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Post by agedhippie on Aug 22, 2016 7:31:35 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 The problem with Afrezza is that once you use it you no longer have a closed loop system - part of the feedback loop is depends on a system that is not integrated. That's the operational reason why Afrezza will not be used, and functionally it fails the primary requirement - no human intervention required.
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Post by uvula on Aug 22, 2016 8:04:06 GMT -5
Agedhippie, the AP will need human intervention. Batteries, filling it up, keeping the site clean, etc. Personally I'd probably keep looking at it to make sure it was working and it would stress me out. Different people will want different things and it will be great to have several good options to choose from. (Disclaimer: investor, not diabetic)
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Post by uvula on Aug 22, 2016 8:06:17 GMT -5
Also no one claimed that no human intervention was the primary requirement of an AP. It us all about better control and easier compliance.
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Post by madog365 on Aug 22, 2016 8:23:16 GMT -5
First generation of AP will not be a fully closed loop system. You can expect the first wave to be “hybrid” closed loop with which patients still require meal bolus" - Similar to the youtube video posted above. IMO.
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Post by peppy on Aug 22, 2016 8:33:09 GMT -5
artificial pancreas is a euphemism.
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Post by sportsrancho on Aug 22, 2016 12:41:43 GMT -5
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Post by agedhippie on Aug 22, 2016 15:53:16 GMT -5
Agedhippie, the AP will need human intervention. Batteries, filling it up, keeping the site clean, etc. Personally I'd probably keep looking at it to make sure it was working and it would stress me out. Different people will want different things and it will be great to have several good options to choose from. (Disclaimer: investor, not diabetic) By human intervention I meant having to do things every couple of hours. Of the tasks you are talking about the most common one is a site change which is every three days. When you did that you would refill the pump as well, batteries last for ages and will always make it to the next site change. It comes down then to dealing with diabetes every few hours or once every three days - an easy choice Your comment is perceptive because it's exactly that cycle people went through with the pump. The biggest concern was that it would kill you in your sleep. At the beginning you tended to watch the thing like a hawk and compulsively scan the online diabetic community for any problems. When nothing came up people became progressively more comfortable with pumps to the stage now where for a new pumper the anxiety stage only lasts a few days. As to the idea of "no human intervention was the primary requirement of an AP" being a requirement, it's the whole point. It's what will give the medical profession their improved compliance and will ensure buy-in from the diabetics because of the quality of life improvement. All of that said there are people who will never be comfortable with an AP because they don't trust it, don't want to trust it, or just don't want to be hooked up to a machine - these are all perfectly valid.
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Post by lakon on Aug 23, 2016 9:47:33 GMT -5
Agedhippie, the AP will need human intervention. Batteries, filling it up, keeping the site clean, etc. Personally I'd probably keep looking at it to make sure it was working and it would stress me out. Different people will want different things and it will be great to have several good options to choose from. (Disclaimer: investor, not diabetic) By human intervention I meant having to do things every couple of hours.Do you mean, like eating? You already inhale far more frequently so that cannot be much of an impediment. It sure sounds like you already made up your mind, but unfortunately, I don't think that reality will satisfy. I wish you luck that your dream becomes a reality. More solutions are better.
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Post by agedhippie on Aug 23, 2016 12:26:12 GMT -5
By human intervention I meant having to do things every couple of hours. Do you mean, like eating? You already inhale far more frequently so that cannot be much of an impediment. It sure sounds like you already made up your mind, but unfortunately, I don't think that reality will satisfy. I wish you luck that your dream becomes a reality. More solutions are better. There is obviously a big gap in understanding here - have a look at diabetes burnout. I think there should be as many options as possible, diabetics are not one size size fits all.
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Post by myocat on Aug 23, 2016 13:16:56 GMT -5
My daughter worn a CGM for 2 weeks. Id did provide near real time readings but it was uncomfortable to her when she played sports or swimming. She took it off completely. If they can package a small CGM and insulin dispenser to the Dexcom size, then it worth considering. Then again, pricing must be affordable. The term AP might be misleading.... I think. I hope Viacyte can really make the AP using stemcells.
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Post by mnholdem on Aug 23, 2016 13:22:50 GMT -5
My daughter worn a CGM for 2 weeks. Id did provide near real time readings but it was uncomfortable to her when she played sports or swimming. She took it off completely. If they can package a small CGM and insulin dispenser to the Dexcom size, then it worth considering. Then again, pricing must be affordable. The term AP might be misleading.... I think. I hope Viacyte can really make the AP using stemcells.
Google/Verily is diligently working on it.
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Post by sweedee79 on Aug 23, 2016 14:14:32 GMT -5
Do you mean, like eating? You already inhale far more frequently so that cannot be much of an impediment. It sure sounds like you already made up your mind, but unfortunately, I don't think that reality will satisfy. I wish you luck that your dream becomes a reality. More solutions are better. There is obviously a big gap in understanding here - have a look at diabetes burnout. I think there should be as many options as possible, diabetics are not one size size fits all. I think Aged Hippie is talking about not having to worry about his diabetes as much... His priority is the freedom he would get with a so called closed loop AP .. he isn't as concerned about getting the best A1C numbers or whether or not his insulin is superior.. He wants freedom from the disease. I can understand that frame of thought. My dad says he is a prisoner to his diabetes and is unable to live a normal life. So yes, diabetes burnout is a problem for many reasons.. one of which is tracking the disease every single day of your life. So for some people with T1 diabetes the AP might be the way to go.
In my dad's case I believe that he would feel more at ease if his diabetes was easier to control but he also wants to feel better. He worries and becomes distressed over his numbers and is often tired from Novolog. When he is on Afrezza he feels so much better because it is a superior insulin IMO which more closely mimics normal insulin release. For my dad, personally I would not want him on any AP that didn't use Afrezza because the quality of his life is so much better when he is on a superior insulin, for him it is obviously a healthier solution. Even without an AP, the extra work is worth it.. .
I don't agree that an AP using the same old same old insulin will capture the entire T1 market... but it may be an option for some. I believe we are a long way off from having an AP that is miraculous.... Presently I think that Afrezza is the superior insulin and treatment for T1 AND T2 diabetes on the market and it will just be a shame if that is never realized. I am happy that they are coming with a machine they call an AP.. but I also want to see a superior insulin used with this machine and Novolog or Humalog are not.
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Post by agedhippie on Aug 23, 2016 15:35:29 GMT -5
There is obviously a big gap in understanding here - have a look at diabetes burnout. I think there should be as many options as possible, diabetics are not one size size fits all. I think Aged Hippie is talking about not having to worry about his diabetes as much... His priority is the freedom he would get with a so called closed loop AP .. he isn't as concerned about getting the best A1C numbers or whether or not his insulin is superior.. He wants freedom from the disease. I can understand that frame of thought. My dad says he is a prisoner to his diabetes and is unable to live a normal life. So yes, diabetes burnout is a problem for many reasons.. one of which is tracking the disease every single day of your life. So for some people with T1 diabetes the AP might be the way to go. I would have given this more thumbs up if I could have - the whole paragraph but in particular the bold part.
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Post by madog365 on Oct 20, 2016 8:18:38 GMT -5
insulinnation.com/treatment/why-you-still-have-to-bolus-with-the-first-artificial-pancreas/I believe this is big news for Afrezza as it is the only approved insulin that would fit this system during it's commercialization early next year. See note from Dr. Kowalski: Update: Dr. Kowalski responded by email to Insulin Nation’s query about why there isn’t an insulin available that could handle automatic bolus adjustments in an artificial pancreas system. Here is a passage from that response: “We have been working on a number of approaches to speed up insulin action and have spent millions of dollars on research in this area over the past decade. It’s hard. Insulin delivered through the skin does not work fast like insulin made in your pancreas, which gets in the blood quickly. This is compounded by the fact that insulin coming through your skin can’t anticipate you eating like your brain does. And, insulin through the skin doesn’t reach your liver quickly, while that’s the first place insulin acts after the pancreas. There are two broad ways to tackle this – new insulin molecules and new means of delivery. We’ve supported multiple versions of each. Novo Nordisk has a faster insulin in the pipeline and there is Afrezza, but beyond that we are working hard to deliver better solutions.”
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Post by mnkdnewbie on Oct 20, 2016 8:27:58 GMT -5
insulinnation.com/treatment/why-you-still-have-to-bolus-with-the-first-artificial-pancreas/I believe this is big news for Afrezza as it is the only approved insulin that would fit this system during it's commercialization early next year. See note from Dr. Kowalski: Update: Dr. Kowalski responded by email to Insulin Nation’s query about why there isn’t an insulin available that could handle automatic bolus adjustments in an artificial pancreas system. Here is a passage from that response: “We have been working on a number of approaches to speed up insulin action and have spent millions of dollars on research in this area over the past decade. It’s hard. Insulin delivered through the skin does not work fast like insulin made in your pancreas, which gets in the blood quickly. This is compounded by the fact that insulin coming through your skin can’t anticipate you eating like your brain does. And, insulin through the skin doesn’t reach your liver quickly, while that’s the first place insulin acts after the pancreas. There are two broad ways to tackle this – new insulin molecules and new means of delivery. We’ve supported multiple versions of each. Novo Nordisk has a faster insulin in the pipeline and there is Afrezza, but beyond that we are working hard to deliver better solutions.” I posted the sec doc for Nvo the other day stating they received questions from the fda for their aspart the quote above is referring to. I wonder what the fda questions were? And how long before it is approved or denied.
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