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FDA Approves Wearable "Artificial Pancreas" 119

Posted by samzenpus
from the a-spoonful-of-sugar dept.
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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FDA Approves Wearable "Artificial Pancreas"

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  • I hope this machine takes that into account.

    • It is for type I diabetics, whose distinguishing characteristic is that they can't make more than trace amounts of insulin.
    • by VanGarrett (1269030) on Sunday September 29, 2013 @04:06PM (#44987235) Homepage

      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.

    • by Anonymous Coward on Sunday September 29, 2013 @03:54PM (#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.

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

  • When MT says they plan an 'improved device', they mean it's ready now - just waiting for certification . . .
    • 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 (Score:5, Interesting)

    by girlintraining (1395911) on Sunday September 29, 2013 @03:42PM (#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 (Score:5, Informative)

      by ColdWetDog (752185) on Sunday September 29, 2013 @04:11PM (#44987257) Homepage

      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: (Score:3, Informative)

        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 si

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

          • by Rujiel (1632063)
            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.
    • 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 u

      • 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

        • 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 exampl

      • Re:Insta-death (Score:4, Insightful)

        by levork (160540) on Sunday September 29, 2013 @08:52PM (#44988531) Homepage

        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.

        • by kermidge (2221646)

          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.

          • by levork (160540)

            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 su

            • by kermidge (2221646)

              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 aske

        • 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

          • by levork (160540)

            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

            • > 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 themsel

              • by levork (160540)

                Well, I can't speak to the evidence to or against the protocol for massive insulin overdose. Family members of diabetics are drilled on how to deal with hypoglycemic events, certainly moderate insulin overdoses (from e.g. underestimating the bolus for a meal) just come with the territory and that's about all I'm equipped to deal with. I think the protocol is simply based on: low brain blood sugar = seizure/brain damage/coma/death, avoid at all cost. Just based on that, delivering sugar directly to the blood

            • 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 questionin

        • by switcha (551514)
          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 pret
          • by levork (160540)

            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'

        • by seffala (134325)

          My daughter had a near-experience with this. Typically, you enter two values into the pump: your current blood glucose level, and the number of carbs you are going to (or in the case of a child, have) eat(en). The pump uses a conversion formula to dose you for the carbs, either shorting the amount if your glucose is low, or increasing the amount if your glucose is high.

          A school nurse new to the pump reversed the numbers. My daughter had eaten about 60g of carbs, and her blood glucose level was ~160, but the

  • by Anonymous Coward on Sunday September 29, 2013 @03:47PM (#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.

    • by Anonymous Coward

      > 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!

  • 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...

  • 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, manua

    • 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.
    • by seffala (134325)

      1. The Dexcom G4 CGM (new this year) is remarkably accurate. We're rarely more than 10 points from a finger stick. Surprisingly, sometimes it asks us to calibrate with a finger stick, we enter the number, and it disagrees with what we just entered. We'll finger stick again, and find out it's right.

      2. The *huge* advantage of a CGM that you're not acknowledging is that it gives you the derivative of your blood sugar, not just the value. You check your HbA1C for the integral, why wouldn't you use a CGM for the

  • 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 do

  • 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.

  • 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?

  • 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.

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

  • 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 d

  • 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.
    • by NeoXon (1718618)
      Exactly. A friend of mine already had this in 2006, I am pretty sure. It measured the actual blood sugar level and adjusted the amount of injected insulin accordingly. I wonder how this appeared on Slashdot in 2013.
      • Same here, my Ex had one...(of course she's crazy and irresponsible and ended up breaking it), still..this technology is not new.

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