FDA Approves Animas Vibe and CGM for Children


The U.S. FDA has approved Animas Vibe Insulin Pump and Continuous Glucose Monitoring (CGM) System for management of diabetes in children and adolescents, ages 2 to 17.

The Animas Vibe System was the first integrated system with Dexcom G4 PLATINUM CGM technology and is the only such system available in the U.S. for pediatric patients as young as age 2. The Animas Vibe 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.  

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.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. 
  • 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.

Orders for the Animas Vibe System are currently being accepted, with anticipated shipment to patients beginning this month. In the meantime, if you have any questions, please don’t hesitate to e-mail me or give me a call at 215-688-6033.

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