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Post by compound26 on Oct 10, 2016 19:17:14 GMT -5
What do you think about doing an inexpensive a A1C challenge on a larger (and somewhat nation-wide ) scale? Say we get 10 (I just picked a random number) diabetic (on Afrezza) and 10 non-diabetic, all on a volunteer basis (each paying for his/her own bill . Perhaps we can set up an appointment (say noon time on central time or pacific time on a certain date) and go to the same restaurant chain (say Chipotle, again, I just picked a random chain) and order the same food. Then at certain time (say one hour after we started eating), we can use the same (brand and model) BG testing tool to test the BG level. We can then post the results (upload a screenshot) on twitter or other social media (maybe even tudiabetes.org and other diabetic forum, if appropriate). Does this help to showcase the power of Afrezza to bring down BG levels and improve its awareness a bit? If so, will any of you be interested in participating in such an event? If anyone else is interested, I am in for one. The more the merrier.
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Post by mnholdem on Oct 10, 2016 19:45:31 GMT -5
You would want to inform the local media way ahead of time & invite them to send their reporters and camera men/women. Have media literature ready for them so they don't screw up the important facts about Afrezza.
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Post by fiddler on Oct 10, 2016 20:19:00 GMT -5
Would it have any effect on insurers?
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Post by Deleted on Oct 10, 2016 20:35:11 GMT -5
Would it have any effect on insurers? No but would have impact on PWD life. Insurance will come around. For now pre auth would be the route if insurance doesn't cover it. Any thing else?
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Post by agedhippie on Oct 10, 2016 21:29:42 GMT -5
Would it have any effect on insurers? No but would have impact on PWD life. Insurance will come around. For now pre auth would be the route if insurance doesn't cover it. Any thing else? It's not that easy. There are a stack of things that effect the outcome other than the insulin. Whether you levels are rising or dropping and how fast will have a huge effect. Insulin resistance. Meter accuracy varies wildly as they are only required to be +/-20% so the worst possible difference between two readings is 40%. The food itself - proportions of different components. Anyway - I have readings for lots of the food I eat at 1 hour intervals so a burrito bowl with chicken, white rice, black beans, cheese, mild salsa, and sourcream with 5u of Novolog starts at 103 and is 105 at the 1 hour mark. The real event is at the 3 hour mark - this goes 103 105 123 146 126 so the spike is at 3 hours (146) because the fiber from the beans delays digestion. On Afrezza I would need a second shot to cope with that.
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Post by silentknight on Oct 11, 2016 8:32:56 GMT -5
I'm currently living overseas at the moment but I'd volunteer to be one of the non-diabetic participants if I was stateside. The curiosity in me would love to see the results.
How crazy would it be if the Afrezza patients numbers were better than mine? The product might just be that good.
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Post by boomboom on Oct 11, 2016 12:40:05 GMT -5
How about having 50+ afrezza users congregate in a public outdoor area having an open-challenge to any non-diabetics who walk by. Have an assortment of foods available (picnic style) and have an afrezza user sit down with a non-diabetic to the exact same meal. What a great way to meet someone and learn about diabetes and you also get a nice meal with it. Take a glucose measurement before the meal, after the meal, and maybe keep them around to take another reading 30min after the meal. If the non-diabetic wins, give them a prize (t-shirt). If they lose, suggest they give a $5 donation to a diabetes foundation to help further the noticeable progress with diabetes treatments now being seen with Afrezza right in front of them. Make it kid friendly with lawn games so parents will have incentive for coming out and staying. Food, games, and prizes can all be done pretty cost-effectively.
The hard part will be getting 50+ titrated/confident afrezza users in one spot to accept the challenge
If you strategically pick a day when there is not much news going on you could probably get a few news stations to come report it. It will probably be the most exciting thing for that day and get a lot of good press.
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Post by dictatorsaurus on Oct 11, 2016 12:45:31 GMT -5
All these crazy ideas make sense for OxiClean, not for an FDA approved controlled drug.
I've seen some suggest hiring homeless street bums to wear Afrezza shirts and hire street performers. Insanity!
Truly a sign how desperate and dire the situation is. Not sure what the management role is in this to make it a success?
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Post by compound26 on Oct 11, 2016 12:51:12 GMT -5
How about having 50+ afrezza users congregate in a public outdoor area having an open-challenge to any non-diabetics who walk by. Have an assortment of foods available (picnic style) and have an afrezza user sit down with a non-diabetic to the exact same meal. What a great way to meet someone and learn about diabetes and you also get a nice meal with it. Take a glucose measurement before the meal, after the meal, and maybe keep them around to take another reading 30min after the meal. If the non-diabetic wins, give them a prize (t-shirt). If they lose, suggest they give a $5 donation to a diabetes foundation to help further the noticeable progress with diabetes treatments now being seen with Afrezza right in front of them. Make it kid friendly with lawn games so parents will have incentive for coming out and staying. Food, games, and prizes can all be done pretty cost-effectively. The hard part will be getting 50+ titrated/confident afrezza users in one spot to accept the challenge If you strategically pick a day when there is not much news going on you could probably get a few news stations to come report it. It will probably be the most exciting thing for that day and get a lot of good press. boomboom sounds like a great idea. As you noted, it will difficult to get 50+ titrated/confident afrezza users in one spot to accept the challenge. How about Mannkind finding one or two Afrezza users in each major JDRF or TCOYD walk/event to do a mini A1C challenge? Not necessary having meals. Even having an orange juice or coke will be fine (kind of like a live version of what Matt B did in his extreme coke and glucose challenge videos).
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Post by boomboom on Oct 11, 2016 14:26:44 GMT -5
All these crazy ideas make sense for OxiClean, not for an FDA approved controlled drug. I've seen some suggest hiring homeless street bums to wear Afrezza shirts and hire street performers. Insanity! Truly a sign how desperate and dire the situation is. Not sure what the management role is in this to make it a success? Dictatorsaurus, agree with everything you said. These ideas are not by any means normal and is what you would expect to see from an infomercial like OxiClean. But there must be some merit to doing something like this since the company is doing something very similar per Ranchos update regarding the meeting she just setup. "Also in attendance was a T1 diabetic who has been using AFREZZA since it came on the market. His current Hba1c since using AFREZZA is 5.9.
He took his BS at the start, then drank orange juice and ate a muffin. He announced his starting BS
as 116 and continued to eat and drink during the meeting. Periodically he would announce his BS and it never rose above 144. "Whats the difference between a large scale and small scale version of this? Its PR, its unique, and its cheap. Just because it has never been done before by an FDA approved drug does not mean its not going to be effective. Do you know what enables products like OxiClean to have live demonstrations in front of people? Its not because its cheesy. Its not because its cheap. Its because they are so certain that it is going to work in front of an audience. If a controlled drug was able to demonstrate that kind of confidence...I think that would capture at least a little bit more attention. Dont you?
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Post by dreamboatcruise on Oct 11, 2016 14:45:57 GMT -5
All these crazy ideas make sense for OxiClean, not for an FDA approved controlled drug. I've seen some suggest hiring homeless street bums to wear Afrezza shirts and hire street performers. Insanity! Truly a sign how desperate and dire the situation is. Not sure what the management role is in this to make it a success? Dictatorsaurus, agree with everything you said. These ideas are not by any means normal and is what you would expect to see from an infomercial like OxiClean. But there must be some merit to doing something like this since the company is doing something very similar per Ranchos update regarding the meeting she just setup. "Also in attendance was a T1 diabetic who has been using AFREZZA since it came on the market. His current Hba1c since using AFREZZA is 5.9.
He took his BS at the start, then drank orange juice and ate a muffin. He announced his starting BS
as 116 and continued to eat and drink during the meeting. Periodically he would announce his BS and it never rose above 144. "Whats the difference between a large scale and small scale version of this? Its PR, its unique, and its cheap. Just because it has never been done before by an FDA approved drug does not mean its not going to be effective. Do you know what enables products like OxiClean to have live demonstrations in front of people? Its not because its cheesy. Its not because its cheap. Its because they are so certain that it is going to work in front of an audience. If a controlled drug was able to demonstrate that kind of confidence...I think that would capture at least a little bit more attention. Dont you? With oxyclean there is no problem with cherry picking what they show in order to make it look like it is a miracle product. With drugs, society isn't well served by allowing marketing to be manipulated. I do think the fast onset of Afrezza is important and beneficial, but still the FDA would take a very skeptical stance as they rightly should. A reading immediately after a meal, or even 30 min, doesn't capture the entirety of the postprandial clinical response. As aggedhippie pointed out just above, for some meals his spike occurs 3 hours out. I think Afrezza is an absolute game changer, but there are valid reasons why there are pretty tight restrictions on how marketing is done. Even traditional RAAs could probably pick a particular type of food and a particular time for BG measurement where they would win a contest. A1c and/or CGM showing time in zone are much more meaningful than a simple finger stick after a meal.
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Post by Deleted on Oct 11, 2016 14:56:04 GMT -5
Dictatorsaurus, agree with everything you said. These ideas are not by any means normal and is what you would expect to see from an infomercial like OxiClean. But there must be some merit to doing something like this since the company is doing something very similar per Ranchos update regarding the meeting she just setup. "Also in attendance was a T1 diabetic who has been using AFREZZA since it came on the market. His current Hba1c since using AFREZZA is 5.9.
He took his BS at the start, then drank orange juice and ate a muffin. He announced his starting BS
as 116 and continued to eat and drink during the meeting. Periodically he would announce his BS and it never rose above 144. "Whats the difference between a large scale and small scale version of this? Its PR, its unique, and its cheap. Just because it has never been done before by an FDA approved drug does not mean its not going to be effective. Do you know what enables products like OxiClean to have live demonstrations in front of people? Its not because its cheesy. Its not because its cheap. Its because they are so certain that it is going to work in front of an audience. If a controlled drug was able to demonstrate that kind of confidence...I think that would capture at least a little bit more attention. Dont you? With oxyclean there is no problem with cherry picking what they show in order to make it look like it is a miracle product. With drugs, society isn't well served by allowing marketing to be manipulated. I do think the fast onset of Afrezza is important and beneficial, but still the FDA would take a very skeptical stance as they rightly should. A reading immediately after a meal, or even 30 min, doesn't capture the entirety of the postprandial clinical response. As aggedhippie pointed out just above, for some meals his spike occurs 3 hours out. I think Afrezza is an absolute game changer, but there are valid reasons why there are pretty tight restrictions on how marketing is done. Even traditional RAAs could probably pick a particular type of food and a particular time for BG measurement where they would win a contest. A1c and/or CGM showing time in zone are much more meaningful than a simple finger stick after a meal. For argument sake Afrezza would outperform RAa in those situations too
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Post by dreamboatcruise on Oct 11, 2016 15:12:52 GMT -5
With oxyclean there is no problem with cherry picking what they show in order to make it look like it is a miracle product. With drugs, society isn't well served by allowing marketing to be manipulated. I do think the fast onset of Afrezza is important and beneficial, but still the FDA would take a very skeptical stance as they rightly should. A reading immediately after a meal, or even 30 min, doesn't capture the entirety of the postprandial clinical response. As aggedhippie pointed out just above, for some meals his spike occurs 3 hours out. I think Afrezza is an absolute game changer, but there are valid reasons why there are pretty tight restrictions on how marketing is done. Even traditional RAAs could probably pick a particular type of food and a particular time for BG measurement where they would win a contest. A1c and/or CGM showing time in zone are much more meaningful than a simple finger stick after a meal. For argument sake Afrezza would outperform RAa in those situations too Would likely depend on how the challenge was constructed. The big picture though if there were to be these challenges between PWD on Afrezza and people without diabetes is that they indeed might be able to show a lower postprandial BG from a meter if the food and subsequent timing of BG test is well matched to Afrezza. If you followed some of the early adopters when Sam was posting regular A1c's or subsequent periodic posts, I think you'd see that overall the A1c of a cohort of well controlled PWDs on Afrezza would not beat a cohort of non-diabetic people. This is why it would be valid to take a close look at appropriates of any marketing campaign that might imply that Afrezza "cures" diabetes and results in better BG control overall than someone without diabetes. Afrezza is amazing, and we've seen people achieve nearly non-diabetic levels with A1c... but marketing would have to somehow capture that "nearly" in order to be considered balanced and fair within the FDA's view. This is why they require marketing to be based on scientifically evaluated and statistically meaningful data from controlled trials rather than anecdotal experiments shown to consumers. Presentation in front of doctors are treated differently than marketing intended for consumers.
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Post by Deleted on Oct 11, 2016 15:16:43 GMT -5
For argument sake Afrezza would outperform RAa in those situations too Would likely depend on how the challenge was constructed. The big picture though if there were to be these challenges between PWD on Afrezza and people without diabetes is that they indeed might be able to show a lower postprandial BG from a meter if the food and subsequent timing of BG test is well matched to Afrezza. If you followed some of the early adopters when Sam was posting regular A1c's or subsequent periodic posts, I think you'd see that overall the A1c of a cohort of well controlled PWDs on Afrezza would not beat a cohort of non-diabetic people. This is why it would be valid to take a close look at appropriates of any marketing campaign that might imply that Afrezza "cures" diabetes and results in better BG control overall than someone without diabetes. Afrezza is amazing, and we've seen people achieve nearly non-diabetic levels with A1c... but marketing would have to somehow capture that "nearly" in order to be considered balanced and fair within the FDA's view. This is why they require marketing to be based on scientifically evaluated and statistically meaningful data from controlled trials rather than anecdotal experiments shown to consumers. Presentation in front of doctors are treated differently than marketing intended for consumers. Not interested in all that. Just wanted to highlight in any type of situation Afrezza will win due to follow up dosing no matter how the challenge is constructed. There are people using raa since years and still spike into 200 and 400. Most Afrezza users rarely go over 200
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Post by dreamboatcruise on Oct 11, 2016 15:29:37 GMT -5
Would likely depend on how the challenge was constructed. The big picture though if there were to be these challenges between PWD on Afrezza and people without diabetes is that they indeed might be able to show a lower postprandial BG from a meter if the food and subsequent timing of BG test is well matched to Afrezza. If you followed some of the early adopters when Sam was posting regular A1c's or subsequent periodic posts, I think you'd see that overall the A1c of a cohort of well controlled PWDs on Afrezza would not beat a cohort of non-diabetic people. This is why it would be valid to take a close look at appropriates of any marketing campaign that might imply that Afrezza "cures" diabetes and results in better BG control overall than someone without diabetes. Afrezza is amazing, and we've seen people achieve nearly non-diabetic levels with A1c... but marketing would have to somehow capture that "nearly" in order to be considered balanced and fair within the FDA's view. This is why they require marketing to be based on scientifically evaluated and statistically meaningful data from controlled trials rather than anecdotal experiments shown to consumers. Presentation in front of doctors are treated differently than marketing intended for consumers. Not interested in all that. Just wanted to highlight in any type of situation Afrezza will win due to follow up dosing no matter how the challenge is constructed. There are people using raa since years and still spike into 200 and 400. Most Afrezza users rarely go over 200 I have seen people on basal/RAA that have achieved pretty darn good control. If a person knows exactly what to eat to match the RAA PD/PK profile, control can be damn good. It is a chore and a pain and Afrezza is a better solution... no doubt. With RAA's you have to eat to the insulin whereas with Afrezza you can dose to the food. However, whoever that is that is spiking to 400 could also dose more RAA to avoid the spike, accepting that they will have to monitor the tail and take some form of sugar to correct for when they go too low. We know that Afrezza overall is 1) much better than RAA, but 2) doesn't result in everyone having non-diabetic blood sugar. A simplistic anecdotal finger stick still isn't a clinical trial... and is susceptible to biased design of the challenge. But I will leave the discussion at that. I'm not a detractor from Afrezza... merely someone that mostly believes in tight control on what is used for marketing of drugs. Hopefully we will have some real clinical trials soon to show superiority.
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