Slashdot Mirror
FDA Approves Wearable "Artificial Pancreas"
kkleiner writes "The FDA has approved a device that acts as an "artificial pancreas", which both continuously monitors a patient's glucose levels and injects appropriate amounts of insulin when needed. When blood-sugar levels become low, the device from Medtronics warns the wearer and will eventually shut down. The MiniMed 530G looks to offer an on-the-go solution for the growing number of people suffering from Type 1 diabetes who have to test their blood and inject insulin throughout the day. The company plans to improve the device to make a fully automated version down the road."
I hope this machine takes that into account.
“He’s not deformed, he’s just drunk!”
What about the poor Type-II fat bastards? They could link it to a 1.5L tank of insuline on their motorized carts they use to walk around and keep on eating burgers and being muricans.
Where's my vat-grown replacement pancreas implant?!
What makes this different from already existing insulin pumps other than the marketing?
"What does it run?"
You couldn't even read the first sentence? "The FDA has approved a device that acts as an "artificial pancreas", which both continuously monitors a patient's glucose levels and injects appropriate amounts of insulin when needed."
You are a tome of knowledge. You should work for the FDA and make sure these devices are safe before they're approved. I'll bet no one at the manufacturer or the FDA ever even considered that insulin levels change during the day. What do THEY know about insulin or endocrinology after all?
Do we now collectively owe millions of diabetics an artificial pancreas?
My point is that 'appropriate' changes depending on the time of day and whatever activity you are engaged in. Some times you need more insulin than others. Does the machine 'know' when?
“He’s not deformed, he’s just drunk!”
It is for type I diabetics, whose distinguishing characteristic is that they can't make more than trace amounts of insulin.
Don't be daft. It's a standard insulin pump that has one added feature. If you go hypoglycemic, it stops pumping. It is NEVER okay to go hypoglycemic. No matter the time of day or year or your mood. So it's always safe for it to function this way. And yes, it DOES know when you go hypo. Because it has an integrated continuous glucose monitor (CGM).
Yippee! On my way to the liquor store right now then...
Everything I write is lies, read between the lines.
TSA "Screeners" will have a new toy to fondle instead of my genitals.
When MT says they plan an 'improved device', they mean it's ready now - just waiting for certification . . .
As has been covered before, airport full body scanners tend to kill medical devices like this. People have had devices like these, along with pacemakers and other equipment die after being subjected to high energy bursts of EMI; which is exactly what airport scanners do. While the goverment claims they're phasing these out, they are still in the field -- high power portable x-ray and 'mwave' scanners that are being used at customs checkpoints, or on unsuspecting civilians on the road. And then there's those pesky aircraft carriers that carry gigawatt radar scanners that on several occasions have locked people in their cars, garages, etc., due to EMI when they were passing by.
All of this kind of unregulated and largely unmonitored technology poses a very real danger to technology like this; And with so many people having diabetes, this could mean that entire towns' worth of diabetics drop dead while the government claims "it's a mystery why everyone with implantable medical devices died after we irradiated them..."
My point is; The laboratory environment these things were designed (and approved) in is very different from the environment they're going to be used in. And there's no evidence the FDA has taken this into consideration from what's provided here. Indeed, they have a poor track record of having an impartial approval process; I do not believe that 'FDA Approved' means much more than 'Scientology Approved' these days -- but this is to be expected when the FDA's income is derived directly from the companies' whose products they approve -- companies literally pay for approval. Anywhere else, this would be a clear conflict of interest. But when it comes to the safety of our food, drugs, and medical supplies... it's business as usual.
#fuckbeta #iamslashdot #dicemustdie
Currently, I'm using a Dexcom continuous glucose monitor, and an Omnipod insulin pump. The advantage of being able to automatically turn down one's basal rate is an advantage, yes. I do this manually for myself, based on my Dexcom readings. But it isn't all that your pancreas does. If your blood sugar is diving too quickly, you have to supplement with sugar orally to make up for the fact that your pancreas isn't secreting hormones to make your liver release stored glycogen, or you may go too low and pass out. Often if I engage in unexpected exercise (moving boxes, changing a tire, spontaneous run) shortly after bolusing for a meal, my sugar will crash because my body becomes more responsive to the insulin I've taken, and once I've taken it, I can't un-take it. Kills spontaneity.
Your pancreas also supplies you with insulin automatically based upon your blood sugar fluctuations... this product doesn't. You have to manually calculate your mealtime boluses and make the pump give it too you.
This bionic pancreas is the technology I'm excited about, and can't wait for it to come to market. It automatically calculates and releases both insulin AND glucagon in measured amounts to keep your blood sugar levels as close to normal as I've ever seen.
Insulin pumps with glucose monitors have been around for several years. I fail to see what's new about this, unless they've improved the glucose monitor. The model my friend had several years ago required a very large (and painful) needle to draw enough blood. It was painful enough that she stopped using it and went back to manual measurements/pump settings after about a month.
My brother has a normal insulin pump. They work by continuously pumping in "fast acting" insulin into you (the basal rate), if you eat a meal, you have to calculate by hand the amount of extra insulin needed and press buttons on the unit to deliver the required amount. And yes, it knows that at different times of the day, you need more insulin than others. This is totally separate from the slow acting insulin that type 2 users sometimes take an injection of once or twice a day. If for whatever reason, the insulin delivery doesn't work properly, he'll start to have problems quickly, under a couple hours.
His also has a blood meter which starts beeping if his insulin level falls below a certain level. What his pump doesn't do is automatically change the amount of insulin delivered on the fly. Any change in insulin delivery has to be programmed. If he eats an apple, he has to press buttons to dose himself. If his body chemistry changes and that basal rate needs to be adjusted, it has to be programmed. My understanding from him is that the blood glucose measurement isn't especially accurate, though I can't remember why.
This is just the next generation of those same components. The generation after this, expect to see a unit that does a lot more dosing automatically. I think the technology is there, we just need to clear the regulatory hurdles.
Typically insulin pumps deliver insulin in two modes: Basal and Bolus. While a bolus is a large injection provided as quickly as reasonable, the Basal is a rate of delivery which can be instructed to vary over the course of the day. I would imagine that the device described in the article likely organizes injection in this fashion, with the added feature that if your blood glucose spikes, it will react to that automatically.
I had an insulin pump for a number of years (from the same manufacturer that made the device in this article, in fact), so I am familiar with the usage. I, personally, had problems using it (I sweat too much for the catheter to stay in reliably), but I think that they're a great technology for those who can use them. This growing automation is certainly a good thing.
Learning about brewing beer, by brewing beer.
We've had insulin pumps for decades, and continuous glucose monitoring systems for many years. This is just a small iteration on top of that. The new thing? If the CGMS thinks your blood glucose is low, the pump is instructed to stop giving insulin.
This ain't an artificial pancreas by any measure - even the manufacturer says as much.
i like my pancreas with bacon and real maple syrup...and a cold glass of milk.
artificial? yeah figures...its probably that bisquick crap man i hate that stuff...
never bring a twinkie to a food fight.
Yes, it's nice it has a continuous glucose monitor. Oh yeah, continuous glucose monitors are pretty bad at detecting when you've gone hypoglycemic (delays up to 30 min or more possibly because they monitor interstitial fluid glucose levels, not blood glucose levels)
Might as well face it I'm addicted to data.
The sensors don't work well. They require frequent re-calibration with a normal glucometer, they hurt to install and the feedback loops are bound by the difference between blood vessel glucose and interstitial flued blood sugar, which can take as long as 30 minuts. A real pancreas has *capillary* flow to monitor, and can be much more responsive to food or glucagon triggered changes in glucose.
This is about as much of an "artifical pancreas" as glasses are "artifical eyes". They still require frequent, manual jiggering of basal rates and carbohydrate/insulin ratios to handle actual eating, the feedback is just not good enough or fast enough to really replace the beta cells of the pancreas.
Now, cutting off insulin if blood sugar is ludicrously low is reasonable, and desirable due to the loss of awareness of low blood sugar common to Type 1 diabetics like myself. *BUT WE WOULDN'T NEED IT IF THEY HADN'T DISCARDED BEEF AND PORK INSULIN!!!!!* The "human"" insulin, which is several times the prices of beef insulin, has no medical advantage whatsoever. It's grossly more profitable because it's got a whole set of exciting and very profitable new patents. And the new insulan has a *MUCH* higher rate of hypoglycemic unawareness associated with it, from my personal experience. But doctors were educated to hear the word "human!" as being the ideal. *Beef insulin is better!!!!* It lasts noticeably longer with similar chemical treatment to long-lasting human insulin. But brother, try laying hands on a bottle of it in the last 5 years!
And as it is, the continuous sensors of this new system require almost as many glucose tests to stay calibrated as a well regulated Type 1 diabetic would use without the continuous sensor. So it's an entirely add-on cost, of limited utility, but matches the uneducated dreams of many and requires a whole new insulin pump ($3000 US investment for the pump, alone) to able to use. The only big advantage is night-time monitoring: that's admittedly useful, I've had real problems with night time highs and lows, and have tried continous sensors for precisely that. Unfortunately, since the old sensors had to be put somewhere away from the insulin infusion set, The resulting tangles of pump and tubes and taped down widgets made sleep difficult and the whole rig more likely to wake me up with disconnection failures than with an actual blood sugar warning.
I can see this for bedridden patient use, such as pregnant women with gestational diabetes: but for normal home use? I don't think it's there yet, and it's very expensive on a daily basis.
Dr. Faustman, at Massachusetts General Hospital, has a program entering the second round of human testing that modifies the human immune system to *stop killing insulin producing cells*, and insulin producing cells are formed from adult stem cells and cure the Type 1 diabetes. I'm waiting for *that* to finish clinical testing.
http://www.faustmanlab.org/
The treatment used is the BCG vaccine, used worldwide by millions of people for tuberculosis, but administered in small daily doses for a month, with very tight blood glucose control. If this works, the market is about to drop out of the insulin pump and the medical insulin market. They're entering Phase II of human testing (where they experiment with doses and durations, to get the treatment right for humans and verify its effectiveness. (Humans are a different species: animal testing is not enough for this.)
It's a good day for a news story like this. Congress is spending the weekend trying to repeal the 2.3% Obamacare tax on devices like this.
Also if the probe is the same as the one they currently sell, its crazy expensive, has to be replaced every 3 days and has an enormous needle. Too bad they don't mention any of that in the article.
Your problem is that you're looking to television to inform you. The purpose of tv is to entertain and sell. That's it.
What companies are working on an implantable version of this device?
What technology would be required for that to work? Wireless power charging, skin port for med refills, PAN (personal area network) for reporting, blood vessel graft or passthrough, anti-rejection coating, what else?
Does that mean my wearable real pancreas is out of style?
It's probably for the best, because it's starting to get a little smelly.
You are welcome on my lawn.
I hope this machine takes that into account.
I'm sure the scientists involved - who are much smarter than you, of that I have no doubt - thought of that. Dipshit.
Dipshit.
Buttface...
Eheh eheh. I don't like this channel, Beavis. Change it. Eheh eheh.
That is not true. Look at PODS. They are about 5 bucks each, yes they only last for three days, but the needle is smaller than the short pen syringes.
> I'm sure the scientists involved - who are much smarter than you, of that I have no doubt - thought of that. Dipshit.
Why aren't you on 4chan co-surfing with the Breaking Bad finale?
(-1: Post disagrees with my already-settled worldview) is not a valid mod option.
Hi, I'm not an expert but I believe the PODS are for delivering insulin, and have small needles. The systems for monitoring glucose have larger needs and cost more money. Informally, I've heard they can be kept in a week, but are no fun to insert.
Might as well face it I'm addicted to data.
Considering how many times the Physio Control division of Medtronics was shut down by the FDA for shoddy engineering/manufacturing practices there is no way I would willingly allow one of their devices to be attached to or implanted in my body. While they did spin off Physio Control to try and get away from all the bad press related to the deaths they have caused I still hold them responsible for products released while they owned that company.
Dr. Anath Shalev has some research on blocking beta cell atopsis in T2 (a lot of T2s also go on insulin)
http://www.uab.edu/medicine/diabetes/faculty/faculty-bios/201-anath-shalev
It's hard to make a closed-loop control because most continuous blood glucose monitors don't measure the blood, but the residual glucose in the intersitial fluid, and this lags blood glucose by several minutes, which can be a big deal, depending on the food type.
Blood sugar doesn't have a linear-time-invariant response to food input, different macronutrients can create different contours in blood sugar level over spans of time. Generally, a pump can't guess how many units to move in the bolus unless it knows specifically what you ate, it's not just a matter of dose, it's a matter of how long -- different foods require a more time-release bolus, sugars require a spike, all-at-once bolus.
Don't blame me, I voted for Baltar.
When they create an artificial brain that really works that all the CONgressMEN can use, hopefully with a beefier morality chip installed.
The mind conceives, the body achieves, the spirit manifests.
My son, now 11 has had low glucose suspend on his pump here in the UK for about 4 years.
This story is about approval of said facility by the FDA in the US. This is not an artificial pancreas in any way shape or form.
The problem lies with the fact that sometimes the sensor is WAY out. Every now and again the readings beggar belief - last night at 2am wasn't too bad - it said he was 7 (European units) when in fact he was 18. We have known the pump to go into low glucose suspend when he's asleep on the sensor and his blood sugar shoot up and he develops blood ketones. I've spoken to Medtronic in the UK and in the US about this. They're aware of the problems.
With regards to the excitement that providing health care in the US seems to generate, all of my sons equipment is funded by the National Health Service. I have never met anyone who has begrudged him access to these facilities, and I wouldn't begrudge them to you.
And it's not new. I've been wearing an insulin pump for the better part of 15 years.
From Scott Hanselman, who actually depends on this sort of stuff to stay alive:
"It's WAY too early to call this Insulin Pump an Artificial Pancreas"
http://www.hanselman.com/blog/ItsWAYTooEarlyToCallThisInsulinPumpAnArtificialPancreas.aspx
Read the article, it is very interesting and he makes some very compelling arguments as to why this is a bit too much hype...
The only "new" thing here is that the pump can AUTOMATICALLY stop delivery. This is a very small software tweak. The only thing that's different about this than getting a new firmware update for your iPhone - is that it requires BOAT LOADS of FDA certification to simply add the trivial (and obvious) feature - because hey, it is automatically messing with medication delivery.
There are two other less obvious things about it that really makes it a non-story:
1. Blood Glucose (BG) levels can rise or fall fast for one of many reasons. (Most "short-acting") insulins that are delivered from such a device take about 2 hours to reach their peak. So if the device realizes you are low and cuts off delivery - there is a good chance you could have "active" insulin already in your body which has yet to take affect. So the fact that delviery has been cut-off doesn't buy you too much - you still need to probably get some fast-acting carbs or glucogon to deal with the low blood sugar condition - or the fact that the "active" insulin could make you go even *lower* over the next 2 hours.
2. Most people who own the "Continuous Glucose Monitor" (CGM) piece very rarely use it. It is expensive, and yet another device to wear. They use them occasionally to get an idea of long-term trends, and for help in adjusting overall insulin levels that they program into the pump. It is also very inaccurate. (Blood tests taken from fingertips are the most accurate, though not even completely accurate themselves). Blood tests taken from a CGM worn on the abdomen or back, etc. are even less-so. So it suffers an inaccuracy which is like a time-lag" - i.e. your blood glucose level might rapidly falling and low - but a measurement from that site might not indicate that - just yet.
The "Artificial Pancreas" projects that people are referring to are ones in which the pump can deliver both insulin *and* glycogen - and have the intelligence to AUTOMATICALLY deliver them both as need. This is difficult, because now you have to "tell" the pump what your eating, and things like fat, protein and carbs will raise the BG. So for a device to do this without "knowing" what your eating, and to be able to do it with CGM data which isn't very accurate and not very timley, and to adjust it by delivering insulin which has a relatively slow absorption curve (over the course of hours) - makes for a difficult and messy problem.
Yup, which is why it looks like this particular new unit is only automated in terms of avoiding the most dangerous situation - hypoglycemia, and it probably only triggers when it detects a falling trend that is dangerously low. (e.g. alarm at 60 mg/dl and falling, shutdown at 50 and falling maybe? Although that might be too late, it's better than continuing injection.)
I've been a Type I for almost two decades (maybe two? I need to figure out how long ago eighth grade was...) - This unit addresses one of the primary reasons I have avoided pumps until now.
retrorocket.o not found, launch anyway?
There are other types that are not insulin delivery but monitoring. They are smaller than pods and are replaced weekly.
As it clashed with her colon :)
They've had this system available for over a decade. It's just an insulin pump with a monitor, and that's been available for quite some time.
There are 2 groups of people you can make fun of on the Internet without fear of attack. The illiterate, and the Amish.
I'd add that it's really difficult to see how they'd ever completely solve this problem -- your pancreas knows how much insulin to manufacture not just because it's measuring your blood glucose (all over your body, all the time), but because insulin production is just one factor in a cascade of dozens of different hormones, all promoting or inhibiting insulin production, and each other, for many different kinds of reasons. Your natural insulin production level is the product of a ton of different physiological vectors, only some of them tangentially related to the food you ate, and even if insulin is leading or trailing glucose levels, there are related hormones that cover the gaps over seconds and minutes, or allow compensation by other systems.
Endocrine systems are some of the most finely-tuned and subtle mechanisms in biology. They're like a Tesla, where seemingly-complicated frobs like neurons are like golf carts.
Don't blame me, I voted for Baltar.
I presume you really mean [something] around the body is sending info via nerves to the pancreas about blood glucose throughout the body? If so, what is the 'something'? (Or do you mean that the pancreas itself is measuring blood glucose *in the pancreas* and that that's an approximation of "all over your body" due to blood flow?)
The something is the panoply of chemical signals that are generated by cells, of all kinds, all over the body that promote or inhibit insulin production.
Don't blame me, I voted for Baltar.
I'm a type 1 as well and have been for about 10 years now, been on a pump pretty much since I was diagnosed. The pumps aren't really any more dangerous than injections and they're a lot more convenient and accurate as well. If your concern is hypoglycemia the pump might actually put you less at risk than an injection would. The ability to do things like dual boluses or square waves also helps a lot depending on what you're eating.
That said, I don't think this particular technology is anything special. So far as I know this is basically the existing pump/monitor combo Medtronic has been pushing for a while now just with a new feature to cut off the pump in the event it detects signs of hypoglycemia. The existing system sucks because you end up having to inject two different devices, the infusion set for the pump, and another device for the monitor, and they can't be anywhere near each other either. I might consider getting an integrated pump/monitor if they can ever manage to get both functions in a single package, but till then count me out. I'm actually betting they come up with a cure for at least some forms of type 1 diabetes before they manage to overcome that particular hurdle though.
Curiosity was framed, Ignorance killed the cat.