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Post by uvula on Apr 7, 2016 18:32:00 GMT -5
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Post by uvula on Apr 7, 2016 18:38:18 GMT -5
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Post by agedhippie on Apr 7, 2016 19:06:04 GMT -5
Medtronics are trying to avoid the hammering they took over calling the 640G an artificial pancreas. The 670G is nowhere near an AP either. It lacks the second chamber for glucagon to bring up your levels when you are heading low and it requires you to handle meal time bolusing. This is little better than the other predictive suspend pumps. The only difference is that it will increase as well as reduce doses. This is before we start to talk about the Enlite CGM which is no Dexcom. If you want a prediction, the iLet which is following a year behind and is a proper artificial pancreas will kill the 670G stone dead. The iLet together with the UVA APs are the leaders as they don't require human intervention in full operation since the pump does everything. This is more like the future for Type 1 - www.betabionics.org |
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Post by uvula on Apr 7, 2016 19:32:13 GMT -5
How can the beta bionics device work so perfectly? Does the glucagon make up for the non-ultra-fast insulin used with the device? The graph in the Ted Talk video looks so good it looks like afrezza isn't necessary if you use this device.
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Post by agedhippie on Apr 7, 2016 21:09:42 GMT -5
How can the beta bionics device work so perfectly? Does the glucagon make up for the non-ultra-fast insulin used with the device? The graph in the Ted Talk video looks so good it looks like afrezza isn't necessary if you use this device. Kudos to you for watching the Ted Talk! The guy is brilliant. Yes, the glucagon is largely responsible for the performance. It mimics what the body does and causes excess insulin to be neutralized. Glucagon works extremely fast, far faster than even Afrezza, so it catches you the moment you begin to drop. This allows you to dose the insulin aggressively locking your level into the range you saw. Some of the AP systems use FIAsp which is Novo Nordisk's faster acting insulin (FDA approval expected mid to later 2016). While faster than Novolog it is not as fast as Afrezza. Other than a mechanical failure it is very difficult, borderline impossible, to become hypoglycemic with this system. I want one, as does almost every Type 1 I know! |
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Post by uvula on Apr 7, 2016 21:18:54 GMT -5
what am I missing? Certainly Al was aware of glucagon. How is afrezza an unmet need? Tandem Diabetes and probably others have or are working on insulin and glucagon pumps.
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Post by stevil on Apr 7, 2016 23:37:00 GMT -5
How can the beta bionics device work so perfectly? Does the glucagon make up for the non-ultra-fast insulin used with the device? The graph in the Ted Talk video looks so good it looks like afrezza isn't necessary if you use this device. Kudos to you for watching the Ted Talk! The guy is brilliant. Yes, the glucagon is largely responsible for the performance. It mimics what the body does and causes excess insulin to be neutralized. Glucagon works extremely fast, far faster than even Afrezza, so it catches you the moment you begin to drop. This allows you to dose the insulin aggressively locking your level into the range you saw. Some of the AP systems use FIAsp which is Novo Nordisk's faster acting insulin (FDA approval expected mid to later 2016). While faster than Novolog it is not as fast as Afrezza. Other than a mechanical failure it is very difficult, borderline impossible, to become hypoglycemic with this system. I want one, as does almost every Type 1 I know! Lilly is working on something similar. My cousin works in the research department there and was sharing something very similar with me when I saw her a couple months back. Her view on Afrezza was that it could make waves, but that it'd have to do so quickly as Lilly views their system as being more favorable to meet DM1 demand. It essentially allows them to forget about taking care of themselves. Everything would be automated. |
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Post by mbracket123 on Apr 8, 2016 0:36:20 GMT -5
What is the cost for it -anyone know off hand?
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Post by rockstarrick on Apr 8, 2016 1:28:30 GMT -5
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Post by rockstarrick on Apr 8, 2016 1:32:53 GMT -5
Kudos to you for watching the Ted Talk! The guy is brilliant. Yes, the glucagon is largely responsible for the performance. It mimics what the body does and causes excess insulin to be neutralized. Glucagon works extremely fast, far faster than even Afrezza, so it catches you the moment you begin to drop. This allows you to dose the insulin aggressively locking your level into the range you saw. Some of the AP systems use FIAsp which is Novo Nordisk's faster acting insulin (FDA approval expected mid to later 2016). While faster than Novolog it is not as fast as Afrezza. Other than a mechanical failure it is very difficult, borderline impossible, to become hypoglycemic with this system. I want one, as does almost every Type 1 I know! Lilly is working on something similar. My cousin works in the research department there and was sharing something very similar with me when I saw her a couple months back. Her view on Afrezza was that it could make waves, but that it'd have to do so quickly as Lilly views their system as being more favorable to meet DM1 demand. It essentially allows them to forget about taking care of themselves. Everything would be automated. Pretty tough to get an Artificial Pancreas System to react to your every meal, (and snacks). Mealtime glucose spikes will always need special attention in my opinion. Afrezza is here to stay. |
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Post by Deleted on Apr 8, 2016 6:29:06 GMT -5
I enjoyed Dr. Damiano's TEDx presentation. Clearly an extremely bright and motivated man on an important mission.
With all due respect, time for a little reality.
The # of variables that need to be evaluated to determine dosing and not just dosing of a single med but two. The computing power needed will be substantial. Remember the name Duane DeSisto - he was CEO of Insulet and began with them well before they actually commercialized their first pump. His recent comment on the whole artificial pancreas thing was that he did not think he would see it in his lifetime and software, predictive analytics would be the barrier. For years and years, analysts would badger Duane on conference calls that MDT was coming out with a patch pump like Insulet's OmniPod and each time Duane's response was the same - "you guys keep telling me MDT has one coming but I never see it". Well, MDT scrapped their plans - my point being some of this technology is very very hard to develop.
It can take an unprecedented amount of time, money and of course tenacity and making the right decisions at critical times - does this sound like the attributes of a serial medical device entrepreneur and if so, does it describe someone in particular who is near and dear to all of us? BTW - a few years ago at a conference you know who talked about how Afrezza would impact the pump business. Afrezzauser and others have ditched the pump.
The other reality is that insulin pumps are now on the radar for competitive bidding which means if it comes to fruition, pump reimbursement is going to get crushed. Right now, I think when a patient is due for a new pump its around $7,000 (don't hold me to this exact #) and in addition, an infusion set or two each week. For all you engineers out there, want to guess how much a dual chamber pump with a sophisticated and powerful computer to drive the predictive analytics is going to cost?
Looking at the Beta Bionics website, it is interesting to learn that they are a B corp or some type of organization not driven for shareholder value but for public benefit. It is also interesting to note that they indicate that among shareholders with greater than 5% ownership Eli Lilly is listed.
As we all have experienced, there are a lot of great ideas out there that in theory could be very beneficial to patients. The reality is that very few are brought to market, it's hard to do, very hard.
Think about it for a minute. A single daily injection of basal insulin combined with Afrezza makes for a simple, effective and easy to comply with method of treating diabetes. While every therapy has its risks, the number of moving parts with this combination is far less than with a dual chamber pump that is driven by a massive software program that has to have an immense number of variables analyzed to determine dosing. Hats of to Dr. Damiano but I am not so sure that the product can work for the masses, that the product can be produced in a large enough quantity to spread the fixed costs over a large enough user base and that the costs to support a pump business with such a small user base won't make it economically unfeasible.
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Post by peppy on Apr 8, 2016 7:09:26 GMT -5
I enjoyed Dr. Damiano's TEDx presentation. Clearly an extremely bright and motivated man on an important mission. With all due respect, time for a little reality. The # of variables that need to be evaluated to determine dosing and not just dosing of a single med but two. The computing power needed will be substantial. Remember the name Duane DeSisto - he was CEO of Insulet and began with them well before they actually commercialized their first pump. His recent comment on the whole artificial pancreas thing was that he did not think he would see it in his lifetime and software, predictive analytics would be the barrier. For years and years, analysts would badger Duane on conference calls that MDT was coming out with a patch pump like Insulet's OmniPod and each time Duane's response was the same - "you guys keep telling me MDT has one coming but I never see it". Well, MDT scrapped their plans - my point being some of this technology is very very hard to develop. It can take an unprecedented amount of time, money and of course tenacity and making the right decisions at critical times - does this sound like the attributes of a serial medical device entrepreneur and if so, does it describe someone in particular who is near and dear to all of us? BTW - a few years ago at a conference you know who talked about how Afrezza would impact the pump business. Afrezzauser and others have ditched the pump. The other reality is that insulin pumps are now on the radar for competitive bidding which means if it comes to fruition, pump reimbursement is going to get crushed. Right now, I think when a patient is due for a new pump its around $7,000 (don't hold me to this exact #) and in addition, an infusion set or two each week. For all you engineers out there, want to guess how much a dual chamber pump with a sophisticated and powerful computer to drive the predictive analytics is going to cost? Looking at the Beta Bionics website, it is interesting to learn that they are a B corp or some type of organization not driven for shareholder value but for public benefit. It is also interesting to note that they indicate that among shareholders with greater than 5% ownership Eli Lilly is listed. As we all have experienced, there are a lot of great ideas out there that in theory could be very beneficial to patients. The reality is that very few are brought to market, it's hard to do, very hard. Think about it for a minute. A single daily injection of basal insulin combined with Afrezza makes for a simple, effective and easy to comply with method of treating diabetes. While every therapy has its risks, the number of moving parts with this combination is far less than with a dual chamber pump that is driven by a massive software program that has to have an immense number of variables analyzed to determine dosing. Hats of to Dr. Damiano but I am not so sure that the product can work for the masses, that the product can be produced in a large enough quantity to spread the fixed costs over a large enough user base and that the costs to support a pump business with such a small user base won't make it economically unfeasible. All really good points. Well written. I want to pick up the subject of Charge. The computing power needed will be substantial. Think about that kind of charge sitting next to your cells. That is a lot of electrons.
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Post by mnholdem on Apr 8, 2016 7:22:12 GMT -5
Kudos to you for watching the Ted Talk! The guy is brilliant. Yes, the glucagon is largely responsible for the performance. It mimics what the body does and causes excess insulin to be neutralized. Glucagon works extremely fast, far faster than even Afrezza, so it catches you the moment you begin to drop. This allows you to dose the insulin aggressively locking your level into the range you saw. Some of the AP systems use FIAsp which is Novo Nordisk's faster acting insulin (FDA approval expected mid to later 2016). While faster than Novolog it is not as fast as Afrezza. Other than a mechanical failure it is very difficult, borderline impossible, to become hypoglycemic with this system. I want one, as does almost every Type 1 I know! Lilly is working on something similar. My cousin works in the research department there and was sharing something very similar with me when I saw her a couple months back. Her view on Afrezza was that it could make waves, but that it'd have to do so quickly as Lilly views their system as being more favorable to meet DM1 demand. It essentially allows them to forget about taking care of themselves. Everything would be automated. Interesting discussion. I'm thinking it may be beneficial to add an excerpt from the September 14, 2014 interview of Alfred Mann which clarifies his views of the artificial pancreas.
SF: 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?
AM: 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/
In a manner consistent with the level of adoption of the Continuous Glucose Monitor by type 1 & type 2 diabetics, the high cost of the artificial pancreas will likely be a insurmountable barrier to universal adoption. Only a relatively small % of global diabetics will be able to afford to utilize either device. A low-cost CGM would complement Afrezza . However, if low-cost AP's become available, their development poses no threat whatsoever to the pharmaceutical companies, with their myriad of diabetes drugs.
An FDA-approved Artificial Pancreas will not pose any threat to Afrezza whatsoever, IMHO, and any argument that MannKind must hurry up before the AP takes away the unmet need for a prandial insulin like Afrezza is a very weak argument indeed.
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Post by suebeeee1 on Apr 8, 2016 7:55:34 GMT -5
While Afrezza is primarily marketed to type 1 diabetics as the mealtime insulin, it had been my contention since I have seen how well it works on my husband (type 2), that this is the huge market of the future.
The typical type 2 did not grow up knowing that this disease could kill them, as did many type 1s. In fact, they generally have no symptoms. For many, they will treat a flu with more effort than they put into diabetes. There is a reason it is called a silent killer.
They will take their pills because that is easy. Most don't even test their blood regularly. Our doctor is always complimenting my husband for staying slim and exercising, so I guess there are a lot of Type 2s that don't even do that.
Most type 2s (if they live long enough) will eventually become insulin dependent. It is the nature of the disease. Afrezza is the easiest way these folks can use insulin, not test their blood sugar (we can't advertise it as that but it IS the reality), and keep their levels within normal range. They don't want to use needles and many don't comply well because of the need to inject, count carbs and proteins and worry about hypoglycemia.
So will the artificial pancreas allow all type 1s to enjoy a far less complicated life?. I sure hope so. But I'm not worried. Our real market are the type 2s.
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Post by uvula on Apr 8, 2016 9:04:45 GMT -5
I'll keep it short.
Cost is a good argument against the AP.
Massive computing power is a weak argument. (Getting the necessary data is the difficult part. The computing power is not the limiting factor.)
Can someone address the graphs in the Ted talk. Are they good because they have so few data points? Does anyone know if the lower limit is the ADA recommended ( but not ideal) a1c of 7 or the afrezza-possible a1c of 6? These graphs are not theoretical or "some day in the future". They are real and now. Thank you.
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