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Clinical
Studies Confirm
Prestige IQTM Blood Monitor
Offers Outstanding Accuracy
and Ease of Use.
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Prestige IQ TM Blood
Glucose Monitoring System Shows
excellent Correction With Laboratory Standard |
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| CLINICAL SITE EVALUATION OF THE PRESTIGE IQ TM
BLOOD GLUCOSE MONITOR |
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| Objective : To demonstrate
the accuracy of the Prestige IQ Blood Glucose Monitor result when compared
to the Yellow spring Instrument 2300 STAT PLUS Blood Glucose Analyzer as
the standard laboratory reference instrument. |
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| Introduction : A Clinical
devaluation of the Prestige IQ Blood Glucose Monitor was performed by Home
Diagnostic, Inc. at a large, metropolitan Diabetes Care Center in Atlanta,
Georgia. Trained healthcare professionals collected duplicate finger stick
blood samples from 145 adult diabetic patients. Blood samples were tested
congruently on the Prestige IQ and the YSI Glucose Analyzer laboratory instrument.
Accuracy was verified by comparing the Prestige IQ results to the YSI laboratory
standard using linear regression analysis. |
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| Statistical Analysis of Performance
: Using linear regression analysis, the Prestige IQ test results, when compared
to the YSI blood glucose results, generated an r-value or correlation of
0.9794. Which is near to an ideal slope of 1.000. This shows that there
is an excellent correlation between the Prestige IQ and the YSI laboratory
standard. Results show that the Prestige IQ meets the performance criteria
for this industry standard. |
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| Conclusion : Over a wide range
of blood glucose values (43-413mg/dL), Prestige IQ Blood Glucose Monitor
results show an excellent correlation with YSI laboratory standard results. |
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In a clinical evaluation comparing the
Prestige IQ Blood Glucose Monitor versus the YSI laboratory standard,
the Prestige IQ meets the national Committee for clinical Laboratory
Standards criteria. |
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| Similar clinical studies has
also been conducted at IKFE, Mainz and Germany. |
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Patients Confirm the
Prestige IQ Blood Glucose
Monitoring System is Easy to Use |
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| Introduction : A patient
evaluation of the Prestige IQ Blood Glucose Monitoring System was performed
by Home Diagnostics, Inc. at a large metropolitan Diabetes Care Center in
Dallas, TX. The purpose of the study was to evaluate the feedback from patients
with diabetes regarding ease of use of the Prestige IQ Blood Glucose Monitor
and Prestige Smart System Test Strips. |
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| Participants with diabetes ranging in age from 29 - 84 years
were asked to demonstrate specific task including coding of meter, performing
quality control testing using a standard strip and glucose control solution
and performing a finger stick blood glucose test. |
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| Conclusion : All participants
rated the Prestige IQ Blood Glucose Monitor as very easy to code. In addition,
90% of participants rated the overall finger-stick blood glucose test as
very easy . easy to perform. Ninety - nine percent of participants strongly
agree / agree that they would use the Prestige IQ Blood Glucose Monitor
their daily blood glucose levels. Overall, 100% of the participants rated
the Prestige IQ as excellent or good. |
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