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FDA Approves Animas Vibe, Allowing Display of Dexcom G4 Platinum CGM On Pump Screen

Twitter summary: FDA Approves Animas Vibe, allowing display of Dexcom G4 Platinum CGM on Pump Screen; Shipments begin in January 2015

Nearly 20 months after its initial FDA submission, J&J Animas just announced FDA approval of its Vibe insulin pump integrated with Dexcom's G4 Platinum CGM for people with diabetes ages 18 and older. This “integration” means that the Animas Vibe system will display Dexcom CGM data right on the pump screen, meaning Vibe users will not need to carry a separate G4 Platinum receiver – a big win for patients in terms of convenience. Animas is now accepting order requests for the Vibe on its website and anticipates shipments to begin in January 2015.

For current Animas OneTouch Ping users, there will be a $99 “ezAccess Upgrade Program” to get the Vibe System - more details are posted here. To be eligible, you must have a OneTouch Ping Insulin Pump that is still in warranty and was purchased before December 1, 2014. On its own, the Animas Vibe insulin pump has a retail price of $7,150, though it will be covered by insurance like other pumps – Animas can tell you what you will pay based on the plan you have. While currently only approved for adults, Animas plans to soon submit a supplemental request to the FDA for approval in pediatrics – we’ll stay tuned!

The user interface on the Animas Vibe will be the same in the US as it is already in the international version (which received European approval back in 2011), aside from changes in language and units (US version will show mg/dl, rather than mmol/l as in the European version). Key aspects of the Vibe’s design are a color screen display of CGM data and waterproof durability. Unfortunately, the Animas Vibe will not be able to upgrade to the recently released “G4AP algorithm,” which significantly improves the accuracy of the Dexcom G4 Platinum CGM through an online software update.

The Vibe is the first pump to offer integration with Dexcom CGM. Previously, those wishing to see CGM data on their pump screen could only choose Medtronic pumps (e.g., MiniMed 530G, MiniMed Revel). Several other CGM-integrated pumps are on the horizon, including the Tandem t:slim integrated with the Dexcom G4 Platinum CGM (launch expected in mid 2015/early 2016) and both the Insulet OmniPod and the Asante Snap pump integrated with Dexcom’s Gen 5 app (expected launch in 2016 or later). CGM and pump integration is not only convenient for patients, but an essential step towards an artificial pancreas – we’re not quite there yet, but these developments are certainly moving us in the right direction! For now, it’s exciting that patients can choose between multiple CGM-integrated pumps in the US. –AB/AJW

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