FDA Approves the First Insulin Pump and Glucose Monitoring System for Children

Knobbe Martens
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West Chester, Pennsylvania-based Animas Corporation recently announced FDA approval for the use of the Animas®Vibe® Insulin Pump and Continuous Glucose Monitoring (CGM) System for children and adolescents, ages two to seventeen. A Johnson & Johnson Diabetes company, Animas brings the industry one step closer to bringing a viable artificial pancreas to the market that is approved for pediatric patients.

Although previously approved for adult patients eighteen and older, children have greater insulin sensitivities than adults, and have a lower compliance with regular injections throughout the day. In addition, parents and caregivers are constantly required to monitor glucose levels and worry throughout the day about injections.

According to Animas, the Vibe System is the only integrated system available for pediatric patients as young as age two. The system allows the patient, and parents and caregivers, to deliver insulin and to monitor glucose trends in children. Diabetes patients, and especially children, cannot always feel the symptoms of when glucose levels are too low or too high, but the Animas Vibe System provides customizable alerts and alarms to provide the information to the patient.

According to John Wilson, Vice President of Insulin Delivery, Animas:

We’re thrilled that the FDA approval of this new indication for the Animas® Vibe® System for the first time now allows children as young as age two access to a CGM-enabled pump.

In its press release, Animas emphasized the value of insulin pump therapy in assisting patients to make more informed decisions about their insulin needs. According to Animas, the therapy has been demonstrated as an effective and significant improvement in blood glucose control compared to multiple daily injections of insulin.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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