Home Diagnostics Introduces
Advanced Performance, No Coding Testing Systems
Home Diagnostics, Inc. has received 510(k) clearance from the U.S. Food and Drug Administration to launch two new, advanced-performance, no-coding blood glucose monitoring systems.
TRUE2go™ is the world’s smallest blood glucose meter, and will help patients better manage their diabetes on the go. TRUEresult™ is an advanced performance, no-coding meter ideal for at-home testing. The new TRUE systems feature no-coding technology that simplifies blood glucose testing by eliminating the need for users to code the meter for each new box of test strips. Both of these systems utilize new TRUEtest™ Strips, featuring GoldSensor™ Laser Accuracy that provides enhanced precision and accuracy of test results.
“Together these systems, along with TRUEtest™ Strips, were specifically designed to better fit patients’ active lifestyles and make it easier and affordable for them to better manage their diabetes,” said Teri Sasse, R.N., M.S., Director of Professional Marketing for Home Diagnostics. “And the unique advantages of the TRUEfill™ design for TRUEtest™ Strips allow patients to achieve first-test success and highly accurate results.”
Advanced Performance Features
TRUE2go™ twists onto the top of a vial of TRUEtest™ Strips, offering patients the convenience of anywhere, on-the-go testing. TRUEresult™ offers advanced monitoring features like a 500-test memory, four testing reminder alarms, and a Ketone test reminder. Both systems feature: results as fast as four seconds, a tiny, 0.5 microliter sample size, and a strip release button that helps avoid used-strip handling.
TRUEtest™ Strips, conveniently and affordably used by both systems, feature state-of-the-art technology. Patent-pending GoldSensor™ Laser Accuracy provides enhanced precision and accuracy of test results. Two fill-detect electrodes ensure adequate blood sample, preventing false starts and erroneous results. Two additional electrodes accurately measure the glucose reaction and send the signal to a sensor. Finally, the innovative TRUEfill™ beveled tip allows for greater sampling precision. These advanced features ensure highly accurate test results and first-test success by allowing for greater sampling precision and consistency.
Proven Precise, Accurate and Easy to Use
The two systems have undergone extensive clinical testing with both patients and healthcare professionals to confirm their accuracy, precision and ease-of-use; using the ISO Standard (15197:2003), the FDA-recognized consensus standard, as the benchmark for proving each system’s accuracy and precision. The ISO Standard specifies that 95% of glucose results must be within + or -20% of a reference standard for results greater than or equal to 75 mg/dL, and within + or -15 mg/dL for results less than 75 mg/dL. Both TRUEresult™ and TRUE2go™ Systems exceed these regulatory requirements with 99.4% of results for TRUEresult™ – and 99.1% of TRUE2go™ results – within ISO accuracy limits.
In addition, both the TRUE2go™ and TRUEresult™ Systems received positive ratings from patients for ease of use. In fact, patients were able to obtain clinically accurate results with the TRUE2go™ and TRUEresult™ Systems while using minimal written instructions.
“As a principal investigator on several studies with both of these new meters, I was very impressed with their accuracy, no-coding performance, small sample size, and ease of use,” said Hal Joseph, Physician Assistant and Certified Diabetes Educator, Clearwater Valley Hospital and Clinic, Orofino, ID. “The small size of the TRUE2go™ is very beneficial, making it an ideal meter for travel or testing away from home. I am all about preventing complications and that is achieved by more frequent testing. The TRUEresult™ and TRUE2go™ meters are very useful tools in helping patients achieve the goal of avoiding diabetes-related concerns.”
A clinical abstract highlighting the precision, accuracy and innovation of the new TRUE2go™ System has been selected for poster presentation at the upcoming Eighth Annual Diabetes Technology Meeting in Bethesda, MD in November.
Covered By Insurance, Affordable for Cash-Paying Patients
These two new meters, with TRUEtest™ Strips, are among the most affordable of any no-coding systems with advanced performance. The new meters and TRUEtest™ Strips are covered by most insurance plans, as well as Medicare Part B and most Medicaid plans.
Since Home Diagnostics is the exclusive co-brand supplier of blood glucose monitoring supplies for leading pharmacies including CVS, Rite Aid and Walgreens as well as national distributors such as AmerisourceBergen, Cardinal Health and McKesson, the new TRUE2go™ and TRUEresult™ Systems and TRUEtest™ Strips will be co-branded with the brand name of patients’ favorite pharmacies.
About Home Diagnostics, Inc.
Based in Fort Lauderdale, Florida, Home Diagnostics, Inc. (NASDAQ: HDIX) is a leading developer, manufacturer and marketer of diabetes management solutions. Home Diagnostics, Inc. offers a portfolio of high-quality blood glucose monitoring systems that spans the spectrum of features and benefits to help every person with diabetes better monitor and manage their disease. The Home Diagnostics, Inc. product line includes TRUE2go™, TRUEresult™, TRUEtrack™, Sidekick®, TRUEread™ and Prestige Smart System® blood glucose monitoring systems. The products are available in more than 45,000 pharmacies throughout the U.S. or for more information please visit www.homediagnostics.com.
NICO-1184 TRUE2go, TRUEresult, TRUEtest, GoldSensor, TRUEfill, TRUEtrack, Sidekick, TRUEread and Prestige Smart System are trademarks of Home Diagnostics, Inc. All other trademarks are property of their respective owners.