Some news on Dexcom-Omnipod: DexCom, Inc. Fourth Quarter 2010 Earnings Conference Call

On 3rd of march there was DexCom, Inc. Fourth Quarter 2010 Earnings Conference Call (audio here).

The news is Insulet and Dexcom made up their minds to withdraw their filing at FDA of current integrated product and integrate the Gen 4 sensor by Dexcom with second generation Omnipod (minute 14:20).
Due to omnipod 2 product plan and the trials required by FDA they plan to submit a new filing to FDA at the beginning of 2012.
The reason of this decision is due to FDA new requirements which demand more and different trials than before.

[My note: this would have required more money and delayed the product launch on the market, making omnipod first gen and seven plus an out-of-market product.]

(minute 11) Dexcom says they received CE mark (that’s European approval for device to sell) for their Gen 4 sensor for ambulatorial use, and they confirm it will launch in Europe together with Animas integrated product, now pending CE mark approval, during the first semester of this year. It’s Animas (J&J) that filed for the CE mark, so is upon Animas the decision to push for approval and reach market as soon as possible.
(minute 13:40) Dexcom tells us that Animas integrated product will be called … (sorry, listen and tell me how do you spell it, it sounds to me as “the vibe” but I’m not of english language).

(minute 34:35) As far as regards Gen 4 system by Dexcom in USA, Dexcom says FDA now consider CGM as risky devices and calls for more trials and better on the field test usages. So Dexcom will do another trial now and hopes to submit a PMA to FDA by this summer and if everything goes well the product should reach USA market at the beginning of 2012.

Thank you!

Thanks for the update.

Thanks for the update!

Garidan, your ears are good! It is VIBE. Check out

FDA is creating third world health care in the USA because of its clinical trial requirements.

Wow, CGM is a “risky device?” T1 by its very nature is ever changing and risky which is exactly why CGM is so helpful. Use it to spot the trends and test before treating. We are way better off with it than without it, wake up FDA!

Thanks, I didn’t noticed that at diatribe.

You are right: FDA says CGM is risky because people bases it’s decision on taking insulin or not upon its readings.
But so should be glucometers, and your thermometer …

“Vibe” is not on my dictionary: what does it mean ?

And as far as you know, when Diatribe says it is similar to PING, do they mean tha PING sold in Canada, which has the remote command (recently upgraded to full colors) ?

I would need the remote for my baby: she is 2 years old and I would love to bolus and see CGM data without her to be aware of anything.

Vibe is a slang term, so it would not be in your dictionary. It means a good “vibration” or a good feeling about someone or something.

The “VIBE” discussed in diatribe was the one for the EU. The other question was if the CGM would report to the pump or remote. I do not remember which why it was going to be set.

I’m so glad that FDA considers CGMS to be “risky”. Hypo-induced car crashes, Dead-in-Bed syndrome, lost eyesight, lost limbs, cardiovascular disease, and greatly reduced life expectancy are all (apparently) “safe”.

Next week, they’ll probably put a black-box warning on another dangerous drug, that widely-studied one called “placebo” – because it causes SO MANY cases of dry mouth and headache.

I agree. The FDA is tone deaf. If I was a startup I’d be tempted to skip the US market. We may have to accept that products will always roll in the US a year or two after they launch elsewhere. It is such a transitional time in the CGM and pump markets and so much good stuff on the horizon, I have no patience!

is there a link for the TEXT of this? I can’t get the audio download. There was a link for the report before this one, but i can’t find a link to the TEXT.

A transcript may eventually be available at This site has the Q3 but has yet

to show the Q4. Click “transcript center,” then do a search for DXCM, and a little ways down on the left

you can click transcripts located under “business intelligence.”

trying to upload mp3 recording but no go