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Post by agedhippie on Aug 20, 2016 10:08:28 GMT -5
Isn't "an intelligent closed-loop monitor/pump system" the definition of a pancreas? A real pancreas has a better signaling system, a better insulin, and a superior (pumpless) path for delivering that insulin. The moniker "artificial pancreas" just seems to promise way more than is actually achieved. A real pancreas will always be better, but until the cure arrives I will take a artificial alternative. Think of it like an artificial leg - nobody is going to say it's as good as the real thing but it's a whole lot better than a peg and crutches regardless of how wonderful the peg or crutch might be (the example springs to mind as I had an uncle who was a pilot in WW2 and lost a leg, as kids we used to be in awe of his tin leg.)
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Post by rockstarrick on Aug 21, 2016 1:08:32 GMT -5
The question of a true artificial pancreas was posed to Duane DeSisto a few years ago, when he was still CEO of Insulet. From a round table discussion of industry leaders that took place before Afrezza was approved by the FDA, DeSisto's thought on the AP was very unexpected: Moderator: "Duane, how far away are we from a true cutting edge artificial pancreas?” Duane: “Umm, I don’t think anyone in this room will live long enough to see it… CGM sensing is not accurate enough to deliver insulin by itself.” “If you’re really going to do this you’re going to need insulin that, basically, reacts more like your body, so it goes in almost instantaneously and has a very low tail. And if all that gets resolved, here’s the question. How does it know that you’re eating a pound of pasta because you’re going to run the Boston Marathon? It doesn’t! So it’s going to basically load you up with insulin and, by mile two, you’re going to look like me running… ” Read more: mnkd.proboards.com/thread/4630/why-duane-desisto-hired#ixzz4HqVxODguI agree with Duane, it's nearly impossible for any type of a closed loop chemical feed pump system to land on a given set point, the closed loop system overshoots and undershoots the desired set point, sometimes for several hours before stabilizing, then after the system does stabilize, anything requiring the pump to speed up or slow down, (like a meal for example) will restart the roller coaster ride again until the set point is achieved and the pump stabilizes. I have seen some very impressive trends of these new systems, but still highly doubt they could dial one in tight enough to deliver something as critical as insulin. The closed loop systems I worked with were chlorine feed pumps for a Municipal Water System, and they were nothing but trouble, Calculating a feed rate and manually setting the pump worked Way better than any closed loop system. I'd have to see it to believe it could do better than Afrezza. Just my opinion Good Luck Everybody
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Post by agedhippie on Aug 21, 2016 9:11:58 GMT -5
The question of a true artificial pancreas was posed to Duane DeSisto a few years ago, when he was still CEO of Insulet. From a round table discussion of industry leaders that took place before Afrezza was approved by the FDA, DeSisto's thought on the AP was very unexpected: Moderator: "Duane, how far away are we from a true cutting edge artificial pancreas?” Duane: “Umm, I don’t think anyone in this room will live long enough to see it… CGM sensing is not accurate enough to deliver insulin by itself.” “If you’re really going to do this you’re going to need insulin that, basically, reacts more like your body, so it goes in almost instantaneously and has a very low tail. And if all that gets resolved, here’s the question. How does it know that you’re eating a pound of pasta because you’re going to run the Boston Marathon? It doesn’t! So it’s going to basically load you up with insulin and, by mile two, you’re going to look like me running… ” Read more: mnkd.proboards.com/thread/4630/why-duane-desisto-hired#ixzz4HqVxODguI agree with Duane, it's nearly impossible for any type of a closed loop chemical feed pump system to land on a given set point, the closed loop system overshoots and undershoots the desired set point, sometimes for several hours before stabilizing, then after the system does stabilize, anything requiring the pump to speed up or slow down, (like a meal for example) will restart the roller coaster ride again until the set point is achieved and the pump stabilizes. I have seen some very impressive trends of these new systems, but still highly doubt they could dial one in tight enough to deliver something as critical as insulin. The closed loop systems I worked with were chlorine feed pumps for a Municipal Water System, and they were nothing but trouble, Calculating a feed rate and manually setting the pump worked Way better than any closed loop system. I'd have to see it to believe it could do better than Afrezza. Just my opinion Good Luck Everybody Oscillations in closed loop systems are a function of how crude the feedback system is. If you want an example of a high performance closed loop system you could look at the avionics in a modern fighter plane - they are technically aerodynamically unstable but the closed loop systems let the pilots fly them none the less. Oscillation damping is 'simply' a case of developing a suitable algorithm for the feedback loop. In the case of the APS this has taken about 10 years to get to the point where the FDA will approve it next year. The work isn't over as they will continually try to improve time in range. So right now the APS is good enough to use. For those that don't want to wait there is the OpenAPS where people have banded together to build their own AP out of available parts (yes this idea scares me as well). Even using off the shelf components they can remain in range over 80% of the time and saw and average drop in HbA1c from 7.1 to 6.2^ - this is an insulin only system designed for zero user intervention so this is impressive for a literally homemade system. The commercial systems are considerably more compact, have proper designed components, and give better results. Afrezza may give better result but in the end the benefit from that is likely to be so marginal (anything under HbA1c 6.3 is essentially the same for complications) and the benefit of zero touch to quality of life is so overwhelming that it is literally life changing. Afrezza is the better buggy whip the AP is the internal combustion engine. If I think this why do I bother with investing in Afrezza at all? Because the impact of the AP will be devastating in certain sectors, but at the end of the day those sectors form less than 20% of the market and my sights are on the 80%. I don't need the whole market, just a large market
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Post by mnholdem on Aug 21, 2016 9:36:12 GMT -5
Al Mann thought along the same lines, as he shared in this Sept 2014 interview: Steven Freed: I know you’ve been involved with the artificial pancreas and there’s been a lot of new information coming out, some trials that have proven successful. Do you really think that there is going to be, some day, an artificial pancreas, a machine that will control someone’s life that could go wrong and actually kill someone, possibly? The FDA is probably going to require so many tests and studies to be done. Do you ever think it is a possibility that it could happen?
Al Mann: I have to answer that in two ways. First of all, will an artificial pancreas be created that could effectively and safely control glucose levels in diabetes? I believe the answer to that question is “yes.” Do I think that it should be developed, and for the following reason I believe the answer to that question is “probably not.” After introduction of insulin pumps by MiniMed over thirty years ago, and soon afterward also glucose sensors, only 35% of people with type 1 diabetes in the United States are using insulin pumps, even fewer outside the United States, and hardly any type 2s globally. While insulin pumps do provide the best insulin therapy today, they don’t adequately address what I call my three Cs: cost, convenience and complexity. They are too expensive. They are too complicated. They are too inconvenient. I believe that a combination of Afrezza plus a reasonable basal insulin may not provide glucose control quite as good as by an artificial pancreas, the results would not be much poorer and would actually be good enough so that I don’t really see a real business opportunity for such a sophisticated and expensive system as the artificial pancreas. Surely there will likely be some type 1 patients that would use an artificial pancreas but the real need is for therapy that would be much more widely used.Source: www.diabetesincontrol.com/an-exclusive-interview-with-al-mann-founder-and-ceo-mannkind-corp/
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Post by rockstarrick on Aug 21, 2016 10:08:56 GMT -5
I agree with Duane, it's nearly impossible for any type of a closed loop chemical feed pump system to land on a given set point, the closed loop system overshoots and undershoots the desired set point, sometimes for several hours before stabilizing, then after the system does stabilize, anything requiring the pump to speed up or slow down, (like a meal for example) will restart the roller coaster ride again until the set point is achieved and the pump stabilizes. I have seen some very impressive trends of these new systems, but still highly doubt they could dial one in tight enough to deliver something as critical as insulin. The closed loop systems I worked with were chlorine feed pumps for a Municipal Water System, and they were nothing but trouble, Calculating a feed rate and manually setting the pump worked Way better than any closed loop system. I'd have to see it to believe it could do better than Afrezza. Just my opinion Good Luck Everybody Oscillations in closed loop systems are a function of how crude the feedback system is. If you want an example of a high performance closed loop system you could look at the avionics in a modern fighter plane - they are technically aerodynamically unstable but the closed loop systems let the pilots fly them none the less. Oscillation damping is 'simply' a case of developing a suitable algorithm for the feedback loop. In the case of the APS this has taken about 10 years to get to the point where the FDA will approve it next year. The work isn't over as they will continually try to improve time in range. So right now the APS is good enough to use. For those that don't want to wait there is the OpenAPS where people have banded together to build their own AP out of available parts (yes this idea scares me as well). Even using off the shelf components they can remain in range over 80% of the time and saw and average drop in HbA1c from 7.1 to 6.2^ - this is an insulin only system designed for zero user intervention so this is impressive for a literally homemade system. The commercial systems are considerably more compact, have proper designed components, and give better results. Afrezza may give better result but in the end the benefit from that is likely to be so marginal (anything under HbA1c 6.3 is essentially the same for complications) and the benefit of zero touch to quality of life is so overwhelming that it is literally life changing. Afrezza is the better buggy whip the AP is the internal combustion engine. If I think this why do I bother with investing in Afrezza at all? Because the impact of the AP will be devastating in certain sectors, but at the end of the day those sectors form less than 20% of the market and my sights are on the 80%. I don't need the whole market, just a large market Oscillations !! If you only knew how long I tried to come up with that word last night. I can't imagine the technology in the APS that actually gives it the ability to land on a given set point. I know they've done it, I've seen the trends, but with my experience, (non medicinal), these closed loop systems are really temperamental and require frequent calibration. I just hope that if/when they do come up with a system reliable enough for the FDA to approve, Afrezza is part of it. I do know that the quicker the logic program that runs the pump receives the data, the less severe the oscillations are and the pump will stabilize faster. It makes sense that if Afrezza really is "ultra rapid acting" that the APS would perform better when used with Afrezza compared to other rapid acting insulin options. all just my opinion good luck hippie !!
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Post by agedhippie on Aug 21, 2016 10:26:30 GMT -5
I think he is on the money there with pumps - the obstacles are cost, complexity, and convenience. I know a lot of diabetics who have pumps but either don't use them or only use them occasionally. The AP doesn't really touch cost since the bulk of the cost is in the CGM (pumps have a relatively long life). With bolus wizards to calculate dose pump complexity is lower than it was but it's still definitely there - with the AP complexity disappears though. Convenience, hmm. From a diabetes standpoint it's impossible to beat - press go and forget about your diabetes until the pump needs refilling in a few days time. The hmm part comes because you still have something you have to carry around.
Bottom line is that I think once it starts to roll the AP will take most of the Type 1 market in the developed world. Endos will put their patients on because of the ability to get a patient's HbA1c into the low 6s regardless of compliance history. I don't see it as the end of the road though and smart insulin will kill everything once it hits the market but that's years away yet IMHO.
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Post by Deleted on Aug 21, 2016 10:55:54 GMT -5
I agree with Duane, it's nearly impossible for any type of a closed loop chemical feed pump system to land on a given set point, the closed loop system overshoots and undershoots the desired set point, sometimes for several hours before stabilizing, then after the system does stabilize, anything requiring the pump to speed up or slow down, (like a meal for example) will restart the roller coaster ride again until the set point is achieved and the pump stabilizes. I have seen some very impressive trends of these new systems, but still highly doubt they could dial one in tight enough to deliver something as critical as insulin. The closed loop systems I worked with were chlorine feed pumps for a Municipal Water System, and they were nothing but trouble, Calculating a feed rate and manually setting the pump worked Way better than any closed loop system. I'd have to see it to believe it could do better than Afrezza. Just my opinion Good Luck Everybody Oscillations in closed loop systems are a function of how crude the feedback system is. If you want an example of a high performance closed loop system you could look at the avionics in a modern fighter plane - they are technically aerodynamically unstable but the closed loop systems let the pilots fly them none the less. Oscillation damping is 'simply' a case of developing a suitable algorithm for the feedback loop. In the case of the APS this has taken about 10 years to get to the point where the FDA will approve it next year. The work isn't over as they will continually try to improve time in range. So right now the APS is good enough to use. For those that don't want to wait there is the OpenAPS where people have banded together to build their own AP out of available parts (yes this idea scares me as well). Even using off the shelf components they can remain in range over 80% of the time and saw and average drop in HbA1c from 7.1 to 6.2^ - this is an insulin only system designed for zero user intervention so this is impressive for a literally homemade system. The commercial systems are considerably more compact, have proper designed components, and give better results. Afrezza may give better result but in the end the benefit from that is likely to be so marginal (anything under HbA1c 6.3 is essentially the same for complications) and the benefit of zero touch to quality of life is so overwhelming that it is literally life changing. Afrezza is the better buggy whip the AP is the internal combustion engine. If I think this why do I bother with investing in Afrezza at all? Because the impact of the AP will be devastating in certain sectors, but at the end of the day those sectors form less than 20% of the market and my sights are on the 80%. I don't need the whole market, just a large market Lol comparing modern fighter jet with AP. Do you know how many times in a second the current conditions are evaluated to make the decision and the time lapse between each unit of feedback in terms of lag .
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Post by agedhippie on Aug 21, 2016 10:59:42 GMT -5
Oscillations !! If you only knew how long I tried to come up with that word last night. I can't imagine the technology in the APS that actually gives it the ability to land on a given set point. I know they've done it, I've seen the trends, but with my experience, (non medicinal), these closed loop systems are really temperamental and require frequent calibration. I just hope that if/when they do come up with a system reliable enough for the FDA to approve, Afrezza is part of it. I do know that the quicker the logic program that runs the pump receives the data, the less severe the oscillations are and the pump will stabilize faster. It makes sense that if Afrezza really is "ultra rapid acting" that the APS would perform better when used with Afrezza compared to other rapid acting insulin options. all just my opinion good luck hippie !! The AP has one advantage, while there is an ideal value it's not necessary to hit it and provided you stay in that range you are good. I have painful memories of analog feedback loops in electrical motors! The AP market would give their eye teeth for a liquid insulin with Afrezza's characteristics.
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Post by agedhippie on Aug 21, 2016 11:11:24 GMT -5
Lol comparing modern fighter jet with AP. Do you know how many times in a second the current conditions are evaluated to make the decision and the time lapse between each unit of feedback in terms of lag . Oddly enough I wrote software for BAE systems modelling wing control surfaces for the Eurofighter many years ago! The point was that it is possible to get feedback loops to maintain stability in unstable systems, even really high speed ones like aircraft. The body is a lot slower and there are good interpolation algorithms so a 2 or 5 minute sample rate is enough to maintain stability in an AP.
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Post by audiomr on Aug 21, 2016 16:33:09 GMT -5
A real pancreas has a better signaling system, a better insulin, and a superior (pumpless) path for delivering that insulin. The moniker "artificial pancreas" just seems to promise way more than is actually achieved. A real pancreas will always be better, but until the cure arrives I will take a artificial alternative. Think of it like an artificial leg - nobody is going to say it's as good as the real thing but it's a whole lot better than a peg and crutches regardless of how wonderful the peg or crutch might be (the example springs to mind as I had an uncle who was a pilot in WW2 and lost a leg, as kids we used to be in awe of his tin leg.) I basically agree. I just don't think "artificial pancreas" is a realistic name for what the system actually is. Good marketing but somewhat misleading.
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Post by mannmade on Aug 21, 2016 22:32:32 GMT -5
Can anyone clarify how AFREZZA was used with the AP in the trials? If AFREZZA was used with the AP in trials then wouldn't that suggest this it will continue to be used once approved by FDA?
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Post by Deleted on Aug 21, 2016 22:46:51 GMT -5
Can anyone clarify how AFREZZA was used with the AP in the trials? If AFREZZA was used with the AP in trials then wouldn't that suggest this it will continue to be used once approved by FDA? www.youtube.com/watch?v=GGgGjtM5ipg
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Post by mannmade on Aug 21, 2016 22:55:44 GMT -5
Ty. Not to make it seem overly simplistic but I viewed the video and it seemed to me that without AFREZZA the AP will not work. Also aside from the minaturization that will be needed to make it more convenient imho it seems that one shot of basal, a cgm and AFREZZA are pretty darn close to getting same results. The woman raved about using inhaled insulin and the charts shown make inhaled insulin's use to be key to the AP's success. What am I missing?
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Post by rockstarrick on Aug 21, 2016 23:20:05 GMT -5
Can anyone clarify how AFREZZA was used with the AP in the trials? If AFREZZA was used with the AP in trials then wouldn't that suggest this it will continue to be used once approved by FDA? Actually, one of the biggest problems while developing the APS were mealtime glucose spikes, these spikes caused the oscillations that me and the hippie were discussing. As your glucose started to rise due to meal digestion, the pump would speed up and deliver insulin, the higher your glucose climbed, the faster the pump would feed insulin. Unfortunately, pumps cannot stop on a dime, so the APS would overshoot and undershoot the given set point until finally stabilizing. Afrezza actually helped the system stabilize faster because the logic program controlling the pump received the data quicker. I do believe if/when the APS is approved, Afrezza will be in the mix somewhere, just because it is faster acting than other mealtime insulin options. i have shared this article before, but there is a section that explains how Afrezza helped with the mealtime glucose spikes, it's towards the end of the article. www.jdrf.org/wp-content/uploads/2013/11/MTI1310_Artificial-Pancreas_2013700119.pdfGood Luck
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Post by agedhippie on Aug 22, 2016 7:18:00 GMT -5
Ty. Not to make it seem overly simplistic but I viewed the video and it seemed to me that without AFREZZA the AP will not work. Also aside from the minaturization that will be needed to make it more convenient imho it seems that one shot of basal, a cgm and AFREZZA are pretty darn close to getting same results. The woman raved about using inhaled insulin and the charts shown make inhaled insulin's use to be key to the AP's success. What am I missing? You miss the point of an AP. Certainly in todays AP devices you could do better with Afrezza and basal, I doubt you even need the CGM. What you are missing is that it still requires me to deal with my diabetes every couple of hours or so and after a few years of doing this people want to stop which is where the AP comes in. The first gen AP is already here. Results say it can reliably get your HbA1c below 6.5 and keep you in range most of the time. This is with ordinary RAA insulin only. Once stable liquid glucagon can be produced this will improve hugely. As it is current performance is good enough to be marketable and endos will start moving people to them, but very slowly.
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