- Three posters provide further evidence of the high levels of accuracy of the CONTOUR®NEXT ONE blood glucose monitoring system
- One poster presents a new methodology for revealing the differences between blood glucose monitoring systems
PARIS, Feb. 21, 2017 /CNW/ - At the 10th International Conference on Advanced Technologies and Treatments for Diabetes (ATTD), Ascensia Diabetes Care presented data from four scientific posters. Three of these posters provided further evidence for the high levels of accuracy of the CONTOUR®NEXT ONE blood glucose monitoring system (BGMS), including evidence to show that the CONTOUR®NEXT ONE meets the tightened accuracy requirements of the FDA Over-the-Counter BGMS Guidance recently issued in 2016. The fourth poster presented a new methodology for revealing the differences between multiple BGMS that meet EN ISO 15197:2015 (ISO 15197:2013) accuracy criteria. The ATTD 2017 began yesterday in Paris, France and continues through February 18, 2017.
In two posters (ATTD7-0166 and ATTD7-0177) the accuracy of the Second-Chance® sampling feature of the CONTOUR®NEXT ONE blood glucose monitoring system was evaluated. This feature prompts users to reapply blood if there is not enough the first time, helping to avoid lancing for a second time and the wasting of strips. A laboratory and clinical study were conducted for each system to examine accuracy in each setting. The clinical studies used intentionally insufficient blood samples to produce Second-Chance® sampling opportunities. This was followed by a reapplication, and the results from the systems were compared with YSI reference results.
In the clinical study of 52 subjects using the CONTOUR®NEXT ONE BGMS, 100% of subject fingertip self-test results fell within ±0.8325 mmol/L or ±15% of YSI reference results and 92.9% of self-test results were within ±0.555 mmol/L or ±10% of YSI reference results. Dr. Lars Krinelke, Medical Director, Global Medical Affairs at Ascensia Diabetes Care, said: "For Second-Chance® sampling to benefit people with diabetes and their healthcare professionals, it is of great importance that this feature delivers the benefit of accuracy that is similar to the levels of accuracy observed with the first attempt at blood glucose testing. These studies confirm the high levels of accuracy of the Second-Chance® sampling feature in the CONTOUR®NEXT ONE blood glucose monitoring system. Second-Chance® sampling has the potential to help people with diabetes reduce the costs of test strips by offering a second opportunity to obtain highly accurate readings with the original strip that was used."
The third poster (ATTD7-0280) assessed the accuracy of the CONTOUR®NEXT ONE BGMS used by subjects with and without diabetes, when evaluated against the criteria of the FDA OTC BGMS Guidance 2016. This guidance requires that 95% of results are within ±15% and 99% are within ±20% of a comparator reference method across the entire tested range. In this study, the results for subject fingertip self-tests showed that 99.5% were within ±15% and 99.7% were within ±20%, demonstrating that the CONTOUR®NEXT ONE system meets these criteria.
The final poster (ATTD7-0272) presented a new method for distinguishing differences between BGMSs that meet the ISO accuracy criteria. This new methodology uses probability curves to examine accuracy across the entire blood glucose range, and showed that there can be differences between systems that have met the ISO accuracy criteria. This type of information might be important and especially useful in the low blood glucose range where small errors in BGMS measurements can have substantial consequences for patient-related outcomes, particularly related to hypoglycemia risk.
Michael Kloss, CEO of Ascensia Diabetes Care, added: "These findings support Ascensia Diabetes Care's ongoing commitment to scientific research. The accuracy data demonstrate our ongoing commitment to ensuring excellence in our products and the new methodology presented shows our contribution to bold innovations and scientific discovery."
The CONTOUR® NEXT ONE BGMS received CE Mark approval in Europe in April 2016, the CONTOUR®NEXT ONE BGMS received U.S. Food and Drug Administration (FDA) clearance in November 2016, and the CONTOUR®NEXT ONE BGMS received a medical device license from Health Canada in December 2016.
Notes for Editors
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 33 countries.
For further information please visit the Ascensia Diabetes Care Canada website at: http://www.ascensiadiabetes.ca
© Copyright 2016 Ascensia Diabetes Care Canada Inc
®TM see www.ascensiadiabetes.ca/tm-mc
1. Christiansen M et al. User Performance Evaluation of a New Wireless-Enabled Blood Glucose Monitoring System that Links to a Smart Mobile Device in Subjects With and Without Diabetes. Poster presented at the 10th International Conference on Advanced Technologies and Treatments for Diabetes (2017).
2. Harrison B and Brown D. Performance and Accuracy Capability of a New, Wireless Enabled Blood Glucose Monitoring System that Links to a Smart Mobile Device: Laboratory and Clinical Sample Reapplication Studies. Poster presented as poster discussion at the 10th International Conference on Advanced Technologies and Treatments for Diabetes (2017).
3. 4. Pardo S, Shaginian R and Simmons D. Use of Accuracy Probability Curves: A New Method for Distinguishing Differences between Blood Glucose Monitoring Systems Meeting ISO 15197:2013 Accuracy Requirements. Poster presented at the International Conference on Advanced Technologies and Treatments for Diabetes (2017).
SOURCE Ascensia Diabetes Care
For further information: Genevieve Brown, Ascensia Diabetes Care, E-mail: [email protected], Phone: 416-254-4154