It's finally here!
A whopping 19 months after being sent in for regulatory review, JnJ's new integrated Animas Vibe insulin pump + continuous glucose monitor has gotten the green light from the FDA to be sold in the United States! (See also: it finally got some 'good vibes' from regulators ;) )
Word came early Monday morning in the form a press announcement that on Nov. 25, the FDA had finally OK'd the Animas Vibe -- the long-awaited combo device merging the Dexcom G4 Platinum CGM and Animas Ping pump.
This means that for the first time ever here in the States, people with diabetes will have a second option for a pump-CGM integrated device besides Medtronic's system.
The new Animas Vibe is the first insulin pump in the States to integrate with the Dexcom G4, which a number of other pump companies are aiming for as well.
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Vibe becomes Animas' seventh pump model to be launched in the U.S. since 2000, and it's amazing to note that it's the company's first new model to hit the U.S. market since the Animas Ping debuted in 2008. And from the JnJ corporate messaging we've seen, they're looking to use this Animas Vibe launch as a way to "reinvigorate and re-establish" their brand.
Sadly, it's taken so long for the Vibe to get through the regulatory process that a lot has changed, and much of this is five-year old tech that may already seem outdated upon delivery. After all, MedT first brought the pump and CGM together eight years ago!
But choice is great and always worth celebrating, and there is a lot of excitement today from many in the D-Community who've been anxiously awaiting this news for a long time -- particularly since Dexcom got FDA approval in late 2012 for its G4 tech, that makes up half of the new Vibe, which btw has been available in Europe since June 2011 and in Canada since September 2013.
Animas tells us there really aren't any many significant differences from the overseas Vibe version, but there are a few cool new features:
- a high-contrast screen with color-coded trend lines (blue, red, or green) indicating low, high, or within-range numbers
- a non-adjustable hypo safety alert set at 55 mg/dL
- customizable audio alerts allowing you to create your own tune or set to vibrate
- Food Database where you can log in the carbs you're eating and have it calculate the insulin (an improvement, as it was only on the remote meter before)
- "Jump to Value" feature added, meaning a recommended bolus will self-populate on the screen with one button push and you can adjust from there rather than scrolling up to an amount from 0.0u as before (an improvement)
- Insulin On Board (IOB) will be shown right on a newly-added CGM status screen! (improvement)
- easier interfaces for personal pump settings like carb ratios, insulin sensitivity and glucose targets (improvement)
- waterproof pump up to 12 feet, with casing that has various color choices (no change from existing Ping)
- a small basal rate increment of .025 units/hour (no change from current pump)
What isn't touted in the marketing materials are key differences that matter to us patients, especially those who've used Animas pumps in the past:
- No meter remote! This was a huge draw for many with the Animas Ping, especially kids who weren't always standing still at time of BG checks or dosing, and many women who like to wear the pump in their bras or under dresses and can't easily access the device in public. The meter-remote JnJ offers (a somewhat-outdated OneTouch Ping meter) has been a big benefit, but the remote signal built in would interfere with the CGM signal, we're told, so it was either an integrated meter-remote or CGM. An Animas spokesperson tells us that even though it's not offered at launch, "that does not preclude us from using remotes moving forward. We continue to evaluate all aspects of the pump for each new product in development." Animas is now offering a (non-integrated) OneTouch Verio IQ meter at no charge with the Animas Vibe, but that offer doesn't extend to government-funded folks on Medicare or Medicaid.
- Not for kids: Sorry, parents and families -- it seems like a broken record playing this tune, but the Animas Vibe follows in the footsteps of other devices being approved for adults long before pediatric use. No regulatory approval for that yet. So unless your doc wants to go "off-label," anyone under age 18 won't be able to buy the Vibe for now. No word from the company on their timeline for submitting for pediatric approval yet either.
- Not the latest tech: When the Vibe came out in Europe, they were the first to offer the latest in CGM tech from Dexcom. That's not true now; you heard the recent news of Dexcom's FDA approval for a new advanced algorithm providing better CGM performance? Well, the Vibe won't include that, as it uses an old-school IR port that just doesn't support the new G4 algorithm. So if you want the advantages of the new algorithm, you'll either have to rely on a separate receiver or wait for the next-gen Animas Vibe.
Interestingly, JnJ didn't submit their paperwork to the FDA until April 2013, and chose not to conduct human factors testing that regulators wanted, delaying things even longer until final submission of all necessary materials in early 2014. The FDA approved the Vibe on Nov. 25. Translation: the FDA basically only took about 9-12 months to turn over this review, but the process dragged out thanks to delays on the Animas side.
Animas is now taking orders for the Vibe, and the device should be available to patients starting in January 2015, we're told by JnJ Diabetes Solutions Communications Director Dave Detmers, who represents all the company brands including Animas, Lifescan, and OneTouch.
Note that brand new Vibe customers will get the Animas pump and Dexcom G4 in the package, sans Dexcom receiver — as the pump serves as the receiver. If you're already using a Dexcom G4 and wish to switch to this system, you could purchase a new Animas pump and enable communication between the CGM and pump simply by entering the CGM transmitter ID code into the Vibe system (then you wouldn't need the G4 receiver anymore, of course). You can also still get a G4 receiver if you want one to use at the same time.
Cost: The Vibe costs $7,150, before any insurance is factored in, and that does not include the CGM component costs! Those are an additional $799 for the transmitter, and $499 for each 4-pack of sensors. Lifescan plans to offer an EZAccess Upgrade program, which offers patients who qualify the opportunity to upgrade to the latest technology, but they're not naming pricing on that yet. We've heard rumors that existing Animas pumpers using a 2020 model or the Animas Ping would be offered a low-cost upgrade to the new Vibe system for as little as $99, but we couldn't substantiate that, so no promises there.
To put this announcement into context as far as impact: remember, it was only a year ago that JnJ was trying to sell off the Animas unit and couldn't do that, so instead spun it off into a separate entity. Those within the corporate ranks may be marketing this as a boost for the company, but the reality is that the future of Animas is anything but certain. TBD on that.
In the meantime, we patients get a win from this new Vibe as a second pump-CGM choice beyond what Medtronic offers, integrating the popular Dexcom CGM system. And probably within the next year or so, we'll see the Tandem t:slim-G4 combo get FDA approval too -- meaning we'll have two Dexcom-integrated pumps on the market.
We're happy to have those choices, to be sure!