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FDA Approves Wearable "Artificial Pancreas"

samzenpus posted about a year ago | from the a-spoonful-of-sugar dept.

Medicine 119

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."

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Insulin levels flucuate, just like blood pressure (1, Offtopic)

fustakrakich (1673220) | about a year ago | (#44986895)

I hope this machine takes that into account.

Re:Insulin levels flucuate, just like blood pressu (0)

Anonymous Coward | about a year ago | (#44986947)

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."

Re:Insulin levels flucuate, just like blood pressu (1)

fustakrakich (1673220) | about a year ago | (#44986987)

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?

Re:Insulin levels flucuate, just like blood pressu (1)

Anonymous Coward | about a year ago | (#44987027)

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).

Re:Insulin levels flucuate, just like blood pressu (1)

turning in circles (2882659) | about a year ago | (#44987411)

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)

Re:Insulin levels flucuate, just like blood pressu (2)

lesliev (1707190) | about a year ago | (#44987545)

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.

Re:Insulin levels flucuate, just like blood pressu (0)

Anonymous Coward | about a year ago | (#44988717)

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.

Re:Insulin levels flucuate, just like blood pressu (1)

turning in circles (2882659) | about a year ago | (#44988913)

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.

Re:Insulin levels flucuate, just like blood pressu (0)

Anonymous Coward | about a year ago | (#44991629)

There are other types that are not insulin delivery but monitoring. They are smaller than pods and are replaced weekly.

Re:Insulin levels flucuate, just like blood pressu (4, Informative)

Jjeff1 (636051) | about a year ago | (#44987189)

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.

Re:Insulin levels flucuate, just like blood pressu (2)

iluvcapra (782887) | about a year ago | (#44989211)

My understanding from him is that the blood glucose measurement isn't especially accurate, though I can't remember why.

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.

Re:Insulin levels flucuate, just like blood pressu (1)

Andy Dodd (701) | about a year ago | (#44991445)

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.

Re:Insulin levels flucuate, just like blood pressu (0)

Anonymous Coward | about a year ago | (#44986957)

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?

Re:Insulin levels flucuate, just like blood pressu (2)

demonlapin (527802) | about a year ago | (#44986997)

It is for type I diabetics, whose distinguishing characteristic is that they can't make more than trace amounts of insulin.

Re:Insulin levels flucuate, just like blood pressu (4, Informative)

VanGarrett (1269030) | about a year ago | (#44987235)

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.

Re:Insulin levels flucuate, just like blood pressu (0)

Anonymous Coward | about a year ago | (#44988163)

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.

Re:Insulin levels flucuate, just like blood pressu (0)

Anonymous Coward | about a year ago | (#44988267)

Dipshit.

Buttface...

Re:Insulin levels flucuate, just like blood pressu (0)

Anonymous Coward | about a year ago | (#44988643)

Eheh eheh. I don't like this channel, Beavis. Change it. Eheh eheh.

Re:Insulin levels flucuate, just like blood pressu (2)

Impy the Impiuos Imp (442658) | about a year ago | (#44988755)

> 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?

Type II? (-1)

Anonymous Coward | about a year ago | (#44986899)

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.

Re:Type II? (0, Interesting)

Anonymous Coward | about a year ago | (#44987083)

Type 2 diabetes is well supported by the FDA through their revolving door [rense.com] policy with Monsanto, ensuring that RoundUp and GMO crops are beyond legislation control, corn farmers get their subsidy, HFCS is so cheap that it's in all processed food, type 2 diabetes blooms across the whole population, the "health" industry reaps rich rewards, medical insurance skyrockets, disposable income for good food plummets, and the population eats more cheap delicious sugar-laden junk in a self-reinforcing cycle.

Everyone is happy, what's not to like?

Re:Type II? (0)

Anonymous Coward | about a year ago | (#44987223)

While there are concerns with the abundance of corn in everything and the politically warped power of the corn lobby, HFCS isn't the tipping point on fatass diabetes.

Re:Type II? (1)

ColdWetDog (752185) | about a year ago | (#44987231)

Remain classy, AC and stay on topic.

If you can't blame either Apple or the NSA, wait until the next post comes up.

Re:Type II? (0)

Anonymous Coward | about a year ago | (#44987497)

If you can't blame either Apple or the NSA, wait until the next post comes up.

Why wait for that, when you can always blame Microsoft and/or Bill Gates' Foundation?

Re:Type II? (1)

sjames (1099) | about a year ago | (#44987819)

If you want to blame something, blame the fat free processed food craze. They remove all the fat that lets you taste the food properly and that signals that you've had enough and replace it with a ton of sweetener and salt so it doesn't taste quite like cardboard. That way you can load up on carbs and never quite feel full.

Re:Type II? (1)

LordLimecat (1103839) | about a year ago | (#44988203)

Ive been all over these type of threads many times, and I still dont really get what makes a food "processed", or what makes "processed" worse for you.

I mean its a great scare-word, conjuring up images of "chemicals" (another great scareword!), industrial equipment, and men in cleanroom suits, but does cane sugar count as "processed" (given the bleaching process)? What about cooking something, is that "processed"? Is dannon yogurt "processed"?

Id also note that "they" provide whatever foods are being demanded; you can hardly claim that theres no competition in the "food" industry, so if consumers didnt demand these foods noone would produce them.

Re:Type II? (0)

Anonymous Coward | about a year ago | (#44988295)

Time for your remedial reading comprehension course.

The key word(s) in the GP's post wasn't "processed", they were "fat free".

It's fat that turns on the "I'm full" sensor. It's carbs which cause the damage to the metabolism, and convert to triclycerides which clog up your arteries.

You would have understood that if you'd actually read the GP post rather than blindly reacting to the word "processed".

Re:Type II? (1)

sjames (1099) | about a year ago | (#44989063)

The demand is created by quacks suggesting that anyone who isn't eating fat free is a fat slob. (and so, creating fat slobs). Unfortunately, many of those quacks have professional credentials that convince much of the public that they have a clue what they're talking about when a quick look at the history of their advice shows otherwise. It's hard to be sure how many of them are actually on the payroll of the very producers of those foods that are actually bad for you.

As for the rest, when your knee settles down, realize it's the fat free craze that is the key part. Achieving it requires ingredients not found in anyone's home kitchen and often not found in a chef's kitchen either. Most people call that 'processed food' Feel free to Google.

Re:Type II? (0)

Anonymous Coward | about a year ago | (#44990197)

Processed foods are generally pre-packaged (cans/tv dinners/ready to eat meats) foods. They are usually not very good for you because they contain a lot of additives to help the food taste okay to eat (the processes the food goes though tends to destroy the flavours).
    The biggest issue in processed food is salt, go look in your freezer at any tv dinners/ready to cook meals/etc and have a look at how much salt they contain. The recommended daily intake for sodium in Australia for a healthy male over the age of 12 is 920-2,300 mg. Now, considering that nearly everything you eat contains some sodium, how much of your RDI is left after your single meal?

Re:Type II? (1)

LordLimecat (1103839) | about a year ago | (#44988185)

what's not to like?

Well, the rampant ignorance over HFCS for one.

Given how remarkably similar HFCS is to straight up sucrose (and once your body processes it, the difference is negligable as they both become glucose / fructose mixes of almost the same ratio), it staggers belief that the problem is TYPE of sugar rather than quantity. I would argue that 40g of "sugars" per soda (thats ~1/10 lb) is the problem, not whether its "cane" or "corn" sugar, HFCS, "processed sugar", or whatever you want to call it.

and the population eats more cheap delicious sugar-laden junk in a self-reinforcing cycle.

Clearly thats a conspiracy by Monsanto, not a choice by consumers to eat bad foods. Anything at all to shift the blame off of the individual and on to "the man", right?

Re:Type II? (1)

Alioth (221270) | about a year ago | (#44990067)

The problem with HFCS isn't that it is HFCS, it's that it is absurdly cheap. This means it's going into all sorts of stuff you wouldn't normally expect sugar to be in, to make cheap crap food palatable. It even shows up in things like beef burgers, for example - where no one expects to find sugar. Unless you go out of your way to only buy natural fresh foods from premium suppliers, it can be difficult to avoid food with too much sugar. Now that's fine if you're middle class and can afford both the time and the higher cost of only fresh natural foods - but if you're time starved or cash starved (or both) you may go for foods you don't think would contain sugar only to find that they do because it makes cheap unpalatable food vaguely edible.

Cheapskates (-1)

Anonymous Coward | about a year ago | (#44986907)

Where's my vat-grown replacement pancreas implant?!

What? (0)

Anonymous Coward | about a year ago | (#44986931)

What makes this different from already existing insulin pumps other than the marketing?

Re: What? (3, Informative)

Damien Greathouse (2884225) | about a year ago | (#44986963)

The current the pumps do not adjust the insulin levels. Instead the user and the doctor program it to pump different amounts at different times. The current sensors just log the blood sugars to the pump for easier downloading and analysis at the doctors office.

Re: What? (1)

Anonymous Coward | about a year ago | (#44987213)

This pump only adjusts the basal rate down if you go too low. Doesn't do anything to either increase insulin automatically based on high readings, or release glucagon to help your body counter a low by releasing stored sugar. There is someone in Massachusetts right now with just such a device. It is still going through trials, and I'll be first in line when they release it.

Re:What? (2)

demonlapin (527802) | about a year ago | (#44987003)

The integrated glucometer.

Re:What? (1)

ArcadeMan (2766669) | about a year ago | (#44987181)

The Slashdot advertisement, that's what.

Re:What? (1)

cyborg_zx (893396) | about a year ago | (#44991121)

Because all the people here without type-1 diabetes are going to run out and get this?

Disappointed the article doesn't answer... (1)

ysth (1368415) | about a year ago | (#44986941)

"What does it run?"

Re:Disappointed the article doesn't answer... (5, Interesting)

Anonymous Coward | about a year ago | (#44987177)

Having worked at Medtronic, but not at the Minimed division, I would guess that it doesn't really have an OS. The HMS Plus and Magellan devices didn't contain a RealTime OS or anything similar and the Magellan was originally programmed by a pacemaker engineer before I got on the project, so they use C to make embedded software, but there's no underlying OS like VxWorks, etc.

Re:Disappointed the article doesn't answer... (0)

Anonymous Coward | about a year ago | (#44989025)

Why not Industrial TRON? (the OS, *not* the movie)

http://en.wikipedia.org/wiki/TRON_project [wikipedia.org]

Re:Disappointed the article doesn't answer... (1)

wiredlogic (135348) | about a year ago | (#44989289)

Because you don't need an OS and the consequential complexity involved in using one for doing simple hardware control.

Cool (-1)

Anonymous Coward | about a year ago | (#44986959)

Do we now collectively owe millions of diabetics an artificial pancreas?

Re:Cool (4, Insightful)

Chrontius (654879) | about a year ago | (#44987985)

It's probably cheaper than any other method of managing their condition like amputation, disability payments, and nursing homes.

Keeping diabetes from going from the "cheap to manage" to "terribly expensive" stage is probably, like most other healthcare things, a net savings once you get to even the medium term.

Re:Cool (1)

EmagGeek (574360) | about a year ago | (#44990561)

What's even cheaper is eradicating the instances of lifestyle diabetes - which are all of those cases of diabetes that occur by personal choice. Yes, there are autoimmune cases of diabetes, but the vast majority of diabetes cases occur by choice in people who refuse to put the fork down when they've had enough to eat, or refuse to stop drinking 5 gallons/day of sugared soda.

One of the new features of Obamacare is that insurance companies can steer you into healthy lifestyles and charge you a surcharge if you do not comply. Starting in 2014, our insurance company charges up to a $100/month-person surcharge for being "outside the fence" of acceptable measurements, which include BMI, blood pressure, fasting glucose, resting heart rate, and bodyfat percentage. You have to go in once/year for measurement, and if you are outside the box, you can remeasure again in 6 months.

We also have to turn in "verifiable workouts" either by going to an approved gym (at our expense), or log walks/runs/bike rides, etc with our smartphones - basically proving that we aren't sitting on our tails all the time. Failure to comply brings a surcharge (which is not a premium increase, btw - this is how Obama advertised that premiums would not go up. They aren't. But surcharges - oh boy...)

Not many insurance companies are doing this, but I imagine that more and more will as more and more people sign up and cost billions in treatment or obesity and inactivity-related disease.

Re:Cool (2)

Andy Dodd (701) | about a year ago | (#44991485)

And go figure, you're posting this drivel on an article about a device specifically targeted at Type I (autoimmune) diabetics... A device which, among other benefits, will help a Type I diabetic manage weight better by enabling them to maintain tight bloodsugar control without excessive hypoglycemia incidents. (Common problem for a Type I - eat a meal, take insulin, and then exercise without properly reducing your mealtime insulin dose to compensate. End result - hypoglycemia which requires you to eat more. A CGMS makes it a lot easier to properly plan insulin deliveries without overcorrections/oscillations.)

Yippee! (0)

ls671 (1122017) | about a year ago | (#44987051)

Yippee! On my way to the liquor store right now then...

New TSA Happy Toy (0)

Anonymous Coward | about a year ago | (#44987065)

TSA "Screeners" will have a new toy to fondle instead of my genitals.

And... (1)

djupedal (584558) | about a year ago | (#44987109)

When MT says they plan an 'improved device', they mean it's ready now - just waiting for certification . . .

Re:And... (2)

girlintraining (1395911) | about a year ago | (#44987433)

When MT says they plan an 'improved device', they mean it's ready now - just waiting for certification . . .

Alternatively, they've already identified potential design limitations but as the certification process takes longer than the development of a new model, they have opted to complete the certification process and begin getting a return on investment, while pursuing parallel development of a replacement model.

Insta-death (5, Interesting)

girlintraining (1395911) | about a year ago | (#44987131)

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.

Re:Insta-death (0)

Anonymous Coward | about a year ago | (#44987165)

Except for all the existing insulin pumps and existing continuous glucose monitors. Remember that time when a whole town of diabetics died because their insulin pumps... oh wait. That didn't happen. Or that time when a whole town of diabetics died because their CGMs.. oh wait. That didn't happen either. Hmm.

Re:Insta-death (1)

girlintraining (1395911) | about a year ago | (#44987383)

Except for all the existing insulin pumps and existing continuous glucose monitors. Remember that time when a whole town of diabetics died because their insulin pumps... oh wait. That didn't happen. Or that time when a whole town of diabetics died because their CGMs.. oh wait. That didn't happen either. Hmm.

And yet, the FDA has been investigating an unusually high number of insulin pump failures, to the point that 13 recalls [massdevice.com] have been issued as of 2010. These failure rates were not anticipated during testing, and thus the likely explanation is environmental factors. And then there's people like this woman [diabeteshealth.com] who has had multiple pump failures... a statistically unlikely event that happened to her twice in short order. And she's not the only one... the internet is filled with stories of people who have had "bad luck" with pumps. This is a strong indicator that environmental factors are in play in pump failures -- and the first one that comes to mind for me is EMI; that's why hospitals ask you to turn off cell phones. They can screwup devices a lot less sensitive than an insulin pump, and they're only pumping out a few hundred mW of RF when active. Airport scanners are several orders of magnitude more than that -- to the point Medtronic tells people not to take them through airport scanners because of the high probability of failure. And those gigawatt radar systems on aircraft carriers? Well... is it really that much of a stretch that if they can cause cable TV blackouts, lock owners out of cars, cause garage doors to randomly open and close... at a distance of over 40 miles... that this is an unlikely scenario? Especially when you consider something like 80% of the US population lives within 50 miles of one of the country's borders -- the majority of which is butted against two oceans?

Re:Insta-death (1)

CyprusBlue113 (1294000) | about a year ago | (#44987843)

This is a strong indicator that environmental factors are in play in pump failures -- and the first one that comes to mind for me is EMI; that's why hospitals ask you to turn off cell phones. They can screwup devices a lot less sensitive than an insulin pump, and they're only pumping out a few hundred mW of RF when active.

If you only knew a quarter of the reality of how much RF energy is pumped through hospitals by the various competing crap wifi/nursecall/monitoring systems they install, you'd totally freak out.

Re:Insta-death (4, Informative)

ColdWetDog (752185) | about a year ago | (#44987257)

Funny, you don't see many dead diabetics in the waiting area, do you? You'd think with all of the media coverage given to people who just get stared at wrong by the TSA we would see a couple more of these sorts of disasters on CNN.

I'm not any friend of Medtronic - they seem to do a barely adequate job on a day to day basis. But give the engineers a bit of credit - they don't just stick these things on a bunch of rabbits and then go out to the bar (the engineers, not the rabbits). The certification process actually does include running the devices by airport scanners these days. Who would have guessed?

Re:Insta-death (3, Informative)

girlintraining (1395911) | about a year ago | (#44987297)

Funny, you don't see many dead diabetics in the waiting area, do you?

You don't see many terrorists either, but few people would suggest they aren't out there simply because they aren't wearing their "I'm With the Taliban" t-shirts while going through customs.

You'd think with all of the media coverage given to people who just get stared at wrong by the TSA we would see a couple more of these sorts of disasters on CNN.

You'd think, from watching CNN, that only pretty, underage, white girls get kidnapped too. Unfortunately for minorities, boys, and ugly people, they get kidnapped too.

But give the engineers a bit of credit - they don't just stick these things on a bunch of rabbits and then go out to the bar (the engineers, not the rabbits).

Well, actually that's exactly what they do... prior to human testing, they test on animals. And it wouldn't be rabbits, it'd be pigs, who possess a more similar liver to our own than a rabbit does.

The certification process actually does include running the devices by airport scanners these days. Who would have guessed?

Well, you would have, for one. Perhaps a citation would help in establishing your credibility regarding this claim? Let me show you how: If you google "diabetic airport scanner", and click on the first link [loop-blog.com] , and they said this: "Medtronic has conducted official testing on the effects of the new full body scanners at airports with Medtronic medical devices and have found that some scanners may include x-ray. If you choose to go through an airport body scanner, you must remove your insulin pump and CGM (sensor and transmitter). Do not send your devices through the x-ray machine as an alternative. To avoid removing your devices, you may request an alternative screening process."

This would seem to suggest that the certification process does indeed now include airport scanners... principally in the "don't do this" column of the report.

"I didn't see it on CNN, so it didn't happen!" (2)

Rujiel (1632063) | about a year ago | (#44987673)

Your problem is that you're looking to television to inform you. The purpose of tv is to entertain and sell. That's it.

Re:"I didn't see it on CNN, so it didn't happen!" (2)

girlintraining (1395911) | about a year ago | (#44988809)

Your problem is that you're looking to television to inform you. The purpose of tv is to entertain and sell. That's it.

A television is just a device. It's a tool, like a hammer, a screwdriver, or a car. It has no innate purpose; it is up to the user to create purpose in it. While a TV, and televised material as a whole, is often used for entertainment and marketing, it is neither exclusively used as such, nor should we encourage it to only be used in that capacity.

"They say that ninety percent of TV is junk. But, ninety percent of everything is junk." -- Gene Roddenberry, creator of Star Trek

Re:"I didn't see it on CNN, so it didn't happen!" (1)

Rujiel (1632063) | about a year ago | (#44990209)

If it weren't for a advertisers, there would be no talent displayed. On the other hand, where there is no talent, there still will be advertizing. Exceptions to this are few and far between. Even those who use broadcasting corps as tools for propaganda only do so under the condition of money for the broadcaster. Money is always the bottom line, unless you're watching Democracy Now.

Re: Insta-death (0)

Anonymous Coward | about a year ago | (#44989577)

I have an implanted spinal cord stimulator by Medtronics. I have to get one of those pat downs instead of the scanner every time I fly. BTW I've never had an inappropriate pat down; the TSA agents have always been professional and courteous. Of course, I used to get those famous pat downs by the old "West German" female politzi when traveling as a US Army soldier during the Cold War. After those, nothing the TSA might do would seem invasive. Another BTW, the spinal cord stimulator has made a huge improvement in my back and chest pain.

Re:Insta-death (0)

Anonymous Coward | about a year ago | (#44987361)

The article doesn't really go into this, but the new pump is a very minor change compared to current pump I wear and the CGM I could wear (if insurance would pay for it). The improvement was adding trend prediction and then using the prediction to suspend the pump if the CGM thinks I'd get low. Yes, it's totally an improvement if you get low while asleep (as I do sometimes), but your objections could just as easily be applied to the old pumps as the new and I already opt-out of scanning for a pat down because of the current pump. Nothing in this new pump changes that. So, the idea that this FDA approval is invalid is wonky. The problem if anything is that the scanners are even allowed on 4th amendment grounds and that they're don't fall under FDA or FCC approval for safety and non-interference.

Re:Insta-death (1)

Antique Geekmeister (740220) | about a year ago | (#44987535)

What are the failure modes? If the insulin pump fails to deliver insulin, won't the diabetic notice with their next glucose test? Don't most travel with spare insulin and a few syringes, in case of pump failure, at least for long distance travel? How damaging is complete pump failure?

Conversely, what happens if the insulin is all delivered at once? An insulin pump holds what, typically, a few days of insulin? Can a diabetic keep ingesting enough sugar with juice or soda or candy to keep their blood sugar up for brain function, even if the insulin dose is overwhelmingly high? And the insulin, according to the last diabetic I met, only lasts a few hours: it's not a long-term effect, even with a huge amount injected, right?

Re:Insta-death (2)

cgriffiths (2668515) | about a year ago | (#44987789)

Can a diabetic keep ingesting enough sugar with juice or soda or candy to keep their blood sugar up for brain function, even if the insulin dose is overwhelmingly high? And the insulin, according to the last diabetic I met, only lasts a few hours: it's not a long-term effect, even with a huge amount injected, right?

As a type 1 diabetic from experience and research on the matter if by accident all the insulin in the pump was delivered, even a quarter of it could easily be enough to put somebody into a coma or kill them. It can appear that insulin acts over a few hours as this is the rate which the body reacts to it and the quantities involved relating to the glucose in the system and the insulin.

In the UK insulin injections tend to be 100 "units" per ml or 10 microlitres per unit and my insulin injections contain 3ml of insulin which are injected according to dosage. To me a unit is equal to 5 grams of carbohydrates being eaten but having such a huge amount of insulin will very negatively affect the person rendering them either unconscious or completely unable to function properly. If left like that on their own for too long then ultimately it is unlikely that they will wake up ever or they would have lost a lot of brain function, this would be a lot worse taking such a huge amount of insulin from a malfunctioning pump in their sleep.

I'd imagine that when all the glucose has been acted upon by the insulin in the system, the insulin will remain in the body as more glucose is being introduced which will be acted upon again until the insulin runs out. Luckily though if you are with someone with plenty of experience or who are trained and have fast acting glucose at hand in a high enough quantity it may be possible for it to be managed without going to hospital. There are of course other people who have "brittle diabetes" which react much more strongly to small amounts of insulin which could be deadly or people who get need less insulin per gram of carbohydrate.

Re:Insta-death (1)

Antique Geekmeister (740220) | about a year ago | (#44989203)

I'm afraid that you're doing a flat linear extrapolation, which is understandable. If 5 grams of carbohydrate = 1 "unit", and the maximum reservoir size of the "Paradigm Series 7" is 3 millileters or 300 units, that's about 1500 grams of sucrose. That's about 3 pounds of carbohydrate: it's *possible* to eat that much in a few hours, but sounds awful.

I'm wondering, though, if there are other limiting biological factors that prevent the body's cells from being able to deplete the glucose that fast. For example, 1500 grams of carbohydrate is approximately If one gram of carbohydrate is approxaimatley 4 kCal (commonly referred to as "calories when discussing food), 1500 grams of carbohydrate is _6000_ caloiries worth of food. I'd like to suggest that you can't possibly metabolize a well supplied stream of glucose to your blood stream that fast. so Also, thinking about this, an insulin pump is normally connected to subcutaneous tissue, not to a large blood vessel. So I'd expect some delay as the large dose of insulin has to diffuse through existing tissue: I'd expect extraordinarily low blood sugar around the injection site, but can one take in enough glucose or sucrose orally to keep the blood glucose from bottoming out?

It's a fascinating question for just such possible risks of a mechanical insulin pump failure. I'm finding a few studies mentioning LD50 tests for human insulin, but they're all behind paywalls. I also found this article about insulin overdose suicide attempts (http://ccforum.com/content/11/5/r115) Many of them seem to have taken 300 units or more of insulin, and were universally treated in the ER with various I/V's of 30% dextrose, mostly successfully. It shows that prompt treatment is successful, but it's not clear if it would work to simply guzzle juice.

Re:Insta-death (3, Insightful)

levork (160540) | about a year ago | (#44988531)

My wife is a long term Type One Diabetic and has worn a pump and CGMS for years, so I'm somewhat qualified to answer here:

If the insulin pump fails to deliver insulin, won't the diabetic notice with their next glucose test?

Yes, the diabetic will notice. In fact, the CGMS (continuous glucose monitoring system) itself will notice and should alarm (and the article is about a pump with a CGMS built in). Keep in mind that the pump can actually fail to deliver insulin because the tubing is kinked, or the injection site is occluded - so this can be a more common occurrence than you think and isn't actually directly due to pump failure.

Don't most travel with spare insulin and a few syringes, in case of pump failure, at least for long distance travel?

Yep. My wife's diabetic medical supplies easily take up half of her carry on baggage.

Conversely, what happens if the insulin is all delivered at once? An insulin pump holds what, typically, a few days of insulin? Can a diabetic keep ingesting enough sugar with juice or soda or candy to keep their blood sugar up for brain function, even if the insulin dose is overwhelmingly high?

This is the scary scenario. It's never happened to my wife, and the pump manufacturers had better go to great lengths to ensure it never happens. The type of insulin used in a pump is fast acting, so if all the insulin is delivered at once she will pretty much immediately need to eat a lot of sugar or go into a coma. We're talking entire bags of cookies within minutes.

Re:Insta-death (1)

kermidge (2221646) | about a year ago | (#44988845)

I read that most efficient delivery food was dried dates, don't know if you've seen this or if it's so. Also saw it listed on a glycemic index chart, at the top. I think honey is right up there as well, but if the container leaks it's hellacious sticky compared to a bag of cookies.

Re:Insta-death (1)

levork (160540) | about a year ago | (#44989301)

Yes, dried fruit is very concentrated carbohydrate. Re: glycemic index - not sure how typical this is for diabetics but my wife ignores glycemic index in her diet and focuses entirely on carbohydrate content. As far as she's concerned, the type of carb only matters by a few minutes; she can back this up by looking at her blood glucose chart after a meal vs her CGMS. In a life or death situation a few minutes might matter, so your point re: honey vs cookies is a valid point, but actually honey IS a better substitute than cookies because of the fat content in the cookies: the fat gets in the way of fast digestion of the carb content. I was being a bit facetious about the cookies earlier.

Re:Insta-death (1)

kermidge (2221646) | about a year ago | (#44990205)

Thanks. I was wondering how things actually worked for her, and I appreciate your explanation. My intent re dried dates was that my understanding was that they were the most compact and efficient way of delivering high sugar content speedily in a way that is convenient for many. (Full disclosure: I like 'em anyway; I find them tasty, and good for a quick energy hit.)

I got hipped to the glycemic index thing from a diabetic housemate who bought the book, not really knowing what he might be getting or asked to understand; he gave it to me to read, trusting that I might somehow magically be able to explain it to him. So I read, read some more, got online, etc. Told him that some people did some real research as distinct from 'common knowledge' and found some things which seemed to work reliably over time for a bunch of people. Said that making small changes in what he ate (choice of bread, for example) and making a few adjustments for total intake of what over the course of a day might help him even things out (his levels often spiked badly more days than not.)

Had him talk to his doc about it. Took some doing, but upshot was that at the end of six months of peripatetic practice, and with doctor's eventual blessing - and change in insulin brand or type, I fergit which - the guy was able to make adjustments, find he liked the change in foods and doing some actual daily effort to meal planning to arrive at an overall daily balance, he got his readings to stay steady and within target range - for the first time in close to ten years. I thought that in the main the stuff made sense but was nervous as hell about trying to advise the guy (again, after I talked to his doctor, for his approval, mostly), but was glad that it worked.

Oh, the cookies. Funny, 'cuz I know two diabetics in the house who routinely carry a baggie of cookies. Not cheap, but ubiquitous, and it's one of those "everybody knows" solutions. I like the point you make about the fat content.

I have enough things on my own plate at the moment and truly hope that diabetes is not someday added to the mix; I have sympathy and respect for anyone having to deal with that disease; anything which is invented or done (the gene stuff, for instance) to help gets my interest and my hopes that it works well.

Re:Insta-death (1)

Antique Geekmeister (740220) | about a year ago | (#44988907)

How much sugar? And for how long will she have to keep ingesting that much every, say, 15 minutes? Does opening up the body's ability to metabolize glucose this way have another limiting factor that will limit how much oral glucose is needed? I'm quite curious: there was a report a few months ago of an implanted insulin pump that could be remotely tricked into delivering its 30 day supply of insulin all at once, and I'm wondering if this could be reasonably survived with oral glucose or sucrose and frequent glucose testing to manage it.

Re:Insta-death (1)

levork (160540) | about a year ago | (#44989365)

The problem here is that insulin dose tends not to be linear to carbohydrate consumed, so while my wife knows e.g. that if she eats 40 g of carbs she'll only have to give 2 units of insulin, she may actually have to cover 60 g of carbs with 5 units of insulin. I'm making up these numbers but the point is they're numbers worked out over years of trial and error, and also vary at different times of day.

So basically there's no way she would know how much glucose she would need to consume for very high doses of insulin; it's not something you try to experiment for. In a situation where her pump catastrophically failed and dumped all 6-7 days worth of insulin (that's the capacity of her unit; that's probably typical for a external pump user), her immediate priority would be to start eating as much glucose as she can: high blood sugar is better than low blood sugar. Even then, there's no way she could digest it fast enough without having her blood sugar drop precipitously low, leading to seizure etc, so emergency services would need to be called and told that she needs a dextrose IV drip. At this point it's a race between her digestive system and the rate at which the insulin kicks in, and the insulin is likely to win. If I happened to be around I'd stand by with a glucagon shot - this is an emergency injection that tells the liver to dump glycogen, essentially also raising blood sugar - but even then? Unlikely to be sufficient.

tl;dr I would say it's impossible to eat your way out of a catastrophic insulin overdose - you really need IV dextrose and a hospitalization. My earlier comment about box of cookies notwithstanding. The pump manufacturers know this and one would hope they have umpteen safeguards against it in, both in the hardware and software.

Re:Insta-death (1)

Antique Geekmeister (740220) | about a year ago | (#44990603)

> Even then, there's no way she could digest it fast enough without having her blood sugar drop precipitously low, leading to seizure etc, so emergency services would need to be called and told that she needs a dextrose IV drip.

This is the interesting claim that I don't see any experimental evidence for. This is a catastrophic event: is there anything else that would provide bottlenecks for the body's ability to consume glucose, such as limits of the other components of the ATP cycle in the cells themselves? Would those limits, themselves, be biologically catastrophic? If the short term danger of hypoglycemia is starving the brain of glucose, can guzzling or continuously sipping from a bottle of syrup keep such a diabetic alive until then, even if they are groggy or confused? (I business partner I met with regularly hated long meetings, because they could slip from a perfect blood sugar to 40 mg/dL, half human normal if lunch was late and they were focused strongly, and nabbing snacks or grabbing sweetened drinks caused social issues in the meetings. And they wouldn't realize until they tried to talk just how low their blood sugar was!)

It's not something I'd want to test on humans, but it would be fascinating animal experiments to get some idea of how to treat a diabetic who's had a pump overdose. In fact, I'd be quite surprised if such overdoses haven't happened by accident in hospitals with staff unfamiliar with diabetic doses: I've certainly received the wrong dose of medication from hospital staff.

Re:Insta-death (1)

Antique Geekmeister (740220) | about a year ago | (#44990613)

Glucagon shots rely on converting glycogen to glucose: how much is available in a normal human? And I assume they wouldn't work at all for someone who's been doing extended physical exercise, such as a marathon, and has depleted their glycogen?

This is all fascinating material: systems failure analysis, and detecting where assumptions about failure modes are not based on measurement or based on pure extrapolation, is one of the tasks I get paid for professionally, so I hope you don't mind that I'm questioning your claims. It's genuine curiosity.

Re:Insta-death (1)

switcha (551514) | about a year ago | (#44989529)

Does she carry a glucogon shot with her? My daughter never goes anywhere without hers, and all family and teachers have been trained to use it if they ever find her passed out. It's a massive dose of sugar that will instantly shoot her blood sugars to the roof if she ever goes hypoglycemic to the point of losing consciousness. To the question of counteracting a full dose of the pump's entire reservoir, I don't know if the amounts of glucogon in the shot would be sufficient, but we've been told it's a pretty massive dose for emergency situations. As in "If you find her unconscious, give her this shot 1st, call 911 2nd." Also, the new T-slim pump uses a new system where insulin is relayed from a main reservoir to a tiny holding area from where insulin is actually pumped down the tube to the port. In theory, the person in never directly exposed to the full reservoir.

Re:Insta-death (1)

levork (160540) | about a year ago | (#44989587)

We do have glucagon rescue shots around, I mentioned it in another post on this thread and it would definitely be something to use in a theoretical pump overdose emergency.

But keep in mind that glucagon is not a fixed dose of sugar: it's a hormone that triggers the liver to convert stored glycogen into blood glucose. So, it all depends on how much stored glycogen your liver happens to have, which is a function of your recent meals, time of day, whether you've been exercising or not, etc. Dumping your liver's entire store of glycogen may not be enough to counteract a massive insulin dose. Basically, it'll just tide you over until emergency services arrive.

Re:Insta-death (0)

Anonymous Coward | about a year ago | (#44987661)

I am not convinced that you now what you're talking about.
If you ever had an FDA audit you would know that they are definetivley not in the pocket of the pharmaceutical industry. They even are getting clueful about computer systems (See GAMP5 - risk based validation, etc.). And the surprising thing is that they are really on the right track on how to validate computer systems right. And if you want to get a new medical device approved there is a TON of EM testing that you have to do.

Re:Insta-death (0)

Anonymous Coward | about a year ago | (#44988479)

As has been covered before, airport full body scanners tend to kill medical devices like this.

Which is why pump wearers like me remove our insulin pumps, place them in the same dish as our cell phone and car keys, and send them through the luggage X-ray. I've been doing that for 25 years. Never had a device fail, nor have I experienced any rise in blood sugar due to being separated from the device for 2-3 minutes. Perhaps the sky isn't falling, Chicken Little?

Re:Insta-death (0)

Anonymous Coward | about a year ago | (#44989447)

Type 1 diabetic and semi-frequent business traveler... i miss the days of the old machines, because they didnt pick up my pump. Now, I have to wait for the silly hand swab for bomb-making (or whatever else they are looking for) residue test every single time. That said -- I've never had a pump from going through security, and I don't think I've ever had a pump that went through security fail (they last for 3 days... could be easy for one to alarm out 2 days later without me remembering the correlation). I get somewhere in the neighborhood of one failure a month.

Just data... conclusions are your own.

Not as 'artificial pancreas' as it seems (5, Informative)

Anonymous Coward | about a year ago | (#44987153)

Currently, I'm using a Dexcom [dexcom.com] continuous glucose monitor, and an Omnipod [myomnipod.com] 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 [myglu.org] 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.

Re:Not as 'artificial pancreas' as it seems (1)

Anonymous Coward | about a year ago | (#44987459)

> 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.

I'll say. It's hell on my sex life to have to get a snack right in the midst of whoopee, and my wife is not into having snacks smeared on her body. Male sexual response can be very, very sensitive to blood sugar: low enough to get started is too high to last through a long session!

How is this new? (0)

Anonymous Coward | about a year ago | (#44987167)

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.

No. This is not an artificial pancreas. (2)

PongStroid (178315) | about a year ago | (#44987309)

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.

yuck (1)

Connie_Lingus (317691) | about a year ago | (#44987343)

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...

Ancient technology, sensors still blow goats (1)

Anonymous Coward | about a year ago | (#44987425)

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.

Re:Ancient technology, sensors still blow goats (0)

Anonymous Coward | about a year ago | (#44987541)

The sensors don't work well. They require frequent re-calibration with a normal glucometer, they hurt to install

A diabetic who is afraid of a weekly insertion needle? Really? There are bigger problems ahead for that person than having to recalibrate the CGM twice a day.

Re:Ancient technology, sensors still blow goats (1)

TheRecklessWanderer (929556) | about a year ago | (#44988489)

The reality is, no matter how much something will help people, if it doesn't make the medical behemoth more money or heaven forbid will make them lose money, they won't do it. In fact, if a "cure" for insulin had been found and bought by pfizer (as an example) and shelved, it wouldn't surprise me at all.

Real replacement pancras functions in human testin (1)

Anonymous Coward | about a year ago | (#44987505)

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.)

Pay a 2.3% Obamacare tax, or no insulin (1)

Kohath (38547) | about a year ago | (#44987521)

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.

Re:Pay a 2.3% Obamacare tax, or no insulin (0)

Anonymous Coward | about a year ago | (#44988731)

Right, but now the 5000 dollar device is covered by insurance. So instead of paying 5000 dollars, you pay 115 dollars. That is less. Why is this hard for some people to understand?

Re:Pay a 2.3% Obamacare tax, or no insulin (0)

Anonymous Coward | about a year ago | (#44989769)

This is also a great example of the american pay-what-the-market-will-bare medical practice delivering the best products to its consumers! Except it isn't. This device has been available pretty much everywhere else for the last two years under a different name.

Implantable version? (1)

ndrw (205863) | about a year ago | (#44987695)

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?

why fugazi? (1)

PopeRatzo (965947) | about a year ago | (#44987701)

FDA Approves Wearable "Artificial Pancreas"

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.

Be afraid (0)

Anonymous Coward | about a year ago | (#44989059)

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.

Let me know... (0)

slick7 (1703596) | about a year ago | (#44989941)

When they create an artificial brain that really works that all the CONgressMEN can use, hopefully with a beefier morality chip installed.

Low Glucose Suspend is NOT new. (0)

Anonymous Coward | about a year ago | (#44990157)

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.

It's called an "Insulin Pump" (0)

Anonymous Coward | about a year ago | (#44990533)

And it's not new. I've been wearing an insulin pump for the better part of 15 years.

Hanselman: not (yet) an artificial pancreas (1)

Koyaanisqatsi (581196) | about a year ago | (#44990909)

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 [hanselman.com]

Read the article, it is very interesting and he makes some very compelling arguments as to why this is a bit too much hype...

NOT artificial pancreas - just a firmware update (1)

bradgoodman (964302) | about a year ago | (#44991029)

The current electronic electronic insulin pump and Continuous Glucose Monitor do everything described here (and even appear physically identical to the ones in this article) - EXCEPT for the fact that they will not AUTOMATICALLY suspend insulin delivery if your blood glucose level is too low. It will detect it - and give you an alarm - it just won't AUTOMATICALLY stop it.

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.

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