First CGM-enabled, waterproof insulin pump system now approved in Europe PDF Print E-mail

Animas® Vibe™, the First Integrated Offering from Animas Corporation and Dexcom, Inc., Receives European CE Mark Approval

Press release 2nd June 2011

vibeWEST CHESTER, PA, June 2, 2011 /PRNewswire/ — Animas Corporation announced today the receipt of CE Mark approval for Animas® Vibe™, the first and only continuous glucose monitoring (CGM)-enabled insulin pump system with Dexcom G4™ CGM technology.  Animas® Vibe™ brings together the unique features of an Animas® insulin pump and the convenience of Dexcom CGM, which is the only sensor approved for up to seven days of wear.

As a CGM-enabled system, the Animas® Vibe™ insulin pump functions as a receiver for the Dexcom G4™ Sensor. The system delivers real-time glucose information, alerts for high and low readings, and glucose trend information, enabling patients to make more informed decisions to help control their disease.* Unlike currently available CGM-enabled pump systems, Animas® Vibe™ displays glucose trends in colour and is waterproof.**

vibe-hi-Familys“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 Henry Anhalt, D.O., Chief Medical Officer, Animas Corporation. “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.”

Clinical studies have shown that adults aged 25 and older with type 1 diabetes who use CGM therapy to help manage their disease often experience significant improvements in glucose control.¹ 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.²

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.*

“Diabetes is a demanding disease. Companies like Dexcom and Animas work tirelessly to provide people living with diabetes relief in the day-to-day, hour-by-hour management that is required with this chronic condition,” said Dr. Anhalt. “By combining high-performance pumping with state-of-the-art CGM technology, we’re able to bring people with diabetes tools to better manage their disease.”

Animas® Vibe™ marks the first integrated product offering from Animas Corporation, makers of high-performance insulin pump technology and Dexcom, Inc., the leader in continuous glucose sensing technologies. Now approved in Europe, the product will initially be available to people living with diabetes in the United Kingdom, Germany, France, Italy and Sweden.

Animas® Vibe™ offers:

  • The latest technology available from Dexcom – Dexcom G4™, a tiny, round and flexible sensor with the smallest introducer needle as compared to Abbott Freestyle Navigator® and Medtronic Sof-Sensor®
  • Advanced high-contrast colour pump screen technology, that displays glucose trends with coloured arrows and lines showing where and how fast glucose levels are shifting
  • Dexcom sensor technology approved for up to seven days of wear, delivering more days of CGM data than those approved for a shorter duration
  • Waterproof durability up to 12 feet (3.6 metres) for 24 hours for the insulin pump, with a Dexcom G4™ Transmitter that is waterproof at 8 feet (2.4 metres) for 24 hours
  • Customizable alarms to indicate high and low glucose levels including a hypo-safety alarm fixed at 55 mg/dL (3.1mmol/L)
  • Low basal increment (0.025 U/hr) across all available ranges (0.025 U/hr to 25.00 U/hr) for precise dosing
  • Compatibility with Diasend® communications software, enabling patients to store, review and print both CGM and insulin pump data

The International Diabetes Federation estimates that 285 million people around the world have diabetes. This accounts for approximately 2.8 million people in the U.K., 7.5 million in Germany, 3.9 million in Italy, 4.2 million in France, and 484,400 in Sweden respectively.³

References

¹ New England Journal of Medicine. 2008; 359:1464-76. Continuous Glucose Monitoring and Intensive Treatment of Type 1 Diabetes. Tamborlane, W. Beck, R., Buckingham, B: Pgs. 1464- 1475
² New England Journal of Medicine. 2010; 363:4. Effectiveness of Sensor-Augmented Insulin-Pump Therapy in Type 1 Diabetes. Bergenstal, R., Tamborlane,W., Ahmann, A.: Pgs. 315-318
³ “IDF Diabetes Atlas” International Diabetes Federation. 11 May 2011.http://www.diabetesatlas.org/content/eur-data

More Information

Animas® Vibe™ Fact Sheet

CGM Fact Sheet

g4needlesm


Add this to your website
e-max.it: your social media marketing partner