Study Results
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View full resultsBasic Information
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COMPLETED
NA
226 participants
INTERVENTIONAL
2011-11-30
2011-11-30
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 Monitoring System
Untrained subjects with diabetes use the G3 investigational blood glucose monitoring system.
G3 Investigational Blood Glucose Monitoring System
Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the G3 meter and an investigational sensor. Study staff test subject venous blood and all BG results are compared to a reference laboratory glucose method. Untrained subjects utilize some additional features of the meter using the User Guide and provide feedback.
Interventions
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G3 Investigational Blood Glucose Monitoring System
Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the G3 meter and an investigational sensor. Study staff test subject venous blood and all BG results are compared to a reference laboratory glucose method. Untrained subjects utilize some additional features of the meter using the User Guide and provide feedback.
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 G3 system
* Working for a medical laboratory, hospital or other clinical setting that involves training on and clinical use of blood glucose monitors.
* 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).
* 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.
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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Robert Bernstein, MD, FACE
Role: PRINCIPAL_INVESTIGATOR
Southwest Clinical Research Center
Michael Caswell, PhD
Role: PRINCIPAL_INVESTIGATOR
Consumer Product Testing Co.
Locations
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Consumer Product Testing Co.
Fairfield, New Jersey, United States
Southwest Clinical Research Center
Santa Fe, New Mexico, United States
Countries
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Other Identifiers
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CTD-PRO-2010-009-01
Identifier Type: -
Identifier Source: org_study_id
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