Animas Corporation announced that FDA has approved the use of the Animas Vibe Insulin Pump and Continuous Glucose Monitoring (CGM) System for the management of diabetes in children and adolescents, ages two to 17.
The Animas® Vibe® System was the first integrated system featuring Dexcom G4® PLATINUM CGM technology, and is the only such system available in the U.S. for pediatric patients as young as age two. The Animas® Vibe® System allows patients and their caregivers to view glucose data and administer insulin right from the pump, making it easy to fine-tune insulin delivery to help manage their diabetes.
"CGM-enabled systems, like the Animas® Vibe® System, provide patients with a more complete glucose picture, which is acutely important for children since they might not always be aware of the symptoms associated with high or low blood sugars," said Dr. Brian Levy, Chief Medical Officer, Animas.
In addition to the inclusion of CGM, the Animas® Vibe® System offers a unique combination of features including:
Fine-tuned insulin delivery – Equipped with a Swiss-made motor, the Animas® Vibe® Insulin Pump offers as low a basal increment as 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) to adjust and deliver precise increments of insulin, which is acutely important to children and teens given their higher insulin sensitivities.
Waterproof durability – The only CGM-enabled pump that is waterproof to 12 feet for up to 24 hours; Dexcom G4® PLATINUM Sensor and Transmitter are water resistant up to eight feet for 24 hours. (CGM readings may not be transmitted from the CGM to the pump while in water.) This allows children to live their lives as they want, not as their diabetes dictates.
Customizable Alerts – Customizable alarms to indicate high and low glucose levels. There is also a built-in, non-adjustable hypo safety alert set at 55 mg/dL, that may provide extra peace of mind to both parents and the patients themselves.
CGM in full color – The first CGM-enabled pump with a high-contrast color screen with color-coded trend arrows to show where glucose is heading and how fast, revealing the latest glucose values and trends at a glance.
An accurate, longest-wear sensor – With Mean ARD (Absolute Relative Difference) as the industry standard for measuring CGM accuracy, the Dexcom G4® PLATINUM Sensor 13-percent Mean ARD provides exceptional performance and accuracy for reliable results. Dexcom sensors are the only sensors approved for up to seven days of wear.
One of the smallest introducer needles – The Dexcom G4® PLATINUM Sensor is tiny, round and flexible with one of the smallest introducer needles available.
"It’s been our goal as a company to not only develop the best treatment solutions available, but also ensure that every member of the diabetes community, including children, may access these tools," said John Wilson, Worldwide Vice President of Insulin Delivery, Animas.
Expanding the global presence of the Animas® Vibe® System, along with providing solutions for children with diabetes and their parents, has been a top priority for Animas. The Animas® Vibe® System is also currently available to children ages two and older in parts of Europe, Australia, New Zealand, and Canada.