Status:
COMPLETED
Evaluation of a New Blood Glucose Meter System With Capillary and Venous Blood
Lead Sponsor:
Ascensia Diabetes Care
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The purpose of the study was to evaluate the performance of the meter system in the hands of subjects and healthcare professionals (HCPs). It also evaluated the product user guides in the hands of unt...
Detailed Description
The study evaluated the performance of the blood glucose meter system (BGMS) compared to a laboratory glucose method. Subjects and healthcare professionals tested subject capillary blood and healthcar...
Eligibility Criteria
Inclusion
- Have type 1 or type 2 diabetes
- 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
- Minors \< 18 years of age and adults \> 75 years of age
- 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
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT00797563
Start Date
November 1 2008
End Date
November 1 2008
Last Update
February 29 2016
Active Locations (1)
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1
Consumer Product Testing Co., Inc.
Fairfield, New Jersey, United States, 07004