The Hype.

It seems that the latest hype in the diabetes community is the announcement of the Animas Vibe insulin pump that was announced as receiving European CE Mark approval last week.  I have to admit that like so many others, I am very excited about this.  Being both an Animas pump and Dexcom user, of course I will be happy when the two become integrated.  I took a stab quite a while back at the Medtronic integrated CGMS when it was the Paradigm.  Unfortunately it did not provide accurate results or comfort for me.  But I did really like that the pump and sensors fed the same device.

From the information I’ve gathered, this won’t be available in the US until late this year or next.  I am very disappointed about this.  While I appreciate the process of ensuring medical devices are safe for consumers here in the states, I find it frustrating that they hold up the availability of such devices that would improve the management of blood glucose for those living with diabetes. If it’s safe enough for those living in Europe, what makes the citizens of US different?

There was also a new meter introduced by Animas Canada recently.  I found this out from fellow D Momma, Sherry.

It looks very similar to the Ping meter that’s in use in the US today except the screen is color, just like the pump.  That’s pretty cool isn’t it? 😉 Now if there isn’t much change to the meter, why would the FDA be holding this up too?  I’ve heard that when the Vibe comes to the US it will not have the “Ping” feature meaning that you will not be able to bolus from the meter.  Does that mean the new color screen meter will not be coming with the pump?  Will Animas US offer the new meter before the Vibe?  I’d love to not have to guess the answers to these questions that I’m sure I’m not the only one wondering about.  Come on already FDA!

(note: the pictures are all courtesy of Animas and their Vibe press release)

7 thoughts on “The Hype.

  1. The reality is the Fatal (er, Food) and Drug Administration sees more risk that removing patient control of the pump will actually raise HbA1c than they see in avoiding dangerous hypoglycemic. The logic escapes me, but I trust that eventually, we will see more logic from an organization that seems to do more harm to patients than helping us.

  2. The only way I would consider switching from my MM CGMS to the Vibe is if the meter works as a remote. I’ve had good luck with the MM CGMS… if there is no added benefit I can’t justify the switch. Thanks for sharing the info!!!

  3. Agreed, Stacey. It’s very frustrating to see the delays from the FDA – particularly when the discussions they are having are so backwards, as Scott describes. Hopefully things get moving a little better once the people involved are given the information and are actually able to understand what they’re looking at and talking about. In the meantime, those of us in the U.S. must wait… and watch what happens outside in other countries.

  4. I guess I am the only one who appreciates the FDA doing such a thorough job. I have GP and there are meds people swore by that the FDA wouldn’t approve that were found later to cause heart attacks. It was on the market in europe for over 10 years. I would rather be safe than sorry

  5. Correct me if I’m wrong but the Medtronic Real Time CGM needs to be calibtated 2-4 times a day with a regular blood glucoe monitor per the FDA’s guidelines. Why wouldn’t it be the same for the Animas Vibe? Why get rid of the meter remote?

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