|The US Food and Drug Administration (FDA) has approved the Animas Vibe insulin pump and continuous glucose monitor (CGM) system (Animas) for the management of insulin-requiring diabetes in children aged 2 and older.
The FDA approved the same integrated device in December 2014 for use in adults.
The product incorporates the Dexcom G4 Platinum CGM technology, the sensor for which is small, round, and flexible, with one of the smallest introducer needles available, the company says.
The Animas Vibe enables precise insulin dosing with a low basal increment, ranging from 0.025 to 25.0 units per hour, and bolus increments starting at 0.05 and going up to 35.00 units per bolus, "which is acutely important to children and teens given their higher insulin sensitivities," it notes.
Patients and caregivers can customize dosing, as the device allows for up to 12 personalized settings of insulin-to-carb ratios, insulin-sensitivity ("correction") factors, and blood glucose targets in 30-minute increments.
It is the only CGM-enabled pump that is waterproof to 12 ft for up to 24 hours, although CGM readings may not be transmitted from the CGM to the pump while in water.
Other features include a high-contrast color screen with color-coded trend arrows to indicate glucose levels, and one of the longest-wear sensors the Dexcom CGM is approved for up to 7 days of continuous wear, with a mean absolute relative difference (the percentage of data points above or below a laboratory reference standard for blood glucose) of 13%.
The system also allows for customizable alarms to indicate high or low glucose levels, and there is a built-in, nonadjustable hypo safety alert set at 55 mg/dL, for extra peace of mind.
But the Animas Vibe does not include the capability to suspend the pump based on a preset low glucose level detected by the CGM. That "low-glucose-suspend" feature is thus far available only in Medtronic's MiniMed 530G with Enlite system, approved by the FDA in September 2013.
"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," comments Dr Brian Levy, chief medical officer, Animas, in a statement.
"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 2 with one integrated device," he adds.
This is the only such system available in the United States for pediatric patients as young as age 2; it is also currently available to children ages 2 and older in Europe, Australia, New Zealand, and Canada.
|Although insulin-pump therapy is associated with improved glycemic control in children and adolescents with type 1 diabetes, it is used by less than half of youth, even in some of the world's richest countries.