March 7, 2011

Editorializing Conjecture on CGM Pump Intergration

Europe is going to see Dexcom integration into insulin pumps before those of us on the left side of the pond, or so it seems from Dexcom’s earning call. We have to deal with Zombies first. Oh and it is going to named after a Pontiac.

Dexcom’s earrings call is online. You are welcome to go give it a click. I did. It's here: http://biz.yahoo.com/cc/0/121120.html

I listened for news on the integration of CGM into insulin pumps. Dexcom is working on that with both the Pod People and Animas. (I wish I had as good a nick name for Animas as Pod People is for Insulet with visions of the classic 1956 movie Invasion of the Body Snatchers, if you think of one post it as a comment - must be a 50s B movie.)

Where was I other than Zombie Invasions?

Oh Yeah! Earnings calls, the bit on the next generation of Dexcom sensor and combination Dexcom/pump products starts at about 11 minutes into the call. The good news: Dexcom received a CE mark for the 4th generation sensor. That is the one that will be integrated into the pumps. Dexcom expects it to launch in Europe with a Animas pump in the first half of 2011. The call even mentioned the combo pump thing has a name, “The Vibe.” Well, if you are going to name something after a Pontiac, Vibe is better than Aztec but it is no GTO.

Meanwhile the zombie invasion continues within the FDA or at least as far as getting pump/sensor approvals is concerned. Oops, that was a forward looking editorial statement based on conjecture. What I mean to say is that Dexcom publicly reported actual “constructive discussions” with the FDA on what it may take to get a gen. 4 sensor approved here in these United States.

The bit that confused the heck out of me (not that it is all that difficult to confuse me) is apparently in trials the FDA now considers glucose level manipulation a significant risk.

Really?

Hello FDA - Those living with type 1 kinda hav’ta to manipulate glucose levels 24/7. The manipulating blood glucose up is called eating. Bringing, sorry, manipulating blood sugar down is the whole insulin thing. What you are calling significant risk is what families living with type 1 diabetes call daily living. While I appreciate all the carefulness, I kinda, hav’ta, wanta call BS on the FDA for acting like a bunch of zombies pretending they don’t know there is a lot of glucose manipulation going on already.  Better tools would minimize the whole diabetes varies thing and therefor risk in actual daily lives. Doh! that was editorializing conjecture too.

So it seems commercialization of Dexcom / Pump combo is 6 moths off for Europe.  For us, just like it has been for the last few years, best case is a year here. Seems like the same time system as the cure - you know the one that has been ten years down the road for decades.

disclosure
I have two T1 teens, own a few shares of Dexcom and like movies more than earnings calls.
/disclosure

5 comments:

Garidan said...

You're right about FDA. Look here for opinions.
At diatribe.us they talk about ATTD London meeting where they saw the Vibe. Few words but better than nothing.

Lorraine of "This is Caleb..." said...

Maybe we should pack our bags and move.

Thanks for the update Bennet.

Bernard said...

Thanks, Bennet. I wonder if a group of diabetes bloggers could get together and talk directly with the FDA. We're certainly knowledgeable, opinionated and forceful. I expect all of these qualities are needed to get through the FDA bureacracy.

Hallie said...

I agree with Lorraine! We would LOVE an integrated Dex/Ping. Let's hope it is NOT on the same time frame as the cure. :)

Bennet said...

Bernard

Later in the call Dexcom says they are working with the same folks at FDA they have been working with all a long but the regulatory rule have changed and they had to change with the rules.

I am all for protection and due diligence and at the same time it seems there should be some sense of the larger picture.