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Post by sayhey24 on Apr 28, 2019 8:33:18 GMT -5
Aged - compliant afrezza users in STAT achieved 100% TIR during its field of use basically 8am to 8pm. Being out of range during fasting periods is out of scope for afrezza. You can't do much better than 100%. Afrezza is dragged down by the basal, but you have to have a basal - it's a package. A doctor is going to say Afrezza + basal gives 59% and the alternative gives X, which has the better TIR? It's this simple. STAT says if you use MDI with RAA then Afrezza + basal wins, if you use a hybrid loop then Afrezza + basal loses. Aged - its good to see your understanding of afrezza has matured. However to suggest its a prandial insulin's job to make up for the basal is just medically incorrect. The job of a prandial is to get in, blunt the mealtime spike, get the PWD back to baseline and get out. Until afrezza we have not had a mealime insulin which could do its job properly. The formula for increasing "fasting" time in range is exactly as Dr. Kendal has said - increase the basal. Since afrezza's action is highly repeatable and predictable you have little fear of hypo's during the middle of the night. The fasting TIR equation for afrezza users is Fasting TIR = basal. It is not basal + afrezza.
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Post by agedhippie on Apr 28, 2019 11:07:13 GMT -5
Afrezza is dragged down by the basal, but you have to have a basal - it's a package. A doctor is going to say Afrezza + basal gives 59% and the alternative gives X, which has the better TIR? It's this simple. STAT says if you use MDI with RAA then Afrezza + basal wins, if you use a hybrid loop then Afrezza + basal loses. Aged - its good to see your understanding of afrezza has matured. However to suggest its a prandial insulin's job to make up for the basal is just medically incorrect. The job of a prandial is to get in, blunt the mealtime spike, get the PWD back to baseline and get out. Until afrezza we have not had a mealime insulin which could do its job properly. The formula for increasing "fasting" time in range is exactly as Dr. Kendal has said - increase the basal. Since afrezza's action is highly repeatable and predictable you have little fear of hypo's during the middle of the night. The fasting TIR equation for afrezza users is Fasting TIR = basal. It is not basal + afrezza. You cannot simply increase the basal because then you will get night time hypos from the basal. It's why pumps have a lower output rate at night.
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Post by uvula on Apr 28, 2019 17:55:15 GMT -5
Aged, is the pump also supplying the meal time insulin? Maybe if the pump was basal only and afrezza was used for meals then what sayhey is saying is correct. So you are both correct depending on whether or not the patient is using afrezza.
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Post by sayhey24 on Apr 28, 2019 18:22:36 GMT -5
Aged - its good to see your understanding of afrezza has matured. However to suggest its a prandial insulin's job to make up for the basal is just medically incorrect. The job of a prandial is to get in, blunt the mealtime spike, get the PWD back to baseline and get out. Until afrezza we have not had a mealime insulin which could do its job properly. The formula for increasing "fasting" time in range is exactly as Dr. Kendal has said - increase the basal. Since afrezza's action is highly repeatable and predictable you have little fear of hypo's during the middle of the night. The fasting TIR equation for afrezza users is Fasting TIR = basal. It is not basal + afrezza. You cannot simply increase the basal because then you will get night time hypos from the basal. It's why pumps have a lower output rate at night. According to Dr. Kendal and the analysis he did based on the STAT results, yes you can. The reason is afrezza users do not have insulin onboard during fasting periods, unlike RAA users who do. With the RAA interaction you just never know for sure what the interaction will be so you under dose the basal and use the RAA for adjustments. With afrezza, since its so fast and predictable adjustments are made with the basal with no additional hypos. Afrezza is only used for prandial control. These results are in fact what is being seen in clinical use. We also know the best results being seen with closed loop systems is when afrezza is used for prandial control. The Yale study will further show these results and will build on what the JDRF has already reported. The predictive capabilities of these systems are significantly improved for afrezza users and if its a lower basal output rate at night they will self adjust but with afrezza not being on board its more steady state at night.
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Post by agedhippie on Apr 28, 2019 22:21:45 GMT -5
Aged, is the pump also supplying the meal time insulin? Maybe if the pump was basal only and afrezza was used for meals then what sayhey is saying is correct. So you are both correct depending on whether or not the patient is using afrezza. You can do that, however there is not a lot of incentive. Your body is continually pushing out glucose and the basal insulin is there to balance out that basal glucose flow. The hybrid pump simply see you starting to go low and backs off the basal dose letting your body's basal glucose flow take care of the drop and so head off the hypo. There is a reason Dr Bode (Afrezzauser's endo) calls automated insulin delivery the greatest step forward since the invention of insulin.
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Post by agedhippie on Apr 28, 2019 22:40:26 GMT -5
You cannot simply increase the basal because then you will get night time hypos from the basal. It's why pumps have a lower output rate at night. According to Dr. Kendal and the analysis he did based on the STAT results, yes you can. The reason is afrezza users do not have insulin onboard during fasting periods, unlike RAA users who do. With the RAA interaction you just never know for sure what the interaction will be so you under dose the basal and use the RAA for adjustments. With afrezza, since its so fast and predictable adjustments are made with the basal with no additional hypos. Afrezza is only used for prandial control. These results are in fact what is being seen in clinical use. We also know the best results being seen with closed loop systems is when afrezza is used for prandial control. The Yale study will further show these results and will build on what the JDRF has already reported. The predictive capabilities of these systems are significantly improved for afrezza users and if its a lower basal output rate at night they will self adjust but with afrezza not being on board its more steady state at night. If you increase your basal insulin above your basal glucose output you will have a hypo. It's simple mechanics. This is compounded by your body dropping it's basal output between about 11pm and 4am because you should be asleep. After 4am it gradually rises spiking at around 6am to give you the energy to get up in the morning (dawn phenomena). In other words your basal glucose output is not flat throughout the day so if you reduce it to cope with daytime levels you will have a hypo at night. If you adjust it for nighttime levels you will float high throughout the day. You do not under-dose your basal, that's just stupid and your Endo will slap you. Afrezza cannot be used in a closed loop system because closed loop systems are fully automated and with Afrezza that is not possible (you manually handle prandial insulin). The only studies I am aware of using pumps are Sansum and Yale, there are no other results I am aware of to support the idea that Afrezza plus pump is better than, say, a 670G pump.
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Post by uvula on Apr 29, 2019 8:12:47 GMT -5
I think this issue is the biggest threat to the success of afrezza.
Aged, you are correct that afrezza cannot be used with a fully automated closed loop system because, by definition, it wouldn't be closed loop. But afrezza can be used with an artificial pancreas system if manually dosed afrezza is part of the system. There have been some studies that had good results. Is it worth tbe extra effort???
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Post by mnholdem on Apr 29, 2019 8:25:55 GMT -5
In an interview he gave before he passed away, Al Mann clearly stated that the artificial pancreas would never gain acceptance by the masses because of its expense. Even insulin pumps account for a relatively small percentage of the T1 market and virtually none of the T2 market.
So (in my opinion) this whole debate is a tempest in a teapot and I see no threat to the future of Afrezza by Medtronic or any other pump maker.
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Post by uvula on Apr 29, 2019 8:29:34 GMT -5
Excellent points. If the standard of care changes and T2s get afrezza early on then afrezza will be huge.
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Post by brentie on Apr 29, 2019 8:59:47 GMT -5
In an interview he gave before he passed away, Al Mann clearly stated that the artificial pancreas would never gain acceptance by the masses because of its expense. Even insulin pumps account for a relatively small percentage of the T1 market and virtually none of the T2 market. So (in my opinion) this whole debate is a tempest in a teapot and I see no threat to the future of Afrezza by Medtronic or any other pump maker. 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? 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. www.diabetesincontrol.com/an-exclusive-interview-with-al-mann-founder-and-ceo-mannkind-corp/
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Post by uvula on Apr 29, 2019 9:53:47 GMT -5
Thanks for posting this. Worth repeating.
Al Mann "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."
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Post by mnkdfann on Apr 29, 2019 9:57:23 GMT -5
"three Cs: cost, convenience and complexity"
Perhaps AL was correct, at least back in 2014 when he talked about those being big problems. But I think a lot of new tech has similarly been criticised, only to take off like gang-busters down the road.
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Post by agedhippie on Apr 29, 2019 10:09:28 GMT -5
In an interview he gave before he passed away, Al Mann clearly stated that the artificial pancreas would never gain acceptance by the masses because of its expense. Even insulin pumps account for a relatively small percentage of the T1 market and virtually none of the T2 market. So (in my opinion) this whole debate is a tempest in a teapot and I see no threat to the future of Afrezza by Medtronic or any other pump maker. 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? 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. I definitely think an artificial pancreas (as in a closed loop system) will be released before the end of next year or 2021. The phase 3 clinical trials for three of these pumps are running this year and next. Any device can go wrong and kill you but that's not going to stop people because it is so unlikely. Al Mann made that comment five years ago and in the interval technology has moved on. The cost and accuracy of CGMs is improving, the FDA has changed it's stance on both integration and the use of smartphones as controllers hugely improving usability. Pumps are still expensive but you are beginning to see commodity pumps appearing (the JDRF is even funding one). All of that said I still expect Afrezza to dominate the Type 2 insulin dependent market. I cannot see the insurers covering Type 2 as the population is just so large. Where there are national health systems it may happen (Al Mann's comment above about expecting APs to out perform Afrezza and basal), but I suspect not because of cost - the scoring will say that marginally improved control does not justifies the cost. In the Type 1 market - if you get a pump today you will be on an AP in the future, I think that's a given.
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Post by sweedee79 on Apr 29, 2019 10:29:14 GMT -5
If I had diabetes I would not want Novolog or humolog pumped into my body.. I would want a natural superior insulin. Ive seen the difference in real life... No one could convince me otherwise.
I would also be a bit Leary of having a machine in control of my life.
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Post by sportsrancho on Apr 29, 2019 10:58:28 GMT -5
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