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Post by peppy on Jun 8, 2019 10:42:18 GMT -5
Your most compelling comment was, “The medical community can no longer hide behind the A1C 3 month average and say its good enough”. Dr. Aaron Kowalski has been pretty vocal about this for some time now and using Loop + Afrezza I'm sure he has strong opinion of what "good enough" should be. 2018 ADA standards of Care. In a recent report, mean glucose measured with CGM versus central labo- ratory–measured A1C in 387 participants in three randomized trials demonstrated that A1C may underestimate or overesti- mate mean glucose. Thus, as suggested, a patient’s CGM profile has considerable potential for optimizing his or her glyce- mic management (42). Although performed with older gener- ation CGM devices, a 26-week random- ized trial of 322 patients with type 1 diabetes showed that adults aged $25 years using intensive insulin therapy and CGM experienced a 0.5% reduction in A1C (from ;7.6% to 7.1% [;60 mmol/mol to 54 mmol/mol]) compared with those using intensive insulin therapy with SMBG (21). The greatest predictor of A1C lower- ing for all age-groups was frequency of sensor use, which was highest in those aged $25 years and lower in younger age-groups. Two clinical trials in adults with type 1 diabetes not meeting A1C targets and using multiple daily injections also found that the use of CGM compared with usual care resulted in lower A1C levels than SMBG over 24–26 weeks (22,23). Other small, short-term studies have demonstrated similar A1C reductions us- ing CGM compared with SMBG in adults with A1C levels $7% (53 mmol/mol) (24,25). Read more: mnkd.proboards.com/thread/10068/ada-2018-standards-care?page=1#ixzz5qGutSiXb
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Post by agedhippie on Jun 8, 2019 12:51:13 GMT -5
Aged - RAAs are considered dangerous. Thats the way it is. Every early T2 should be taking insulin but the benefits have out weighed the risk according to the medical community. As a result we have a Rube Goldberg SOC. If afrezza was available in the 1950s it would be included as part of Step One in the SOC. In addition to diet and exercise adding the afrezza as soon as early diabetes is determined is a huge benefit, HUGE! Taking a puff or two of afrezza is night and day different than taking shots at mealtime. As more and more T2s have CGMs and they can get the immediate feedback they will want to take the puff to stay in range which drives compliance. Afrezza feedback with the CGM is immediate. Taking the SGLT2 or GLP1 does little for the mealtime spike and CGMs expose the fraud they are. Not only that gangrene of the balls is not a big selling point for the SGLT2s or pancreatic cancer with the GLP1s. Lets get back to the importance of Levin's results. The results obsolete the need for Steps 3 and 4 of the SOC and simply Step 2 to "take the afrezza". The protocol is now set for the India study and as we have been talking about for years on this board, CGMs don't lie. The medical community can no longer hide behind the A1c 3 month average and say its good enough. Levin has taken the first step in providing the needed study information for real changes to the SOC which we have have been talking about on this board for years. Lets see if this study has made Dr. Kendall's job even easier now. Insulin is considered dangerous, and Afrezza is insulin. Lets not go down the T2s cannot get hypos from Afrezza, because the Levin study showed just that (2.5% of time in hypo). The problem with the Levin study is that the HbA1c reduction is the same as for Trulicity, and Lilly's GLP/GIP drug comfortably out performs both. From a compliance standpoint this is a no-brainer; six or seven doses, CGM monitoring, and it's insulin (failure, impending complications,...) vs. a single weekly shot - weekly shot wins. Afrezza with the second dose protocol will give better TIR if the patient is compliant, but the weekly dose is far more likely to be adopted and so that's where the medical world goes. The India study uses HbA1c rather than TIR last I looked. Unsurprisingly CIPLA just wants to get this approved and aren't spending money on anything else. So no CGMs there. The Levin study is like the STAT study; interesting, but not material. For them to be material they need to be done at scale and with comparator arms. Levin leaves questions hanging like was it Afrezza or simply adding insulin that helped. Could you have had the same effect with basal insulin alone. Could you have had the same effect with intensification (adding GLP-1 or SGLT2). Out of curiosity what do you think is achievable in the next three years with respect to the SOC? My bet would be that very little changes because until the move to TIR happens it's going to be nibbling at the edges, and TIR is going to take a trial like UKPDS which was a huge multi-year trial. Right now logic says TIR is good, but until is is proven to have an impact on complications it remains just a theory and that's not going to change an evidence driven system. I do feel mildly hypocritical arguing against early Afrezza because I think insulin should be the next step after metformin. The problem is that based on experience the medical world thinks that is not practical and they have to go with the practical. It's a struggle to get people just to take a daily pill.
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Post by longliner on Jun 8, 2019 12:56:46 GMT -5
Mildly? ?
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Post by agedhippie on Jun 8, 2019 13:01:07 GMT -5
Mildly? ? Yeah, only mildly. I think insulin should be the second step for T2, but I also realize that it's not going to happen because compliance would be awful (the result of strong preconceptions amongst the public) so lets not kid ourselves about how that goes.
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Post by letitride on Jun 8, 2019 13:15:40 GMT -5
When I only took one pill a day I often forgot now that I take a dozen its much easier to remember. Sometimes things just are not what they seem.
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Post by uvula on Jun 8, 2019 13:17:47 GMT -5
I can't see T2s wanting to use a cgm. Is a cgm is necessary for Afrezza?
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Post by longliner on Jun 8, 2019 13:17:49 GMT -5
When I only took one pill a day I often forgot now that I take a dozen its much easier to remember. Sometimes things just are not what they seem.Words to live by on a message board.
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Post by longliner on Jun 8, 2019 13:27:50 GMT -5
I can't see T2s wanting to use a cgm. Is a cgm is necessary for Afrezza? Uvula, when the option of wearing a non-invasive CGM is available, fit-bit, apple watch etc.. As a non diabetic I have come to realize that this is something I would like to have. I would like to see the affect of different foods on my blood sugar. As the technology evolves Afrezza may be seen as something even non diabetics embrace to level spikes. So, your question got me thinking, cart before the horse etc.. Sorry I didn't answer your question.
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Post by prcgorman2 on Jun 8, 2019 13:38:12 GMT -5
I’m not looking forward to my next A1C. I accept I may become diabetic. My mother did. A cousin on her side is T1. In my case it is most likely going to be a consequence of a life of less than good choices of diet and activity. I love beer and I’m more sedentary that I should be. All that said, if/when I become T2, I do not want to take Afrezza after metformin, and I do want to use a CGM. I accept that dialing in insulin usage and the fact that needs change because of recovery (or not) of the pancreas, but based on everything I’ve ever learned from reading from diabetics (like on Tudiabetes) who use Afrezza, I think that with a CGM I could go straight to Afrezza. I don’t smoke and don’t have asthma. I am trying to make changes in my diet and activity, so maybe I can avoid being a T2. Time will tell.
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Post by agedhippie on Jun 8, 2019 14:04:49 GMT -5
I’m not looking forward to my next A1C. I accept I may become diabetic. My mother did. A cousin on her side is T1. In my case it is most likely going to be a consequence of a life of less than good choices of diet and activity. I love beer and I’m more sedentary that I should be. All that said, if/when I become T2, I do not want to take Afrezza after metformin, and I do want to use a CGM. I accept that dialing in insulin usage and the fact that needs change because of recovery (or not) of the pancreas, but based on everything I’ve ever learned from reading from diabetics (like on Tudiabetes) who use Afrezza, I think that with a CGM I could go straight to Afrezza. I don’t smoke and don’t have asthma. I am trying to make changes in my diet and activity, so maybe I can avoid being a T2. Time will tell. I wouldn't beat yourself up too much. The current evidence is that genetics have far more to do with developing Type 2 than diet. Last I looked they had identified over 100 genes, many of which are linked to weight. For evidence though you need to look no further than the obese segment of the population. Why is it that the minority of that group has Type 2 diabetes (I think it's around 20%)? From what we are told you would have thought that a majority would have Type 2. The truth is that if you have the wrong genes you are in trouble, but lacking those gene feel free to eat what you like because diabetes is not in your future. That is not to say that if you diet you cannot avoid this at least for a while. Weight increases insulin resistance so if you lose weight you may be able to live within the insulin you have available. However Type 2 is progressive at two levels, absolute and relative deficiencies, and while the relative deficiency is negotiable the absolute deficiency is unavoidable.
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Post by longliner on Jun 9, 2019 0:12:43 GMT -5
Mildly? ? Yeah, only mildly. I think insulin should be the second step for T2, but I also realize that it's not going to happen because compliance would be awful (the result of strong preconceptions amongst the public) so lets not kid ourselves about how that goes. Preconception? We aren't talking shots here, just puff the magic dragon. As I stated, provide me with a non invasive CGM (apple watch ect.) And let me watch the food affect on my blood sugar and I too will use the best tool to adust spikes. (Afrezza) I'm not sure how Novo spells it.🙂
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Post by sayhey24 on Jun 9, 2019 5:08:06 GMT -5
Aged - RAAs are considered dangerous. Thats the way it is. Every early T2 should be taking insulin but the benefits have out weighed the risk according to the medical community. As a result we have a Rube Goldberg SOC. If afrezza was available in the 1950s it would be included as part of Step One in the SOC. In addition to diet and exercise adding the afrezza as soon as early diabetes is determined is a huge benefit, HUGE! Taking a puff or two of afrezza is night and day different than taking shots at mealtime. As more and more T2s have CGMs and they can get the immediate feedback they will want to take the puff to stay in range which drives compliance. Afrezza feedback with the CGM is immediate. Taking the SGLT2 or GLP1 does little for the mealtime spike and CGMs expose the fraud they are. Not only that gangrene of the balls is not a big selling point for the SGLT2s or pancreatic cancer with the GLP1s. Lets get back to the importance of Levin's results. The results obsolete the need for Steps 3 and 4 of the SOC and simply Step 2 to "take the afrezza". The protocol is now set for the India study and as we have been talking about for years on this board, CGMs don't lie. The medical community can no longer hide behind the A1c 3 month average and say its good enough. Levin has taken the first step in providing the needed study information for real changes to the SOC which we have have been talking about on this board for years. Lets see if this study has made Dr. Kendall's job even easier now. Insulin is considered dangerous, and Afrezza is insulin. Lets not go down the T2s cannot get hypos from Afrezza, because the Levin study showed just that (2.5% of time in hypo). The problem with the Levin study is that the HbA1c reduction is the same as for Trulicity, and Lilly's GLP/GIP drug comfortably out performs both. From a compliance standpoint this is a no-brainer; six or seven doses, CGM monitoring, and it's insulin (failure, impending complications,...) vs. a single weekly shot - weekly shot wins. Afrezza with the second dose protocol will give better TIR if the patient is compliant, but the weekly dose is far more likely to be adopted and so that's where the medical world goes. The India study uses HbA1c rather than TIR last I looked. Unsurprisingly CIPLA just wants to get this approved and aren't spending money on anything else. So no CGMs there. The Levin study is like the STAT study; interesting, but not material. For them to be material they need to be done at scale and with comparator arms. Levin leaves questions hanging like was it Afrezza or simply adding insulin that helped. Could you have had the same effect with basal insulin alone. Could you have had the same effect with intensification (adding GLP-1 or SGLT2). Out of curiosity what do you think is achievable in the next three years with respect to the SOC? My bet would be that very little changes because until the move to TIR happens it's going to be nibbling at the edges, and TIR is going to take a trial like UKPDS which was a huge multi-year trial. Right now logic says TIR is good, but until is is proven to have an impact on complications it remains just a theory and that's not going to change an evidence driven system. I do feel mildly hypocritical arguing against early Afrezza because I think insulin should be the next step after metformin. The problem is that based on experience the medical world thinks that is not practical and they have to go with the practical. It's a struggle to get people just to take a daily pill. Aged - its not that insulin is dangerous. The problem is subq insulin is dangerous and it requires shots. Everyone in the world uses insulin every day with no problem. Afrezza provides that major step to providing insulin as the body provides it. You keep trying to compare subq to afrezza. They are worlds apart in how they interact with the body. As Al Mann use to say a T2 can get a severe hypo on afrezza but they really really need to try. I have been dealing a lot with Indians lately and few have seen CGMs. They think they are miracle machines. Lets see if Abbott will cosponsor the Indian study. As far as afrezza, SGLT2s and GLP1s, now afrezza provides another option. Get better TIR and potentially stop the progression of T2 or potentially get gangrene of the balls or pancreatic cancer while still not providing what the body needs which is insulin. Pissing out sugar versus having the body properly use the glucose in the blood are solutions which are night and day in difference. More over if the SGLT2 and GLP1s were so good why do we have more steps in the SOC. With afrezza, its take the afrezza, first and last step. I think the question on whats achievable in the next three years is better directed to Dr. Kendall. As I have told Mike its going to be a long slog. However, a well funded clinic approach which bypasses the SOC and current medical community is very doable and would generate significant sales. The patent is now in place as of June 4th so lets see whats next. What I can tell you is if we had the Levin results for Affinity 2 the pps would have rocketed to $50 pre split.
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Post by awesomo on Jun 9, 2019 10:42:57 GMT -5
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Post by agedhippie on Jun 9, 2019 11:18:20 GMT -5
Aged - its not that insulin is dangerous. The problem is subq insulin is dangerous and it requires shots. Everyone in the world uses insulin every day with no problem. Afrezza provides that major step to providing insulin as the body provides it. You keep trying to compare subq to afrezza. They are worlds apart in how they interact with the body. As Al Mann use to say a T2 can get a severe hypo on afrezza but they really really need to try. I have been dealing a lot with Indians lately and few have seen CGMs. They think they are miracle machines. Lets see if Abbott will cosponsor the Indian study. As far as afrezza, SGLT2s and GLP1s, now afrezza provides another option. Get better TIR and potentially stop the progression of T2 or potentially get gangrene of the balls or pancreatic cancer while still not providing what the body needs which is insulin. Pissing out sugar versus having the body properly use the glucose in the blood are solutions which are night and day in difference. More over if the SGLT2 and GLP1s were so good why do we have more steps in the SOC. With afrezza, its take the afrezza, first and last step. I think the question on whats achievable in the next three years is better directed to Dr. Kendall. As I have told Mike its going to be a long slog. However, a well funded clinic approach which bypasses the SOC and current medical community is very doable and would generate significant sales. The patent is now in place as of June 4th so lets see whats next. What I can tell you is if we had the Levin results for Affinity 2 the pps would have rocketed to $50 pre split. Insulin is insulin, it extracts glucose from the blood stream and stores it as fat. If you take X units of insulin it will drop you Y points. There is nothing magical about Afrezza in that respect. If you overdose on Afrezza you will get a hypo just as easily as with RAA, but quicker since the onset is faster. If Al Mann had any scientific evidence to prove that it's really hard for a T2 to get a severe hypo on Afrezza then I would say that is one of Dr Kendall's veins of gold and should have been published years ago. Absent the evidence it's just a theory. I don't like SGLT2 or GLP-1 or the others either, however that's what the SOC says comes first and is the direction they are moving in. Until there is a large scale trial to prove otherwise that will not change. As to TIR, I have tried to find TIR studies for the oral drugs and T2, but without much luck. The problem with the clinic approach is three-fold; funding, legal, and reach. The level of investment needed to get the coverage to make a significant impact is huge and it is difficult given the level of reimbursement from insurance to see how it makes money, especially once you include Medicare patients. Legally as I understand it there can be no tie between Mannkind and the clinic to avoid the anti-kickback laws. Coverage is really a variation on funding. To make an impact you are going to need a lot of clinics geographically dispersed. The June 4th patent, I am assuming that is the one that covers the MDI use of Afrezza, really does nothing unless there is a competing inhaled insulin using the same formula. Since MDI is definitely prior art there is no way that it can limit any other bolus insulin.
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Post by agedhippie on Jun 9, 2019 11:41:25 GMT -5
Yeah, only mildly. I think insulin should be the second step for T2, but I also realize that it's not going to happen because compliance would be awful (the result of strong preconceptions amongst the public) so lets not kid ourselves about how that goes. Preconception? We aren't talking shots here, just puff the magic dragon. As I stated, provide me with a non invasive CGM (apple watch ect.) And let me watch the food affect on my blood sugar and I too will use the best tool to adust spikes. (Afrezza) I'm not sure how Novo spells it.🙂 The problem is not the shot itself, it's having to take the shot (inhaled or injected). It's compliance burden that is the issue. Part of the problem with T2 is that in the early days there is no visible penalty for non-compliance so there is a low threshold for skipping treatment. If an accurate non-invasive CGM could be built into a watch I think that would be a huge step forward.
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