Evaluation of an Karajishi TS Investigational Blood Glucose Monitoring System
NCT ID: NCT02041377
Last Updated: 2016-02-29
Study Results
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View full resultsBasic Information
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COMPLETED
NA
134 participants
INTERVENTIONAL
2014-01-31
2014-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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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
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* People with type 1 or type 2 diabetes
* Able to speak, read, and understand English
* Willing to complete all study procedures
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Ascensia Diabetes Care
INDUSTRY
Responsible Party
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Principal Investigators
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Leslie J Klaff, MD
Role: PRINCIPAL_INVESTIGATOR
Rainier Clinical Research Center
Timothy Bailey, MD
Role: PRINCIPAL_INVESTIGATOR
AMCR Institute
Locations
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AMCR Institute
Escondido, California, United States
Rainier Clinical Research Center
Renton, Washington, United States
Countries
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Other Identifiers
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GCA-2013-002-01
Identifier Type: -
Identifier Source: org_study_id