Blood glucose self-monitoring device

The haemoglobin A1C (HbA1C) assay has become the cornerstone for the assessment of diabetes control and A1c test results are widely used to guide treatment decisions. Especially convenient for people starting on insulin or using insulin, MyStar Extra® is a supportive meter, designed to help people with diabetes be engaged in their insulin management and treatment plan.

The estimated A1c function of MyStar Extra® is based on a new A1c estimation method tracking average glycaemia from self-monitoring data stored in the device. Scientific data presented at EASD 2013 show that the estimation procedure used in MyStar Extra® provides accurate estimates of the long-term average blood glucose value.

“The major advantage of this method is that it can work with infrequent self-monitoring data, for example fasting blood glucose readings and occasional daily profiles, and still provide reliable estimations where other techniques could fail. In-silico studies confirmed that the dynamical estimation procedure of MyStar Extra® tracks accurately the changes in average glyacemia underlying the changes in A1c,” said Dr Boris Kovatchev, Professor at the University of Virginia’s School of Medicine and School of Engineering and Applied Science and Director of the UVA’s Center for Diabetes Technology, on the occasion of the Sanofi Diabetes press briefing at EASD titled “On the right track with MyStar Extra®: New blood glucose meter provides estimated A1c and comprehensive guidance for people with diabetes”.

MyStar Extra® is especially convenient for people starting on or already using insulin as it provides additional blood glucose information on overall glucose control such as three-, seven- and thirty-day fasting plasma glucose averages and fasting plasma glucose trends.

The three-day FPG average is an important parameter for insulin titration. These supportive features may help patients keep track of how their therapy is working for them so they stay motivated to achieve their treatment targets for the prevention of diabetes complications.

“People with diabetes need to actively manage their diabetes to achieve good blood sugar control. Support and guidance through new technologies in self-monitoring of blood glucose can increase patients’ motivation to stay on track – and motivation is very important in a chronic disease like diabetes. What’s more, several studies have shown that ongoing feedback of one’s A1c may really help people to see the value of diabetes self-care and ultimately improve diabetes control”, said Dr William Polonsky, Associate Clinical Professor in Psychiatry at the University of California, San Diego, and Founder and President of the Behavioral Diabetes Institute.

At the Sanofi press briefing the diabetes experts agreed that simple illustrations of therapy progress can also contribute to improved diabetes care and better health outcomes for people with diabetes, particularly for people starting on or already using insulin.

“At Sanofi, our aim is to truly understand the needs of people with diabetes and to provide efficient, simple tools and guidance that help improve living with and treating diabetes”, said Pierre Chancel, Senior Vice President, Sanofi, Global Diabetes. The upcoming launches of MyStar Extra® and MyStar SylkFeel® underscore Sanofi’s commitment to provide innovations and integrated solutions to enhance diabetes self-care.”

The CE marks were obtained by AgaMatrix Inc. for MyStar Extra® and HTL-STREFA S.A. for MyStar SylkFeel®, respectively, the legal manufacturers of the devices and Sanofi’s partners in the development of these products. MyStar SylkFeel® is a new lancing device that provides easy to use and gentle lancing with no vibration so it is less painful for people with diabetes to perform blood sugar testing. In addition, adjustable penetration depths and a safety ejector allow for convenient and safe testing.

Now approved in Europe, MyStar Extra® and the new lancing device MyStar SylkFeel® will be available in selected European countries starting in the last quarter of 2013. They will complement the new MyStar® portfolio of Sanofi, combining devices, services and guidance for simple and effective diabetes management.