Status:
COMPLETED
Evaluation of Labeling Comprehension and Performance of a New Blood Glucose Meter System
Lead Sponsor:
Ascensia Diabetes Care
Conditions:
Diabetes
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The purpose of the study was to evaluate the acceptability of product user guides for untrained subjects and to evaluate the performance of the system with lay users and healthcare providers (HCPs).
Detailed Description
The study evaluated the acceptability of product labeling for performing blood glucose testing with the new blood glucose meter system (BGMS) and for using meter features. Sections of the User Guide a...
Eligibility Criteria
Inclusion
- Have type 1 or type 2 diabetes
- Be at least 18 years of age but have not reached their 76th birthday, with approximately 50% (+10%) being less than 55 years of age, at time of consent
- 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
- Own or operate a computer for personal or professional use beyond that for email correspondence. Subjects will not have to use their personal computer for the study, but computer use will be required.
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 (81mg 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 :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT00804596
Start Date
December 1 2008
End Date
January 1 2009
Last Update
February 29 2016
Active Locations (1)
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1
International Diabetes Center
Minneapolis, Minnesota, United States, 55416