Animas® Vibe™ Insulin Pump and Continuous Glucose Monitoring System Receives FDA Approval

Full release HERE

Animas Site

CHESTERBROOK, Pa., Dec. 1, 2014 /PRNewswire/ -- Animas Corporation today announced FDA approval of 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.
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The Animas® Vibe™ system provides patients with their latest glucose readings on the pump screen[1] 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.[2] 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.[3]
"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," said Dr. Brian Levy, Chief Medical Officer, Animas Corporation.
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[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.
"We are excited to bring Animas® Vibe™ to the U.S., which expands our insulin delivery portfolio and delivers on our promise to provide a range of solutions that help patients perform at their very best," said Ty Lee, Vice President, Johnson & Johnson Diabetes Solutions.
Animas is now accepting orders for Animas® Vibe™ and anticipates shipment to patients to begin in January 2015. For more information, visit

This is such exciting news! I personally have been waiting for the animas vibe to be approved forever it seems! I am sooo happy that it has finally been approved!!!

I was speaking with a Dex Tech this afternoon and just happen to ask about the Animas - Dex integration and he told me he just received an email today it's been FDA US approved and here it is. Does anyone know if they're using the new 505 Dex software and/or if it's just one insertion site or are we still wearing sensor and site? i've been on hold with animas for nearly an hour now, can't get through?


It's definitely still two sites. Not sure about the software version, but I know the Vibe doens't quite have all the features of the Dexcom (doesn't let you log events is the main difference, I think). One huge advantage, especially for anyone who swims, is that the entire pump/Dexcom system is completely waterproof and with you at all times. (I'm debating between getting a Vibe with my current "one pump per lifetime" insurance coverage or getting a separate Dexcom receiver to use with my current Ping and saving the pump upgrade for something really good.)

thanks, jen. yeah, i'm not sure what the advantage is really, only that it's one screen? you make a good point, there may be something much better on the horizon and then..yeah, we've used our pump upgrade for the wrong one. i was hoping something would come out where we only have to stick one thing on our bodies, but how would that work anyway, one site has to infuse the insulin the other has to measure the subq fluid?

WOW! This is such excellent news. I have eagerly been awaiting this for a LONG time. Awesome!

I think the big advantage is that it's one device to carry around and that it's waterproof. Otherwise, I don't think ther'es any difference since they both use the same sensors. In fact, I think you can probably connect a Dexcom receiver and Vibe to the same sensor simultaneously. If I go with separate devices (Ping and Dexcom) they can still both download into Diasend to get graphs and such, so that's probably what I'm going to do, especially if my insurance covers the receiver (the other things, transmitter and sensors, I'd have to pay for on my own).

It is only approved for 18 years and up. It does NOT have the 505 update and because of the dexcom integration will no longer have the remote for BG entry and remote dosing.

I have heard that the software upgrade involving the newer, more accurate algorithm is not available on the Vibe. I'm not sure if this is a regulatory issue or what but that seems to be about the only disadvantage of this system vs. having a separate gizmo for your Dexcom and pump.

I've always liked my Medtronic pumps but had a meeting with a Tslim rep and liked their product a lot and now the Vibe also seems like a really interesting product. Both of my pump failures have been due to moisture ("BUTTON ERROR") so having a waterproof or at least a more water resistant pump would be a plus for me. Learning a new system will be a hassle but probably not insurmountable...hmmm....

I'm getting mine in August 2015. Can't wait.