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Background:
According to the American Diabetes
Association (ADA), 17 million people in the United States have
diabetes. This staggering figure also includes the 5.9 million
people who fail to get diagnosed - leaving this potentially deadly
disease untreated.
To help monitor patients with diabetes,
the ADA recommends a regular A1c test (also known as glycated
hemoglobin or HbA1c), which reflects the average level of blood
glucose over the previous two to three months. Since A1c
levels are not subject to the fluctuations that are seen with daily blood
glucose monitoring, A1c is considered the best test to determine
if a patient's blood sugar is under control over
time.
A1c testing poses challenges
for both physicians and patients. Doctors face the difficulty
of managing patients' testing schedules and compliance rates.
Patients must make time every three months to complete these tests
and then anxiously wait for days to receive their results. An
industry survey of 6,000 diabetic patients found two-thirds failed
to meet the ADA's A1c target levels. However, researchers
found immediate access and feedback to A1c results created
significant improvements in patients' glucose levels.
Now, with Cholestech's
GDX System, A1c testing and results can be done in the
physicians office, enabling a doctor to immediately address patient
needs and disease management issues in one visit - ultimately giving
the physician a better way to care for and manage diabetics, while
also offering a more convenient option for these patients.
Product
Overview:
Cholestech's GDX System uses a single
drop of blood in a disposable test cartridge and takes just five minutes
to generate lab-accurate A1c results.
The system consists of a small analyzer that
uses disposable test cartridges. The GDX System is "CLIA-waived"
under the Clinical Laboratory Improvement Amendments of 1988. It is
simple to use, requires little training and is as accurate as those tests
offered in a lab. In most cases, Medicare and third-party health
insurance reimburse the costs of the test.
GDX Procedure:
| Step
1 - Stick |
Step
2 - Twist |
Step 3 -
Done |
|
Collect blood sample from
fingerstick and add to capillary tube. |
Turn cartridge clockwise when
you see flashing light and
hear "beep". Pour Solution.
Repeat. |
Results ready to discuss with
patient in 5 minutes. |
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Key Features:
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CLIA waived, lab accurate,
NGSP-certified
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Provides average Glucose levels
over 2 to 3 months
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Helps establish a baseline level
prior to treatment
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Results in five minutes with a
simple fingerstick
Cholestech
GDX Forms:
Ad Slicks & Sample Brochures
Manuals, Guides, & Instructions
Product Package Inserts
Controls,
Calibration & MSDS
Medicare Reimbursement & Coding
Technical Documentation
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