Animas Corporation announced FDA approval of the Animas Vibe insulin pump and Continuous Glucose Monitoring (CGM) system for the management of insulin-requiring diabetes in adults ages 18 and older. As the first and only integrated system featuring Dexcom G4 PLATINUM sensing technology with proven accuracy, Animas Vibe allows patients to view glucose data and administer insulin right from the pump; simplifying and aiding their ability to make more informed decisions to fine tune insulin delivery and manage their diabetes.
The Animas Vibe system provides patients with their latest glucose readings on the pump screen1 and a complete view of glucose highs, lows, and rates of change over time. This information complements fingerstick testing results and can be used to help guide immediate and long-term insulin delivery therapy adjustments2. CGM technology measures glucose levels every five minutes and provides real-time glucose values, as well as trend information. CGM has been shown to improve glycemic control in adult patients 25 years and older via lower HbA1c levels, less frequent hypoglycemia, and reduced glucose variability.
"For many people who are insulin dependent, diabetes is a demanding disease that can require day-to-day and hour-by-hour management. We are pleased to now offer people with diabetes in the US a solution with CGM technology that provides the ability to make more informed decisions to manage their disease, which can ultimately improve blood glucose control," said Dr. Brian Levy, chief medical officer, Animas Corporation.
Animas Vibe also offers precise insulin dosing with a low basal increment of 0.025 U/hr across all available ranges (0.025 U/hr to 25.00 U/hr) and a low bolus increment of 0.05 U across all available bolus ranges (0.05 U to 35.00 U). Animas Vibe users can also personalise dosing by choosing individual insulin-to-carb ratios, insulin sensitivity factors, and blood glucose targets in 30-minute increments with up to 12 personal settings.
Dexcom CGM sensor technology is approved for up to seven days of continuous wear with one of the smallest introducer needles on the market. With Mean ARD (Absolute Relative Difference) as the industry's standard for measuring CGM accuracy, Dexcom's 13 per cent Mean ARD provides exceptional performance and accuracy for reliable results.
Waterproof up to 12 feet for up to 24 hours; Dexcom G4 PLATINUM transmitter is water resistant up to 8 feet for 24 hours.
First and only CGM-enabled insulin pump with a high-contrast color screen, featuring color-coded graphs and arrows to indicate direction and rate of glucose change, revealing trends at a glance.
Customizable alarms to indicate high and low glucose levels."We are excited to bring Animas Vibe to the US, which expands our insulin delivery portfolio and delivers on our promise to provide a range of solutions that help patients perform at their very best," said Ty Lee, vice president, Johnson & Johnson Diabetes Solutions.
Animas is now accepting orders for Animas Vibe and anticipates shipment to patients to begin in January 2015.Expanding the global presence of Animas Vibe has been a top priority for Animas, and today marks its introduction to the US Animas Vibe is also available in Europe, Australia, New Zealand, and Canada.