Animas announced that the Food and Drug Administration (FDA) has approved the use of Animas Vibe Insulin Pump and Continuous Glucose Monitoring (CGM) System for the management of diabetes in children and adolescents aged 2–17. This is the only system available for use in pediatric patients as young as 2 years of age.
Clinical studies have shown that patients who use insulin pump therapy along with CGM obtained lower HbA1c levels in comparison to patients who used multiple daily injections and self-monitoring of blood glucose.
The Animas Vibe System allows for basal increment as low as 0.025U/hr across all available ranges (0.025–25.00U/hr) and a low bolus increment of 0.05U across all available bolus ranges (0.05–35.00U) for precise insulin delivery. In addition, the CGM-enabled pump is waterproof to 12 feet for up to 24 hours. The Dexcom G4 PLATINUM Sensor and Transmitter are waterproof up to 8 feet for 24 hours.
A safety alert is set at 55mg/dL to indicate hypoglycemia and patients can customzie alarms to indicate high and low glucose levels. Its high-contrast color screen displays trend arrows to show the latest glucose values. The Dexcom G4 PLATINUM Sensor 13% Mean Absolute Relative Difference (ARD) shows accurate and reliable results. It also uses one of the smaller introducer needles currently available.
The Animas Vibe System is anticipated to begin shipping this month.
For more information call (877) YES-PUMP or visit Animas.com.