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Post by akemp3000 on Oct 16, 2019 3:21:42 GMT -5
Puzzling that some don't seem to get that CGMs/TIR in combination with Afrezza is the greatest advancement in diabetes treatment in a generation. This is going to greatly improve both longevity and the quality of life for most diabetics. While it's true that a CGM maker's priority is to get one attached to every diabetic, they will LOSE MARKET SHARE if their results don't meet or exceed those achieved by their competition using Afrezza. It might also be true that there is a small niche that could achieve good results with with RAA's but this will not be the much larger global market moving forward as results are shared. IMO, some of these perspectives aren't really puzzling at all  GLTA longs. |
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Post by agedhippie on Oct 16, 2019 8:33:34 GMT -5
Puzzling that some don't seem to get that CGMs/TIR in combination with Afrezza is the greatest advancement in diabetes treatment in a generation. This is going to greatly improve both longevity and the quality of life for most diabetics. While it's true that a CGM maker's priority is to get one attached to every diabetic, they will LOSE MARKET SHARE if their results don't meet or exceed those achieved by their competition using Afrezza. It might also be true that there is a small niche that could achieve good results with with RAA's but this will not be the much larger global market moving forward as results are shared. IMO, some of these perspectives aren't really puzzling at all GLTA longs. The ADA SOC drives diabetes treatment and it is evidence based. Once there is trial data things will change, but right now it's all theoretical and they don't do theory. The CGM you get is dependent on any deal the insurer has done with a manufacturer. The difference between CGM A + Afrezza or CGM B + Afrezza is likely to be very small since fundamentally the CGM is just there to tell you when the best time to take the next dose is. The target right now is driving adoption, hence this trial, rather than going after competitors' market share. I'm sitting squarely in that niche  . I don't see the gain to me in having to double the number of insulin doses I take with all the disruption that implies for what STAT says will be an inferior result. That's the extreme view. Realistically I have things set up so I can get the same results as STAT with less effort, why would I change? I have tried getting others to use Afrezza and the big obstacle is that nobody I talk to wants to move off their current treatment. This is going to take something highly visible and compelling. |
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Post by mango on Oct 16, 2019 9:37:24 GMT -5
Puzzling that some don't seem to get that CGMs/TIR in combination with Afrezza is the greatest advancement in diabetes treatment in a generation. This is going to greatly improve both longevity and the quality of life for most diabetics. While it's true that a CGM maker's priority is to get one attached to every diabetic, they will LOSE MARKET SHARE if their results don't meet or exceed those achieved by their competition using Afrezza. It might also be true that there is a small niche that could achieve good results with with RAA's but this will not be the much larger global market moving forward as results are shared. IMO, some of these perspectives aren't really puzzling at all GLTA longs. The ADA SOC drives diabetes treatment and it is evidence based. Once there is trial data things will change, but right now it's all theoretical and they don't do theory. The CGM you get is dependent on any deal the insurer has done with a manufacturer. The difference between CGM A + Afrezza or CGM B + Afrezza is likely to be very small since fundamentally the CGM is just there to tell you when the best time to take the next dose is. The target right now is driving adoption, hence this trial, rather than going after competitors' market share. I'm sitting squarely in that niche . I don't see the gain to me in having to double the number of insulin doses I take with all the disruption that implies for what STAT says will be an inferior result. That's the extreme view. Realistically I have things set up so I can get the same results as STAT with less effort, why would I change? I have tried getting others to use Afrezza and the big obstacle is that nobody I talk to wants to move off their current treatment. This is going to take something highly visible and compelling. We’ve been seeing the CGM data with Afrezza for years. What’s theoretical about it? We have a robust amount of real-life observational, demonstrable, reproducible and verifiable Afrezza + CGM data. |
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Post by ktim on Oct 16, 2019 10:23:05 GMT -5
Puzzling that some don't seem to get that CGMs/TIR in combination with Afrezza is the greatest advancement in diabetes treatment in a generation. This is going to greatly improve both longevity and the quality of life for most diabetics. While it's true that a CGM maker's priority is to get one attached to every diabetic, they will LOSE MARKET SHARE if their results don't meet or exceed those achieved by their competition using Afrezza. It might also be true that there is a small niche that could achieve good results with with RAA's but this will not be the much larger global market moving forward as results are shared. IMO, some of these perspectives aren't really puzzling at all GLTA longs. Some of those perspectives aren't puzzling, but at least one is. I think the bolded is what many would question. Meters will be evaluated on things like accuracy, cost, ease of use and tracking/alarm features. A doctor is not going to confuse the action of the insulin with the monitoring function of the meter. If the doc prefers and normally recommends Dexcom and RAA and some patient comes in insisting he wants to use Afrezza and a Libre and then gets better TIR, it would likely be a rare doctor that would blame the Dexcom for the difference in results. Part of the essence of science is understanding what effects are attributable to different contributing factors, and doctors are scientists. Further, the FDA would not allow CGM manufacturers to conflate the two and make claims of superior time in range supported by trials comparing apple and orange insulin... i.e. Dexcom "partnering" with MNKD and then doing a trial pitting Dexcom/Afrezza against Libre/RAA, I'd all but guarantee would be unusable as marketing to claim Dexcom is superior to Libre. |
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Post by ktim on Oct 16, 2019 10:39:38 GMT -5
The ADA SOC drives diabetes treatment and it is evidence based. Once there is trial data things will change, but right now it's all theoretical and they don't do theory. The CGM you get is dependent on any deal the insurer has done with a manufacturer. The difference between CGM A + Afrezza or CGM B + Afrezza is likely to be very small since fundamentally the CGM is just there to tell you when the best time to take the next dose is. The target right now is driving adoption, hence this trial, rather than going after competitors' market share. I'm sitting squarely in that niche . I don't see the gain to me in having to double the number of insulin doses I take with all the disruption that implies for what STAT says will be an inferior result. That's the extreme view. Realistically I have things set up so I can get the same results as STAT with less effort, why would I change? I have tried getting others to use Afrezza and the big obstacle is that nobody I talk to wants to move off their current treatment. This is going to take something highly visible and compelling. We have a robust amount of real-life observational, demonstrable, reproducible and verifiable Afrezza + CGM data. If you're talking about people posting results on social media, from a scientific viewpoint the theoretical portion would be that the results are attributable mainly to the physiological action of the insulin and not mainly to a) selection bias of who tends to post results (those showing off a success) or b) a bias that early adopters behave differently than others (for instance more motivated to be diligent about follow on doses). Those are the sorts of factors why medical professionals will still want to see proper clinical trials. Fortunately this means there is a reason to believe these trials can yield positive results on sales over time. |
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Post by mango on Oct 16, 2019 10:44:55 GMT -5
We’ve been seeing the CGM data with Afrezza for years. What’s theoretical about it?We have a robust amount of real-life observational, demonstrable, reproducible and verifiable Afrezza + CGM data. If you're talking about people posting results on social media, from a scientific viewpoint the theoretical portion would be that the results are attributable mainly to the physiological action of the insulin and not mainly to a) selection bias of who tends to post results (those showing off a success) or b) a bias that early adopters behave differently than others (for instance more motivated to be diligent about follow on doses). Those are the sorts of factors why medical professionals will still want to see proper clinical trials. Fortunately this means there is a reason to believe these trials can yield positive results on sales over time. RCTs have many drawbacks and limitations and commonly do not reflect what is observed in real-life. Real-life evidence is evidence, not sure why some tend to disregard it. The biases that you bring up is interesting since bias is a tremendous drawback with RCTs. RCTs are notoriously bias in every sense of the word. You get a bigger picture by having both, and in the case with Afrezza, we have both and the picture is very clear. |
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Post by mannmade on Oct 16, 2019 11:11:28 GMT -5
Dexcom selected Afrezza for this trial for a reason...
I know Kevin Sayer knew Al Mann and in fact I have spoken with Kevin and he understands and appreciates Afrezza capabilities. Am guessing it was no accident Dexcom selected Afrezza and that they had their reasons.
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Post by ktim on Oct 16, 2019 11:26:37 GMT -5
Dexcom selected Afrezza for this trial for a reason... I know Kevin Sayer knew Al Mann and in fact I have spoken with Kevin and he understands and appreciates Afrezza capabilities. Am guessing it was no accident Dexcom selected Afrezza and that they had their reasons. It is a leap of an assumption that Dexcom had anything to do with the selection of insulin. The sponsor is the clinic, not Dexcom. Why are you claiming Dexcom selected Afrezza? It is highly likely this clinic wanted to trial Afrezza and then set about finding a willing CGM manufacturer to donate equipment. If you have evidence Dexcom is driving the testing of Afrezza that indeed would be news, but I think you've made that part up. |
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Post by prcgorman2 on Oct 16, 2019 12:23:29 GMT -5
If Dexcom voluntarily provided CGMs as you've suggested, my assumption they did so based on an agreement they have access to the data collected. I agree that isn't 'driving' the study, but they didn't turn it down either.
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Post by mannmade on Oct 16, 2019 12:44:50 GMT -5
MY Bad... as I did not understand that Dexcom had no say. However not too far of a stretch to think they might have had input into the program. I do know Kevin Sayer is a fan of Afrezza and regardless of how the decision to combine the two was made it is likely not by accident.
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Post by ktim on Oct 16, 2019 12:48:12 GMT -5
If Dexcom voluntarily provided CGMs as you've suggested, my assumption they did so based on an agreement they have access to the data collected. I agree that isn't 'driving' the study, but they didn't turn it down either. This is a a very small trial so cost compared to Dexcom's size would be minimal. Are you trying to imply that you think this shows Dexcom has some preference for Afrezza and they would not have done this for any other pharma wanting to test a drug in such a trial? Respectfully, I think that is a stretch. From a marketing standpoint, having Dexcom be viewed as the preferred CGM for trials (and promoting CGM use and TIR as relevant metric in general) is likely a good one. I'd think they'd want to have as much of the scientific literature as possible based on their CGM. Potentially they might find the data useful. They get tons of the CGM data from patients already, but maybe they'd be interested in a data set with additional non CGM metrics. This trial is good news, and hopefully very good news when results are presented. I just don't understand why everything always has to be hyped into something it is not. Actually I guess I do understand why people try. So perhaps I'd say I don't believe in this forum being primarily about unchallenged, unsubstantiated hype. |
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Post by mytakeonit on Oct 16, 2019 14:40:18 GMT -5
And so we call it Proboards versus Conboards.
But, that's mytakeonit
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Post by mnholdem on Oct 16, 2019 17:10:18 GMT -5
Positive outcomes from this clinical trial may warrant DexCom to fund a larger clinical trial, or maybe, also form a partnership (co-promote). Similar to the STAT study, this one will be likely be considered a “pilot” study. MannKind appears to be gathering data to determine (with reasonable confidence) what could be a major Phase 4 trial down the road, one that would have the potential of positioning Afrezza as the gold standard, superior in multiple respects to existing prandial treatments. I hope that is the case, but it could also be possible that the CEO’s strategy is to tread water while the pediatric trials progress. He is, IMO, a linear thinker so I (a critical thinker) also consider this to be a possibility. |
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Post by agedhippie on Oct 16, 2019 17:34:54 GMT -5
We’ve been seeing the CGM data with Afrezza for years. What’s theoretical about it? We have a robust amount of real-life observational, demonstrable, reproducible and verifiable Afrezza + CGM data. What we are seeing are a few people posting their CGM results, that is not evidence of the type that is going to move the needle. You could flip around a comment that was made earlier and say, " It might also be true that there is a small niche that could achieve good results with with RAA's Afrezza". There are no large scale results for Afrezza. RCT bias is well known, I agree. People get better results than usual because they have a level of support that is not normally available. |
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Post by sayhey24 on Oct 16, 2019 19:11:50 GMT -5
We’ve been seeing the CGM data with Afrezza for years. What’s theoretical about it? We have a robust amount of real-life observational, demonstrable, reproducible and verifiable Afrezza + CGM data. What we are seeing are a few people posting their CGM results, that is not evidence of the type that is going to move the needle. You could flip around a comment that was made earlier and say, " It might also be true that there is a small niche that could achieve good results with with RAA's Afrezza". There are no large scale results for Afrezza. RCT bias is well known, I agree. People get better results than usual because they have a level of support that is not normally available. Aged - if I remember correctly just a few short years ago you argued CGMs were for a niche audience. The reality is afrezza is human insulin which near mimics first phase pancreatic release. Human insulin has proven to do a pretty damn good job of reducing BG for thousands of years. In fact it is the gold standard. As it took a little time for CGMs to catch on, it will also take afrezza a bit more time but its coming. When did Al Mann get FDA approval for the first CGM, 1999, twenty years ago? Trying to argue afrezza users properly dosing will not see great results is probably an argument you don't want to have. These "few people" as you call them showing great CGM results is not the tip of the iceberg but rather the ripple out in the ocean which is really the building tsunami heading for shore. There is only so long the ADA and medical community can try and hide the CGM numbers. Have you put many CGMs on T2s? The results are very predictable and pretty amazing as their BG shoots up after a meal and stays up for hours and hours as their metformin does little except to help the PWD have gas waiting and waiting and waiting for their BG to come down. |
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GLTA longs. 
. I don't see the gain to me in having to double the number of insulin doses I take with all the disruption that implies for what STAT says will be an inferior result. That's the extreme view. Realistically I have things set up so I can get the same results as STAT with less effort, why would I change? I have tried getting others to use Afrezza and the big obstacle is that nobody I talk to wants to move off their current treatment. This is going to take something highly visible and compelling.
