Evaluation of a New Blood Glucose Meter System With Capillary and Venous Blood
Completed · Not applicable
Conditions studied: Diabetes Mellitus
In brief
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 untrained subjects.
Key facts
- Study ID
- NCT00797563
- Run by
- Ascensia Diabetes Care
- People needed
- 102
- Starts
- 2008-11-01
- Expected to finish
- 2008-11-01
- 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 > 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
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 (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
Where it is running
- Consumer Product Testing Co., Inc. — Fairfield, New Jersey, United States
Full record on ClinicalTrials.gov
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