User Study of an Investigational Blood Glucose Monitoring System
NCT ID: NCT01447121
Last Updated: 2016-02-29
Study Results
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View full resultsBasic Information
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COMPLETED
NA
118 participants
INTERVENTIONAL
2011-09-30
2011-09-30
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 System
Untrained subjects with diabetes use an investigational blood glucose monitoring system (Tatsu/Tradewind Investigational BG Monitoring System) to self-test capillary blood obtained from fingerstick.
Tatsu/Tradewind Investigational BG Monitoring System
Tradewind is a Bayer investigational meter that used an investigational sensor.
Interventions
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Tatsu/Tradewind Investigational BG Monitoring System
Tradewind is a Bayer investigational meter that used an investigational sensor.
Eligibility Criteria
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Inclusion Criteria
* 18 years of age and older
* Able to speak, read, and understand English
* Willing to complete all study procedures
Exclusion Criteria
* Working for a medical laboratory, hospital, or other clinical setting that involves training on and clinical use of blood glucose monitors
* Pregnancy
* Hemophilia or any other bleeding disorder
* 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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Timothy Bailey, MD
Role: PRINCIPAL_INVESTIGATOR
AMCR Institute
Locations
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AMCR Institute
Escondido, California, United States
Countries
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Other Identifiers
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CTD-PRO-2011-005-01
Identifier Type: -
Identifier Source: org_study_id
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