Performance of an Investigational Blood Glucose Monitoring System in a Clinical Setting
NCT ID: NCT01268488
Last Updated: 2016-11-03
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
98 participants
INTERVENTIONAL
2010-12-31
2010-12-31
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 System
Untrained subjects with diabetes obtained capillary fingerstick, palm, and forearm blood and performed Blood Glucose (BG) tests using a Ninja 2 investigational blood glucose meter and the Contour® sensor. This BG monitoring system will not proceed to marketed product.
Ninja 2 Investigational Blood Glucose Meter
Untrained subjects with diabetes performed Blood Glucose(BG) tests from the subject's capillary blood obtained from fingerstick, palm, and forearm using the Ninja 2 investigational meter. All BG results were compared to a reference laboratory glucose method. Subjects' success at performing basic tasks using only the User Guide were rated by study staff.
Interventions
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Ninja 2 Investigational Blood Glucose Meter
Untrained subjects with diabetes performed Blood Glucose(BG) tests from the subject's capillary blood obtained from fingerstick, palm, and forearm using the Ninja 2 investigational meter. All BG results were compared to a reference laboratory glucose method. Subjects' success at performing basic tasks using only the User Guide were rated by study staff.
Eligibility Criteria
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Inclusion Criteria
* Type 1 or type 2 diabetes
* Currently self-testing blood glucose at home at least twice daily
* Able to speak, read, and understand English
* Willing to complete all study procedures
Exclusion Criteria
* Hemophilia or any other bleeding disorder
* Employee of competitive medical device company
* Cognitive disorder or other condition which, in the opinion of the investigator, would put the person at risk or seriously compromise the integrity of the study
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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Michael Caswell, PhD
Role: PRINCIPAL_INVESTIGATOR
Consumer Product Testing Company
Locations
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Consumer Product Testing Company
Fairfield, New Jersey, United States
Countries
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Other Identifiers
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CTD-2010-008-02
Identifier Type: -
Identifier Source: org_study_id