Evaluation of Labeling Comprehension and Performance of a New Blood Glucose Meter System

Completed · Not applicable

Conditions studied: Diabetes

In brief

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).

Key facts

Study ID

NCT00804596

Run by

Ascensia Diabetes Care

People needed

74

Starts

2008-12-01

Expected to finish

2009-01-01

Last updated by the study team

2016-02-29

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• International Diabetes Center — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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