Dexcom gets FDA approval

[spike]

http://www.chron.com/disp/story.mpl/ap/fn/3750303.html

[duck]

Interesting. I'd be curious to know what it will cost...

[TvBabe]

Very interesting! I'd like one of these puppies :)

I did a little searching and found out there are two sensors, one is short term (3 days) which is inserted much like an infusion set would be. The other is long term which must be inserted by a doctor and lasts a year.

http://www.dexcom.com/sts.php is the short term sensor

http://www.dexcom.com/lts.php is the long term sensor

By the looks of things the short term sensor is the one mentioned in the approval, they don't mention the long term sensor (darn it).

[duck]

If the short term and long term use the same reader, than it won't be *too* bad...Start using the short term when it is available, opt for the long term version when it is available if you want. My concern is how many doctors can be trained on the outpatient procedure to implant the long term sensor?

[koblenz]

"DexCom management will hold a conference call starting at 4:30 PM (Eastern Time) on Monday, March 27, 2006 to discuss this important development. The conference call will be concurrently webcast. The link to the webcast will be available on the DexCom Inc. website www.dexcom.com under the investor webcast section and will be archived for future reference. To listen to the conference call, please dial (800) 811-0667 (US/Canada) or (913) 981-4901 (International) and use the participant code "6796471" approximately five minutes prior to the start time."

I am going to listen in...

[lelggren]

I love these new developments! They are so great to see and hear about. But, I personally worry about how much of the costs of these that insurance will cover. I bet that they will be pretty **** picky about it for a while....

[Rhino]

Just called.

No insurance coverage at the moment, but I'm prepared to pay out of pocket for it.

They're gonna call/send me a package on it in a few days.

[TvBabe]

Just called.

No insurance coverage at the moment, but I'm prepared to pay out of pocket for it.

They're gonna call/send me a package on it in a few days.

Did they give you some idea about the cost?

[Tatermom]

So where do you carry the receiver? Size of a cell phone..the 1990 cell phone or my cute little phone? Silly question I know:stupid: but everything looks bigger on a little body.

[koblenz]

I just sent an e-mail with the following questions:

"DexCom Folks,

I just read about your recent FDA approval for the STS system am VERY interested. So here are the questions you are probably sick of hearing at this point:

1. Is it FDA approval for general use by the public or to begin clinical trials (I would participate!).
2. Have you folks been working with insurance companies to try and get coverage for patients?
3. How much does the whole system cost?
4. How much do the replacement sensors cost?
5. I would need a prescription from my doctor, right?

Thank you for your time and I look forward to hearing back from you very soon."

Awaiting response...

[spike]

Just called.

No insurance coverage at the moment, but I'm prepared to pay out of pocket for it.

They're gonna call/send me a package on it in a few days.


I called this morning to ask for literature...

[spike]

If the short term and long term use the same reader, than it won't be *too* bad...Start using the short term when it is available, opt for the long term version when it is available if you want. My concern is how many doctors can be trained on the outpatient procedure to implant the long term sensor?

It may not be any more involved then when I had my poodle "chipped" in case she gets lost. :)

[koblenz]

It may not be any more involved then when I had my poodle "chipped" in case she gets lost. :)
... as long as it is way easier than that 'other' thing you get done to your poodles!

[Dewey]

I'd really like to see this (or something like it) come to fruition. I get so frustrated, cause it usually seems that as soon as an interesting (& helpful) gadget like this gets "FDA approved," some issue or other reason is found for it Not to be released. :(

[Cyborg]

Stupid Cramer said it was going up for FDA approval in 6 weeks. I was going to get some stock! :vollkomme

[ghostrider]

How would you compare this to the Guardian RT?

[koblenz]

Here is what I found out from customer service at DexCom:

Number: 1-877-339-2664

Starter kit includes monitor/receiver, case, and 2 sensors: $800.00. They are having a special if you buy now it is only $500.00.

1 pack of 5 replacement sensors $175.00 (OUCH!). $35.00 a sensor.

Right now, the stated shelf life of sensors is 4 months, fridge or no fridge. However, while they can't officially say so, the expect it could be longer and they are going to continue real time testing on shelf life and update their guidelines and results come in.

They expect to be able to start shipping in the next 2 - 3 days.

You need a prescription and your doctor/endo must be trained on it before they will take a prescription from that doc. They were happy to send someone to train my endo at his earliest convenience.

I asked how big the sensor was, compared to an in infusion set cannula, and the lady on the phone was not sure, but was going to e-mail me an answer.

I asked what kind of batteries the monitor/receiver takes (hoping to get a clue to physical size), and she wasn't sure, but would e-mail me.

After I hung up, I realized I should have asked about Canada, England and other countries. Sorry.

So while I am not going to go out and buy one right now, I am thinking...Hmmmmmmmm

[spike]

Here is what I found out from customer service at DexCom:

Number: 1-877-339-2664

Starter kit includes monitor/receiver, case, and 2 sensors: $800.00. They are having a special if you buy now it is only $500.00.

1 pack of 5 replacement sensors $175.00 (OUCH!). $35.00 a sensor.

Right now, the stated shelf life of sensors is 4 months, fridge or no fridge. However, while they can't officially say so, the expect it could be longer and they are going to continue real time testing on shelf life and update their guidelines and results come in.

They expect to be able to start shipping in the next 2 - 3 days.

You need a prescription and your doctor/endo must be trained on it before they will take a prescription from that doc. They were happy to send someone to train my endo at his earliest convenience.

I asked how big the sensor was, compared to an in infusion set cannula, and the lady on the phone was not sure, but was going to e-mail me an answer.

I asked what kind of batteries the monitor/receiver takes (hoping to get a clue to physical size), and she wasn't sure, but would e-mail me.

After I hung up, I realized I should have asked about Canada, England and other countries. Sorry.

So while I am not going to go out and buy one right now, I am thinking...Hmmmmmmmm


Looks like you asked more questions than I did. I asked them to send me literature on their meter.

[Cyborg]

Me too! Signed up for the literature and for a local representative to contact me. They also took down my endo's info so they could contact them, hopefully to train them on the device... And I bought some stock!

[spike]

Me too! Signed up for the literature and for a local representative to contact me. They also took down my endo's info so they could contact them, hopefully to train them on the device... And I bought some stock!

oh, I forgot, they got my doc's name and phone number too.

[koblenz]

I didn't give em' my endo's name yet. I have my regular appt next month, and wanted to discuss it with him before they started pestering him and saying "Jeff gave us your name and that we should come talk to you....".

... cause I HATE it when people do that to me...

[spike]

I didn't give em' my endo's name yet. I have my regular appt next month, and wanted to discuss it with him before they started pestering him and saying "Jeff gave us your name and that we should come talk to you....".

... cause I HATE it when people do that to me...

ah, there's NO way they can get ahold of my doctor unless his office staff permits that!

[Cyborg]

ah, there's NO way they can get ahold of my doctor unless his office staff permits that!

Same here... I gave the doctor's office phone number, not his personal home phone (which I don't have anyhow).

[Dewey]

I called customer service, and got a bit of good info. So far, the only meter/sensors that are approved, are the short term ones, and all of Koblenz' info. about the starter kit, etc., is accurate. The person I spoke with said the sensor would last approximately 3 days. I gave him my endo's information so that a training session could be set up. I'm very interested in this product, and am hoping to at least try it out. If nothing else, I'll have tried, so it'll definitely be worth it.

I also asked about the long term sensor, as I was a little more interested in going that route, but the FDA hasn't approved those yet. When/if they do, I'd rather use them, as the sensor would last a year.....The price is a bit steep, but currently less than the RT & its sensors.

I wouldn't mind having it implanted. I have a piece of glass stuck inside my hand anyway (the doctor didn't want to remove it cause it's around nerves & tendons), lol. I've also seen others who have had devices implanted, and they've done very well for long periods of time, so am not worried. My only concern would be the accuracy of the product, but I'd like to give it a chance.

[Cyborg]

I called customer service, and got a bit of good info. So far, the only meter/sensors that are approved, are the short term ones, and all of Koblenz' info. about the starter kit, etc., is accurate. The person I spoke with said the sensor would last approximately 3 days. I gave him my endo's information so that a training session could be set up. I'm very interested in this product, and am hoping to at least try it out. If nothing else, I'll have tried, so it'll definitely be worth it.

I also asked about the long term sensor, as I was a little more interested in going that route, but the FDA hasn't approved those yet. When/if they do, I'd rather use them, as the sensor would last a year.....The price is a bit steep, but currently less than the RT & its sensors.

I wouldn't mind having it implanted. I have a piece of glass stuck inside my hand anyway (the doctor didn't want to remove it cause it's around nerves & tendons), lol. I've also seen others who have had devices implanted, and they've done very well for long periods of time, so am not worried. My only concern would be the accuracy of the product, but I'd like to give it a chance.

What price did they quote you for the long term sensor?

[Dewey]

What price did they quote you for the long term sensor?
Unfortunately, he didn't provide a price, since it hasn't yet been approved. :( I was hoping he would, but no luck. :frown:

[JediSkipdogg]

Unfortunately, he didn't provide a price, since it hasn't yet been approved. :( I was hoping he would, but no luck. :frown:

Wouldn't a long term sensor need some sort of surgical procedure, even if it's outpatient? Assuming that, then I don't see how any price could even be put on it. You could get a price for the sensor, but at what price would the "implanting" of the sensor be charged? That would be up to what hospital you have it done at.

[koblenz]

You could get a price for the sensor, but at what price would the "implanting" of the sensor be charged?
Dude, just give me a call and I will be over there with my rusty spoon and duck tape and insert it for you... NO CHARGE!

[JediSkipdogg]

Dude, just give me a call and I will be over there with my rusty spoon and duck tape and insert it for you... NO CHARGE!

I think I trust my Macgyver skills more than you. LOL

[Cyborg]

Guess I shouldn't have bought their stock so soon. Seems like there might be some patent infringement. Not sure what it's all about...

Anyhow, the good news is that a Dexcom rep just called. We are planning on getting together next week for a demo of the device. The rep is pumper and is wearing the CGMS. Can't wait to check it out!

[spike]

Guess I shouldn't have bought their stock so soon. Seems like there might be some patent infringement. Not sure what it's all about...

Anyhow, the good news is that a Dexcom rep just called. We are planning on getting together next week for a demo of the device. The rep is pumper and is wearing the CGMS. Can't wait to check it out!

We expect a full report after the rep shows you their new toy!