Dexcom Gen 4 predicted FDA approval in US by end of 2012 (now available in Europe)

Thanks for the information Dave.

Oh yes. Insurance reimbursement for medical devices is an unknown concept atleast in Scandinavia. Therefore, lucky me, need to pay 591$ for my dexcom 4-sensor pack.

Also note that the current private insurance in the U.S. generally pays for CGM therapy while socialized medicine in Europe does not.

Not true. Here in Italy CGM is paid by Public Health Service, but it's true that few are diagnosed to need a CGM. But if you need it (hypo unawareness being first cause, or pregnancy) you pay nothing.
The same for micropumps.
I think CGM use should be wider spread, but public money is tight (I agree this) so you need to pay it for yourself as a plus.

I've been waiting on the new Omnipod for 6 months, it has been approved in Europe for 8 months and is still not available for sale there, it is still awaiting FDA approval in the US but I'm not holding my breath, I would probably die from asphyxiation.

Once I read FDA and EMA (European Medicines Agency) have different focuses: EMA states a drug is safe, FDA states it's safe AND gives clinical benefit, so the longer timings for approval (not a CGM or new POD case).
Here an interesting article on "FDA pendulum theory" link

Finally, some commentators have included former FDA Commissioner Andrew von Eschenbach recent Wall Street Journal article in their discussion of “speeding up FDA approvals.” He advocated “creating FDA pilot programs to bring promising therapies to patients more quickly by allowing them to be approved based on safety, with efficacy to be proven in later trials.”

Speculation on FDA’s position. FDA is certain to oppose Dr. von Eschenbach’s proposal if offered as a legislative amendment. However, FDA is still deciding its position on FAST/TREAT and the Breakthrough Act.

In response to a Congressional question, FDA spoke favorably of the Breakthrough Act. The key is that FDA is given discretion to provide more rapid and higher level process, but is not directed to change the standard of proof or the meaning of efficacy or safety.

FDA has been more hesitant about FAST/TREAT. Informally, it opposed a prior iteration because, among other things, it lowered standards by not requiring prior validation of a surrogate endpoint. My understanding is that FDA is considering whether its concerns have been addressed by these later versions of the bills.

The problem that we are going to run into soon as they attempt to interface these medical devices with mobile devices that the FDA approvals will not be able to keep pace with technology changes. Dexcom mentioned this issue in their last conference call.

Yes I can see that as a problem. Supposedly Omnipod has partnered with Dexcom to create a fully integrated pod/cgms like what is available from medtronics. Only problem is first Omnipod already partnered with Abbott on the Freestyle meter which is used for their Pod/PDMS so unless Abbott is giving up on it's Freestyle Navigator system this partnership isn't likely to get much further than the drawing board. It sucks that the FDA is unable to keep up, but as I posted earlier, Insulet isn't even able to supply their new pods in countries that have already approved it, so it's not going to happen here any time soon even if the FDA does in fact approve it.

gardian - I had heard similar information on dLife. One thing they mentioned was that if FDA did approve based on safety first, that most insurance would not cover them until it was approved for efficacy.

So I think it's a good thing if FDA approvals can be based on safety, but concerned that in the end, we might not get access to them except out of pocket or long appeals with insurance .

Next year Insulet will switch to lifescan Verio Pro/IQ strips (another new PDM .... ). Anyway Abbott had only strips agreement, nothing to do with CGM.

But it is the alliances between the companies that are holding the project up. And as Abbott still has the strip agreement until I think next year they are not going to relinquish their piece of the diabetic pie any sooner than the contract states. It just pushes the actual product further down the production line. I think it would be fantastic to push one button on one device and have both a cather and sensor inserted at the same time. Heck if it could be integrated real time to my iphone even better. The problem with Type 1's and some type 2's is we represent such a very small part of the whole diabetic market. Adult type 1's even with the LADA's and MODY's who are correctly diagnosed make up about 10%. With that small a market share it's hard to get companies to get off their collective asses. The companies that do are those with a stake in maintaining the herd i.e. becton dickinson, ely lily, novo-nordisk, and sanofi-aventis. Their profits come from just the daily maintenance, and although they are making small improvements like the nano needles and pens in general they do not have a vested interest in improving the quality of life of the herd. jmho

Insulet and dexcom had already a prototype of PDM talking to a seven plus sensor. The "integration" is only the use of the PDM as a receiver and display, just to have only one "remote".
Last year dexcom had Gen 4 almast ready so Insulet decided to not file for FDA and wait for Dexcom Gen 4 integration. I hope they'll do it next year, together with the new PDM with lifescan strips, otherwise there would be too many "versions" of PDM ...
link 2011

[january 2011]Insulet is evaluating whether it makes sense to move forward with the existing combination product that uses our SEVEN Plus, and the current OmniPod, or whether it would be more beneficial for potential patients to incorporate our current or future generation CGM technology into Insulet's next-generation OmniPod platform and conduct a more expansive trial as requested by FDA

I read that as well G but then the issue became how are we going to provide new PDM's to all the current Pod users. Heck as I said the new Pod has been approved in Europe for 8 months and is still not available for purchase.
My husband always said, never buy the first model of anything, i.e. cars etc, but he would probably say wait til they work out the bugs from this before you jump in. As someone on MDI, I am ok with waiting, I joined the Omnipod users group just to get a sense of what works and doesn't work. It seems in the beginning pod failures were rampant, now they seem to be more rare, so at least that is a step in the right direction. I live about 10 miles from Insulet and have been invited to the factory for a tour. At some point I may take them up on it.

Dexcom is one of my least favorite companies right now.

We've seen several hints from Dexcom that their 5th gen sensor can be used with mobile phone. (Guessing that we are talking bt le connection here).

Medtronic is worse, so which CGM are you left with ?

Problem isn't with the dexcom itself; it is with the customer service. They send out the dexcom before it is approved by the insurance company. After reading this thread maybe they did it to get rid of the old style before the new model comes out. Anyway I sent it back Saturday since customer service told me it could take 30 to 45 days for approval. Once it gets approved I will have them send it back to me. I kept trying to wait on the animas vibe to come out; but it appears the FDA wants it to become obsolete before they release it. I still want the dexcom; just not having a very good experience with them.

As much as I would be happy with just one device attached to my body, I need either the sensor technology to get much better or have the ability to replace the insulin in the pod.

I only start getting good results from my DEXCOM sensors after about 24-48 hours. After that, I get great results for 10-12 days. Unfortunately, due to my high insulin requirements, I only get about 40-48 hours on my pods.

If I could just get both devices to report their results and talk to one device, I would be happy with that improvement.

In watching the FDA's track record, I'm not holding my breath. I'll have to be content with the fact that diabetes treatment has still advanced rapidly, even in the last 13 years that I've been dealing with it.

Alan

I have to say, that Dexcom customer service has been terrific in my experience. Whenever a sensor has been very inaccurate or if I get a couple of instances of ??? they have always replaced them without ANY pushback. On the earnings conference call they indicated they assume they will have demand for the Dexcom 7 sensors for almost a year since a lot of people will have bought the Dexcom 7 in the last year and won't be able to replace it until their insurance will cover it (in my experience one year after purchase) -- so they probably can judge the inventory pretty well and in any case will have at least a year from now to get rid of the Dex7 sensors.

My biggest gripe (other than accurance which the Gen4 should improve somewhat on) is that the expiration date for the sensors is often only 3-5 months from when I get the sensors.

It not quite limited a market for Type 1 as you might think because us Type 1 test about 4x as often as Type 2. There are about 285M diagnosised diabetic in the world and about 26 million in the US. http://www.idf.org/diabetesatlas/5e/the-global-burden As you said, about 10% (or less) are type 1. So say there are 2 million type 1 diabetics in the US testing an average of 4x per day - that's about 3 BILLION test strips a year in the U.S. alone. At ~$.50/strip on average that is a $1.5B U.S. market for type I testing. Even if people test a bit less than 4x per day, that is a big market worthy of investment.

We don't exactly have an orphan disease, it just not quite in the same catagory as type 2.

But to me that just seems to continue the same argumkent, ok well if we can get them to use 3 billion test strips per year, what is our incentive as big Pharma to enable them to stop having to use our 3 billion strips per year. I didn't necessarily say we had an orphan disease, what I said, or more what I meant is we are a cash cow to the big pharma companies and there really is no incentive for them to do any better. Except for the invention of the CGM and analog insulins there really have been no significant changes or advancements in diabetes treatment lately. When cell phones first came out they were the size of suitcases (almost) now you can have one stuck on your ear. The first insulin pump came out, and as far as I can tell except for minor cosmetic changes pumps are still not that different. I don't want to just be content with it, I want to make some noise. We may be a big market strip wise, but we seem to be a fairly quiet market when it comes to getting stuff done.