Abbott Introduces New, Easier-to-Use And More Accurate Line Of FreeStyle Test Strips In Europe

Main Category: Diabetes
Article Date: 16 May 2010 - 1:00 PDT

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Abbott (NYSE: ABT) announced European availability of its new generation of FreeStyle® and FreeStyle Lite® blood glucose test strips at the 45th Annual Meeting of the German Diabetes Society (DDG). The new FreeStyle line of test strips features a new, easier-to-use ZipWik* design tapered test strip that offers a better blood glucose testing experience.1,2 The new test strips are designed to ensure faster blood application, to reduce the number of error messages and wasted test strips, and to deliver a significantly improved level of accuracy.

"The new FreeStyle line of test strips represents Abbott's latest success in delivering innovative products for people living with diabetes," said Heather L. Mason, senior vice president, Abbott Diabetes Care. "By providing a better testing experience and achieving greater levels of accuracy, Abbott is delivering on what patients and health care professionals demand in diabetes care, especially for people who use insulin to manage their diabetes."

The new FreeStyle line of test strips is compatible with all FreeStyle blood glucose monitoring systems,eliminating the need to switch meters. The new test strips also offer all the same benefits FreeStyle users have come to expect, specifically: no-coding required, the world's smallest blood sample size and virtually pain-free testing.

New FreeStyle Line of Test Strips Achieves New Level of Accuracy

The new FreeStyle line of test strips is the most accurate ever produced by Abbott and capable of meeting a tighter accuracy standard than exists today.3

The new test strips produce finger-stick blood glucose test results such that 95 percent of results fall within:

- ±15 percent of the true glucose value for glucose values equal to or greater than 5,6 millimoles/liter (mmol/L); and,
- ±0,56 mmol/L of the true glucose value for glucose values less than 5,6 mmol/L.4

This improved level of accuracy provides added confidence for health care professionals and people with diabetes when managing diabetes and dosing insulin.

The new FreeStyle and FreeStyle Lite test strips do not use the GDH-PQQ5 enzyme, which can be affected by common non-glucose sugars. The new FreeStyle line of test strips uses the GDH-FAD6 enzyme, which is unaffected by common non-glucose sugars, such as maltose or galactose, and minimizes the potential for interference.7

European CE Mark (Conformité Européenne) approval for the new FreeStyle and FreeStyle Liteblood glucose test strips was obtained in October 2009. The new test strips are now available to customers in Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, the Netherlands, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Over the coming months, the new strips will be available to customers in Australia, Israel and Norway. Abbott submitted 510(k) applications to the FDA in August 2009 for the new FreeStyle and FreeStyle Lite test strips.

About Abbott Diabetes Care

Abbott Diabetes Care, based in Alameda, California, is a leader in developing, manufacturing and marketing glucose monitoring systems designed to help people better manage their diabetes. Additional information about Abbott Diabetes Care may be found at http://www.abbottdiabetescare.com.

* ZipWik is a trademark of the Abbott Group of companies in various jurisdictions.

1. Home Testing of the Omni Glucose Test Strip by Lay Users in 2008, Abbott Diabetes Care, Data on file, Alameda, CA, USA.

2. Versus original FreeStyle brand test strips.

3. The International Organization for Standardization (ISO) specifies the requirements for home use blood glucose monitoring systems in ISO standard 15197.

4. Accuracy of Four Blood Glucose Monitoring Systems, 2009, Abbott Diabetes Care, Data on file, Alameda, CA, USA.

5. Glucose dehydrogenase pyrroloquinoline quinine

6. Glucose dehydrogenase flavin adenine dinucleotide

7. The new FreeStyle brand of test strips is not affected by interfering substances, including oxygen, uric acid, aspirin and paracetamol.

Source
Abbott

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