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Post by sweedee79 on Apr 8, 2016 10:02:40 GMT -5
I can tell everyone right now... that my dad.. Type 1 would NEVER consider getting an artificial pancreas.... never never never never ... too expensive... too complicated.. doesn't like computers.. and also just knowing all we have had to go thru getting Afrezza.. I cant imagine the rigmarole we would have to go thru to get an AP ... these problems are not unique to Afrezza .. Insurance providers don't like to spend money .. I think that the insurance company would want proof that it is medically necessary to have an AP when the disease can be controlled as well on a less expensive option. It will be met with the same obstinance in the doctors office..
Our market is both T1 and T2 ... I just don't see an AP replacing the need for Afrezza ... or making Afrezza somehow obsolete.... Its a nice option for those that want it... or those that can afford it ..
and I have a question regarding an AP... what kind of insulin would it deliver?? We know that Afrezza is a monomer.. and that Novolog is a hexamer that hangs in the body and causes weight gain.. Afrezza mimics natural insulin release ...
IMO the wide spread use of an AP is many years away...
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Post by agedhippie on Apr 8, 2016 10:07:54 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. It's apples and oranges. Insulin lowers your blood glucose levels, glucagon raises the levels. Also glucagon is currently only used in an emergency for severe or persistent lows. They are just releasing nasal spray delivery of glucagon for smaller corrections which is really interesting. All the pump manufacturers are working on APs as well as a few startups. Conventional pumps will become obsolete (any insulin only pump will just be an AP with disable functionality).
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Post by agedhippie on Apr 8, 2016 10:14:50 GMT -5
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. The highlighted section is key. I can live my life without having to think about glucose levels at all. No CGM alerts, no blood monitoring, no insulin bolus (inhaled or injected), no random spikes and drops, no worry about drinking (*cough*) or exercise, I can eat or snack when and what I want - just living. Why would I not want that?
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Post by agedhippie on Apr 8, 2016 10:19:43 GMT -5
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. That is the whole point of the AP and why the 670G is not an AP. An AP like the iLet or UVA AP handles all of that itself without me having to touch it.
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Post by agedhippie on Apr 8, 2016 10:34:52 GMT -5
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. Absolutely the case - Afrezza is the perfect drug for Type 2. Insurers will almost never cover pumps or CGMs for Type 2 so there is no way they will cover an AP for a Type 2. I can't remember if your dad is a Type 1 or Type 2. If he is Type 1 it would be reasonably simple to get a pump or in time an AP since they are considered medically necessary for a Type 1. The insurers cannot block pumps since Medicare covers them which puts the insurer in an indefensible position (they can be sued). My endo has his Type 1s on pumps as soon as they are diagnosed. There are people who don't trust pumps (a friend of mine refused to go on one for years because of that) and that is their decision which I respect entirely. Faster is better but the current generation of pumps are fine with existing insulins. The smarts compensate for the speed. Maybe. I know my endo has told me he will start moving his patients over as soon as he can. Basically then the pump warranty expires they get an AP.
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Post by agedhippie on Apr 8, 2016 11:07:14 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. Cost is not an argument since it is comparable with existing options (pump + CGM). The decrease in A1c results from the trials will force insurers to cover APs in the same way it forced them to cover CGMs and pumps despite their howls - trials prove medical necessity. Compute power is not a requirement. You need less compute power than your average smartphone. The Ted talk graph is real. I have seen similar graphs from other AP projects. One of the biggest problem with the small scale trials they have done to date is depression following the end of the trial, the doctors warn you about it up front, because you briefly get back so much of your life and then you have to stop. This not hypothetical. Within two years these devices will be available.
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Post by agedhippie on Apr 8, 2016 11:10:31 GMT -5
Sorry if that looks like I bombed the site but I wanted to answer people. The summary though: Yes they exist, they work as advertised, they will be huge in the Type 1 market. Trials are happening this year, 2017 to 2018 launch for at least two.
No, Afrezza is not doomed as a chunk of the Type 1 market and the whole of the Type 2 market will be untouched which is at least 80% of all diabetics.
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Post by stevil on Apr 8, 2016 11:20:04 GMT -5
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. ya, I'm curious to see how it works. From what she said, it'd be linked to your phone and you'd have a few options... you'd pick small meal, snack, large meal and it'd shoot a bolus of insulin, probably larger than needed because the glucagon could always correct on the over and as agedhippie said, it's much faster than insulin, so it'd be better to shoot too much rather than not enough. There was also talks of being able to take a picture of your food and the device would somehow figure out how much to release. I'm not trying to dissuade anyone from investing in Afrezza. It's just wise to be aware of what else is on the horizon with the competition. I have only talked to 3 diabetics, but their faces light up whenever they talk about it, but that's probably because they're already educated on the AP. I just think that Afrezza might require too much education for diabetics to really get excited about. I'm not sure they understand the science behind it all too well... Hopefully we'll get everyone hooked on Afrezza before all this stuff comes out so that they won't even want an AP
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Post by pengiep on Apr 8, 2016 11:23:30 GMT -5
One quibble about the "too much education required for Afrezza". I'm thinking there's actually got to be a lot more education required for injecting as a mistake in your injections is hella lot more likely to kill you with a hypo than would be the a mistake with Afrezza.
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Post by rockstarrick on Apr 8, 2016 11:51:10 GMT -5
I'll paste this in sections, this subtopic is buried deep in this article. Inhaled Insulin Studied In APS Research Another research project being watched closely comes from the Sansum Diabetes Research Institute and the University of Califor- nia, Santa Barbara (UCSB), where the still experimental inhaled insulin from MannKind Corp. is being used in an APS research trial. (See “MannKind Gears Up To Make Commercial Case For Inhaled Insulin Afrezza” — Pharma- ceutical Approvals Monthly, September 2013.) JDRF’s Kowalski told Medtech Insight the study is the only one where Afrezza (insulin human [rDNA origin]) Inhalation Powder, a fast-acting insulin, is being used in an APS. The study is investigating the use of Afrezza in conjunction with a regular basal and bolus system, and the equipment in the study includes an OmniPod patch pump from Insulet and a DexCom sen- sor. In a joint announcement with JDRF, the project’s lead researcher, Howard Zisser, MD, explained that the trial addresses one of the big questions in diabetes research: “How do we manage meals with the arti cial pancreas?” The issue is a concern, because follow- ing a meal many diabetics have a dif cult time managing their glucose levels, and the standard subcutaneous method of delivering insulin is slow compared with how fast glucose
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Post by rockstarrick on Apr 8, 2016 11:53:54 GMT -5
I'll paste this in sections, this subtopic is buried deep in this article. Inhaled Insulin Studied In APS Research Another research project being watched closely comes from the Sansum Diabetes Research Institute and the University of Califor- nia, Santa Barbara (UCSB), where the still experimental inhaled insulin from MannKind Corp. is being used in an APS research trial. (See “MannKind Gears Up To Make Commercial Case For Inhaled Insulin Afrezza” — Pharma- ceutical Approvals Monthly, September 2013.) JDRF’s Kowalski told Medtech Insight the study is the only one where Afrezza (insulin human [rDNA origin]) Inhalation Powder, a fast-acting insulin, is being used in an APS. The study is investigating the use of Afrezza in conjunction with a regular basal and bolus system, and the equipment in the study includes an OmniPod patch pump from Insulet and a DexCom sen- sor. In a joint announcement with JDRF, the project’s lead researcher, Howard Zisser, MD, explained that the trial addresses one of the big questions in diabetes research: “How do we manage meals with the arti cial pancreas?” The issue is a concern, because follow- ing a meal many diabetics have a dif cult time managing their glucose levels, and the standard subcutaneous method of delivering insulin is slow compared with how fast glucose appears in the bloodstream after a meal. Co- principal investigator Francis J. Doyle, III, PhD, associate dean of research engineering at UCSB, explained that using “inhaled, ultra- rapid-acting insulin, we have a chance now to manage blood glucose even better by emulat- ing a more natural pancreatic function. We can get the insulin quickly into circulation and it will be cleared quickly and safely from the bloodstream.” Research has shown a person with diabetes might see a blood glucose spike as high as 60 mg/dL after a meal, but with the fast-acting insulin that spike might be consid- erably smaller – somewhere around 20 mg/dL. In August, MannKind released data from its Study 171, a Phase III clinical study of Afrezza’s • Switching to Afrezza administered using the MedTone inhaler in combination with their basal insulin (174 patients).
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Post by sweedee79 on Apr 8, 2016 12:05:30 GMT -5
Faster is better but the current generation of pumps are fine with existing insulins. The smarts compensate for the speed. Even if the glucose counteracts the insulin and stabilizes sugar in the blood... the insulin is still in the body.. Insulin stores fat.. its a problem with injectable hexamer insulin.. nothing is without its problems since its an artificial pancreas... not a real one.. so while it sounds quite amazing I have my doubts that it will be as perfect as you say.. My dad is T1 .. I have a chance of inheriting his disease since it is genetic.. and if it were me I would rather have a more natural form of insulin.. to each his own.. What I saw with my dad is that while on hexamer insulin he slowed down.. and gained weight.. I also saw more depression on the hexamer.. while on Afrezza he was happier and more energetic and lost a lot of weight... yes he still had to take his insulin, but that wasn't a big deal to him anymore considering he felt so much better... I guess we shall see.. One day there will be something that is near perfect.. I just don't think that is in the cards in the near future..
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Post by rockstarrick on Apr 8, 2016 12:10:12 GMT -5
I'll paste this in sections, this subtopic is buried deep in this article. Inhaled Insulin Studied In APS Research Another research project being watched closely comes from the Sansum Diabetes Research Institute and the University of Califor- nia, Santa Barbara (UCSB), where the still experimental inhaled insulin from MannKind Corp. is being used in an APS research trial. (See “MannKind Gears Up To Make Commercial Case For Inhaled Insulin Afrezza” — Pharma- ceutical Approvals Monthly, September 2013.) JDRF’s Kowalski told Medtech Insight the study is the only one where Afrezza (insulin human [rDNA origin]) Inhalation Powder, a fast-acting insulin, is being used in an APS. The study is investigating the use of Afrezza in conjunction with a regular basal and bolus system, and the equipment in the study includes an OmniPod patch pump from Insulet and a DexCom sen- sor. In a joint announcement with JDRF, the project’s lead researcher, Howard Zisser, MD, explained that the trial addresses one of the big questions in diabetes research: “How do we manage meals with the arti cial pancreas?” The issue is a concern, because follow- ing a meal many diabetics have a dif cult time managing their glucose levels, and the standard subcutaneous method of delivering insulin is slow compared with how fast glucose appears in the bloodstream after a meal. Co- principal investigator Francis J. Doyle, III, PhD, associate dean of research engineering at UCSB, explained that using “inhaled, ultra- rapid-acting insulin, we have a chance now to manage blood glucose even better by emulat- ing a more natural pancreatic function. We can get the insulin quickly into circulation and it will be cleared quickly and safely from the bloodstream.” Research has shown a person with diabetes might see a blood glucose spike as high as 60 mg/dL after a meal, but with the fast-acting insulin that spike might be consid- erably smaller – somewhere around 20 mg/dL. In August, MannKind released data from its Study 171, a Phase III clinical study of Afrezza’s • Switching to Afrezza administered using the MedTone inhaler in combination with their basal insulin (174 patients). Over the 24-week treatment period, A1c levels decreased comparably in the Afrezza-Gen2 group (–0.21%) and the insulin aspart group (–0.40%) and the Afrezza device met its nonin- feriority endpoint. (See Exhibit 6.) MannKind is expected to submit data from Study 171, as well as Study 175, which showed positive results of Afrezza’s use by T2 diabetics, to the FDA by the end of this year. The agency rejected MannKind’s submission in 2011, and requested additional studies. (See “Cautious FDA Is Obstacle For Burgeoning Diabetes De- vice Market” — Medtech Insight, August 2011.) However, many analysts now expect Afrezza to receive regulatory approval. The product has a large market potential, estimated by some in the multibillions; however, MannKind is likely to need a partner to help with the expensive task of commercializing the product if approved. So far, a partner has not emerged publicly, but potential matches could come from one of several major diabetes companies such as Novo Nordisk AS, Sano , Eli Lilly & Co., or J&J. Numerous other APS endeavors are taking place around the globe, including one involv- ing the product development rm Cambridge Consultants, which announced in June a partnership with the Institute of Metabolic Science (IMS) at Addenbrooke’s Hospital in Cambridge, UK. The project is designed to develop an application that would allow a CGM to communicate with a smartphone or tablet via Bluetooth and then link to an insulin pump. Company of cials say a nurse- assisted system has previously been trialed in a hospital setting, and home use of the system has already been established. As the race to bring an APS to market moves closer to the nish line, more deals and part- nerships are likely to be announced, and new companies are expected to join the race – either with a goal of reaching the market, or develop- ing a technology that could be acquired by the larger players in the eld. The diabetes market has been seen as a fairly attractive space, with the right mix of innovation and a very large and engaged patient population that not only offers vigorous feedback on products, but also is will- ing to advocate for new treatments that make managing their disease easier and safer. [#2013700119]
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Post by agedhippie on Apr 8, 2016 13:22:54 GMT -5
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. I have only talked to 3 diabetics, but their faces light up whenever they talk about it, but that's probably because they're already educated on the AP. I just think that Afrezza might require too much education for diabetics to really get excited about. I'm not sure they understand the science behind it all too well... Education isn't the problem - the problem is that I still have to carry around stuff and use it whenever I eat anything. I want to forget I have diabetes. That is the promise of the AP and why those diabetics eyes light up when they talk about it. It's very hard to convey exactly how big a deal this is for a Type 1 and is why organizations like the Lilly, JDRF and NIH are funding clinical trials for these devices.
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Post by stevil on Apr 8, 2016 13:23:39 GMT -5
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. The highlighted section is key. I can live my life without having to think about glucose levels at all. No CGM alerts, no blood monitoring, no insulin bolus (inhaled or injected), no random spikes and drops, no worry about drinking (*cough*) or exercise, I can eat or snack when and what I want - just living. Why would I not want that? The reason I'm sticking with this stock for now is to give diabetics the choice to make the "right" decision. Convenience isn't the best option necessarily. It would be for those who don't place high importance on treating their bodies the best way possible. There is likely a large percentage of diabetics who want to not take their healthcare in their own hands. I think anybody with a chronic disease would be guilty of that- not trying to stereotype diabetics in that respect. But the AP likely wouldn't be the best option for those who were properly educated and motivated to take the best care of themselves. In other words, Afrezza would still be superior, but it'd come down to preference, convenience, and proper understanding of how to use each tool.
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