- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02041286
Evaluation of an Karajishi Contour Investigational Blood Glucose Monitoring System
January 29, 2016 updated by: Ascensia Diabetes Care
User Performance of the Karajishi Contour Blood Glucose Monitoring System
The purpose of this study is to determine if subjects who have diabetes can operate the Investigational Blood Glucose Monitoring System (BGMS) without training and obtain valid glucose results.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
136
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Escondido, California, United States, 92026
- AMCR Institute
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Washington
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Renton, Washington, United States, 98057
- Rainier Clinical Research Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 BGMS (or used a Bayer Contour 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intended Users of the Monitoring System
Subjects with diabetes use the Karajishi Contour Investigational BG Monitoring System with no training. The criteria for the intended use population:
|
Subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Karajishi Contour Investigational BG Monitoring System with no training.
All BG results are compared to reference method results obtained from subject capillary plasma.
Also, study staff test subject venous blood and BG results are compared to reference method results obtained from subject venous plasma.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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-test fingerstick blood use an investigational Blood Glucose Monitoring System (BGMS) with no training.
BGMS results are compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer.
YSI Analyzer BG results are 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).
|
1 hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 test subject venous blood using an investigational Blood Glucose Monitoring System (BGMS).
Venous BGMS results are compared with subject venous plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer.
YSI Analyzer venous plasma BG results are 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).
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1 hour
|
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-test Alternative Site (AST) palm blood using an investigational Blood Glucose Monitoring System (BGMS) with no training.
BGMS AST palm results are compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer.
YSI Analyzer BG results are 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).
|
1 hour
|
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 obtain and test subject fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS).
BGMS results are compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer.
YSI capillary plasma results are 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).
|
1 hour
|
Number of Subject Responses That Strongly Agree or Agree or Are Neutral With Questionnaire Statements
Time Frame: 1 hour
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Staff will obtain subject responses using short questionnaires to provide feedback on instructions for use and the basic operation of the BGMS.
Subjects may respond Strongly Agree; Agree; Neutral; Disagree; or Strongly Disagree.
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1 hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Leslie J Klaff, MD, Rainier Clinical Research Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2014
Primary Completion (Actual)
January 1, 2014
Study Completion (Actual)
January 1, 2014
Study Registration Dates
First Submitted
January 17, 2014
First Submitted That Met QC Criteria
January 17, 2014
First Posted (Estimate)
January 22, 2014
Study Record Updates
Last Update Posted (Estimate)
February 29, 2016
Last Update Submitted That Met QC Criteria
January 29, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- GCA-2013-001-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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