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FDA Expands Labeling for Animas Vibe Insulin Pump
The FDA has expanded the labeling for the Animas Vibe insulin pump and continuous glucose monitoring system (Animas Corporation/Johnson & Johnson) to include the management of diabetes in children and adolescents 2 to 17 years of age. The system was originally approved in December 2014 for use in adults (18 years of age or older).
The Animas Vibe system allows patients and their caregivers to view glucose data and to administer insulin directly from the pump, making it possible to fine-tune insulin delivery to help manage patients’ diabetes. The system includes the Dexcom G4 platinum sensor, which is indicated for detecting trends and tracking patterns in persons 2 years of age and older.
Insulin pump therapy has shown significant improvement in blood glucose control compared with multiple daily injections in numerous clinical studies, according to Animas. In addition, studies have shown that patients who used insulin pump therapy in combination with continuous glucose monitoring obtained lower hemoglobin A1c levels compared with patients who used multiple daily injections and self-monitoring of blood glucose.
The Animas Vibe insulin pump offers a basal increment as low as 0.025 units/h across all available ranges (0.025 units/h to 25.00 units/h) and a low bolus increment of 0.05 units across all available bolus ranges (0.05 units to 35.00 units) to deliver precise increments of insulin, which is important for children and teens given their higher insulin sensitivities, Animas contends.
Shipment of the device to patients is expected to begin this month.
Sources: Animas Corporation; January 11, 2016; and Animas Corporation; December 1, 2014.