CHESTERBROOK, Pa., Jan. 11, 2016 /PRNewswire/ -- 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. "The approval of the pediatric indication for Animas® Vibe® System enables parents and caregivers to both deliver insulin precisely, and monitor glucose trends accurately in children as young as age two with one integrated device."

The value of insulin pump therapy has been demonstrated in numerous clinical studies, showing significant improvement in blood glucose control when compared to multiple daily injections. Furthermore, studies have shown that patients who used insulin pump therapy in combination with CGM obtained lower HbA1c levels, relative to patients who used multiple daily injections and self-monitoring of blood glucose.1, 2 This greater insight into blood glucose trends helps children with Type 1 diabetes and their parents to make more informed decisions about their insulin needs.
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.

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