Performance Evaluation of an Investigational Blood Glucose Monitoring System
NCT ID: NCT01598610
Last Updated: 2016-02-29
Study Results
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View full resultsBasic Information
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COMPLETED
NA
220 participants
INTERVENTIONAL
2012-05-31
2012-05-31
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
DIAGNOSTIC
NONE
Study Groups
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Intended Users of the Monitoring System
Untrained subjects with diabetes use CONTOUR® PLUS Investigational BG Monitoring System.
CONTOUR® PLUS Investigational BG Monitoring System
Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the CONTOUR® PLUS Investigational BG Monitoring System. Study staff test subject venous blood. All Blood Glucose (BG) results are compared to a reference laboratory glucose method.
Interventions
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CONTOUR® PLUS Investigational BG Monitoring System
Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the CONTOUR® PLUS Investigational BG Monitoring System. Study staff test subject venous blood. All Blood Glucose (BG) results are compared to a reference laboratory glucose method.
Eligibility Criteria
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Inclusion Criteria
* 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
* Previously participated in a study using the CONTOUR PLUS system
* 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 or someone who is not a family member but is living within the household of someone who works for such a company.
* A condition, which in the opinion of the investigator, would put the person or study conduct at risk (reason for exclusion will be clearly documented by investigator or designee).
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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Phillip D Toth, MD, FACP
Role: PRINCIPAL_INVESTIGATOR
Midwest Institute For Clinical Research
Michael Caswell, PhD
Role: PRINCIPAL_INVESTIGATOR
Consumer Product Testing Co.
Locations
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Midwest Institute For Clinical Research
Indianapolis, Indiana, United States
Consumer Product Testing Co.
Fairfield, New Jersey, United States
Countries
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Other Identifiers
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CTD-2012-002-01
Identifier Type: -
Identifier Source: org_study_id
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