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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

See complete Grady-LX study results.

* Based on NCCLS method comparison and bias estimation using patient samples, document EP9-A, Vol. 15, # 17.

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