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 US for paediatric 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 paediatric 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. 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 that 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.
The features contains 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.
Another feature is 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.
It also has 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.
It comprises 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-per cent mean ARD provides exceptional performance and accuracy for reliable results. Dexcom sensors are the only sensors approved for up to seven days of wear.
It is 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.
“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.”
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.
Orders for the Animas Vibe system are currently being accepted, with anticipated shipment to patients beginning this month.