Evaluation of a New Blood Glucose Meter System With Capillary and Venous Blood
NCT ID: NCT00797563
Last Updated: 2016-02-29
Study Results
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View full resultsBasic Information
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COMPLETED
NA
102 participants
INTERVENTIONAL
2008-11-30
2008-11-30
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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Subjects with diabetes
Subjects with diabetes use a new blood glucose monitoring system (BGMS) Apollo Blood Glucose Monitoring System with capillary blood; healthcare professionals use the new BGMS with subject capillary and venous blood.
Apollo Blood Glucose Monitoring System
Subjects with diabetes use a new blood glucose monitoring system with capillary blood; healthcare professionals use the new blood glucose monitoring system with subject capillary and venous blood. All results are compared to a laboratory glucose method - Yellow Springs Instrument (YSI).
Interventions
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Apollo Blood Glucose Monitoring System
Subjects with diabetes use a new blood glucose monitoring system with capillary blood; healthcare professionals use the new blood glucose monitoring system with subject capillary and venous blood. All results are compared to a laboratory glucose method - Yellow Springs Instrument (YSI).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Be \> 18, \< 76 year of age at time of consent, with approximately 50% (+10%)being less than 55 years of age
* Be willing to complete all study procedures
* Be routinely testing their blood sugar at home (at least once per day)
* Be able to speak, read, and understand English and understand the Informed Consent document
* Be able to read the labeling instructions
Exclusion Criteria
* Pregnancy
* Physical (dexterity), visual, or neurological impairments that would make the person unable to perform testing with the BGMS
* Disorders in the fingertip lancing areas
* Acute or chronic infections, particularly skin infections
* Infection with a blood borne pathogen
* Taking prescription anti-coagulants or having clotting problems that may prolong bleeding. Taking aspirin daily (81 mg or 325 mg) is not reason for exclusion
* Hemophilia or any other bleeding disorder
* Having a condition which, in the opinion of the Principal Investigator or designee, would put the person at risk or seriously compromise the integrity of the study
* Working for a competitive medical device company
18 Years
75 Years
ALL
No
Sponsors
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Ascensia Diabetes Care
INDUSTRY
Responsible Party
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Principal Investigators
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Joy Frank, RN
Role: PRINCIPAL_INVESTIGATOR
Consumer Product Testing Co., Inc.
Locations
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Consumer Product Testing Co., Inc.
Fairfield, New Jersey, United States
Countries
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Other Identifiers
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CTD-2008-17
Identifier Type: -
Identifier Source: org_study_id
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