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Post by agedhippie on Oct 16, 2019 20:43:48 GMT -5
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. I would argue that CGM users are still a niche audience. And the numbers returned by STAT were not great (Medtronics out performed them with their 670G pump in their phase 3 trials). Yes some individuals get great results, but so do some individuals on RAA. Numbers, numbers, numbers - without trial data this changes nothing. Anyway to put the CGM user population into context these slides are from Dexcom's presentation to the 36th J.P.Morgan Healthcare Conference. First the CGM users in the total US & EU markets, and then for intensive insulin users (people using both basal and bolus insulin - the current market):   |
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Post by ktim on Oct 17, 2019 1:00:30 GMT -5
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. A few short years ago they were hard to get covered for T1s and next to impossible for T2s, weren't they? Not to mention some people didn't like having a cumbersome invasive device on them all the time. All these factors are slowly improving. Better insurance coverage, smaller adhered sensor pods and now totally implantable sensors. I'd still call CGM a niche for T2, but it may not be years from now... doesn't mean it's inaccurate to say it is niche now. |
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Post by mytakeonit on Oct 17, 2019 1:53:36 GMT -5
CGMs are fairly new ... so are those really charts reflective of 2017's numbers? If not, then more current numbers would be really exciting.
But, that's mytakeonit
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Post by sayhey24 on Oct 17, 2019 5:27:54 GMT -5
Aged - these charts are from 2017 when you were arguing CGMs will remain a niche market. Since, the Libre has been approved for direct PWD use and great adoption has occurred. 2020 will even see greater adoption and wider acceptance.
The point being as more PWDs see their numbers and know their metformin doing little to nothing they will want something which really solves the problem.
The big study needed is afrezza vs GLP1 for TIR. Hopefully Dr. Kendall is working it.
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Post by hellodolly on Oct 17, 2019 7:31:11 GMT -5
Aged - I think you made Sayhey's point. That graph confirm's the length of time for adoption of the CGM and the little slice of the pie is the ripple that will turn into the tsusnami.
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Post by prcgorman2 on Oct 17, 2019 8:38:05 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. Touch a nerve? What did I write that was hype? |
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Post by agedhippie on Oct 18, 2019 9:01:38 GMT -5
Aged - these charts are from 2017 when you were arguing CGMs will remain a niche market. Since, the Libre has been approved for direct PWD use and great adoption has occurred. 2020 will even see greater adoption and wider acceptance. The point being as more PWDs see their numbers and know their metformin doing little to nothing they will want something which really solves the problem. The big study needed is afrezza vs GLP1 for TIR. Hopefully Dr. Kendall is working it. I am still arguing that it's a niche market. The numbers are undoubtedly growing and will continue to grow, but it's from a very low base which means the totals are going to be small for some time. Interestingly the biggest driver is going to be the APS developments because now people will have to use a CGM for the system to work. That will pull the CGM adoption numbers towards the pump adoption numbers. The market you look to be focused on is the Type 2 market and you are not alone in that as Dexcom has that as a focus and it doing a lot of trials to support this. However, this is all at the MDI end of the Type 2 market, not at the early stage with metformin. I cannot see the CGM being widely available to Type 2 diabetics until the cost can be driven down to near or below the current cost for test strips for non-insulin using diabetics. |
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Post by sayhey24 on Oct 20, 2019 7:45:56 GMT -5
Aged - As time goes on and I re-look at what Al had said the more I realize how much of a genius he was. Al told us many years ago the big market for afrezza was with the T2s. He also told us it should be the only treatment most T2s should need. He was also convinced afrezza would not only stop the progression but reverse diabetes in some T2s.
Right now the way PWDs received treatment is medically incorrect. If afrezza was available 70 years ago things would be different but it is what it is right now and will change but will take a long time as we now have a massive industry in place which afrezza obsoletes. As I told Mike C when he first started at MNKD as our Chief Marketing Officer, if it was not for CGMs and the cloud, afrezza would be doomed. At that point Mike had no idea what I was talking about and thought I was nuts. Without seeing the CGM numbers the community could simply hide behind A1c.
As far as T1s Al said a patch pump was the way to go along with afrezza. Coming from the guy who invented both the CGM and APS along with afrezza I think he knew what he was talking about. He told us the problem with APS was not the technology but rather the insulin. The insulin was just too damn slow. Have you been following the use of fiasp in the pumps? Lots and lots of issues with sight irritation forcing most to stop usage. Are you aware of any other ultra fast RAA developments in the pipeline for near term release. I am not.
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Post by lennymnkd on Oct 20, 2019 9:03:34 GMT -5
With that said , I never realized how difficult it would be to convince type 2’s this is we’re they should be at (AFREZZA) .. it’s the old kick the can down the road , regardless of who tells them what . If it’s not mandatory to there health conditions.. it’s always not me ... I’m fine it’s the other guy . There has to be a better understanding for these people and what could be ahead for them . How you market that I don’t know / my god they marketed gluten paranoia as just one example... there was a business book out years ago /YOU HAVE TO HURT THEM TO HELP THEM .... let them (type2’s ) know what they may be up against... in a more frank way!
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Post by shawnonafrezza on Oct 20, 2019 9:56:42 GMT -5
sayhey24 URLI insulin is due for 2020 which is faster than Fiasp and the trials were done in pump. I know Al made pumps, don't think he was in the APS game. That didn't start until he was busy with Afrezza. I'm still not convinced Afrezza should be first line for T2. I'm 100% in diet camp unless I can find the papers that Afrezza can fix beta cell function.
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Post by agedhippie on Oct 20, 2019 10:14:02 GMT -5
Aged - As time goes on and I re-look at what Al had said the more I realize how much of a genius he was. Al told us many years ago the big market for afrezza was with the T2s. He also told us it should be the only treatment most T2s should need. He was also convinced afrezza would not only stop the progression but reverse diabetes in some T2s. Right now the way PWDs received treatment is medically incorrect. If afrezza was available 70 years ago things would be different but it is what it is right now and will change but will take a long time as we now have a massive industry in place which afrezza obsoletes. As I told Mike C when he first started at MNKD as our Chief Marketing Officer, if it was not for CGMs and the cloud, afrezza would be doomed. At that point Mike had no idea what I was talking about and thought I was nuts. Without seeing the CGM numbers the community could simply hide behind A1c. As far as T1s Al said a patch pump was the way to go along with afrezza. Coming from the guy who invented both the CGM and APS along with afrezza I think he knew what he was talking about. He told us the problem with APS was not the technology but rather the insulin. The insulin was just too damn slow. Have you been following the use of fiasp in the pumps? Lots and lots of issues with sight irritation forcing most to stop usage. Are you aware of any other ultra fast RAA developments in the pipeline for near term release. I am not. You can reverse (as in put it into remission) Type 2 in some people by any number of things from diet, to metformin, to insulin. That's not in dispute. For insulin there have been trials with basal insulin showing this so there is no reason why Afrezza or RAA would not also work. I was definitely unaware that Al had invented the APS. The concept has been around forever, the problem has always been getting functional components (turns out smartphones where the key). On insulin Al was being a bit economical with the truth. Yes fast onset, fast clearance is desirable for an APS, but you can get perfectly acceptable results with what we have today. The NEJM has the outcome from the Tandem phase 3 trial of Control-IQ and it is significantly better that the compliant STAT group achieved with Afrezza (TIR of 71% vs. 62.5%). The Medtronics 670G has the same TIR as the Tandem pumps so both hybrid APS systems comfortably out perform Afrezza based on STAT. The Medtronics pump released next year has a target TIR of 80% so that gap is getting wider. None of the pump results are using "ultra-rapid" (inverted commas since I am unconvinced that it is) Fiasp, it's all Humalog or Novolog. At one point Fiasp was not approved for pumps because of occlusions rather that irritation (although that is definitely an issue), however it widely used in pumps. Oddly I would be happier to use Fiasp in a Loop or similar APS than in the commercial systems because the PK/PD curves are different so there will be miscalculations - the homemade APS systems have corrected curves available for Fiasp because they don't have the FDA to cope with. Near time release of other ultra-rapid insulins? Eli Lilly have URLi, and have already submitted applications with Europe and Japan. They will file with the FDA before year end, so I would say a 2020 release date. There are some others out there but nothing near term. |
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Post by agedhippie on Oct 20, 2019 10:17:54 GMT -5
With that said , I never realized how difficult it would be to convince type 2’s this is we’re they should be at (AFREZZA) .. it’s the old kick the can down the road , regardless of who tells them what . If it’s not mandatory to there health conditions.. it’s always not me ... I’m fine it’s the other guy . There has to be a better understanding for these people and what could be ahead for them . How you market that I don’t know / my god they marketed gluten paranoia as just one example... there was a business book out years ago /YOU HAVE TO HURT THEM TO HELP THEM .... let them (type2’s ) know what they may be up against... in a more frank way! I think this squarely hits the nail on the head. The problem with getting people with Type 2 to change is that there is no obvious penalty for not changing so they can keep postponing a decision. Problems only become visible in the long term by which time it is to late. |
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Post by sportsrancho on Oct 20, 2019 10:33:47 GMT -5
This is where Vdex/clinic atmosphere comes in handy because maybe they get sent over by a physician who is retiring and has referred his patients to Vdex and let’s say they’re on Metformin.. Vdex takes them off Metformin and gives them some samples of Afrezza..helps them get started, explains to them what will happen years later, where their A1c needs to be so they have the best quality of life and then the patient sees and feels the difference after he/she is on Afrezza.
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Post by mango on Oct 21, 2019 8:24:29 GMT -5
sayhey24 URLI insulin is due for 2020 which is faster than Fiasp and the trials were done in pump. I know Al made pumps, don't think he was in the APS game. That didn't start until he was busy with Afrezza. I'm still not convinced Afrezza should be first line for T2. I'm 100% in diet camp unless I can find the papers that Afrezza can fix beta cell function. Al was very much in the APS game. He funded and founded, Medical Research Group, an artificial pancreas developer. His foundation, the Alfred E Mann Foundation, has been dedicated to an APS. aemf.org/item/diabetes/ |
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Post by shawnonafrezza on Oct 21, 2019 9:16:21 GMT -5
sayhey24 URLI insulin is due for 2020 which is faster than Fiasp and the trials were done in pump. I know Al made pumps, don't think he was in the APS game. That didn't start until he was busy with Afrezza. I'm still not convinced Afrezza should be first line for T2. I'm 100% in diet camp unless I can find the papers that Afrezza can fix beta cell function. Al was very much in the APS game. He funded and founded, Medical Research Group, an artificial pancreas developer. His foundation, the Alfred E Mann Foundation, has been dedicated to an APS. aemf.org/item/diabetes/TIL. Ahead of his time. I remember that design and the whole implant idea that never took off. Would've been nice. |
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