FDA Approves New Integrated Insulin Pump System

Animas Corporation today announced that the FDA has approved its Animas Vibe insulin pump and continuous glucose monitoring (CGM) system for the management of insulin-requiring diabetic adults.

Using Dexcom CGM sensor technology, which is approved for up to 7 days of continuous wear, the Animas Vibe system provides patients with their latest glucose readings on the pump screen and a complete view of glucose highs, lows, and rates of change over time. Alongside fingerstick testing results, this information can help guide immediate and long-term insulin delivery therapy adjustments, Animas noted.

The device’s CGM technology measures glucose levels every 5 minutes and provides real-time glucose values, in addition to revealing trend information at a glance. The Animas Vibe system also allows patients to administer insulin right from the pump, which assists with diabetes self-management. In addition, users can personalize their insulin dosing by choosing individual insulin-to-carb ratios, insulin sensitivity factors, and blood glucose targets in 30-minute increments.

“For many people who are insulin dependent, diabetes is a demanding disease that can require day-to-day and hour-by-hour management,” stated Dr. Brian Levy, chief medical officer of Animas, which is part of Johnson & Johnson Diabetes Solutions Companies. “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.”

The company is now accepting orders for Animas Vibe and expects to commence shipment to patients in January 2015.