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Post by rfogel on Dec 7, 2019 12:58:29 GMT -5
I think I'm understanding it a bit better now. So the middle graph from the link in my original post indicates afrezza controlled well the first 90 minutes but then glucose started rising. It also implies to maintain that really good control would require another dose at the end of that 90 minutes and maybe yet another dose 90 minutes after that -- is that about right? I wish they would have used a higher dose of lispro for comparison. The dose they used doesn't appear to have had any effect whatsoever. Also, thanks to mnholdem for the vimeo links to Dr. Kendall discussing afrezza. I was hoping to find a real presentation to some group. I was wanting to assess his ability as a "pitchman" for the drug. On vimeo he seems a bit sluggish, like maybe jet lagged a bit. Is he better on stage? Dr. Kendall is a polished presenter. He is presenting the 5 to 7 studies which form the basis of the new "ultra acting" class in February if what MC said this week is correct. His focus has been getting the new class and changing the SoC. When you are talking afrezza, it makes no sense to look at the effect after 2.5 hours. The graphs are meaningless. It is out of the system. It is done working which is it beauty. Lispro is not. Its still hanging around. If you believe what Aged says thats the benefit of the RAAs which is ridiculous. What do they say about a house guest after 3 days - its beginning to smell like dead fish? We have a whole industry trying to make AI pumps to figure out how much RAA is still hanging around so they can properly continue to dose. afrezza obsoletes the need for any of this. With afrezza if you BG is rising at 2hr, take another puff - simple and repeatable with little chance of a server hypo. Of course prior to CGMs this was not obvious to most. Mike talked about a connected care service in last weeks talk so it will be interesting what they do; OneDrop; Onduo; something else. The second dosing is more a T1 thing. With a T2 the pancreas is probably still making enough insulin so in most cases there is little need for second dosing. IMO, afrezza should be prescribed as part of the Step 1 in the SoC. Take a walk, lose a few pounds and take the afrezza for 3 months and then go back to the doctor. Maybe after the 3 or 6 months there is no longer a need for the afrezza with some early stage T2s. Regarding "there is little need fo second dosing" in T2, the graph suggests otherwise -- presuming, that is, they used just ordinary T2s in the study. For the 16U afrezza dose, glucose begins rising again at about 45 minutes and for the 24U dose it begins rising again at about 90 minutes so that by 3 hours, it's back to 40 md/dl above normal. It gradually tapers off after that but doesn't get back to normal until about 5.5 hours. They should have gone ahead and dosed again at 90 minutes to demonstrate that afrezza could prevent that rise. That may be the reason the standard of care indicates the T2 should be started on long acting insulin if all else has failed. Actually, thinking about it, the study probably should have compared to long acting insulin instead of lispro.
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Post by sayhey24 on Dec 9, 2019 19:08:59 GMT -5
rfogel - look at the poster closely - it says the PWDs were given 2 "sequential" mixed meal tolerance tests. It does not say exactly what was given but lets assume some fast acting carbs followed by some slow digesting carbs like pizza. The goal was to provide a quick glucose spike and then try to maintain it for hours to see how long afrezza and lispro would act.
This is probably not a typical meal situation but shows that these PWDs needed extra afrezza at the 2hour mark which can be easily done by taking another puff. After 2 hours afrezza is done which is exactly what you want. A non-diabetic at the 2 hour mark should be back at baseline, lets say 87 mg/dl.
Now- the reason the SoC indicates T2s should start on a basil is because insulin is a last resort. Its dangerous. It requires needles and and causes hypos. Asking a T2 to take shots at each meal is a big ask and could cause a hypos.
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Post by agedhippie on Dec 9, 2019 21:34:54 GMT -5
rfogel - look at the poster closely - it says the PWDs were given 2 "sequential" mixed meal tolerance tests. It does not say exactly what was given but lets assume some fast acting carbs followed by some slow digesting carbs like pizza. The goal was to provide a quick glucose spike and then try to maintain it for hours to see how long afrezza and lispro would act. This is probably not a typical meal situation but shows that these PWDs needed extra afrezza at the 2hour mark which can be easily done by taking another puff. After 2 hours afrezza is done which is exactly what you want. A non-diabetic at the 2 hour mark should be back at baseline, lets say 87 mg/dl. Now- the reason the SoC indicates T2s should start on a basil is because insulin is a last resort. Its dangerous. It requires needles and and causes hypos. Asking a T2 to take shots at each meal is a big ask and could cause a hypos. Mixed meal is in inverted commas because it's not really a meal at all, it's liquid! Typically they use something like Boost or Ensure because the composition is precisely known. Last time I had one it was Ensure. The reason for a T2 to take basal is is because their body is still producing insulin, just not enough. The aim is to use basal insulin to replace the insulin that would otherwise have been used for that role and save all their insulin for dealing with meal time. It's done that way around because the basal insulin role is relatively dumb, the pancreas just steadily drips out insulin not doing anything to clever, whereas the meal time insulin is smart, the pancreas continually changes the amount of insulin to keep the blood glucose flat and tweaks it with glucagon to get it just so - that is a lot more valuable so you want your pancreas to do that and not deal with basal output.
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Post by sayhey24 on Dec 10, 2019 6:36:54 GMT -5
Aged - the reason basil is given first with T2s is because insulin is dangerous. It requires needles and causes hypos. Not until afrezza was there an insulin not considered dangerous. First treating with basil is the medically incorrect way to treat diabetes. The first thing all T2s lose is first phase insulin release. The issue all T2s have is dealing with the post meal spike.
Until CGMs this was not obvious to most. Now it is. There is no way to hide the numbers anymore when people can look at a CGM and see it for themselves.
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Post by prcgorman2 on Dec 10, 2019 7:14:02 GMT -5
Whew! It’s like watching a heavy-weight match. You guys and gals are awesome. The most interesting thing I read was “consistency of absorption” as compared to “Speed trumps accuracy”. But then I read over and over that consistency is not possible. People pay for convenience. Just ask 7/11 and QuickTrip and McDonald’s. I suspect a 1 year Eversense and Afrezza will be more convenient than a pump. Regardless of what I think, what a great thread about understanding study results summarized on a poster.
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Post by agedhippie on Dec 10, 2019 7:54:31 GMT -5
Aged - the reason basil is given first with T2s is because insulin is dangerous. It requires needles and causes hypos. Not until afrezza was there an insulin not considered dangerous. First treating with basil is the medically incorrect way to treat diabetes. The first thing all T2s lose is first phase insulin release. The issue all T2s have is dealing with the post meal spike. Until CGMs this was not obvious to most. Now it is. There is no way to hide the numbers anymore when people can look at a CGM and see it for themselves. Bit confused here. Basal *is* insulin. And the medical world still considers Afrezza dangerous in that it carries exactly the same warnings other insulin for hypos. It does avoid the shared insulin pen warning though Basal and Afrezza both have their place. Bolus insulin like RAA or Afrezza get used once you cannot produce enough insulin for meals while taking the correct basal insulin dose, in other words don't use excess basal to cover meals. It is far less intrusive to take one shot a day than 6 or 7 correctly timed Afrezza doses. Ask the patient which they would rather take and the majority are going to be for a single shot. In Type 2 basal + GLP-1 premix is gaining favor as an alternative to basal + bolus. It would be interesting to see a trial where of basal only vs. bolus only landed. It may well have already been done, but obviously not with Afrezza.
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Post by agedhippie on Dec 10, 2019 8:02:51 GMT -5
Whew! It’s like watching a heavy-weight match. You guys and gals are awesome. The most interesting thing I read was “consistency of absorption” as compared to “Speed trumps accuracy”. But then I read over and over that consistency is not possible. People pay for convenience. Just ask 7/11 and QuickTrip and McDonald’s. I suspect a 1 year Eversense and Afrezza will be more convenient than a pump. Regardless of what I think, what a great thread about understanding study results summarized on a poster. With smart pumps and loops you can go a long time with just letting the pump deal with things. Minimizing the need to think about diabetes is the key. If I am going to have to take a second dose for a meal that is going to lose you a lot of people (or rather, they will not take the second dose and will grumble about the results). If I can get my interaction with diabetes down to changing a pump site every three days I am sold! If you want to see what is coming on the pump side this link is good - diatribe.org/tech-horizon-automated-insulin-delivery-systems-coming-2020. Bear in mind that the loop people are further down this line because they don't have to deal with the FDA. Shawn mentioned in passing someone who had been running a loop for a few days with zero intervention. Ultimately Afrezza will not win a fight with the APS, but there will remain a huge market outside the APS so it really doesn't matter.
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Post by mango on Dec 10, 2019 8:24:55 GMT -5
Whew! It’s like watching a heavy-weight match. You guys and gals are awesome. The most interesting thing I read was “consistency of absorption” as compared to “Speed trumps accuracy”. But then I read over and over that consistency is not possible. People pay for convenience. Just ask 7/11 and QuickTrip and McDonald’s. I suspect a 1 year Eversense and Afrezza will be more convenient than a pump. Regardless of what I think, what a great thread about understanding study results summarized on a poster. With smart pumps and loops you can go a long time with just letting the pump deal with things. Minimizing the need to think about diabetes is the key. If I am going to have to take a second dose for a meal that is going to lose you a lot of people (or rather, they will not take the second dose and will grumble about the results). If I can get my interaction with diabetes down to changing a pump site every three days I am sold! If you want to see what is coming on the pump side this link is good - diatribe.org/tech-horizon-automated-insulin-delivery-systems-coming-2020. Bear in mind that the loop people are further down this line because they don't have to deal with the FDA. Shawn mentioned in passing someone who had been running a loop for a few days with zero intervention. Ultimately Afrezza will not win a fight with the APS, but there will remain a huge market outside the APS so it really doesn't matter. Afrezza is being studied with an APS by Yale in clinical trials. It won’t have to compete with it since it’ll be used with it. 😁 Improving Post-Prandial Blood Glucose Control With Afrezza During Closed-Loop Therapy
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Post by mango on Dec 10, 2019 9:16:58 GMT -5
Aged - the reason basil is given first with T2s is because insulin is dangerous. It requires needles and causes hypos. Not until afrezza was there an insulin not considered dangerous. First treating with basil is the medically incorrect way to treat diabetes. The first thing all T2s lose is first phase insulin release. The issue all T2s have is dealing with the post meal spike. Until CGMs this was not obvious to most. Now it is. There is no way to hide the numbers anymore when people can look at a CGM and see it for themselves. Bit confused here. Basal *is* insulin. And the medical world still considers Afrezza dangerous in that it carries exactly the same warnings other insulin for hypos. It does avoid the shared insulin pen warning though Basal and Afrezza both have their place. Bolus insulin like RAA or Afrezza get used once you cannot produce enough insulin for meals while taking the correct basal insulin dose, in other words don't use excess basal to cover meals. It is far less intrusive to take one shot a day than 6 or 7 correctly timed Afrezza doses. Ask the patient which they would rather take and the majority are going to be for a single shot. In Type 2 basal + GLP-1 premix is gaining favor as an alternative to basal + bolus. It would be interesting to see a trial where of basal only vs. bolus only landed. It may well have already been done, but obviously not with Afrezza. Aged, sayhey is right, and it is medically incorrect to use basal insulin for T2D anyway. People with T2D have a lose of the first-phase insulin response (a homeostatic mechanism) and this needs to be restored. Basal insulin doesn’t address this underlying defect—but Afrezza does. Afrezza restores the first-phase and all the wonderful things that come with it as a result (basal does not). 🙂
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Post by rockstarrick on Dec 10, 2019 9:30:23 GMT -5
With smart pumps and loops you can go a long time with just letting the pump deal with things. Minimizing the need to think about diabetes is the key. If I am going to have to take a second dose for a meal that is going to lose you a lot of people (or rather, they will not take the second dose and will grumble about the results). If I can get my interaction with diabetes down to changing a pump site every three days I am sold! If you want to see what is coming on the pump side this link is good - diatribe.org/tech-horizon-automated-insulin-delivery-systems-coming-2020. Bear in mind that the loop people are further down this line because they don't have to deal with the FDA. Shawn mentioned in passing someone who had been running a loop for a few days with zero intervention. Ultimately Afrezza will not win a fight with the APS, but there will remain a huge market outside the APS so it really doesn't matter. Afrezza is being studied with an APS by Yale in clinical trials. It won’t have to compete with it since it’ll be used with it. 😁 Improving Post-Prandial Blood Glucose Control With Afrezza During Closed-Loop TherapyAfrezza was the most efficient way to overcome mealtime glucose spikes in the early APS trials. It doesn’t matter what you combine Afrezza with, the results are always better with regards to mealtime control. No but this, or but that, at mealtime, Afrezza is superior, period. www.jdrf.org/illinois/wp-content/uploads/sites/83/2013/07/The-Artificial-Pancreas-A-Race-to-the-Finish.pdf
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Post by sellhighdrinklow on Dec 10, 2019 9:31:29 GMT -5
Whew! It’s like watching a heavy-weight match. You guys and gals are awesome. The most interesting thing I read was “consistency of absorption” as compared to “Speed trumps accuracy”. But then I read over and over that consistency is not possible. People pay for convenience. Just ask 7/11 and QuickTrip and McDonald’s. I suspect a 1 year Eversense and Afrezza will be more convenient than a pump. Regardless of what I think, what a great thread about understanding study results summarized on a poster. With smart pumps and loops you can go a long time with just letting the pump deal with things. Minimizing the need to think about diabetes is the key. If I am going to have to take a second dose for a meal that is going to lose you a lot of people (or rather, they will not take the second dose and will grumble about the results). If I can get my interaction with diabetes down to changing a pump site every three days I am sold! If you want to see what is coming on the pump side this link is good - diatribe.org/tech-horizon-automated-insulin-delivery-systems-coming-2020. Bear in mind that the loop people are further down this line because they don't have to deal with the FDA. Shawn mentioned in passing someone who had been running a loop for a few days with zero intervention. Ultimately Afrezza will not win a fight with the APS, but there will remain a huge market outside the APS so it really doesn't matter. Agedhippie...you are tethered to tubes with an AI pump that can malfunction and kill you by giving you an overdose of insulin. Last I heard your A1C was 6.3. I'm not tethered to a pump, take one shot a day, use Afrezza and have an A1C of 5.3. I lead as normal of a life as could possibly be as a Type 1 and I'm healthier. Unless of course you consider 6.3 better than 5.3. I'm also guessing you go hypo much more often than me because it rarely happens to me.
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Post by rockstarrick on Dec 10, 2019 9:38:31 GMT -5
It’s down towards the end of the 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 artificial pancreas?” The issue is a concern, because follow- ing a meal many diabetics have a difficult time managing their glucose levels, and the standard subcutaneous method of delivering insulin is slow compared with how fast glucose,,, Read till your hearts content 😎✌🏻
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Post by brentie on Dec 10, 2019 9:38:38 GMT -5
Aged - the reason basil is given first with T2s is because insulin is dangerous. It requires needles and causes hypos. Not until afrezza was there an insulin not considered dangerous. First treating with basil is the medically incorrect way to treat diabetes. The first thing all T2s lose is first phase insulin release. The issue all T2s have is dealing with the post meal spike. Until CGMs this was not obvious to most. Now it is. There is no way to hide the numbers anymore when people can look at a CGM and see it for themselves. But Al knew... SF: People with type 2 are usually started out on a basal insulin. AM: Well, that is medically incorrect. Starting a type 2 on basal insulin is done today because current prandial insulin products are not physically sound so they are delayed about as long as they can be. Lantus has been so successful as the first insulin used in type 2 because of the problems with current prandial products. SF: Some studies or most of the studies have shown that type 2 diabetes starts as a post prandial disease. Would it make more sense to start a type 2 on a post prandial insulin or on a prandial insulin, rather than even a basal insulin? AM: The first loss in type 2 is really the early phase 1 pancreatic spike and that is then followed by loss of the phase 2 prandial insulin. Almost all postprandial issues are from use of current prandial insulins. What is needed first in type 2 should be a very fast acting prandial insulin, not a basal insulin. Afrezza provides insulin kinetics close to the kinetics of pancreatic insulin in response to a glucose spike. Afrezza should be the first insulin employed and that should actually be prescribed in early type 2. www.diabetesincontrol.com/an-exclusive-interview-with-al-mann-founder-and-ceo-mannkind-corp/
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Post by shawnonafrezza on Dec 10, 2019 10:30:49 GMT -5
With smart pumps and loops you can go a long time with just letting the pump deal with things. Minimizing the need to think about diabetes is the key. If I am going to have to take a second dose for a meal that is going to lose you a lot of people (or rather, they will not take the second dose and will grumble about the results). If I can get my interaction with diabetes down to changing a pump site every three days I am sold! If you want to see what is coming on the pump side this link is good - diatribe.org/tech-horizon-automated-insulin-delivery-systems-coming-2020. Bear in mind that the loop people are further down this line because they don't have to deal with the FDA. Shawn mentioned in passing someone who had been running a loop for a few days with zero intervention. Ultimately Afrezza will not win a fight with the APS, but there will remain a huge market outside the APS so it really doesn't matter. Agedhippie...you are tethered to tubes with an AI pump that can malfunction and kill you by giving you an overdose of insulin. Last I heard your A1C was 6.3. I'm not tethered to a pump, take one shot a day, use Afrezza and have an A1C of 5.3. I lead as normal of a life as could possibly be as a Type 1 and I'm healthier. Unless of course you consider 6.3 better than 5.3. I'm also guessing you go hypo much more often than me because it rarely happens to me. In the T1D community we refer to this as, "a dick move" for those wondering. You should be ashamed for that.
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Post by sellhighdrinklow on Dec 10, 2019 12:17:30 GMT -5
Really, how so?
Agedhippie is here more than anybody, pontificating his expertise on diabetes. Dick move? Hardly !! Maybe you just are unaware. If so, try to catch up.
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