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Post by olderteampt on Jun 11, 2020 9:35:06 GMT -5
For me the biggest benefit of the MNKD DXCM Trial was that DXCM was able to see first hand when a diabetic inhales Afrezza "how fast the DXCM glucose monitor readings change". That in itself might be the catalyst to help get the word out. When you have a product that does something unique that no other diabetic medication can do then you have something special!
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Post by olderteampt on Jun 11, 2020 10:01:41 GMT -5
I left one key point out in my new post. What all Diabetic patients need is a 2 part treatment. Part 1)Identify if there is a problem in the fastest and safest way possible and the CGM provides the solution to part 1). Part 2) If a problem is identified with CGM the CGM cannot solve the problem. To correct the problem you need intervention. Afrezza provides that in the fastest and safest way possible.
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Post by agedhippie on Jun 11, 2020 18:05:49 GMT -5
For me the biggest benefit of the MNKD DXCM Trial was that DXCM was able to see first hand when a diabetic inhales Afrezza "how fast the DXCM glucose monitor readings change". That in itself might be the catalyst to help get the word out. When you have a product that does something unique that no other diabetic medication can do then you have something special! Why would Dexcom care? They sell CGMs, not insulin. Not to mention their licensing revenue from insulin pump manufacturers. Plus at the end of the day the TIR was the same.
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Post by Deleted on Jun 11, 2020 18:11:27 GMT -5
For me the biggest benefit of the MNKD DXCM Trial was that DXCM was able to see first hand when a diabetic inhales Afrezza "how fast the DXCM glucose monitor readings change". That in itself might be the catalyst to help get the word out. When you have a product that does something unique that no other diabetic medication can do then you have something special! Why would Dexcom care? They sell CGMs, not insulin. Not to mention their licensing revenue from insulin pump manufacturers. Plus at the end of the day the TIR was the same. DXCM cares if it will add sales of their devices. You might have a person using Afrezza and not using a CGM. A partnership will enhance both parties. The other issue - CGM users will realize how slow their RAAs work and when they learn about how fast Afrezza works.....it will be a no brainer!
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Post by sayhey24 on Jun 11, 2020 18:17:57 GMT -5
Aged - maybe because use of the Dexcom with afrezza had a significant A1c reduction. For the T2 non-pump users this may sell another Dexcom or two. In fact maybe it might promote earlier use of insulin in T2s replacing SGLT2 or the GLP1s. If Dexcom could crack that market it would be huge $$$.
Aside from us here on this board, few in the community currently understand TIR. Sad to say but A1C is still the standard, not TIR.
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Post by Deleted on Jun 11, 2020 19:07:08 GMT -5
Aged - maybe because use of the Dexcom with afrezza had a significant A1c reduction. For the T2 non-pump users this may sell another Dexcom or two. In fact maybe it might promote earlier use of insulin in T2s replacing SGLT2 or the GLP1s. If Dexcom could crack that market it would be huge $$$. Aside from us here on this board, few in the community currently understand TIR. Sad to say but A1C is still the standard, not TIR. True - TIR will become the gold standard only when CGM have a market share of 85%. It will be a slow. MNKD will have to do serious studies to prove that T2's should use Afrezza for better control and even then it will take years to change habits.
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Post by olderteampt on Jun 12, 2020 8:07:44 GMT -5
DXCM would care because they have to service their customers. When they talk to their customers and their customers are having health issues because of their Diabetes and not staying in range then they would not be happy. If your customers are staying in range and not developing health issues because of Afrezza then you would have healthier happier customers. You(Dexicom) would also be selling more CGM's in the long run because your customers would not be dying of diabetic complications. Aged, I thought you be be smarter than that to not realize why.
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Post by agedhippie on Jun 12, 2020 9:24:11 GMT -5
Why would Dexcom care? They sell CGMs, not insulin. Not to mention their licensing revenue from insulin pump manufacturers. Plus at the end of the day the TIR was the same. DXCM cares if it will add sales of their devices. You might have a person using Afrezza and not using a CGM. A partnership will enhance both parties. The other issue - CGM users will realize how slow their RAAs work and when they learn about how fast Afrezza works.....it will be a no brainer! The speed of action is just one parameter. That is offset by the need to dose twice as often. You have to look at the whole picture. Few people will move for speed of action alone, what matters is a material improvement with no extra work.
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Post by agedhippie on Jun 12, 2020 9:58:37 GMT -5
Aged - maybe because use of the Dexcom with afrezza had a significant A1c reduction. For the T2 non-pump users this may sell another Dexcom or two. In fact maybe it might promote earlier use of insulin in T2s replacing SGLT2 or the GLP1s. If Dexcom could crack that market it would be huge $$$. Aside from us here on this board, few in the community currently understand TIR. Sad to say but A1C is still the standard, not TIR. Dexcom have large scale trials showing that CGMs alone significantly reduce HbA1c. That's how they got the insurers to finally pay for CGMs. The problem Dexcom runs into is cost. There is no way a health system could survive the cost of widespread CGM use without significantly increasing premiums. They need to reduce their prices and the Libre is helping with that push
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Post by sayhey24 on Jun 12, 2020 12:06:05 GMT -5
Aged - maybe because use of the Dexcom with afrezza had a significant A1c reduction. For the T2 non-pump users this may sell another Dexcom or two. In fact maybe it might promote earlier use of insulin in T2s replacing SGLT2 or the GLP1s. If Dexcom could crack that market it would be huge $$$. Aside from us here on this board, few in the community currently understand TIR. Sad to say but A1C is still the standard, not TIR. Dexcom have large scale trials showing that CGMs alone significantly reduce HbA1c. That's how they got the insurers to finally pay for CGMs. The problem Dexcom runs into is cost. There is no way a health system could survive the cost of widespread CGM use without significantly increasing premiums. They need to reduce their prices and the Libre is helping with that push Dexcom does have trials showing CGMs alone significantly reducing A1C. Now they have a study showing that in addition to the "previously" demonstrated significant reduction the Dexcom in conjunction with afrezza demonstrated an even further "significant reduction". Who knows maybe this further "significant" A1C reduction is a great talking point for Dave Kendall for SoC changes. Significant reductions on top of significant reductions. Even I could make that argument and for Dave he said this is the easiest job he has ever had so we will leave it to the expert. Maybe it gives Kevin Sayer a reason to actively back afrezza. Heck, he was Al's accountant when TS Insulin was invented. Maybe he comes out with a Dexcom LT for T2s. Kevin IMO has a marketing happiness problem. To be honest, second dosing afrezza with a CGM is a no-brainer and a non-issue. When looking at the CGM and the numbers are too high you want to second dose as long as afrezza cost is not an issue. Taking another finger poke and another poke from the needle is an issue.
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Post by agedhippie on Jun 12, 2020 22:17:29 GMT -5
Dexcom have large scale trials showing that CGMs alone significantly reduce HbA1c. That's how they got the insurers to finally pay for CGMs. The problem Dexcom runs into is cost. There is no way a health system could survive the cost of widespread CGM use without significantly increasing premiums. They need to reduce their prices and the Libre is helping with that push Dexcom does have trials showing CGMs alone significantly reducing A1C. Now they have a study showing that in addition to the "previously" demonstrated significant reduction the Dexcom in conjunction with afrezza demonstrated an even further "significant reduction". Who knows maybe this further "significant" A1C reduction is a great talking point for Dave Kendall for SoC changes. Significant reductions on top of significant reductions. Even I could make that argument and for Dave he said this is the easiest job he has ever had so we will leave it to the expert. Maybe it gives Kevin Sayer a reason to actively back afrezza. Heck, he was Al's accountant when TS Insulin was invented. Maybe he comes out with a Dexcom LT for T2s. Kevin IMO has a marketing happiness problem. To be honest, second dosing afrezza with a CGM is a no-brainer and a non-issue. When looking at the CGM and the numbers are too high you want to second dose as long as afrezza cost is not an issue. Taking another finger poke and another poke from the needle is an issue. The HbA1c was a secondary result in a failed study without a comparator arm so that study goes nowhere. To put it in context Dexcom did a study using CGMs with Type 2s and got exactly the same reduction just by using a CGM. Dexcom are going to look at this study and say that on those grounds Afrezza made zero contribution to the HbA1c reduction. This is the bit Shawn and I kept hammering but people don't seem to want to hear. The second dose is a big deal because it doubles the number of times you have to think about and deal with your diabetes. That seriously matters.
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Post by cedafuntennis on Jun 12, 2020 22:50:28 GMT -5
So if one has diabetes, rather than having to think twice about spending 2 seconds to adjust immediately, they would chose to have members amputated and other severe repercussions so common with diabetes. To me, it looks like a no-brainer.
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Post by sayhey24 on Jun 13, 2020 7:41:16 GMT -5
Dexcom does have trials showing CGMs alone significantly reducing A1C. Now they have a study showing that in addition to the "previously" demonstrated significant reduction the Dexcom in conjunction with afrezza demonstrated an even further "significant reduction". Who knows maybe this further "significant" A1C reduction is a great talking point for Dave Kendall for SoC changes. Significant reductions on top of significant reductions. Even I could make that argument and for Dave he said this is the easiest job he has ever had so we will leave it to the expert. Maybe it gives Kevin Sayer a reason to actively back afrezza. Heck, he was Al's accountant when TS Insulin was invented. Maybe he comes out with a Dexcom LT for T2s. Kevin IMO has a marketing happiness problem. To be honest, second dosing afrezza with a CGM is a no-brainer and a non-issue. When looking at the CGM and the numbers are too high you want to second dose as long as afrezza cost is not an issue. Taking another finger poke and another poke from the needle is an issue. The HbA1c was a secondary result in a failed study without a comparator arm so that study goes nowhere. To put it in context Dexcom did a study using CGMs with Type 2s and got exactly the same reduction just by using a CGM. Dexcom are going to look at this study and say that on those grounds Afrezza made zero contribution to the HbA1c reduction. This is the bit Shawn and I kept hammering but people don't seem to want to hear. The second dose is a big deal because it doubles the number of times you have to think about and deal with your diabetes. That seriously matters. With CGMs there is no need for an additional comparator arm. The comparator arm are the same PWDs. With CGMs you know exactly how they were performing prior to the introduction of the changed medication - in this case afrezza. In this study - prior to afrezza you had these PWDs on the CGM and RAA. In this study they took 25 people, measured their baseline with the RAA and CGM and then switched them to afrezza. If the previous Dexcom studies are correct these PWDs should have already seen some A1c benefit prior to afrezza since they were already using the CGM with the RAA. IMO, going forward this is the way to do studies as you don't have the variable of different people being compared. Instead you have the exact same person. The failure of this study was measuring TIR during sleeping hours. This needs to be factored out. This study included it which made it a flawed study. The big question is what do the AGPs look like which are not included in the abstract. Concerning the second dose with a T2 you and Shawn are wrong. In the case of a T2 there is a lot of leeway and its really up to the T2 how good they want their numbers to be. If a T2 like Joey wants great numbers looking at his CGM 1hr after eating and second dosing is no big deal. They want to do it. If they miss a second dose every once in a while - oh well. For the T2 who has high A1cs and is being put on a cocktail of poisons like SGLT2s, etc. one puff of afrezza during meal should significantly improve their numbers even if they don't second dose. Afrezza provides the T2 choice and should be used prior to TZDs, SGLT2 and GLP1s and of course metformin as its creates the greatest harm due to the lost time in addressing the problem. Per the abstract - Patients were titrated from pre-meal insulin plus basal insulin to inhaled insulin plus basal insulin over 2 weeks and followed for 14 weeks. At Week 14, mean (±SE) times spent above (>180 mg/dL; -1.7±3.2 mins; P=0.60), in (70 180 mg/dL; -1.2±2.6 mins; P=0.65), and below (<70 mg/dL; +2.9±2.5 mins; P=0.26) glycemic goal range were not significantly different from baseline. However, A1c significantly decreased from baseline at Week 14 (-0.76%±0.18; P=0.0002). At Week 14, Quality of Life (QoL) Total score did not significantly change from baseline (+0.19±0.13; P=0.15). However, Useful (+0.46±0.20; P=0.03), Freeing (+0.92±0.24; P=0.0008), and Difficult ( 0.68±0.28; P=0.02) QoL subdomains significantly improved from baseline at Week 14
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Post by cjc04 on Jun 13, 2020 11:19:10 GMT -5
Dexcom does have trials showing CGMs alone significantly reducing A1C. Now they have a study showing that in addition to the "previously" demonstrated significant reduction the Dexcom in conjunction with afrezza demonstrated an even further "significant reduction". Who knows maybe this further "significant" A1C reduction is a great talking point for Dave Kendall for SoC changes. Significant reductions on top of significant reductions. Even I could make that argument and for Dave he said this is the easiest job he has ever had so we will leave it to the expert. Maybe it gives Kevin Sayer a reason to actively back afrezza. Heck, he was Al's accountant when TS Insulin was invented. Maybe he comes out with a Dexcom LT for T2s. Kevin IMO has a marketing happiness problem. To be honest, second dosing afrezza with a CGM is a no-brainer and a non-issue. When looking at the CGM and the numbers are too high you want to second dose as long as afrezza cost is not an issue. Taking another finger poke and another poke from the needle is an issue. The HbA1c was a secondary result in a failed study without a comparator arm so that study goes nowhere. To put it in context Dexcom did a study using CGMs with Type 2s and got exactly the same reduction just by using a CGM. Dexcom are going to look at this study and say that on those grounds Afrezza made zero contribution to the HbA1c reduction. This is the bit Shawn and I kept hammering but people don't seem to want to hear. The second dose is a big deal because it doubles the number of times you have to think about and deal with your diabetes. That seriously matters. “It doubles the amount of times you have to think about and deal with your diabetes” Haha,,, thats funny!! People with diabetes are NEVER not thinking about and dealing with their diabetes. And my wife has a 5.6 A1c with incredible TiR, and is living like a non diabetic. When is someone other than her going to figure out how to use this miracle drug!?!?!.
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Post by agedhippie on Jun 13, 2020 13:36:58 GMT -5
So if one has diabetes, rather than having to think twice about spending 2 seconds to adjust immediately, they would chose to have members amputated and other severe repercussions so common with diabetes. To me, it looks like a no-brainer. The reasons for that are twofold. First, nobody ever expects to have a limb so that doesn't factor into their calculations which is one reason Type 2 compliance is pretty awful - no immediate consequences. And second, aside from the fact it's not 2 seconds, you have to do this for the rest of your life which is hopefully decades unlike treating an acute disease which days to months. This makes friction in treatment really important - they less the patient has to do the more likely they are to do it and keep doing it.
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