Country for PR: United States
Contributor: PR Newswire New York
Friday, February 08 2019 - 08:00
AsiaNet
OneTouch(R) Blood Glucose Monitoring System Accuracy Proven in New Long-Term Study
CHESTERBROOK, Pennsylvania, Feb 8, 2019 /PRNewswire-AsiaNet/--

--Research demonstrates clinical accuracy of OneTouch Select Plus(R) platform, 
and demonstrates the value of a continuous and systematic testing program to 
verify product performance for as long as it has been available to patients 

New research published in a leading diabetes technology journal shows the 
long-term clinical accuracy of the OneTouch Select Plus(R) blood glucose test 
strip platform and highlights the products' consistently accurate performance. 
This is the latest study in a series of recent studies that confirm the 
OneTouch(R) brand blood glucose monitoring system accuracy.

A study published this week in the Journal of Diabetes Science and Technology 
(JDST) the OneTouch Select Plus(R) blood glucose monitoring platform's three 
years of proven accuracy across multiple clinical studies in patients with 
diabetes. The study results were derived from more than 21,000 data points from 
over 200 different strip batches released since the launch of the OneTouch 
Select Plus(R) test strip in 2015. Results show that the system consistently 
met the minimum requirements of the International Organization for 
Standardization (ISO) standard 15197:2013 and the European harmonized version 
EN ISO 15197:2015, with an average of 97.6% of results within specification, 
demonstrating both product accuracy and consistency.[1]

"This study is an example of the clinical rigor and importance that LifeScan 
applies to its post-market program, which I consider to be a recommendable 
practice for diabetes device companies," said Dr. Guido Freckmann, Medical 
Director of the Institut fur Diabetes-Technologie Forschungs- und 
Entwicklungsgesellschaft mbH an der Universitat, Ulm and a leading blood 
glucose monitoring accuracy expert. "In this study, results are based on more 
than 21,000 blood glucose meter readings gathered in a clinical setting and 
paired against corresponding reference instrument readings - all using OneTouch 
Select Plus(R) test strips - over a period of years. This sort of continuous, 
systematic testing methodology enhances the picture of performance given by 
other accuracy studies, including those I have authored."

This study is the latest in a series of studies highlighting OneTouch(R) blood 
glucose monitoring system accuracy. In a March 2018 JDST study ( 
https://c212.net/c/link/?t=0&l=en&o=2350867-1&h=1428212136&u=http%3A%2F%2Fjournals.sagepub.com%2Fdoi%2Fpdf%2F10.1177%2F1932296817730380&a=a+March+2018+JDST+study), 
leading experts in self-monitoring of blood glucose (BG) tested the OneTouch 
Verio Flex(R) blood glucose monitoring system and found that the "new system 
showed a high level of measurement accuracy." All three lots that were tested 
met and exceeded the minimum requirements of the International Organization for 
Standardization (ISO) 15197:2013 standard for system accuracy. [2]

This study follows the publication of a third study ( 
https://c212.net/c/link/?t=0&l=en&o=2350867-1&h=3051526367&u=http%3A%2F%2Fjournals.sagepub.com%2Fdoi%2Ffull%2F10.1177%2F1932296817703133&a=third+study 
) in the April 2017 issue of the same journal that detailed the OneTouch 
Verio(R) platform's seven years of proven accuracy across more than 70,000 
clinical data points.[3] 

"Self-monitoring of blood glucose is still the most accurate, effective and 
accessible way people with diabetes can track their blood sugars," said Dr. 
David Shearer, Senior Director Worldwide Medical Affairs and Senior Safety 
Officer, LifeScan, Inc. "With the OneTouch Select Plus(R) and the OneTouch 
Verio(R) range of blood glucose monitoring systems, we are proud to offer 
people with diabetes and their care teams very accurate products that they know 
they can trust."

The OneTouch Select Plus(R) blood glucose monitoring system and OneTouch Select 
Plus(R) test strips and the OneTouch Verio Flex(R) blood glucose monitoring 
system and OneTouch Verio(R) test strips are offerings from the iconic 
OneTouch(R) brand by LifeScan. Product availability varies by country. The 
three Journal of Diabetes Science and Technology studies mentioned were funded 
all or in part by LifeScan.   

About LifeScan, Inc.
With a vision to create a world without limits for people with diabetes, 
LifeScan, Inc. is a world leader in blood glucose monitoring - globally more 
than 20 million people depend on OneTouch(R) brand products to help them manage 
their diabetes. For over 35 years, LifeScan has had an unwavering commitment to 
improving the quality of life for people with diabetes by developing products 
defined by simplicity, accuracy, and trust. For more information, visit 
www.LifeScan.com and www.OneTouch.com.

[1] Setford, et al. Evidence from a Long-term, Systematic Post-Market 
Surveillance Program; Clinical Performance of a Haematocrit Insensitive Blood 
Glucose Test-Strip. Journal of Diabetes Science and Technology (2019) TBD

[2] Annette Baumstark, PhD, Nina Jendrike, MD, Stefan Pleus, MSc, Christina 
Liebing, PhD, Cornelia Haug, MD, and Guido Freckmann, MDAccuracy evaluation of 
a new system for self-monitoring of blood glucose with three test strip lots 
based on ISO 15197:2013 (Journal of Diabetes Science and Technology (2017) 1-2

[3] Setford, et al. Seven-year surveillance of the clinical performance of a 
blood glucose test strip product. Journal of Diabetes Science and Technology 
(2017) 1-8

SOURCE: Lifescan, Inc.

CONTACT: Bridget Kimmel
         +1-(215)-688-6033,
         BKimmel@its.jnj.com
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