Evaluation of an Karajishi Contour Investigational Blood Glucose Monitoring System (ISO/FDA Study)
NCT ID: NCT02150109
Last Updated: 2016-02-29
Study Results
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View full resultsBasic Information
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COMPLETED
NA
372 participants
INTERVENTIONAL
2014-06-30
2014-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Persons With Diabetes
Untrained subjects WITH Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System).
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.
Persons With and Without Diabetes
Untrained subjects WITH/WITHOUT Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System).
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
Yes
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-2014-002-01
Identifier Type: -
Identifier Source: org_study_id