When exactly the Animas Vibe integrated insulin pump and continuous glucose monitor (CGM) hits the U.S. market is now up to the FDA.
Almost two years after the Animas Vibe got OK'd for sale in Europe, this Monday Johnson & Johnson submitted the pump to the U.S. regulatory agency. The company publicly announced the submission during their first quarter earnings call early this morning.
Our Diabetes Community has been anxiously awaiting this news since October, when Dexcom got FDA approval for its G4 Platinum CGM that will make up half of the new Vibe -- a combo of the G4 and latest Animas pump, their seventh model to be launched in the U.S. since 2000.
Animas Global Communications Director Caroline Pavis tells us there are really no significant differences from the Animas Vibe product that's been available overseas since Summer 2011. But based on the Animas 2020 pump platform, the Vibe does have additional user benefits:
- a high-contrast screen with color-coded trend lines (blue, red, or green) indicating low, high, or within-range numbers
- a small basal rate increment of .025 units/hour
- a non-adjustable hypo safety alert set at 55 mg/dL
- waterproof pump casing with various color choices
- personalized audio alerts allowing you to create your own tune or set to vibrate
Really, the only difference between the new U.S. product and the one already available in Europe is that it will use the G4 Platinum sensor just approved here in the States, rather than the older G4 used overseas to date. The Platinum has a different membrane and different algorithm from the original G4 introduced in Europe, which greatly improves accuracy, according to Dexcom's Executive VP of Corporate Development Steve Pacelli. The Platinum version is the only one available in the U.S., and is about 20% more accurate than the Dexcom 7, and about 25% more accurate in hypogylcemia detection according to studies, he says.
Pavis also says JnJ is in the process of getting regulatory approval in Europe to update the CE Mark status allowing for G4 Platinum sensor use in that older version of the Vibe, as well as for pediatric use for those younger than 18. In February, Dexcom asked FDA to expand approval of the G4 to pediatric patients who are as young as two years old.
Animas has also submitted the Vibe for approval in Canada and is awaiting word on approval there. UPDATE: The Animas Vibe got approval from Health Canada (the Canadian version of the FDA) on Sept. 9, according to that agency and also a JnJ spokeswoman. Details aren't yet available on commercial availability, as of Sept. 18, 2013.
Once approved, brand new Vibe customers would 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 wanted 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, Pacelli says. (Then you wouldn't need the G4 receiver anymore, of course.)
Existing Animas pumpers using their 2020 model or the Animas Ping, which communicates with a fingerstick meter, will be offered a low-cost upgrade to the new Vibe system. We've heard rumor that this could cost as little as $99, but we couldn't substantiate that, so no promises there.
Will the new Vibe be co-promoted on Dexcom's website? "We have multiple pump partners... we're also working with Tandem on an integrated system (with the t:slim pump), so we may build out a pump section on our website," Pacelli says. "Of course we want customers to know that the integrated pump products are an option."
While there's no timeline for when the FDA might OK the new Animas Vibe, the review process is typically taking a year to 18 months for these types of devices. Details on pricing and availability aren't mapped out yet before the regulatory agency's review is finalized, JnJ tells us.
The FDA process could move quicker in this case since it won't be the first pump integrated with CGM to be introduced here in the U.S. There is already a precedent set through Medtronic's Paradigm REAL-Time 522/722, introduced way back in April 2006. The FDA is currently reviewing the Medtronic's next-generation of system, the Veo, which can automatically suspend insulin during a hypoglycemic episode, a feature known as low-glucose suspend -- which the FDA has grappled with over safety concerns. That new system, which will be known as the 530G here in the U.S., could be approved at any time.
But really, it's anyone guess what the timing will be... here's to hoping for sooner rather than later!