Prestige IQ® Monitor Studies

Clinical Site Evaluation of the Prestige IQ® Blood Glucose Monitor

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 using 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 clinical site evaluation study results.

Clinical Study Confirms Prestige IQ® Blood Glucose
Monitor Offers Outstanding 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 an 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 accuracy study results.

Patient Evaluation on Ease of Use of the Prestige IQ® Blood Glucose Monitoring System

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 in 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 of the meter, performing quality-control testing using the standard strip and glucose control solution, and performing a fingerstick 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 fingerstick 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 patient evaluation study results.

Shuster Laboratories, Inc.
Prestige Smart System® Product Evaluation Report

Summary

• Shuster Laboratories, Inc. works closely with leading retail stores to help ensure that their private label products meet the highest quality standards
   
• Through its TAQA (Technically Advanced Quality Assurance) program, Shuster can provide retailers with a 99+ assurance level of product quality
   
• The TAQA program is based upon the best of both international (ISO) and current U.S. standards such as FDA, USP, ASTM, etc. and includes product risk assessment
   
• As part of the TAQA program, a performance evaluation of all package components is conducted to assist proper mechanical function when used as directed

Results

Home Diagnostics' TrueTrack Smart System® received an overall TAQA score of 9.5 out of a possible 10. A score of 9.0–10.0 is an “approved” rating (meets TAQA quality standards).

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