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Evaluation of an Karajishi TS Investigational Blood Glucose Monitoring System

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ClinicalTrials.gov Identifier: NCT02041377
Recruitment Status : Completed
First Posted : January 22, 2014
Results First Posted : February 16, 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 subjects who have diabetes can operate the Investigational Blood Glucose Monitoring System (BGMS) with no training and obtain valid glucose results.

Condition or disease Intervention/treatment Phase
Diabetes Device: Karajishi TS Investigational Blood Glucose Monitoring System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 134 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: User Performance of the Karajishi Contour TS Blood Glucose Monitoring System
Study Start Date : January 2014
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar
Drug Information available for: Dextrose

Arm Intervention/treatment
Experimental: Intended Users of the Monitoring System

Subjects with diabetes used the Karajishi TS Investigational Blood Glucose Monitoring System with no training. The criteria for the intended use population:

  1. At least 60% of subjects will be younger than age 65
  2. At least 10% of subjects will have type 1 diabetes
Device: Karajishi TS Investigational Blood Glucose Monitoring System
Subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Karajishi TS Investigational Blood Glucose Monitoring System with no training. All BG results were compared to reference method results obtained from 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 ]
    Subjects with diabetes self-tested fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS) with no training. 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 subject venous blood 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 Blood Glucose (BG) Results From Alternative Site Testing (AST) Palm Blood Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method [ Time Frame: 1 hour ]
    Subjects with diabetes self-tested Alternative Site (AST) palm blood using an investigational Blood Glucose Monitoring System (BGMS) with no training. BGMS AST palm 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).

  3. Number of Subject 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 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).

  4. Number of Subject Responses That Strongly Agree or Agree or Are Neutral With Questionnaire Statements [ Time Frame: 1 hour ]
    Staff obtained subject responses using short questionnaires to provide feedback on instructions for use and the basic operation of the BGMS. Subjects could respond Strongly Agree; Agree; Neutral; Disagree; or Strongly Disagree.



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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
  • People with type 1 or type 2 diabetes
  • 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 TS BGMS (or used a Bayer Contour TS meter)
  • 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 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

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): NCT02041377


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: NCT02041377     History of Changes
Other Study ID Numbers: GCA-2013-002-01
First Posted: January 22, 2014    Key Record Dates
Results First Posted: February 16, 2015
Last Update Posted: February 29, 2016
Last Verified: January 2016