FDA Approves Animas Vibe Insulin Pump and Continuous Glucose Monitoring (CGM) System

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The U.S. FDA has approved the Animas Vibe insulin pump and Continuous Glucose Monitoring (CGM) system for the management of insulin-requiring diabetes in adults ages 18 and older.

As the first and only integrated system featuring Dexcom G4 PLATINUM sensing technology with proven accuracy, Animas Vibe allows patients to view glucose data and administer insulin right from the pump; simplifying and aiding their ability to make more informed decisions to fine tune insulin delivery and manage their diabetes.

The Animas Vibe system provides patients with their latest glucose readings on the pump screen and a complete view of glucose highs, lows, and rates of change over time. This information complements fingerstick testing results and can be used to help guide immediate and long-term insulin delivery therapy adjustments.

CGM technology measures glucose levels every five minutes and provides real-time glucose values, as well as trend information. CGM has been shown to improve glycemic control in adult patients 25 years and older via lower HbA1c levels, less frequent hypoglycemia, and reduced glucose variability.

The Animas Vibe also offers precise insulin dosing with a low basal increment of 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). Animas Vibe users can also personalize dosing by choosing individual insulin-to-carb ratios, insulin sensitivity factors, and blood glucose targets in 30-minute increments with up to 12 personal settings.

Additional key features of Animas Vibe include:

  • Dexcom CGM sensor technology is approved for up to seven days of continuous wear with one of the smallest introducer needles on the market. With Mean ARD (Absolute Relative Difference) as the industry’s standard for measuring CGM accuracy, Dexcom’s 13% Mean ARD provides exceptional performance and accuracy for reliable results.
  • Waterproof up to 12 feet for up to 24 hours; Dexcom G4 PLATINUM transmitter is water resistant up to 8 feet for 24 hours.
  • First and only CGM-enabled insulin pump with a high-contrast color screen, featuring color-coded graphs and arrows to indicate direction and rate of glucose change, revealing trends at a glance.
  • Customizable alarms to indicate high and low glucose levels.

Animas is now accepting orders for Animas Vibe and anticipates shipment to patients to begin in January 2015. For more information, visit www.animas.com.

The Animas Vibe has been available in Europe, Australia, New Zealand, and Canada.

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julie
julie

The only problem is that it will not be compatible with the new Dexcom AP algorithm. Also, Dexcom is filing for G5 FDA approval early in 2015. I just think it took way too long for the Vibe to be FDA approved. I will wait for the Dexcom/Insulet G5 integration.

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