FDA Approves New Animas Insulin Pump
The Animas Vibe continuous glucose monitoring-enabled insulin pump has been approved by the U.S. Food and Drug Administration for use by adults 18 years of age and above who have insulin-dependent diabetes.
The system allows patients to both see glucose data – it measures glucose readings every five minutes – and administer insulin from the pump, making it easier to fine-tune the delivery of insulin and better manage diabetes symptoms.
The system provides the most recent glucose readings along with highs, lows and rates of change over time. Helping to determine what factors might influence episodes of hyperglycemia or hypoglycemia and also can help users administer more accurate insulin doses.
Studies have shown that continuous glucose monitoring helps improve glycemic control, lower A1C levels and reduce episodes of hypoglycemia due to real-time tracking of glucose levels.
“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 U.S. 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 of Animas Corporation.
The system – that combines the precision of Animas with the continuing glucose monitoring technology of Dexcom – is programmable, allowing users to personalize dosing, as well as blood glucose targets. It also has special features including a waterproof pump with a high-contrast color screen that has arrows and color-coded graphs to immediately indicate the rate and direction of glucose changes, customizable alarms to signal highs and lows and a sensor with one of the smallest introducer needles on the market.
The sensor can be worn continuously for up to seven days and is also water resistant.
Animas is now accepting orders for the Animas Vibe system and anticipates shipment to patients to begin in January 2015. For more information, visit www.animas.com.
