FDA Approves Animas Vibe Insulin Pump and Continuous Glucose Monitoring System

The FDA has approved the Animas Vibe insulin pump and continuous glucose monitoring (CGM) system for management of patients with diabetes who require insulin, according to a press release from the manufacturer.

The integrated system, which features Dexcom G4 Platinum sensing technology, allows patients to view glucose data and administer insulin from the pump. The latest glucose readings appear on the pump screen along with a view of glucose highs, lows and rates of change over time. These data complement fingerstick testing results and can be used to guide or adjust immediate and long-term insulin delivery.

Animas Vibe offers insulin dosing with a low basal increment of 0.025 U per hour across all available ranges (0.025 U per hour to 25.00 U per hour) and a low bolus increment of 0.05 U across all available bolus ranges (0.05 U to 35.00 U).

Dosing can also be personalized by selecting individual insulin-to-carbohydrate ratios, insulin sensitivity factors and blood glucose targets in 30-minute increments with up to 12 personal settings, according to the release.

Additional features include:

• Dexcom CGM sensor technology that is approved for up to 7 days of continuous wear.
• Waterproof up to 12 feet for 24 hours, and the Dexcom G4 Platinum transmitter is water-resistant for up to 8 feet for 24 hours.
• Customizable alarms that signal high and low glucose levels.
• A high-contrast color screen with color-coded graphs and arrows to indicate direction and rate of glucose change.

“For many people who are insulin-dependent, diabetes is a demanding disease that can require day-to-day and hour-by-hour management. We are pleased to now offer people with diabetes in the U.S. a solution with CGM technology that provides the ability to make more informed decisions to manage their disease, which can ultimately improve blood glucose control,” Brian Levy, MD, Chief Medical Officer of the Animas Corporation, said in the release.