Comparison Evaluation of Blood Glucose Meter Systems in a Clinical Setting
Status: | Completed |
---|---|
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | May 2012 |
End Date: | June 2012 |
Clinical Evaluation of Bayer G3 / Tatsu System and BGMs From Other Companies
The purpose of this study was to test the performance of an investigational Bayer Blood
Glucose (BG) meter and five additional Blood Glucose Monitoring Systems (BGMSs). The goal
was to obtain glucose samples from subjects with diabetes across the meter operating ranges.
A capillary sample was collected from each subject at 3 different times during the visit to
obtain natural capillary blood samples with a range of glucose concentrations. Some blood
samples were glycolyzed to lower the glucose concentration levels and glucose solution was
added to other samples to raise glucose concentration levels. All meter BG results were
compared with plasma results obtained with a reference laboratory glucose method (YSI
Glucose Analyzer). All lancings and testing were performed by study staff.
Glucose (BG) meter and five additional Blood Glucose Monitoring Systems (BGMSs). The goal
was to obtain glucose samples from subjects with diabetes across the meter operating ranges.
A capillary sample was collected from each subject at 3 different times during the visit to
obtain natural capillary blood samples with a range of glucose concentrations. Some blood
samples were glycolyzed to lower the glucose concentration levels and glucose solution was
added to other samples to raise glucose concentration levels. All meter BG results were
compared with plasma results obtained with a reference laboratory glucose method (YSI
Glucose Analyzer). All lancings and testing were performed by study staff.
Inclusion Criteria:
- Diagnosis of type 1 or type 2 diabetes mellitus
- 18 years of age or older
- Willing to follow all study procedures
Exclusion Criteria:
- Received an investigational drug or device within the last 30 days
- Current use or recent exposure to any prescription medication within 24 hours prior
to screening that in the opinion of the investigator could have an influence on the
subject's ability to participate in the study or on the performance on the test
device
- Positive pregnancy test obtained at screening (test performed for females only,
except if surgically sterile or three years past menopause)
- Hematocrit <32% or >55%
- Inadequate veins (in the opinion of the investigator or designated study staff) for
venous blood withdrawal or intravenous catheter insertion
- Symptomatic coronary artery disease with a history of angina, or history of a
myocardial infarction or coronary intervention (e.g. percutaneous transluminal
coronary angioplasty [PTCA], stent placement) or coronary artery bypass graft (CABG)
within the past 6 months
- Cerebrovascular accident within the past 6 months
- Diagnosis of the following diabetic autonomic neuropathies: symptomatic orthostatic
hypotension, heart rate anomalies, gastroparesis
- Being treated for malignancy, except basal cell or squamous cell skin cancers
- Major surgical operation within 30 days prior to screening
- Active alcohol abuse or substance abuse (as judged by the principal investigator)
- Severe mental illness, mental incapacity, unwillingness or language barriers
precluding adequate understanding or cooperation (as judged by principal
investigator)
- Other medical conditions that would pose safety concerns, interfere with study
conduct or seriously compromise study integrity, as judged by principal investigator
(reason for exclusion will be clearly documented by investigator or designee)
- Working for a competitive medical device company, or having an immediate family
member or someone who is not a family member but is living within the household of
someone who works for such a company
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