Animas’ Glucose-Monitoring Insulin Pump with CGMS OK’d in Europe

Animas said it has received a CE Mark in Europe for its Animas Vibe product, which the company said is the first continuous glucose monitoring-enabled, waterproof insulin pump system for people with diabetes….

The Animas Vibe combines an Animas insulin pump with DexCom’s continuous glucose monitoring (CGM) technology, which is the only real-time glucose information sensor approved for up to seven days of wear.

Clinical studies have shown that adults ages 25 and older with type 1 diabetes who use CGM therapy to help manage their disease often experience significant improvements in glucose control. Furthermore, patients who use insulin pump therapy in combination with CGM obtain lower HbA1c levels relative to baseline and relative to patients who use multiple daily injections and self-monitoring of blood glucose.

CGM-enabled systems, like Animas® Vibe™, provide patients with a more complete glucose picture (compared to fingersticks alone) including customizable high and low alerts and rate-of-change alarms and trends. These features allow patients to make more informed decisions to help control their disease. “The CE Mark approval for Animas Vibe is a significant milestone for our R&D program and for people living with diabetes who are seeking better ways to manage their disease,” said Dr. Henry Anhalt, chief medical officer at Animas in West Chester, Pa. “Avoiding extreme highs and lows in glucose levels is crucial to controlling diabetes and reducing the risk of long-term diabetes complications. Animas Vibe brings together leading pump and CGM technology to provide more freedom and flexibility to people living with diabetes.”

The product will initially be available to people living with diabetes in the United Kingdom, Germany, France, Italy and Sweden.