A New Glucose Meter With Alternative Site Testing
Completed · Not applicable
Conditions studied: Diabetes Mellitus
In brief
The purpose of the study was to evaluate the performance of the blood glucose monitoring system when used with samples taken from the palm and forearm for alternative site testing (AST).
Key facts
- Study ID
- NCT00797212
- Run by
- Ascensia Diabetes Care
- People needed
- 50
- Starts
- 2008-11-01
- Expected to finish
- 2008-11-01
- Last updated by the study team
- 2016-11-03
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 years 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 (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
- Jasper Clinic, Inc. — Kalamazoo, Michigan, United States
Full record on ClinicalTrials.gov
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