FDA Approval for Animas Vibe Insulin Pump with Dexcom G4 PLATINUM CGM (VIDEO)

Animas, a division of Johnson & Johnson, won FDA approval for its Animas Vibe insulin pump and continuous glucose monitoring system. The pump is the first to pair with Dexcom‘s G4 PLATINUM continuous glucose monitor that samples interstitial fluid every five minutes and provides a trending chart of the patient’s sugar levels. This can be quite important, as a single reading doesn’t indicate where the overall trend is moving. The Animas device displays readings obtained wirelessly from the G4 PLATINUM glucometer and the patient can have basal insulin delivery pre-programmed to be delivered depending on glucose readings, or with a push of a button bolus insulin can be pumped in as necessary.

The system is completely water proof, so you can even take it swimming in the Maldives, and it’s a snap to disconnect the pump from the access site for showering and going through airport security.

Some of the system features according to Animas’ announcement:

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.

• 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.⁴
• 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.

Here’s a nifty video from Welcome to Type 1, a Type 1 diabetes information site, describing the Animas Vibe:

Flashback: Animas’ Waterproof Insulin Pump Cleared for Sale in Europe…

Product page: Animas Vibe…

Press release: Animas® Vibe™ Insulin Pump and Continuous Glucose Monitoring System Receives FDA Approval…