Ascensia Diabetes Care’s Product, CONTOUR®NEXT BLOOD GLUCOSE MONITORING SYSTEM, COMPLIES 100% WITH THE STUDY PROTOCOL DEFINED IN RECENTLY PUBLISHED INDEPENDENT ACCURACY ASSESSMENT BY DIABETES TECHNOLOGY SOCIETY
Tokyo, October 4, 2018 – PHC Holdings Corporation (headquarters: Tokyo, Japan) announces that results from a recently published comprehensive independent assessment of 18 blood glucose monitoring systems (BGMSs) have shown that the CONTOUR®NEXT BGMS sold by Ascensia Diabetes Care Holdings AG (hereafter Ascensia Diabetes Care) in the overseas markets was the one which had 100% of data points (311 out of 312) within the protocol limits for accuracy used by the Diabetes Technology Society (DTS) in their Blood Glucose Monitoring System Surveillance Program. Ascensia Diabetes Care is a wholly-owned subsidiary of PHC Holdings Corporation, headquartered in Basel, Switzerland. Based on these results, it was one of the six systems to be awarded a ‘Seal of Approval’ by DTS for meeting stringent standards for accuracy in blood glucose readings. The full results were published in Diabetes Care in August 2018.
The Blood Glucose Monitoring System Surveillance Program, conducted by the DTS, is an independent research study designed to evaluate the accuracy of 18 BGMSs marketed in the U.S. The systems selected represented 90% of the systems used by people with diabetes from 2013 to 2015. Accuracy was assessed in the hands of trained professionals, using systems and three different blood glucose test strip lots that were independently sourced from pharmacists and were tested at three clinical sites. Three accuracy studies were performed on each of the selected BGMSs using a protocol developed by an independent expert panel that included the US government, professional organizations and academia.
According to the study protocol*1, for a blood glucose reading to be compliant, it was required to fall within ±15% of a reference plasma value for a blood glucose ≥100 mg/dL and within ±15 mg/dL of a reference plasma value for a blood glucose <100 mg/dL. Each study included approximately 100 specimens and the number of compliant readings needed to pass depended on the number of specimens. For a study of 100 specimens, at least 91 readings were required to be within the above limits in order to pass. A BGMS that passed all three studies received the DTS Seal of Approval.
The CONTOUR®NEXT BGMS passed all three studies with 100%, 99% and 100% compliance with the study protocol respectively, achieving an overall compliance rate of 100%*2. The CONTOUR®NEXT BGMS was one of six BGMSs from the 18 tested to be awarded the DTS Seal of Approval for passing all three studies. These six all achieved an overall compliance rate of 95% or higher across the three studies. The CONTOUR®NEXT BGMS also proved its high accuracy using the more stringent accuracy threshold of ±10% from the reference value, with 97% of results falling within these stricter accuracy limits.*3
Sabina Furber M.D., Chief Medical Officer, Ascensia Diabetes Care, said: “We are delighted that one of our key products, the CONTOUR®NEXT BGMS, has been highly evaluated in this study. At Ascensia we are very proud of the high levels of accuracy that this system has achieved, as this helps people with diabetes to successfully manage their condition. Accuracy is a critical part of the performance of blood glucose monitoring systems, as patients need accurate readings in order to make appropriate and safe therapy decisions.”
She added: “Our priority as a company is supporting people living with diabetes. We share the view of leading diabetes experts that poor performance of BGMSs can lead to unintended negative consequences for those who live with the condition. International standards of accuracy exist to protect the wellbeing of patients, and we are pleased that these independent findings rank our CONTOUR®NEXT BGMS as one of the high accuracy systems available today.”
The CONTOUR®NEXT system that was included in this study uses the newest generation CONTOUR®NEXT test strips*4 from Ascensia. These test strips are the foundation of highly accurate glucose monitoring across the CONTOUR®NEXT portfolio that includes the CONTOUR®NEXT ONE, CONTOUR®NEXT LINK, CONTOUR®NEXT LINK 2.4*5 and CONTOUR®NEXT EZ. The CONTOUR®NEXT BGMS was first cleared by the FDA in 2012.
*1 Klonoff DC et al. J Diabetes Sci Technol. 2016;10(3):697-707
*2 Klonoff DC et al. Diabetes Care 2018;41:1681–1688
*3 PRESS RELEASE: Diabetes Technology Society (DTS) Releases Results of Blood Glucose Monitor System Surveillance Testing. Published June 23, 2017. Available at https://www.diabetestechnology.org/surveillance.shtml
*4 & 5 These products are available in Japan as well.
About PHC Holdings Corporation
Incorporated in 2014, PHC Holdings Corporation is a global healthcare company. Its subsidiaries include PHC Corporation and Ascensia Diabetes Care Holdings AG. Committed to its corporate mission, “We contribute to the wellbeing of society through our diligent efforts by creating new value propositions for all the people who wish for better health,” the company develops, manufactures, sells and services medical equipment and solutions through its three core businesses for medical devices, healthcare IT and life sciences. PHC Holdings Corporation group’s consolidated net sales in FY2017 marked 192.6 billion yen with global distribution of products and services for more than 125 countries. PHC Holdings Corporation changed its name from Panasonic Healthcare Holdings Co., Ltd. in April, 2018.
For further information on PHC Holdings Corporation, please visit www.phchd.com
About Ascensia Diabetes Care
Ascensia Diabetes Care is a global specialist diabetes care company, dedicated to helping people living with diabetes. Our mission is to empower people living with diabetes through innovative solutions that simplify and improve their lives. We use our innovation and specialist expertise in diabetes to develop high quality solutions and tools that make a positive, daily difference for people with diabetes.
Home to the world renowned CONTOUR® portfolio of blood glucose monitoring systems, our products combine advanced technology with user-friendly functionality that help people with diabetes to manage their condition. We are committed to continued research, innovation and development of new products and solutions. As a trusted partner in the diabetes community, we collaborate closely with healthcare professionals and other partners to ensure our products meet the highest standards of accuracy, precision and reliability, and that we conduct our business compliantly and with integrity.
Ascensia Diabetes Care was established in 2016 through the sale of Bayer Diabetes Care to Panasonic Healthcare Holdings Co., Ltd. Ascensia Diabetes Care products are sold in more than 125 countries. Ascensia Diabetes Care has around 1,700 employees and operations in 31 countries.
For further information, please visit the Ascensia Diabetes Care website at: http://www.ascensia.com
Ascensia and Contour are trademarks and/or registered trademarks of Ascensia Diabetes Care.