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Post by hellodolly on Jul 16, 2018 6:23:11 GMT -5
Aged - when we are talking afrezza we don't care about 24 TIR. We care about the 12 hr TIR basically 8am to 8pm which are the working hours of afrezza. Assuming 6pm dinner afrezza's job is done by 8pm. At that point you have the night shift and that work is done by the basal. To address TIR during the 3rd shift requires a basal adjustment and has nothing to do with afrezza. Prior to afrezza I understand it was not possible to split the day into waking and sleeping hours but afrezza shifts the paradigm. Because of the long RAA tail I understand your 24 hr stance but afrezza has obsoleted this. I know it does not make the numbers "fair" for the RAAs but too bad so sad. Absolute Truism! You can't judge the affects of Afrezza and say that TIR is a 24 hour period when at least 7-10 hours (average sleep) Afrezza isn't in play. Even a PWD who eats more frequently over those waking hours can still get better TIR during the meal periods and an hour or two beyond (stretching it). 24 hours, as a yardstick to measure TIR for Afrezza is (I believe) somewhat a of misnomer. For example new patients introduced to Afrezza may have horrible TIR as they adjust for the correct dosage and the correct time to dose. Regardless of what the package reads, everyone adjusts and adopts this differently, which is a huge benefit. Consequently, as they get better and more proficient at using the correct dose, timing and dose become better and the TIR (centered around the meal) is more accurate. I believe this is what makes Afrezza so valuable as a tool to manage diabetes. Will it become the SOC with my 'laymen' analysis? Maybe, maybe not but, it will certainly be apart of the SOC. By the way, as aside note I saw Afrezza being discussed this morning on my a.m. news channel here in West Palm (Palm Beach County, Northern Broward, Martin and St. Lucie County). It was all good and then the proverbial..."Scientists however are unsure of the long term effects this will have on the lungs" to end the story.
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Post by peppy on Jul 16, 2018 7:52:03 GMT -5
And what is wrong with taking a second or even third bolus with AFREZZA to keep a tight TIR and as a result reduced Hba1c? With RAA’s this is difficult because of stacking and very likely “roller coaster “ effect or worse a hypo event and hospital ER visit. Isn’t the point of AFREZZA’s fast in and fast out that here is less issue with stacking and therefore less severe hypos which implies you would take a second or even third bolus sometimes pending what you eat. If I were diabetic I would gladly use a cgm and sugar surf to maintain a tight TIR. I have my phone with me all the time anyway. With no disrespect to anyone I am not sure why this is so complicated to understand. It seems the very benefit of AFREZZA of fast in/fast out is being used against it by some as a negative. Dosing is different and that is the point as I understand it. I thought the whole point was RAA’s are very complicated to use w carb counting etc and AFREZZA seems (to me at least) so much easier to use. Less work, less complications and better results. This is actually a very good question. The typical scenario is that you bolus at the meal, and then get on with your day until the next meal. People tend not to do multiple boluses because it interferes with their lifestyle. Obviously if your blood sugar goes completely out of control you don't wait for the next meal. With MDI you are told to test and correct at the two hour mark, but it is fairly rare to find people who actually do that although some do. This becomes a compliance issue as you saw with STAT - that non-compliant group was not part of the design. With more time I would be willing to bet the non-compliant group would grow. Contrary to what people seem to think stacking insulin is not a quick way to ER. People routinely stack insulin, pumps and some meters will even manage it for you. You still have to carb count with Afrezza if you are Type 1 as their own trial showed, but you can be less accurate which is a benefit. However is I take an 8u cartridge for a 4u meal I absolutely will have a hypo as the trial showed. Don't take my word for it, look at Dr Edelstein. He takes Afrezza for fast carbs and corrections, for meals he uses his pump. Deaths • Diabetes was the seventh leading cause of death in the United States in 2015. This finding is based on 79,535 death certificates in which diabetes was listed as the underlying cause of death (crude rate, 24.7 per 100,000 persons).5 • Diabetes was listed as any cause of death on 252,806 death certificates in 2015 (crude rate, 78.7 per 100,000 persons) www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf
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Post by agedhippie on Jul 16, 2018 8:00:59 GMT -5
Aged - when we are talking afrezza we don't care about 24 TIR. We care about the 12 hr TIR basically 8am to 8pm which are the working hours of afrezza. Assuming 6pm dinner afrezza's job is done by 8pm. At that point you have the night shift and that work is done by the basal. To address TIR during the 3rd shift requires a basal adjustment and has nothing to do with afrezza. Prior to afrezza I understand it was not possible to split the day into waking and sleeping hours but afrezza shifts the paradigm. Because of the long RAA tail I understand your 24 hr stance but afrezza has obsoleted this. I know it does not make the numbers "fair" for the RAAs but too bad so sad. I am fine with people just looking at the snapshots, but that is not what the medical world calls TIR. Any paper you read, even STAT, has TIR as 24 hours. The other thing is that in the real world people graze. They eat main meals, but they snack and drink in-between. Then there are random glucose spikes and dips which seem to happen for no good reason. If you take a short window and say anything outside of that is nothing to do with Afrezza don't expect the medical world to take you seriously. TIR is for the whole day and it includes everything you eat and drink, as well as the duration to absorb those carbs (not to mention stacking carbs). Afrezza is very good for the two hour post prandial, but that is not TIR.
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Post by goyocafe on Jul 16, 2018 8:13:53 GMT -5
Aged - when we are talking afrezza we don't care about 24 TIR. We care about the 12 hr TIR basically 8am to 8pm which are the working hours of afrezza. Assuming 6pm dinner afrezza's job is done by 8pm. At that point you have the night shift and that work is done by the basal. To address TIR during the 3rd shift requires a basal adjustment and has nothing to do with afrezza. Prior to afrezza I understand it was not possible to split the day into waking and sleeping hours but afrezza shifts the paradigm. Because of the long RAA tail I understand your 24 hr stance but afrezza has obsoleted this. I know it does not make the numbers "fair" for the RAAs but too bad so sad. I am fine with people just looking at the snapshots, but that is not what the medical world calls TIR. Any paper you read, even STAT, has TIR as 24 hours. The other thing is that in the real world people graze. They eat main meals, but they snack and drink in-between. Then there are random glucose spikes and dips which seem to happen for no good reason. If you take a short window and say anything outside of that is nothing to do with Afrezza don't expect the medical world to take you seriously. TIR is for the whole day and it includes everything you eat and drink, as well as the duration to absorb those carbs (not to mention stacking carbs). Afrezza is very good for the two hour post prandial, but that is not TIR. Maybe it’s time to rethink the status quo. Consensus would have you believe the world was flat for hundreds of years.
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Post by peppy on Jul 16, 2018 8:32:14 GMT -5
Aged - when we are talking afrezza we don't care about 24 TIR. We care about the 12 hr TIR basically 8am to 8pm which are the working hours of afrezza. Assuming 6pm dinner afrezza's job is done by 8pm. At that point you have the night shift and that work is done by the basal. To address TIR during the 3rd shift requires a basal adjustment and has nothing to do with afrezza. Prior to afrezza I understand it was not possible to split the day into waking and sleeping hours but afrezza shifts the paradigm. Because of the long RAA tail I understand your 24 hr stance but afrezza has obsoleted this. I know it does not make the numbers "fair" for the RAAs but too bad so sad. I am fine with people just looking at the snapshots, but that is not what the medical world calls TIR. Any paper you read, even STAT, has TIR as 24 hours. The other thing is that in the real world people graze. They eat main meals, but they snack and drink in-between. Then there are random glucose spikes and dips which seem to happen for no good reason. If you take a short window and say anything outside of that is nothing to do with Afrezza don't expect the medical world to take you seriously. TIR is for the whole day and it includes everything you eat and drink, as well as the duration to absorb those carbs (not to mention stacking carbs). Afrezza is very good for the two hour post prandial, but that is not TIR. QUOTE: Then there are random glucose spikes and dips which seem to happen for no good reason.reply: so if RAA's work the same way for everyone, as trials would seem to want, why would this happen, hmmmm? They used to say talk is cheap. Here is what some other people have to say on the subject of RAA's and how good they are.
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Post by mnholdem on Jul 16, 2018 8:52:21 GMT -5
Perhaps folks are looking at this the wrong way in wondering when the ADA will "replace" RAA insulin with Afrezza.
Frankly, I think that it's more likely that the ADA will create a new class of insulin: ultra rapid-acting. Like all the drugs on the ADA Standard of Care, I would see this new class as an alternative to current RAA rather than a replacement. However, scientific understanding is rapidly progressing and evidence continues to mount that a faster insulin that simulates normal pancreatic function has significant health benefits.
That evidence may lead to placing new ultra-rapid acting insulin up the ladder as a 2nd treatment, particularly with treatment immediately following early diagnosis of Type 2 diabetes. However, it doesn't take much research to reach the conclusion that sufficient clinical evidence exists, about how controlling TIR has significant short- and long-term health benefits, to satisfy the ADA's criteria for integrity and quality of data.
Therefore, if the ADA does create a new classification, ultra rapid-acting insulin may find a place in the Standard of Care for both Type 1 and Type 2 diabetes that would benefit sales of MannKind's Afrezza and quite possibly Novo's Fiasp (under pressure from BP).
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Post by cjc04 on Jul 16, 2018 8:54:47 GMT -5
Let’s say this again:-)) When you say "Even STAT has Afrezza as inferior to RAA for TIR unless you take two doses per meal" is clearly incorrect at the 1hr mark. The RAAs are not even close. As Dr. Kendall works through his dosing two things will happen; basal levels will be increased; and meal time initial dose will also be increased. Both will increase TIR at the 2hr mark without the second puff. Lets see what he comes out with but this I believe is where he is headed with the T1s. For the T2s its easy, afrezza first, afrezza only and go big on the dose with no worries. Read more: mnkd.proboards.com/thread/10219/8k-filing?page=5#ixzz5LLI6X0DhI absolutely do not dispute that. At the 1 hour mark Afrezza is very clearly superior using any dosing regime, but TIR is measured for 24 hours because it is a proxy for control. Better TIR should equal less damage so a good or bad TIR for an hour should not be significant in the long run. you’ve never used the drug and you’re drowning us all with your opinion based on slides... well sir, you’ve picked the wrong topic. Diabetes AND Afrezza are part of my everyday life, for 1 hour and 24 hour periods, and TIR is simply a miracle using Afrezza. Which of course, as you say, equals less damage.
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Post by tomtabb on Jul 16, 2018 9:15:34 GMT -5
What have any of the recent posts to do with the 8-k filing?
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Post by uvula on Jul 16, 2018 9:21:55 GMT -5
IMHO agedhippie is one of the most rational and realistic people here.
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Post by agedhippie on Jul 16, 2018 10:08:25 GMT -5
Maybe it’s time to rethink the status quo. Consensus would have you believe the world was flat for hundreds of years. ...and burnt at the stake for saying otherwise. It's a good point. When everyone thinks the world is flat the insane one is the person saying it's round. Changing consensus is hard because it's peoples' beliefs which is why evidence they can believe in is so important. They have to be led in steps.
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Post by uvula on Jul 16, 2018 10:15:03 GMT -5
And if someone a few hundred years ago said "today the consensus is that the world is flat", that person would not be a naysaying fudster. They would be stating a fact even if the fact is based on something that is wrong. Which of course has nothing to do with the 8-k filing.
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8K Filing
Jul 16, 2018 10:28:24 GMT -5
via mobile
Post by cjm18 on Jul 16, 2018 10:28:24 GMT -5
you’ve never used the drug and you’re drowning us all with your opinion based on slides... well sir, you’ve picked the wrong topic. Diabetes AND Afrezza are part of my everyday life, for 1 hour and 24 hour periods, and TIR is simply a miracle using Afrezza. Which of course, as you say, equals less damage. [br Imho, Agedhippie is here 24/7 as a naysaying fudster when it comes to Afrezza. He/she/they have a job to do and it's to refute Afrezza's effectiveness at every turn, every positive post. This is the wild wild west of the internet. Jmho He has not refuted the drugs effectiveness. His negativity isn’t towards the drug itself but the company and the work it’s going to take to get the drug to more diabetics.
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Post by mannmade on Jul 16, 2018 11:01:31 GMT -5
I am really confused as to why we are even having this discussion. Perhaps without CGM’s we might compare AFREZZA to RAA’s in this manner. But we now have cgm’s that allow diabetics to measure their diabetes in “real time” within 5 mins or so of accuracy and cgm’s are fda approved for dosing.
I personally have sat with several T1’s using cgm’s and AFREZZA while they ate fried calamari and French fries along with drinking kalua and also at meals that consisted of seven courses of pasta. None of them went above 140 b cause they had cgm’s and took AFREZZA during the meal.
And they all had hba1c’s in the mid 5’s to mid 6 range without ever having severe hypos. And they did not worry about counting cards they just managed their bg levels in real time.
Can you do this with RAA’s? Seriously why are we even discussing. All imho...
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Post by mnholdem on Jul 16, 2018 11:18:37 GMT -5
We're way off the beaten path on the subject of this particular 8K filing. I'm locking this thread.
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