WITH diabetes (329) and WITHOUT diabetes (43) self-tested fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the number of BGMS results within +/-15% of the laboratory method across the entire tested YSI glucose range.

  5. Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 20% of Laboratory Glucose Method Across the Tested Glucose Range [ Time Frame: 1 hour ]
    Untrained subjects WITH diabetes (329) and WITHOUT diabetes (43) self-tested fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the number of BGMS results within +/-20% of the laboratory method across the entire tested YSI glucose range.

  6. Number of Subject Fingerstick Blood Glucose (BG) Results Within +/- 15% of Laboratory Glucose Method When Obtained and Tested by Study Staff [ Time Frame: 1 hour ]
    Study staff obtained and tested subject (WITH and WITHOUT diabetes) fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI capillary plasma results were used to calculate the number of BGMS results within +/-15% across the tested YSI glucose range.

  7. Number of Subject Fingerstick Blood Glucose (BG) Results Within +/- 20% of Laboratory Glucose Method When Obtained and Tested by Study Staff [ Time Frame: 1 hour ]
    Study staff obtained and tested subject (WITH and WITHOUT diabetes) fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI capillary plasma results were used to calculate the number of BGMS results within +/-20% across the tested YSI glucose range.

  8. Number of Subject Responses That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements [ Time Frame: 1 hour ]
    Staff obtained responses from subjects WITH and WITHOUT diabetes using short questionnaires to provide feedback on instructions for use and the basic operation of the BGMS. Subjects could respond 'Strongly Agree' or 'Agree' or 'Neutral' or 'Disagree' or 'Strongly Disagree.'



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:   Yes
Criteria

Inclusion Criteria:

  • Males and females, 18 years of age and older
  • Able to speak, read, and understand English
  • Willing to complete all study procedures

Exclusion Criteria:

  • Hemophilia or any other bleeding disorder
  • Pregnancy
  • Physical, visual, or neurological impairments that would make the person unable to perform testing with the BGM
  • Previously participated in a BG monitor study using the Karajishi Contour BGMS (or used a Bayer Contour meter)
  • Work for a medical laboratory, hospital, or other clinical setting that involves training on and clinical use of blood glucose monitors
  • Work for a competitive medical device company, or having an immediate family member who works for such a company
  • A condition which, in the opinion of the investigator or designee, would put the person or study conduct at risk

General enrollment guidelines:

  • Most subjects will be persons with type 1 or type 2 diabetes
  • At least 10% of subjects with diabetes will have type 1 diabetes
  • Approximately 10% of subjects will be persons without diabetes
  • At least 60% of subjects will be younger than age 65

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): NCT02150109


Locations
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United States, California
AMCR Institute
Escondido, California, United States, 92026
United States, Washington
Rainier Clinical Research Center
Renton, Washington, United States, 98057
Sponsors and Collaborators
Ascensia Diabetes Care
Investigators
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Principal Investigator: Leslie J Klaff, MD Rainier Clinical Research Center
Principal Investigator: Timothy Bailey, MD AMCR Institute

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Responsible Party: Ascensia Diabetes Care
ClinicalTrials.gov Identifier: NCT02150109     History of Changes
Other Study ID Numbers: GCA-2014-002-01
First Posted: May 29, 2014    Key Record Dates
Results First Posted: July 21, 2015
Last Update Posted: February 29, 2016
Last Verified: June 2015