They said that the Gen 4 has just had their study design and IDE application approved. They said the trial will start “later this summer”. They said that the submission of these pivotal trials should happen “by the end of the year”, but underscored that there may well be delays. I would SPECULATE that would mean the Gen 4 will be available mid year, BUT ONLY IF ALL GOES ACCORDING TO PLAN.
The (idiots) at Obama’s FDA call this a “significant risk device” so this keeps better technology off the market. “On track to complete the trial and complete the submission by the end of the year”. There is no benefit to the bureaucrats at the FDA getting better devices to the market, but if they delay and raise the cost to everyone, the FDAs believes if they delay everything they are doing a stellar job. Now Europe and Asia is getting new products before the US. (But that just my frustration since I’d really like the Gen 4 sooner).
They also said they will be going into trial for the Omnipod integration in H1 2012.
Thanks for the news. I’m very interested in the Gen 4 sensor too.
I understand your frustration with the FDA and I share that frustration. On the other hand I believe that a regulatory agency like the FDA is needed to protect consumer safety. If a medical device were approved too quickly and a safety corner was cut and someone died, especially if you knew that someone, I’m sure you would look at things a bit differently.
We cannot count on a corporation to “do the right thing” when they make decisions with consumer interest on the one hand and their profit on the other. We’ve seen time and again where corporations cut corners and sacrifice the public’s interest in favor of their interest.
Let’s hope that Dexcom can come through this process cleanly and we can begin enjoying their safe gen 4 sensor sometime next year.
Any idea what the FDA means by characterizing the new sensor as “significant risk device”?
Especially for an external device like this, seems like there could be an expedited FDA process. They still require you to test before you make any insulin adjustments. Not like your taking a pill that god knows what it is doing to all the major systems of your body.
My problem with the FDA is the mentality that if some regulation is good, more is better. Yes we want safe devices, but the process is often capricious and the rules aren’t defined. The result is in MUCH more expensive approval cycles which (duh) means more expensive medical benefits. The choice is not between NO approval, but a smart and exploited process.
The problem now, particularly for young companies is you have no idea how expensive and long the FDA process will take. The result is fewer medical benefits are coming to market, and the shift to medical development is to Europe and Asia where the regulations are more common sense.
It is a false choice between safety and an OVERLY burdensome and arbitrary FDA.
For those of us with diabetes looking for improved treatment and a CURE, the FDA is your enemy when they should be keeping us safe. Withholding medical advances without good reason, smart reasons is dumb. It also costs US jobs when we drive our medical development overseas. It shouldn’t cost a billion dollars to develop a new drug (less for a medical device), but that high cost, largely driven by the FDA means we have fewer treatment options. For diabetes, the market is so huge, there is still a lot of development. For less common illnesses, the FDA really makes it prohibitively expensive to develop drugs to treat these illnesses.
Yes, I agree that smart regulation, measured to ensure safety and reasonable expediency is the way to go. Some things that big pharma may characterize as “overly burdensome and arbitrary” may actually make sense to an end-user. I’m not defending the FDA; I just think that the unfettered market, when my health hangs in the balance, is not in my best interest. I like the counterbalance of an authority that requires due diligence on the part of the manufacturer. It’s all about the balance.
If Europe and the Far East has streamlined the process to be more sensitive to product development and the needs of health consumers then I think, by all means we should try to streamline where possible. We shouldn’t drive these jobs offshore.
It sounds like you have some direct experience with the process.
I don’t have any direct involvement in the medical industry, but I know many people who are involved in it. I believe the general problem today is the Obama administration’s view if some regulation is good, than a whole lot more is better. It is often posed as the false choice between doing nothing, or being slow and capricious as a virtue – this doesn’t make anyone safer, it just keeps medical advanced either off the market, or MUCH more expensive than they need to be.
The crime, is that aren’t getting medical advances at a reasonable cost since it is so expensive and time consuming to go through the FDA, new drugs and products don’t make it to market, or if they do, they are twice as expensive as they should be to cover the cost of the FDA process, and since someone (us) has to pay for all the advances that don’t make it to the market for capritoius reasons.
The net effect is that progress towards better treatments and the “cure” for diabetes is happening much more slowing than it would if the FDA helped expidite the proces of getting better treatments to the market safely.
Some will always believe that if the FDA blocks treatments or slow things down, then they MUST be making things safer – that’s just not the case.
I don’t understand why this is considered a “significant risk” device. I mean, you’re specifically told not to use a CGM for the purposes of bolusing and making immediate decisions about insulin delivery, right? It’s for identifying trends at this point in time and that’s all. So why the hold up?
I am fine with the FDA putting a lot of regulation on something like an insulin pump; a pump IS a significant-risk medical device because a malfunction can kill you. But a CGM? Sorry, but that’s just absurd.
I understand we can’t count on corporations to do the “right thing” and as a result I’m fine with regulation. But I think there is good regulation and just stupid regulation, and this is one of those situations where the FDA doesn’t seem to be understanding that (IMO).
I agree with Terry that I don’t trust these companies to have our best interest at heart and they do need someone looking after them. Although you scoff at the FDA calling this a “significant risk device,” don’t forget all the people that had wires break off and get lost in their bodies - do you think the parents of those kids would agree with your assessment? There is a very good reason that these companies have to go thru the testing they do. I personally would not want to use their devices if they were not put thru that testing.
I have been around long enough to see a lot of different drugs pulled off the market because 5 years after being approved, they deemed unsafe. Your wanting to have things get thru easier would only increase that.
The current Dexcom sensor is being made in China. That has nothing to with FDA costs. It has to do with cheap Chinese labor and you get what you pay for.
I totally agree. Smart regulation is needed, but regulations that just slows things down and makes medical costs higher is dumb. It has just gotten totally out of whack.
Besides being news worthy was there much more that came out of the broken sensor wires? Did someone actually have some permanent harm from that?
I agree that regulation needs to happen but in this case regulation is getting in the way of a product that could improve safety. The sensor wire for Gen 4 is supposed to be quite a bit stronger and thus hopefully reduce this problem of broken sensor wires.
I also agree with testing. The reason why everyone is being held up is because the FDA is taking so long in letting everyone know exactly what testing they are looking for.
“I don’t understand why this is considered a “significant risk” device. I mean, you’re specifically told not to use a CGM for the purposes of bolusing and making immediate decisions about insulin delivery, right?”
My opinion on why it is a risk is that people are variable in their safety behaviors. Yes, you are told not to use it to bolus but I would bet that there are some who are confident that their cgm is accurate and who bolus without meter checking. That is one risk since the cgm could be accurate some of the time and not others. There is also a small but significant risk for infection.
Granted, unless this Dex is totally different from the preceding ones, it should go through the process OK. It is never fast enough for the person who wants to use it though!
I have been using Dexcom 7 for over a year.
I know nothing about the Gen 4. Please inform me with details.
In what, if any, ways is the Gen 4 better than my Dexcom7?
The timeline Dex is giving out only leaves 6 months for the FDA to review and approve. Somehow that seems a bit optimistic to me. The FDA took much longer than 6 months to approve the very minor changes to the MM Revel pump, and their recent task force means even more review time now. I hate to say it, but I’m going to guess late 2013 for a new Dex.
First, the wireless signal is stronger and let you have the receiver a little further and never (?) loose data.
Then, the wire that builds up the actual sensor is made differently. They say it can measure better than the seven plus low BG, in the ipo range. They say it’s cheaper to build, but it could mean they earn more, not that you pay less.
Let’s wait and see the first which uses it actually in Europe: it is coming to market next month with Animas Vibe, in UK first but Italy and other countries too.
Yeah, it could be 2013! I don’t really get the FDA approvals process but the investor report indicates that US launch timing will depend on how the FDA categorizes it. Once Dexcom files with the FDA, the FDA will decide whether to categorize it as a “PMA supplement” or as a “PMA.” This will make a huge difference in the launch date. The wait period is 180 days for a PMA supplement versus 300 days for a PMA. So, assuming the clinicals go fine, we could see it sometime between July and November 2012.
Thank you.
Why is it each time I calibrate the resulting number on my receiver is somtimes very close to my blood number but other times not close at all?
It is confusing! The 180 days or 300 days really becomes irrelevant. The FDA is supposed to come back with an answer at that point, but the answer is usually - “We need more data” or “You need to change xyz”. The product rarely is approved in 180 or 300 days currently.
For example, Medtronics filed for the Revel upgrade as a 180 day PMA supplement on 8/6/2008. They got approved on March 10 of 2010. 19 months for a 180 day track. Same basic pump with a software upgrade.
My favorite is the 20 months it took to get a change in raw materials for an adhesive patch approved for MM’s sensors. Good grief - 20 months to approve glue
