May 4, 2011

Peeping in on Dexcom and the FDA

Dexcom released an earnings call yesterday.

Here is my voyeur's disclaimer: I listen to Dexcom’s earning calls more as Peeping Tom looking in a window into what seems to me to be strange courtship of of industry and the FDA around integrating of sensor and pumps. That is more interesting to me than the perspective of a Dexcom shareholder. I think my bias as a parent of diabetic kids is more pronounced than my vested interest in a few Dexcom shares. That said, as you read this, know I write from personal interests and make no bones about them.

This peep and tell used to be a lot easier when the call was available transcribed on Seeking Alpha. I recommend to anyone foolish enough to take my interpretation of the call as fair and balanced to re-think that and listen to the call themselves. They can find it here:
http://investor.shareholder.com/dexcom/events.cfm
While many, if not most folks may find earnings calls only slightly less dull than watching paint dry, listening for yourself will free you from my slant.

The call starts with new board members and a new president as symbols of plans to grow, whoopee. Wait I own shares that should be: Whoopee!

Somewhere in the call was a mention, in passing, of a type 2 CGM study. I opened another window to peep through and found a link and have posed an abstract of that study.

Dexcom talked about working with the FDA collaboratively to define what they need to do to get trials done for the gen 4 sensor. It sounds like Dexcom is hoping to get clarity from the FDA and have trials and the PMA for the 4th generation product started this year. This is significant because gen 4 is this product that will be paired up with pumps from Animas and Omni Pod. As I understood the call the gen 4 product studies are expected to take 60 to 90, under the heroic assumption that Dexcom has a clue about what the FDA wants. (Sorry, was that too sarcastic about FDA intent?) Dexcom is hoping to have a PMA supplement to the FDA by late summer.

Dexcom said on the call, they continue to expect the Animas / Dex integrated product to be introduced in Europe before it comes to market in the USA. In fact they said they expect the combo product to be marketed before the end of this quarter in Europe.

The Pod product is expected to be the new Pod and the gen 4 sensor. Neither of which as far as I can tell FDA blessed. So while both apparently are in works that sounds a bit further down the road. (Insert you favorite piece of FDA timing skepticism here.)

Dexcom seem to think that US products are in the time frame of end of this year or beginning of next year. If I am not mistaken that has been the expected time frame on each call back over a number of years. (Insert you favorite piece of product timing skepticism here. Which is why parents shouldn’t speculate on this stuff - but hey these tools are possibly a means to better lives for our kids - I mentioned we’re parents right?)

Hold not thy breath, lest ye die.


In the ‘interesting conversation’ side bar realm one of the issues the FDA may worry about is the risk of dosing insulin based on a device that isn’t indicated for that use and may not be sufficiently accurate. {Cough: meters} Far be it from me to point out that meter accuracy has been something that advocates have been calling for an improvement in since the late 80s.  Before the DCCT - the bench mark study on tight control taht got the world chasing tight control with meters that were not designed for that.

Granted meters may be more accurate than sensing but the simple fact of living with type 1 is that it is a balancing act. Part of that balance is coping with less than perfect sources of information. Sensing can ad trend to the over all mix of information. Trend can inform urgency. More importantly studies show sensing makes for better results.

So FDA repeat after me: "Perfect is not be the enemy of better."

I feel a number of my typical rants coming on and am looking around to borrow Glen Bech chalk board. If that isn’t a sign I have carried on too long I don’t know what is.

3 comments:

Bernard Farrell said...

I've used my Dexcom for dosing almost from the start. If the number doesn't feel right, I'll pull out my meter and test with it first. Generally this was worked just fine with me. I'll bet most CGM users do exactly the same.

We do need to learn more about the FDA process. Bringing it into the light can only do good. I'm hoping the Roche summit will be a great chance to talk about this.

AmyT said...

Thanks for peeping for us, Bennet.

I recently got ahold of a photo of the new Animas / Dexcom product, called the Vibe. See the end of this post:

http://www.diabetesmine.com/2011/04/rumors-that-prove-true-medtronic-enlite-sensors-and-the-animas-vibe.html

But for all the known reasons, we in the US will probably have a looooonng wait for this thing.

Anonymous said...

Not sure if I read it, or teased it out of an Animas Rep.... I am pretty sure the Rep said integration would not happen before 2012. But, I doubt that. By the time Animas integrates, maybe we will have other options; maybe Minimed would have reduced sensor size even further; maybe one of the smaller pumps like the Jewel will come to market. I am not too fond of the meagre options the pump companies have offered in the five plus years she has been pumping. The pump options are vitually the same as when she was dx'd.