New blood glucose monitoring system

• Easy-to-use meter with advanced accuracy for reliable results with a quick 5-second test time

• No Coding^TM technology means that the meter does not have to be ‘coded’ or calibrated each time a new box of test strips is started

• Personalised features including “pre and post-meal markers” which encourage better self-management in people with diabetes

• Results from studies ^{(1) (2) (3)  (4) (5)} have exceeded the accuracy requirements of the International Organization for Standardization ⁽⁶⁾

Bayer HealthCare announces a new blood glucose monitoring system: the Contour® XT meter which is used exclusively with the Contour® NEXT test strips.  Together they deliver next generation accuracy for reliable results while remaining simple and easy to use. New innovative technology evaluates a single sample seven times for improved accuracy and No Coding^TM technology eliminates miscoding errors.  This is a key feature for people with diabetes as miscoded meters can produce results that are inaccurate by up to 4 mmol/L⁽⁷⁾ which can lead to incorrect dose administration⁽⁸⁾.  The meter also provides patients with individualised blood glucose target ranges, important to help with self management.

“People with diabetes and their carers have to rely on blood glucose meters to help them manage the condition, making the meter a key part of their care regime.  Better self management is a key objective for my patients with diabetes; this device allows them to test by themselves and encourages good testing routines and importantly provides accurate results of their blood glucose level,” said Su Down, Nurse Consultant Diabetes, NHS Somerset Community Health.

Bayer’s Contour® XT meter also offers a choice of functions for patients’ individual needs: level 1 testing for patients looking for basic testing and accuracy, and level 2 testing for patients who would like further information and a more detailed understanding of the results.  This includes “mealtime markers” to help patients understand how food affects their blood glucose levels and reminders to test after eating.

Bayer’s new Contour^® XT meter is easy both for patients to use and for healthcare professionals to teach.  In clinical studies, 100 percent of patients were able to test by themselves using only the materials provided with the system and no additional training and 99 percent of patients were satisfied with the easy-to-use nature of the device ⁽⁹⁾.  These results exceed the accuracy requirements of the International Organization for Standardization ⁽⁶⁾ as well as the more stringent criteria expected during 2012. ⁽²⁾   “Bayer is committed to helping people with diabetes. We are proud of the new Contour XT meter and Contour NEXT test strips, which provide improved accuracy of glucose testing and offer adaptable features which together will help motivate people with diabetes to improve their diabetes self-management,” said a Bayer Spokesperson.

Bayer’s Contour® XT meter is available from diabetes nurses with Contour NEXT test strips available via prescription.  The original Contour test strips are not compatible with the Contour® XT meter therefore it is important patients use Contour NEXT test strips with the new meter.

Ends

The different testing levels

The level 1 testing provides a reading of blood glucose levels in three easy steps and without pushing any buttons.  This everyday simplicity helps people with diabetes establish good testing routines.

Level 2 testing does the same but also offers easily adaptable features that can encourage patients’ diabetes self-management.  Individual high and low settings customize targets, and weekly high and low summaries provide valuable insights and support timely decision-making and help optimize glucose control. 7-, 14-, and 30-day averages allow tracking blood glucose status and give the patient confidence that he/she is on the right track.

Next generation accuracy

Bayer’s innovative technology enables the Contour^® XT system to deliver next-generation accuracy as the mediator in the Contour^® NEXT sensor chemistry provides minimal background noise (meaning there is less interference with the results) making glucose determination easy and accurate, especially in the low range where it is especially important.

The new technology ensures that the sensor remains accurate under a wide variety of storage conditions and compensates for many common interfering substances in the blood (e.g. paracetamol, vitamin C and haematocrit).  Thanks to Bayer’s proprietary meter algorithm, which repeatedly measures specific data points, the system provides unique compensation for factors affecting accuracy.  Bayer’s proprietary electrochemical method plus innovative electrode design converts signals into glucose results and helps correct for many common errors. The No Coding^TM technology eliminates miscoding errors and means that patients do not have to code their meters.  New innovative technology evaluates a single sample 7 times for exceptionally accurate results.

The new device was tested in a number of studies ^{(1) (2) (3) (4)(5)} in which it always showed excellent performance in the hands of both HCPs and untrained patients.  The results exceed the accuracy requirements of ISO 15197:2003⁽⁶⁾ as well as the more stringent criteria expected during 2012. ⁽²⁾

The technical features at a glance

Bayer’s Contour^® XT meter features at a glance:

• New innovative technology evaluates a single sample 7 times for exceptionally accurate results
• Bayer’s No Codingä technology means one step less in testing and prevents insulin dosing errors due to manual miscoding
• Small blood sample (0.6 µL)
• Sip-in™ Sampling with visual feedback helps patient get the right amount of blood
• Fast, easy-to-read display with a 5-second countdown
• Ready to test right out of the box
• Personalized high and low target ranges
• Weekly high and low summaries
• 7-, 14-, and 30-day averages
• Pre- and post-meal markers
• Adjustable post-meal reminder
• Analytical accuracy range: 0.6-33.3mmol/L
• Haematocrit range: 0-70 %
• Memory of 480 results
• Unaffected by oxygen, maltose, galactose and compensates for many common interfering substances
• Download data from the meter to PC with Bayer’s Glucofacts™Deluxe diabetes management software
• Test strip chemistry: FAD-GDH
• Test sample: capillary, venous and arterial whole blood
• Temperature range: 5-45 °C
• Humidity range: 10-93 %
• Altitude: up to 6301 m

Bayer Diabetes Care

Bayer Diabetes Care is dedicated to providing blood glucose meters and support materials designed to simplify the lives of people with diabetes and their healthcare professionals.  Bayer produces several blood glucose monitoring systems for people with diabetes, these are:

• CONTOUR® XT meter and CONTOUR® NEXT test strips- a blood glucose monitoring system that provides next generation accuracy for results patients can rely on to help them make better diabetes management decisions
• CONTOUR® USB - the first blood glucose meter with on-board diabetes management software to help people with diabetes view their blood glucose results and track trends.
• CONTOUR® Link – wirelessly transmits blood glucose results to a compatible Medtronic diabetes device.

About Bayer HealthCare

The Bayer Group is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials.  Bayer HealthCare, a subgroup of Bayer AG with annual sales of EUR 17.2 billion (2011), is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany.  The company combines the global activities of the Animal Health, Consumer Care, Medical Care and Pharmaceuticals divisions.  Bayer HealthCare’s aim is to discover and manufacture products that will improve human and animal health worldwide.  Bayer HealthCare has a global workforce of 55.700 employees (Dec 31, 2011) and is represented in more than 100 countries.  Find more information at www.bayerhealthcare.com.

Bayer: Science For A Better Life

Bayer is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials.  The company’s products and services are designed to benefit people and improve their quality of life.  At the same time Bayer creates value through innovation, growth and high earning power.  The Group is committed to the principles of sustainable development and to its role as a socially and ethically responsible corporate citizen.  Economy, ecology and social responsibility are corporate policy objectives of equal rank.

Globally, in fiscal 2011, Bayer employed more than 112,000 people and had sales of €36.5 billion.  Capital expenditures amounted to €1.7 billion, R&D expenses to €2.9 billion.  For more information, go to www.bayer.com

Bayer’s office in the UK and Ireland are located in Newbury (head office), Cambridge, Dublin, Uxbridge, Sheffield and Norwich. For more information, go to www.bayer.co.uk

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Andrea Postles, Tel. 01635 563 031

E-Mail: andrea.postles@bayer.com

Forward-Looking Statements

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

REFERENCES

1. Performance of a New Blood Glucose Test Strip; poster presented at the 71st Scientific Sessions of the American Diabetes Association (ADA). Bailey T, Wallace J, Parkes J L, Pardo S, Schachner H C, Castro R, Simmons D, Chu A. San Diego, USA. : s.n., 24-28 June 2011.

2. Performance Evaluation of a Novel Blood Glucose Monitoring System presented at the 11th Annual Diabetes Technology Meeting of the Diabetes Technology Society (DTS). Lemke C, Petruschke Th, Wallace J, Pardo S, Parkers J, Matthaei S. Burlingame, California, USA : s.n., 27-29 October 2011.

3. Accuracy Evaluation of the CONTOUR® XT Blood Glucose Monitoring System in a Clinical Setting. David A. Simmons, Jane Wallace, Joan Lee Parkes, Scott Pardo, Holly C. Schachner, Rita Castro, Amy Chu, Timothy Bailey. s.l. : Accuracy Evaluation of the CONTOUR® XT Blood Glucose Monitoring System Poster presented at the World Diabetes Congress of the International Diabetes Federation, 4-8 December 2011.

4. Accuracy Evaluation of the CONTOUR® XT Blood Glucose Meter. Poster presented at the 5th International Conference on Advanced Technologies and Treatments for Diabetes. Warchal-Windham ME et al., Barcelona : s.n., February 8-11, 2012.

5. Performance Evaluation of a Novel Blood Glucose Monitoring System: Contour®XT. Alcaraz J, Rico N, Petruschke Th, Bedini JL. Barcelona : s.n., February 8-11, 2012. poster presented at the 5th International Conference on Advanced Technologies and Treatments for Diabetes.

6. In vitro diagnostic test systems—requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus. International Organization for Standardization, Geneva, Switzerland : s.n., 2003.

7. Best Choice, best practice. A guide to blood glucose meters in the UK market. Evaluation, Dept. of Health (DOH). 2005.

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9. Bayer HealthCare Diabetes Care. Data on file..