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Clinical
Studies
Proven Accuracy and Ease of Use
Accuracy of your monitor is a key component for successful monitoring of your
diabetes. Our Prestige Smart System™ monitors have undergone clinical accuracy
trials to ensure that you receive a high quality product with great performance.
Ease of use is another key factor when selecting a blood glucose monitoring
system. Patient evaluations prove our systems’ easy operation.
Prestige IQ™ Monitor Studies
Grady Diabetes Center Study on Accuracy
Summary
- Trained healthcare professionals collected duplicate fingerstick blood
samples from 145 adults with diabetes at the Grady Diabetes Center in
Atlanta, GA
- Blood samples were tested at the same time on the Prestige IQ™ and the
YSI Glucose Analyzer laboratory instrument
- The YSI (Yellow Springs Instrument) 2300 Stat PLUS Blood Glucose Analyzer
is the gold standard laboratory reference instrument
- Using linear regression analysis, the Prestige IQ™ test results,
compared to the YSI blood glucose results, generated an r-value of 0.9794
- According to National Committee for Clinical Laboratory Standards (NCCLS)*,
a blood glucose monitoring system is considered equivalent to laboratory
standard if the r-value is > 0.9751
* NCCLS Method Comparison and Bias Estimation Using
Patient Samples, EP9-A, Vol. 15, #17.
Results
The Prestige IQ™ meets the NCCLS performance criteria.
See complete Grady-IQ Study results.
German Study on Accuracy
Summary
- 60 patients with diabetes were recruited from the inpatient and outpatient
group at IKFE – an independent clinical laboratory in Mainz, Germany
- Clinic healthcare professionals collected and analyzed fingertip capillary
blood samples using the Prestige IQ Blood Glucose Monitoring System and the
Super GL Glucose-/Lactate-Analyzer
- Duplicate samples were analyzed using the Super GL and the mean of the
results was used in the data analysis
- During a second visit, 14 +/– 7 days, blood glucose values were obtained
again by measuring capillary blood from the fingertip with the Prestige IQ
Blood Glucose Monitoring System and the Super GL laboratory reference
instrument
- Duplicate samples were again analyzed using the Super GL and the mean of
the results was used in the data analysis
Results
The results of the Prestige IQ™ Blood Glucose Monitoring System showed
excellent correlation with the results of the Super GL laboratory method. 96% of
the measurements plotted on the Clarke Error Grid* were contained within a Zone
that is clinically accurate within +/- 20% of the laboratory.
* Clarke WL, Cox D, Gonder-Frederick LA, Carter W, Pohl
SL: Evaluating Clinical Accuracy of Systems for Self-Monitoring of Blood
Glucose. Diabetes Care 1987; 10: 622-628.
See complete German study results.
Baylor University Hospital Study on Ease of Use
Summary
- Participants consisted of 36 patients at the Baylor University Hospital in
Dallas, TX
- Participants first completed a questionnaire about demographics and their
self-care practices
- Patients received instructions on the use of the Prestige IQ™ Blood
Glucose System from a Certified Diabetes Educator or Registered Nurse
- Participants were asked to demonstrate specific tasks, including coding
the monitor, performing quality control testing using the standard strip and
glucose control solution, and performing a finger-stick blood glucose test
- Participants evaluated the skills necessary to perform the tasks by
completing a questionnaire at the conclusion of the study
Results
- 100% of participants rated the Prestige IQ™ as very easy to code
- 90% rated the overall finger stick blood glucose test as very easy/easy to
perform
- 99% strongly agreed/agreed they would use the Prestige IQ™ to monitor
their daily blood glucose levels
- 100% rated the Prestige IQ™ as excellent or good
See complete Baylor study results.
Prestige LX™ Monitor Study
Grady Diabetes Center Study on Accuracy
Summary
- Trained healthcare professionals collected fingerstick blood samples from
99 adult patients at the Grady Diabetes Center in Atlanta, GA
- Blood samples were tested at the same time on the Prestige Smart System™
and the YSI (Yellow Springs Instrument) 2300 Stat PLUS Glucose Analyzer –
the gold standard glucose reference instrument
- Using linear regression analysis, the Prestige LX™ test results,
compared to the YSI blood glucose results, generated an r-value of 0.9847
- A perfect correlation with laboratory values would be 1.00 – in the
study, the Prestige LX™ monitor’s r-value of .9847 is within 1.5% of a
perfect correlation
- According to a National Committee for Clinical Laboratory Standards (NCCLS)*,
a blood glucose monitoring system is considered equivalent to laboratory
standard if the r-value is >0.9751
Results
The Prestige LX™ is accurate when compared to a laboratory instrument and
meets NCCLS criteria.
See complete Grady-LX study results.
* Based on NCCLS method comparison and bias
estimation using patient samples, document EP9-A, Vol. 15, # 17.
