Healthcare Industry News: diabetes
News Release - September 25, 2018
CONTOUR(R)NEXT Blood Glucose Monitoring System Tops the List in Recently Published Independent Accuracy Assessment by Diabetes Technology SocietyBASEL, Switzerland, September 25, 2018 -- (Healthcare Sales & Marketing Network) -- Results from a recently published comprehensive independent assessment of 18 blood glucose monitoring systems (BGMSs) have shown that the CONTOURŽNEXT BGMS finished top of the list for accuracy. The system from Ascensia diabetes Care was the only 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. 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, for a blood glucose reading to be compliant, it was required to fall within ą15% of a reference plasma value for a blood glucose ≥100 mg/dL and within ą15 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 CONTOURŽNEXT BGMS passed all three studies with 100%, 99% and 100% compliance with the study protocol respectively, and finished top of the study rankings, achieving an overall compliance rate of 100%. The CONTOURŽNEXT 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 CONTOURŽNEXT BGMS also finished top using the more stringent accuracy threshold of ą10% from the reference value, with 97% of results falling within these stricter accuracy limits.
Sabina Furber M.D., Chief Medical Officer, Ascensia diabetes Care, said: "We are delighted that one of our key products, the CONTOURŽNEXT BGMS, has been ranked number one 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 CONTOURŽNEXT BGMS as one of the most accurate systems available today."
The CONTOURŽNEXT system that was included in this study uses the newest generation CONTOURŽNEXT test strips from Ascensia. These test strips are the foundation of highly accurate glucose monitoring across the CONTOURŽNEXT portfolio that includes the CONTOURŽNEXT ONE, CONTOURŽNEXT LINK, CONTOURŽNEXT LINK 2.4 and CONTOURŽNEXT EZ. The CONTOURŽNEXT BGMS was first cleared by the FDA in 2012.
- Klonoff DC et al. J diabetes Sci Technol. 2016;10(3):697-707
- Klonoff DC et al. diabetes Care 2018;41:1681-1688
- 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
Source: Ascensia Diabetes Care
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