Abbott receives CE Mark approval for new blood glucose monitoring system

Abbott (NYSE: ABT) today announced that it has received CE Mark (Conformite Europeenne) for its new FreeStyle InsuLinx Blood Glucose Monitoring System, the first blood glucose monitoring device from Abbott that includes a mealtime (bolus) insulin calculator for calculating suggested insulin doses. The new FreeStyle InsuLinx System also offers several additional user-friendly features, including a touch screen interface, automated logbook, personalization preferences and USB connectivity for plug-and-play reports via the new FreeStyle Auto-Assist data management software. The FreeStyle InsuLinx System will be available in select countries within Europe beginning in May. It is currently not available for sale in the United States.

It is estimated that approximately 55.4 million people in Europe are living with diabetes, and of those, many require insulin to manage their condition. For people who use insulin, managing diabetes can often involve challenging calculations to determine an appropriate mealtime insulin dose. Individuals often have trouble with the calculations required for insulin dose adjustment, resulting in insulin dose calculation errors.

In a published study, only 41 percent of people with diabetes could calculate an insulin dose that required adjustment for both carbohydrate intake and blood glucose levels. The FreeStyle InsuLinx System bolus calculator feature is designed to help patients administer an accurately calculated suggested dose of insulin that can help maintain appropriate blood glucose levels, as recommended by a healthcare professional.

"For my patients who require insulin, the steps involved in the self-care of their diabetes can be complicated and overwhelming," said Dr. David Kerr DM FRCPE, Consultant Physician, Bournemouth Diabetes and Endocrine Centre, Royal Bournemouth Hospital, UK. "Insulin is a powerful drug that needs to be dosed accurately and carefully or it can lead to significant adverse consequences. The introduction of new products that are created to make the difficult task of insulin dose calculation easier is important for people with diabetes and for their healthcare professionals, like me."

New Technology Designed to Help Insulin Users

The FreeStyle InsuLinx System is the newest addition to Abbott's portfolio of glucose monitoring products and is designed for people with diabetes who use mealtime (rapid-acting) insulin. The System offers several features that are designed to enable insulin-using diabetes patients to more effectively manage their condition, including:

  • Mealtime (rapid-acting) insulin calculator for calculating a suggested dose
  • Touch screen designed for ease of use
  • Automated logbook
  • Personalization preferences, including the ability to upload a personal photograph to the FreeStyle InsuLinx monitor, weekly messages and pre- and post-meal markers
  • USB connectivity for plug-and-play reports
  • FreeStyle Auto-Assist software, which is PC- and Mac-compatible, designed to help people with diabetes, healthcare teams and caregivers manage diabetes with reports, reminders and messages

The FreeStyle InsuLinx Blood Glucose Monitoring System is compatible with the FreeStyle Lite blood glucose test strips with ZipWik tabs, which are designed to offer easier blood application, resulting in a better blood glucose testing experience for people living with diabetes.

"The FreeStyle InsuLinx Blood Glucose Monitoring System is a significant advance for people with diabetes who use insulin," said Heather L. Mason, senior vice president, Abbott Diabetes Care. "The FreeStyle InsuLinx System has the potential to help change the way insulin users manage their diabetes, because it has been designed to translate glucose results into helpful information that can enable patients to more effectively manage their diabetes."




The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
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