NEW ORLEANS--(BUSINESS WIRE)--At the American Diabetes Association’s 76th Scientific Sessions this week, data are being presented from three studies that evaluated the accuracy and usability of blood glucose monitoring systems from Ascensia Diabetes Care. This is the first presentation of data for the CONTOUR® NEXT ONE blood glucose monitoring system evaluating ease-of-use in the hands of subjects with diabetes. The American Diabetes Association’s 76th Scientific Sessions are taking place in New Orleans from June 10-14, 2016.
The study by Bailey et al. (Poster 81-LB), assessed the usability of the CONTOUR® NEXT ONE blood glucose meter with the CONTOUR® Diabetes App in 43 individuals with type 1 and type 2 diabetes. The study showed that 95.4% of subjects were able to sync their meter with the app and 95.4% were able to access and interpret the blood glucose displays. In addition, 98% of participants found that the blood glucose displays were understandable and 89.7% of subjects were able to initiate and use the bolus calculator feature.1
Lead investigator for the study, Dr. Timothy Bailey, AMCR Institute, San Diego, explained, “The CONTOUR Diabetes App is designed to collect and display detailed information that may help people with diabetes with their management decisions. This study is the first to assess the system’s ease of use. Tools, such as the CONTOUR Diabetes App, may help more people with diabetes and those who care for them to spot important patterns and trends, with the potential to lead to better health outcomes.”
An investigator-initiated study, presented by Dr. Guido Freckmann (Poster 898-P), evaluated the accuracy of the CONTOUR® NEXT LINK 2.4 meter. This linking meter is wirelessly compatible and able to communicate with certain Medtronic insulin pump systems. The study also included five other meters that do not link to Medtronic insulin pumps, but are commonly used with them in various countries worldwide. The meters included were the Accu-Chek® Aviva Nano, Accu-Chek® Mobile, Accu-Chek® Performa Nano, FreeStyle Lite® and OneTouch® Verio IQ.
Capillary blood samples from 100 different subjects with diabetes were measured using each meter and compared to two different comparison methods (glucose oxidase and hexokinase) using the accuracy criteria in ISO 15197:2013 section 6.3. The CONTOUR® NEXT LINK 2.4 was shown to meet these accuracy criteria for both comparison methods. For the glucose oxidase comparison method, all meters except OneTouch® Verio met the ISO accuracy criteria, and for the hexokinase method, all meters except FreeStyle Lite® met the criteria. In addition, the CONTOUR® NEXT LINK 2.4 meter was the only meter tested that met more strict accuracy limits (±10 mg/dl at concentrations ˂100 mg/dL and ±10% at concentrations of ≥100 mg/dL) for both comparison methods.2
Lead investigator for the study, Dr. Guido Freckmann, Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH, said “Meter accuracy is particularly important for insulin pump users, as the blood glucose values are directly used to calculate the required insulin dose from the pump and to calibrate the continuous glucose monitoring sensor. High levels of accuracy are important to ensure pump users have safe and appropriate therapy.”
The outcomes of another study, by Kamecke et al. (Poster 887-P), were also presented. The CONTOUR™ PLUS blood glucose monitoring system was assessed versus three other systems in the hands of patients and professionals against the accuracy requirements of ISO 15197:2013. The CONTOUR™ PLUS meter was shown to fulfil the ISO 15197:2013 criteria for both reference methods used.3
Michael Kloss, CEO of Ascensia Diabetes Care, added: “We are excited to share these new data from several important studies that are being presented at the American Diabetes Association’s 76th Scientific Sessions. The data from these studies shows our ongoing commitment at Ascensia Diabetes Care to scientific research and bold innovations that are aimed at offering new solutions to the diabetes community.”
The CONTOUR® NEXT ONE system, which was evaluated in the Bailey et al. usability study, recently received CE Mark approval in Europe. It features an easy-to-use wireless-enabled smart blood glucose meter that seamlessly connects to the CONTOUR® Diabetes App on a smart phone. The app collects, stores and analyzes patient blood glucose measurements received from the meter.
The CONTOUR® NEXT/PLUS ONE and the CONTOUR® NEXT LINK 2.4 meters have received CE Mark approval in Europe, where they are available in certain markets, and they are currently under 510(k) and PMA review, respectively, by the FDA in the United States, where they are not yet available. Not all features evaluated in these studies will be available in all markets.
ENDS
About Ascensia Diabetes Care
Ascensia Diabetes Care is a global specialist diabetes care company, dedicated to helping improve the lives of people with diabetes by empowering them to take charge of their health. We use our innovation and specialist expertise in diabetes to develop high quality solutions and tools that make a simple, positive, daily difference for people with diabetes.
Home to the world renowned CONTOURTM 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. As a leader in diabetes care and a trusted partner, we collaborate closely with healthcare professionals and other partners to ensure our products meet the highest standards of accuracy and compliance.
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. Following the close of the transaction in all countries, Ascensia Diabetes Care will have almost 1,400 employees and operations in 38 countries.
For further information please visit the Ascensia Diabetes Care website at:
CONTOUR® is a registered trademark of Ascensia Diabetes Care Holdings AG.
References
1 Bailey, T. S. et al. (2016, June) Usability of a New Blood Glucose Monitoring System (BGMS) With A Mobile App Poster presented at the American Diabetes Association’s 76th Scientific Sessions New Orleans, LA.
2 Freckmann, G. et al. (2016, June) Accuracy evaluation of six blood glucose monitoring systems often used with insulin pumps following ISO 15197, section 6.3 Poster presented at the American Diabetes Association’s 76th Scientific Sessions New Orleans, LA.
3 Kamecke, U. et al. (2016, June) Accuracy of four systems for self-monitoring of blood glucose in the hands of patients and professionals Poster presented at the American Diabetes Association’s 76th Scientific Sessions New Orleans, LA.