Status:
COMPLETED
A New Glucose Meter With Alternative Site Testing
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 blood glucose monitoring system when used with samples taken from the palm and forearm for alternative site testing (AST).
Detailed Description
The blood glucose monitoring system may be used for alternative site testing. The blood glucose results obtained by subjects with samples taken from the palm and forearm were compared with fingerstick...
Eligibility Criteria
Inclusion
- 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
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 :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00797212
Start Date
November 1 2008
End Date
November 1 2008
Last Update
November 3 2016
Active Locations (1)
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1
Jasper Clinic, Inc.
Kalamazoo, Michigan, United States, 49007