Home Diagnostics

TrueTrack Smart System® Clinical Studies

Clinical Evaluation of The TrueTrack® Blood Glucose Monitoring System

Summary

Study was conducted to demostrate the accuracy of the TrueTrack Smart System® when used for the first time by diabetes patients
Independent clinical evaluations were performed at four clinical sites across the United States
A total of 229 people with diabetes, experienced in self monitoring their blood glucose levels, were recruited by healthcare professionals to participate in the study
After reading the instructions for use, participants were asked to perform a fingerstick test using the TrueTrack Smart System®
At the same time, trained laboratory professionals obtained fingerstick blood samples from each participant for analysis using the Yellow Springs Instrument (YSI) 2300 STAT blood glucose analyzer
Accuracy was determined by comparing the test results obtained by participants using the TrueTrack Smart System® to the test results obtained by professionals using the YSI blood glucose analyzer

Results

The TrueTrack Smart System® shows excellent correlation with the YSI laboratory standard over a wide range of blood glucose values (52-473 mg/dL). More importantly, study participants successfully used the TrueTrack Smart System® to obtain accurate glucose results.

See complete clinical evaluation study results.

Patient Evaluation on Satisfaction and Ease of Use of the TrueTrack Smart System®

Summary

Diabetes healthcare professionals at four diabetes centers nationwide were asked to recruit up to a total of 40 participants for the study
All patients were diagnosed with diabetes and were familiar with blood glucose monitoring
TrueTrack Smart System® meter kits, test strips and instructions for use were provided to each participant, as well as a questionnaire that asked them to rate their satisfaction with the TrueTrack Smart System® features and evaluate the ease of use of the testing procedure
34 of 40 participants, ranging in age from 13–79, completed the questionnaire: 29% were Type 1 and 59% Type 2; the remaining 12% failed to answer this question on the questionnaire
The reported time since diagnosis ranged from four weeks to 39 years, with 41 of participants being diagnosed for less than five years
The most common meters used by the study population were Accu-Chek® Advantage, OneTouch® Ultra® and Therasense® FreeStyle®
88% of the participants responded that they tested their blood glucose two to three times per day

Results

Satisfaction With TrueTrack Smart System® Features and Benefits

94% were satisfied or very satisfied with the size of the meter
89% were satisfied or very satisfied with the size of the test strip
97% were satisfied or very satisfied with the size of the blood sample
97% were satisfied or very satisfied with the speed of test time

Satisfaction With Ease of Use of the TrueTrack Smart System®

94% rated setting up the date and time as easy or very easy
95% rated the overall coding procedure as easy or very easy
98% rated the overall blood glucose testing procedure as easy or very easy

Evaluation of the TrueTrack Smart System® in Relation to Daily Self-Management of Diabetes

70% agreed that the TrueTrack Smart System® was easier to use than their current system
82% would purchase the TrueTrack Smart System®
44% responded that they would test more frequently

See complete patient satisfaction study results.

Shuster Laboratories, Inc.
TrueTrack 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).

Accuracy Evaluation of the TrueTrack Smart System®:
Results of a New Blood Glucose Monitoring Device Suitable for
Fingertip and Forearm Testing

Summary

The main objective of the study was to evaluate the accuracy and precision of the TrueTrack Smart System® in comparison to the laboratory reference method as the standard
In addition, the study compared the fingertip and forearm test results from the TrueTrack Smart System® against four, commercially available, state-of-the-art blood glucose meters
Study was performed by IKFE, an independent, clinical laboratory and research institute located in Mainz, Germany
Data sets were collected from 102 patients with diabetes by trained healthcare professionals according to the instruction manuals of the manufacturers
The comparative devices used in the study were:
– FreeStyle®
– Ascensia® Contour®
– OneTouch® Ultra®
– Accu-Check® Comfort
– Super GL (laboratory reference method)
During each test series, investigational and comparative devices were used in randomized order; a laboratory reference measurement was performed at the beginning and the end of each test series

Results

The TrueTrack Smart System® showed comparable performance with regard to precision and accuracy at the fingertip and the forearm in comparison to a standard laboratory reference method and the TrueTrack Smart System® has demonstrated clinical equivalence to the current state-of-the-art devices.

See complete accuracy evaluation study results.

Evaluation of the TrueTrack Smart System® Blood Glucose Monitoring System by Healthcare Professionals

Summary

The study was conducted to determine healthcare professionals' satisfaction with the ease of use, design and features of the TrueTrack Smart System®
116 healthcare professionals participated in the evaluation; 76% of the participants were Certified Diabetes Educators
Participants were given a demonstration of the product, including coding the system and performing a glucose test; they were also given the opportunity to experience hands-on operation of the product
After their introduction to the product, participants completed a survey to profile their current blood glucose meter recommendation patterns, and more specifically, questions regarding their experience using the TrueTrack Smart System®
To eliminate study bias, none of the meters or test strips was labeled with the brand name or the manufacturer's name

Results

Diabetes healthcare professionals were very satisfied with the features and benefits of the TrueTrack Smart System®; and gave it high ratings in terms of quality, design and ease of use.

96% rated the overall testing procedure as easy or very easy
96% rated the overall quality of the system as good to excellent

See complete healthcare professional evaluation study results.