I was wanting a pump, but relized I just want a CGM. A pump would still be great but the $$$$. So I'm thinking of just a CGM for now
Stoyan,
Your blog post over at the JDCA starts with a false premise. You state:
"Many people are urging the FDA to approve the artifical pancreas, which some are calling a cure for type 1 diabetes."
Are you serious? Is your hatred of the JDRF this great? Who even has an AP that is remotely ready for the market? Who are the "many"? Who is calling this "over the horizon" technology a cure? In short and respectfully, you are asking the wrong questions.
FWIW, the CNN story is filled with generalizations and lacks specifics on the differences between a LGS system and the AP concepts being tested in a clinical setting. There is a very significant difference! You would be better served analyzing the holes in the CNN story than asking your current question.
IOW, how about asking, "Does the CNN Artificial Pancreas story raise false hopes (again) by suggesting a cure (NOT!) is in the near future?"
The FDA is facing legitimate criticism over the amount of time it has taken to come up with guidelines for both LGS and AP systems. There is no question that the FDA needs a mechanism to evaluate what other regulatory agencies in other countries have received from companies in order to reduce the time to market and the costs both to the manufacturers and the people living with this chronic condition (pretty huge, I think!). Note that these guidelines are DRAFT(!). This means that there will be further delay before companies can really move forward to research AND bring products to market - ARRGGHH!
In the meantime, LGS systems are available in 40+(?) countries and there are lives being regularly lost in the USA that the current LGS system might have saved. Why should USA PWDs be denied this technology? How long will those most likely to benefit have to wait, and for how many will that be too long?
Again, the next time you are poised to attack the JDRF, please ask if you are doing this for the right reasons. As PWDs, we need to focus our efforts towards moving forwards on many (every?) front, not tearing each other apart. Please join me.
I would not trust an AP.
As others have said I see the following problems:
CGM: accuracy, sensor inconsistency some work well others don't, warm up period, what do you do while the sensor gets "wet"
Pump & Infusion sets & Site problems: sometimes works great other times it doesn't
Insulin: doesn't work fast enough.
I'm not even interested in the MM feature to turn off basal on low BG, this would not work for me, if I detect a low I treat with eating glucose tablets, if I also reduce my basal I always end up too high, it seems I have a 2 hour lag in basal adjustment.
It's a nice concept but definately not nearly ready for prime time.
Although I would wait and see with an A P for all of the reasons mentioned above there is a population for whom a less than perfect closed loop system might be very helpful. Insulin dependent nursing home patients often receive very poor diabetes care and a closed loop system might well lead to significant improvement even if the tolerances aren't as fine as many of us would want.
Maurie
That's a very good point Maurie! I agree that perhaps we are not exactly a representative sample and that people in situations in between mine (heh heh heh) and that of people in nursing homes might stand to benefit. Whether the "health care" system would support that or not might be another matter?
As a parent of a 8 year old diabetic I'm not ready yet....I am ready for a non invasive continuous glucose monitor!!
Mike...there is no attack or hatred of the JDRF. The post is meant to get people to share their different opinions on the matter. While we will be discussing the results of our survey at a later time, I can tell you that they reflect the mixed opinions found in this thread too.
Most people are aware of the JDRF AP ad http://jdca2025.files.wordpress.com/2011/11/jdrf_fda_ad_nov_2011-568x1024.jpg which is urging the FDA to pave the way for the artificial pancreas. It has stirred up a lot of debate on other forums as well - including Children With Diabetes - though my questions are focused on what people know about the system, not from the article alone, and how they are currently feeling about it. Opinions may change when we find out more.
I'll say it. The JDRF F******g blows. They denied Dr Faustman money yet ran studies to try and replicate her results. I think they'd get a lot more respect and donations these days if they came to their senses and helped fund phase 2 for her. Even if they don't believe in it they would at least be respecting a large percentage of the diabetic community that really believes in her efforts and showing they want to support a potential real cure. Without saying it, it certainly looks like they don't want to fund anything that might be cost effective for the patient to treat their diabetes if there is even such an animal. It's hard to fathom Mary Tyler Moore who is diabetic herself and is behind that organization.
Maybe the research is more complicated than it's made out to be and they had actual scientists look at their proposal before they passed? I am not remotely a science person and quick googling seems to pull up a bunch of people screeching that doesn't exactly explain why the decision was made all that clearly. Although they seem to be based on events that happened in like 2004 too, so I just feel like the whole process is disorganized. I also sort of suspect that if there was a huge "more accurate data" (MAD!! Nice acronym!!), the problem of goofy test strips and CGMs could be solved, perhaps more cost effectively than experiments that seem to remain largely unproven?
Stoyan, the JDRF ad is not promoting an artificial pancreas, it is asking the FDA to act expeditiously to develop the guidelines.
Your question puts the cart before the horse. If you asked people in 1903 if they would trust the plane to carry them across an ocean you would have received an overwhelmingly negative response.
There is no artificial pancreas commercially available, yet your question acts as though there is. Do you see my concern?
CGM's have not been perfected yet which to me is a serious 1st step! If they developed a small implantable cgm that is dependable they could insert that into the body in a few places. Having multiple sensors to provide information to a insulin pump would make me much more confortable with the idea. With accurate CGM at least we could sleep at night.
We need to get cost under control, it should NOT cost Faustman 25 million for phase II trials on a drug that has been around since early 1900s. Seriously where is the money going. It is very sad if you think about it, the cardinals offered Pujols 22 million a year to play freaking baseball, so one year of his salary could pay for the trial that could save 3 million lives!
That's a very good point about the guidelines too. If the FDA don't have guidelines for the research, there'd be little point in funding it as you could flush the $$$ down the toilet.
Stoyan, I believe that ad is urging support for Low Glucose Suspend. The ad is all about dying in one's sleep due to hypoglycemia. JDRF is well aware that current technology does not yet extend to administering insulin without human intervention, and I see no indication that they are asking the FDA to support such a system.
Would I trust THE artificial pancreas? That's a loaded question... there is no such thing right now. But if a closed-loop system were developed and demonstrated to work, then would I trust it? Yeah, I think I would. Because once such a product were on the market, it would be feeding off of data that were more accurate than what we have today, and it would be working off of insulin that worked as fast as natural insulin does. It would be more than just a Medtronic Revel programmed to respond to a Sofsensor CGM.
Since such a device -- and I prefer to use the term "closed loop insulin delivery system" than the more gimmicky "artificial pancreas" -- doesn't exist, I can't tell you what it would and would not do. I would expect it would automatically treat high BG without user intervention. I would expect it would slow or stop basal rates to treat low BG without user intervention. I would expect it to calculate correction ratios based on its own experiences and measurements. I do NOT expect it to automatically give a bolus for meals, or to rely on after-the-fact corrections, at least not in its first incarnation. I do NOT expect it to be fully transparent; if my BG were too low or two high, I expect it to alert me.
No matter what, the device would still need infusion set changes, reservoir refills, and (if it measures BG via interstitial fluid) fingerstick calibrations. It would still be susceptible to kinked cannulas, slow absorption sites, and air bubbles. It's not anything close to a cure, nor does it claim to be. In short, it does not grant a T1D the freedom to forget everything he or she has learned about having diabetes, but it does grant them the ability to not worry about it 24/7. So, going with those expectations and understandings, yes. I would trust it. I would trust it to do what I expect it to do.
Right now I wear an insulin pump, which is as close to an artificial pancreas as we can get right now. My pump has a CGM component and even my endo says the current one isn't worth me wearing it as it has a ton of problems.
Technology isn't really ready for it, right now. That's why they're still researching it.
Of course I'd trust it - just as far as I trust my Dexcom, or my doctor, or my insurance company. I am a smart, self responsible diabetic. Sign me up today. If we all took the pervasive negative outlook I see in this thread, we'd be stuck in the 1950's with pig insulin. Remember, the rest of the first world is moving much faster than the US, mostly because of the good old FDA. We think the US has such a great health care system, but there are facts that indicate otherwise. While mostly unrelated to diabetes, think about the fact the US ranks about 40th in infant mortality in the world. Think "progress", not NIMBY.
In a word, no. But since it likely won't be approved for use in children for a very, very long time, till it has a proven safety record in adults, it's not something I think is likely to be relevant to my son's situation anyway. I do wish, though, that people would stop looking at it as "the holy grail" or even as a "cure" because it isn't either of those things. It's merely a very complex and hopefully improved insulin delivery system. At its heart, it's not much more than a really high-tech syringe. A *real* cure is one that puts a halt to the autoimmune response and restores the pancreatic beta cells to their proper function. It bothers me that so much emphasis is being put on the development of a device, even such an advanced device, for palliative care rather than on finding a true cure.
Am I ready to trust an artificial pancreas?
Sure!!
Is an artificial pancreas ready to be trusted?
Sadly, no.
I agree with Elizabeth. The AP is definitely NOT a "cure." Just like the pump isn't a cure. It is simply another high tech insulin delivery system. Perhaps more research should be put into stem cells that can grow into beta cells and then treating them with blood from autoimmune, T-1 people. Seeing why the blood kills the beta cells. Starting from there could lead to a "cure."
Why anyone would have even considered a functional AP a cure is beyond me. It would be nothing more then a better machine to help glucose control. Dr Faustman is one of the only people literally trying to reverse the disease in true fashion. Though its probably a long shot just the fact that phase 1 showed exactly what she was looking for is a valid sign of hope. She apparently believes BCG will likely offer some sort of clinical benefit for most if not all people with diabetes.