Abbott Diabetes Sensing Technology FDA Approved

Abbott announced that the U.S. Food and Drug Administration (FDA) has approved the company’s FreeStyle Libre Pro system, a revolutionary continuous glucose monitoring (CGM) system for healthcare professionals to use with their patients with diabetes.

FreeStyle Libre Pro system is designed to empower healthcare professionals to provide better diabetes management for diabetes patients. The system provides healthcare professionals with a visual snapshot of glucose data, known as the Ambulatory Glucose Profile (AGP), giving a more simplified and clear overview of not only glucose levels, but also patterns and trends within those levels. This valuable information helps healthcare professionals make better, customized treatment decisions for their patients – and for a significantly lower cost than other professional CGM products availablei.

On nearly a daily basis, Eugene E. Wright, Jr., M.D. of Duke Southern Regional Area Health Education Center in Fayetteville, N.C., finds it challenging to effectively treat his patients with diabetes when it comes to decisions around insulin, nutrition and medication. “My patients are often out of range, due to inconsistent self-monitoring and insufficient data from traditional glucose meters that are unable to provide a full view of their glucose levels.”

A press release is availble from Abbott website.

Roche launches innovative Accu-Chek Guide blood glucose monitoring systemGuide blood glucose monitoring system

Roche launches of the Accu-Chek® Guide, the next-generation blood glucose monitoring system. This new system is designed to make everyday blood glucose (BG) monitoring easier with features such as the spill-resistant SmartPack test strip vial, which helps users to remove just one strip at a time and avoid spillage or contamination. The Accu-Chek Guide system also provides for advanced accuracy, which enables reliable diabetes management. “As the global leader in diabetes management we are dedicated to supporting people with diabetes, in thinking less about their daily therapy routines. We are very excited to introduce this innovative system, that simplifies blood glucose monitoring and improves the testing experience,” said Roland Diggelmann, CEO Roche Diagnostics. First markets to launch the new system are Denmark, Switzerland and Australia. Morecountries will follow subsequently starting in early 2017.

The Accu-Chek Guide system enables on-board pattern detection that helps to increase awareness of too high or too low glucose readings as well as Bluetooth Low Energy connectivity to the Accu-Chek Connect diabetes management solution via a mobile app. This cloud-based solution guarantees a secure online data exchange and automatic data logging. People with diabetes, caregivers, and healthcare providers can share diabetes information virtually anywhere for timely advice and remote monitoring. Such telemedicine solutions can help people with diabetes and their caregivers manage diabetes more efficiently and give them peace of mind and a feeling of relief. Hence, 97% of 197 participants in a recently published study from France and the US agreed that the system was very easy to use and offers a better testing experience.

The Accu-Chek Guide system not only fulfills current accuracy standards but delivers even tighter 10/10 accuracy for more reliable results3. Consistently accurate measurements are essential for reliable BG monitoring and deriving the correct therapy decisions. Large deviations of the measured BG values from the true glucose levels can result in higher HbA1c levels, glycemic excursions and markedly increased rates of hypoglycemic events, as a recently published retrospective study revealed. In addition, studies have demonstrated that only about half of the BG meters evaluated meet the minimum accuracy requirements as defined by the ISO 15197:2013/EN ISO 15197:2015 Standard.

A press release can be found from Roche Website.