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Post by dreamboatcruise on May 12, 2018 14:16:40 GMT -5
I know a link to this article has appeared in the past but I thought it might be of interest now with the upcoming release of STAT results and the recent discussion of A1c vs TIR with regard to clinicians and payers. In diatribe.org/cgm-and-time-range-what-do-diabetes-experts-think-about-goals Dr. Roy Beck says... "It is important to keep in mind that the population average A1c in people with type 1 diabetes is approximately 8% or higher, and their time-in-range is likely 40%-50%. A goal of 70% time-in-range, or even 60%, is likely unrealistic without drastic changes in their diabetes management approach."One person's opinion but definitely seems to be saying the type of TIR we've seen in social media with Afrezza would require lifestyle changes that those on RAAs would find difficult to do. This seems to refute assertions that high TIR (as high as we've seen with several Afrezza users) is simple to achieve with stacked RAA dosing. So question is whether a non self selected group (STAT Afrezza cohort) achieves results that according to this doctor would be in practice "unrealistic" with traditional therapies. And an interesting editor observation: "Editor’s Note: We had not realized this A1c/time-in-range relationship, and Dr. Roy Beck told us future publications may explore this issue in further depth. Although we talk a lot about A1c not being “everything,” it is a very accepted metric by regulators, healthcare providers, and payers. Knowing the relationship between time-in-range and A1c could be very helpful for getting time-in-range more accepted as an endpoint, especially for the FDA. Time-in-range data can also be gathered in shorter studies (e.g., two weeks), while A1c endpoints take at least three months. Plus, knowing more about time-in-range and CGM patterns at various times of day is a much more actionable way to improve A1c, in our view."
Attitudes are changing with regard to importance of TIR... and the closely linked issue of post prandial hyperglycemia, with studies such as the following one looking at the link between hyperglycemia excursions and cardiovascular disease. onlinelibrary.wiley.com/doi/full/10.1111/jdi.12610I'm not thinking the "beyond A1c" transition occurs overnight, it will not, but there is certainly an opportunity to leverage STAT results if they mirror (or come reasonably close) to what we've seen over the past couple of years. I think many doctors intuitively understand the importance of TIR, and with CGMs the data to support that intuition will start rolling in. |
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Post by Deleted on May 12, 2018 14:53:13 GMT -5
TIR will become the new benchmark. Understand that A1c was the best way to measure compliance for many years as there was no other measuring stick. A1c is an average, it does not reveal peaks and valleys in blood glucose levels and it is those peaks and valleys that cause the long term health complications for people with diabetes. As Al et al have stated, controlling post-prandial blood glucose levels is the key to winning the battle for control of blood glucose levels and Afrezza will do that better than RAAs for a majority of the population. A type 1 who is very very motivated and capable in many cases can achieve tight glucose control with RAAs but this is a pretty small % of the population. Afrezza makes achieving tighter control much easier since it is much more forgiving and predictable. As any clinician about patient compliance. Managing diabetes is a lot more than a few injections and/or pills and just getting a patient who does not have diabetes to take their meds properly is a challenge for a large portion of the patient population. Don't believe me, as a clinician friend. Once upon a time, there was a startup company called Lifescan. They made blood glucose monitors and eventually they were bought by J&J. While there product was not the best in terms of accuracy, it was very easy to use, consumer friendly if you will. Within a couple of years after J&J bought Lifescan, they owned the market. Afrezza is similar in terms of ease of use and its forgiving properties although it is, in my opinion, vastly superior to RAAs and potentially a much better option for type 2s as well. So far though, the market has ignored what Afrezza offers.
The new boss of HHS is Alex Azar. Former head of Eli Lilly US medicine. One of his mantras is value based medicine, ie fee for outcomes vs fee for service.
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Post by mango on May 12, 2018 14:55:02 GMT -5
The importance of TIR is common sense.
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Post by goyocafe on May 12, 2018 15:14:03 GMT -5
TIR will become the new benchmark. Understand that A1c was the best way to measure compliance for many years as there was no other measuring stick. A1c is an average, it does not reveal peaks and valleys in blood glucose levels and it is those peaks and valleys that cause the long term health complications for people with diabetes. As Al et al have stated, controlling post-prandial blood glucose levels is the key to winning the battle for control of blood glucose levels and Afrezza will do that better than RAAs for a majority of the population. A type 1 who is very very motivated and capable in many cases can achieve tight glucose control with RAAs but this is a pretty small % of the population. Afrezza makes achieving tighter control much easier since it is much more forgiving and predictable. As any clinician about patient compliance. Managing diabetes is a lot more than a few injections and/or pills and just getting a patient who does not have diabetes to take their meds properly is a challenge for a large portion of the patient population. Don't believe me, as a clinician friend. Once upon a time, there was a startup company called Lifescan. They made blood glucose monitors and eventually they were bought by J&J. While there product was not the best in terms of accuracy, it was very easy to use, consumer friendly if you will. Within a couple of years after J&J bought Lifescan, they owned the market. Afrezza is similar in terms of ease of use and its forgiving properties although it is, in my opinion, vastly superior to RAAs and potentially a much better option for type 2s as well. So far though, the market has ignored what Afrezza offers. The new boss of HHS is Alex Azar. Former head of Eli Lilly US medicine. One of his mantras is value based medicine, ie fee for outcomes vs fee for service. Agreed. Which is better an A1c of 6.0 with a 90% TIR, 5% Highs, 5% Lows, and No Severe lows, OR a 5.5 A1c with a 70% TIR, 10% Highs, 10% Lows, and 10% Severe lows? |
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Post by olebob1 on May 12, 2018 16:49:00 GMT -5
TIR will become the new benchmark. Understand that A1c was the best way to measure compliance for many years as there was no other measuring stick. A1c is an average, it does not reveal peaks and valleys in blood glucose levels and it is those peaks and valleys that cause the long term health complications for people with diabetes. As Al et al have stated, controlling post-prandial blood glucose levels is the key to winning the battle for control of blood glucose levels and Afrezza will do that better than RAAs for a majority of the population. A type 1 who is very very motivated and capable in many cases can achieve tight glucose control with RAAs but this is a pretty small % of the population. Afrezza makes achieving tighter control much easier since it is much more forgiving and predictable. As any clinician about patient compliance. Managing diabetes is a lot more than a few injections and/or pills and just getting a patient who does not have diabetes to take their meds properly is a challenge for a large portion of the patient population. Don't believe me, as a clinician friend. Once upon a time, there was a startup company called Lifescan. They made blood glucose monitors and eventually they were bought by J&J. While there product was not the best in terms of accuracy, it was very easy to use, consumer friendly if you will. Within a couple of years after J&J bought Lifescan, they owned the market. Afrezza is similar in terms of ease of use and its forgiving properties although it is, in my opinion, vastly superior to RAAs and potentially a much better option for type 2s as well. So far though, the market has ignored what Afrezza offers. The new boss of HHS is Alex Azar. Former head of Eli Lilly US medicine. One of his mantras is value based medicine, ie fee for outcomes vs fee for service. Agreed. Which is better an A1c of 6.0 with a 90% TIR, 5% Highs, 5% Lows, and No Severe lows, OR a 5.5 A1c with a 70% TIR, 10% Highs, 10% Lows, and 10% Severe lows? goyocafe: R you working on a copyright for ur question? I think u nailed it! Keep Severe Lows for the movies. |
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Post by mannmade on May 12, 2018 17:24:17 GMT -5
TIR will become the new benchmark. Understand that A1c was the best way to measure compliance for many years as there was no other measuring stick. A1c is an average, it does not reveal peaks and valleys in blood glucose levels and it is those peaks and valleys that cause the long term health complications for people with diabetes. As Al et al have stated, controlling post-prandial blood glucose levels is the key to winning the battle for control of blood glucose levels and Afrezza will do that better than RAAs for a majority of the population. A type 1 who is very very motivated and capable in many cases can achieve tight glucose control with RAAs but this is a pretty small % of the population. Afrezza makes achieving tighter control much easier since it is much more forgiving and predictable. As any clinician about patient compliance. Managing diabetes is a lot more than a few injections and/or pills and just getting a patient who does not have diabetes to take their meds properly is a challenge for a large portion of the patient population. Don't believe me, as a clinician friend. Once upon a time, there was a startup company called Lifescan. They made blood glucose monitors and eventually they were bought by J&J. While there product was not the best in terms of accuracy, it was very easy to use, consumer friendly if you will. Within a couple of years after J&J bought Lifescan, they owned the market. Afrezza is similar in terms of ease of use and its forgiving properties although it is, in my opinion, vastly superior to RAAs and potentially a much better option for type 2s as well. So far though, the market has ignored what Afrezza offers. The new boss of HHS is Alex Azar. Former head of Eli Lilly US medicine. One of his mantras is value based medicine, ie fee for outcomes vs fee for service. Did you say Lilly? Hmmm.... |
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Post by sayhey24 on May 12, 2018 17:35:31 GMT -5
Why are we always trying to make this more difficult than it is? DIabetes use to be difficult but no more.
DBC you say "One person's opinion but definitely seems to be saying the type of TIR we've seen in social media with Afrezza would require lifestyle changes that those on RAAs would find difficult to do."
The lifestyle change is use the CGM and take afrezza. Sounds pretty easy to me. As Al Mann said afrezza really does make things that easy.
I know guys like Richard Bernstein did not believe Al and got into a few discussions with Al that afrezza could not be that easy but after 3 years of clinical experience Al was right and Bernstein was wrong.
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Post by dreamboatcruise on May 12, 2018 21:11:42 GMT -5
Why are we always trying to make this more difficult than it is? DIabetes use to be difficult but no more. DBC you say "One person's opinion but definitely seems to be saying the type of TIR we've seen in social media with Afrezza would require lifestyle changes that those on RAAs would find difficult to do." The lifestyle change is use the CGM and take afrezza. Sounds pretty easy to me. As Al Mann said afrezza really does make things that easy. I know guys like Richard Bernstein did not believe Al and got into a few discussions with Al that afrezza could not be that easy but after 3 years of clinical experience Al was right and Bernstein was wrong. If you were a doctor and saw every patient with diabetes, I guess everything would be great for MNKD. Sadly it's a huge group of people whose views need to be changed... a meaningful portion of the medical community that treats PWDs. Just saying Al Mann believed it isn't enough. Most wouldn't even know who he was I'm sure. I know no doc I've talked to about Afrezza and MNKD knew who he was until I explained it. |
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Post by cjc04 on May 12, 2018 21:16:24 GMT -5
The importance of TIR is common sense. Obviously not!! If it were, every Endo would be prescribing Afrezza and cgm’s, and not still looking at A1c as the holy grail. |
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Post by cjc04 on May 12, 2018 21:37:49 GMT -5
TIR will become the new benchmark. Understand that A1c was the best way to measure compliance for many years as there was no other measuring stick. A1c is an average, it does not reveal peaks and valleys in blood glucose levels and it is those peaks and valleys that cause the long term health complications for people with diabetes. As Al et al have stated, controlling post-prandial blood glucose levels is the key to winning the battle for control of blood glucose levels and Afrezza will do that better than RAAs for a majority of the population. A type 1 who is very very motivated and capable in many cases can achieve tight glucose control with RAAs but this is a pretty small % of the population. Afrezza makes achieving tighter control much easier since it is much more forgiving and predictable. As any clinician about patient compliance. Managing diabetes is a lot more than a few injections and/or pills and just getting a patient who does not have diabetes to take their meds properly is a challenge for a large portion of the patient population. Don't believe me, as a clinician friend. Once upon a time, there was a startup company called Lifescan. They made blood glucose monitors and eventually they were bought by J&J. While there product was not the best in terms of accuracy, it was very easy to use, consumer friendly if you will. Within a couple of years after J&J bought Lifescan, they owned the market. Afrezza is similar in terms of ease of use and its forgiving properties although it is, in my opinion, vastly superior to RAAs and potentially a much better option for type 2s as well. So far though, the market has ignored what Afrezza offers. The new boss of HHS is Alex Azar. Former head of Eli Lilly US medicine. One of his mantras is value based medicine, ie fee for outcomes vs fee for service. wow,,, best thing I’ve read in a long time!!!! My wife, who is the very motivated and capable type 1 you’re talking about, was considered successful by her Endo because she had an A1c of 6.4.... which included 3 to 5 middle of the night hypo’s per week. Then came Afrezza!!!! Now, with less than half the effort she gave before, and with ZERO middle of the night hypo’s, she just got an A1c of 5.4!!!! How the hell is Afrezza not the #1 conversation in diabetes?  |
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Post by digger on May 13, 2018 6:27:05 GMT -5
The importance of TIR is common sense. Obviously not!! If it were, every Endo would be prescribing Afrezza and cgm’s, and not still looking at A1c as the holy grail. I suspect part of the problem lies with the diabetics. The one single thread that runs though most of the discussions I've read online is the desire to lead just a normal life without having to worry about the details. And they simply don't want to have to deal with the effort required to maintain TIR, or for that matter, A1cs less than 7. I suspect that's one reason for the relatively enthusiastic reception of Medtronics 670G -- www.spglobal.com/marketintelligence/en/news-insights/latest-news-headlines/44244640:"Medtronic in its February earnings call credited the 670G launch for the diabetes business' double-digit growth in the third quarter and predicted the same for the fourth quarter." |
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Post by uvula on May 13, 2018 8:10:10 GMT -5
There is no proof that an a1c of 5 is better than an a1c of 6. I'm not sure there is proof that a TIR of 90% is better than 70%.
Everyone agrees that severe lows are very bad. This could be the most important thing to measure and the biggest advantage of afrezza.
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Post by cjc04 on May 13, 2018 10:37:54 GMT -5
There is no proof that an a1c of 5 is better than an a1c of 6. I'm not sure there is proof that a TIR of 90% is better than 70%. Everyone agrees that severe lows are very bad. This could be the most important thing to measure and the biggest advantage of afrezza. 5.6 is non diabetic and 5.7 is pre diabetic. The proof is..... with a 5.6 A1c, 90% TIR, and no severe lows, means YOU DON’T HAVE DIABETES!! How’s that for proof? Nothing other than Afrezza can accomplish this, I’ve seen it! |
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Post by dreamboatcruise on May 14, 2018 8:41:44 GMT -5
There is no proof that an a1c of 5 is better than an a1c of 6. I'm not sure there is proof that a TIR of 90% is better than 70%. Everyone agrees that severe lows are very bad. This could be the most important thing to measure and the biggest advantage of afrezza. 5.6 is non diabetic and 5.7 is pre diabetic. The proof is..... with a 5.6 A1c, 90% TIR, and no severe lows, means YOU DON’T HAVE DIABETES!! How’s that for proof? Nothing other than Afrezza can accomplish this, I’ve seen it! If you're taking insulin to achieve those numbers... doctors still call that diabetes. 5.6 is great, but Afrezza isn't a cure. Just the next best thing. |
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Post by dreamboatcruise on May 14, 2018 8:48:33 GMT -5
There is no proof that an a1c of 5 is better than an a1c of 6. I'm not sure there is proof that a TIR of 90% is better than 70%. Everyone agrees that severe lows are very bad. This could be the most important thing to measure and the biggest advantage of afrezza. The link provided at bottom of first post is relatively new data showing post prandial BG spikes are a risk factor for cardiovascular disease separable from A1c. It's not directly in terms of TIR, but if one avoids severe lows due to obvious risk and minimizes spikes... that's improved TIR. |
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