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Post by dreamboatcruise on Dec 29, 2017 15:56:25 GMT -5
One of the biggest challenges PWDs seem to face is insurance coverage. I am assuming you have a trick or two as part of your protocol in getting the PWD insurance. About what percent of your patients are being covered? IMO the need for controlled studies at this point is dwarfed by your clinical results if they are as good as you say, and I have no reason to doubt you. Its pretty hard to argue with a pre/post afrezza AGP chart as the numbers don't lie. Your results combined with a profitable business model should allow investment for at least 100 clinics by year-end 2018. Assuming each clinic can do 10 new RXs per week, VDex alone should be doing 2X what the rest of medical community is currently doing. Thinking out loud, 2018 could finally be the year of afrezza and not the year of the dog. Sayhey you are correct that insurance is one of the challenges, but surprisingly, we don't find it that tough to surmount. I don't have precise numbers in front of me, but my guess is that better than 80% of our patients get covered eventually. For competitive reasons, I'll be a little vague about how we do it. It can be a little time-consuming and for that reason, most traditional medical practices won't likely bother. Plus, we had to figure some of it out on our own. It was a similar process as with our treatment protocols in this respect: we knew the basics about how to prescribe and treat patients, but we learned through trial and error how to get better results by doing some things differently. Same with insurance coverage. Regarding our expansion, again, we had to try different things there as well. Here I'll say almost nothing for competitive reasons except this: we had initial ideas, tried them, found they didn't work, and evolved. The whole Vdex experience has required us to think outside the box after we tried something obvious and failed at it. That's why this has taken longer than all of us have wanted. We have been sustained by our belief in Al Mann, Afrezza, and the desire to do something meaningful for PWD. And, the support of so many on this board has certainly helped during some of the darkest moments. I've been a bit of a skeptic given what I've read about struggles, and closures, of other medical clinics and chains specializing in diabetes. Though that can mean there is simply a market opportunity for someone with the drive and inventiveness to succeed where others have failed. Best of luck. Certainly appreciate hearing updates. |
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Post by nadathing on Dec 29, 2017 19:30:08 GMT -5
Just want to say thank you. This has been a long and tough year. The information shared on this thread brings hope and optimism. Have a great Nee Year’s!
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Post by sayhey24 on Dec 30, 2017 10:23:28 GMT -5
I am thinking a VDex booth at ADA in Orlando displaying their results might get some attention and piss a few people off. As we have all been told forever, diabetes is a progressive disease until now especially if we treat early in the diagnosis. What are the current diabetes/prediabetes numbers in the U.S. - over 100M? I am not sure each clinic can service 1M PWDs, they may need more clinics. There are two problems you run into almost immediately with that approach. The first is that doctors will say that VDex results are the result of intensive management and if they could spend that amount of time they could get similar results (as an aside this is a known problem with trials - the higher level of attention from the medical support staff produce better results regardless which makes the control arm important). Secondly that you cannot simply publish practice results and expect to be taken seriously. As VDex said the Medical Board will have problems with that and rightly so. You cannot take a self-selected well motivated group and expect that to translate to the wider population. To prove a protocol you need control groups and blind tests. I suspect that the VDex protocol would hold up, however that sort of trial is expensive and there is not much gain in it for VDex. Lets take your problem one - doctors are short changing the patients and not spending enough time but if they did they could get similar results. Given the fact doctors are following the current Step program, there is ZERO chance they will get the same results. We have early insulin intervention studies since UpJohn's Orinase and they all same the same thing, early insulin intervention works. What we have not had prior to afrezza is an insulin which can stop the meal time spike and when not taking a basal has little chance of producing a hypo. Stopping the spike is huge in stopping progression. Its also what DeFronzo found with the GLP-1/TZD combo. Nothing stops the spike better than afrezza. Your problem two is VDex will not be taken seriously is old school thinking. 2017 was the year of the CGM and AGPs. Endo's are now seeing the value of the AGP and spending more time with PWDs reviewing them. The reality is no one needs an Endo to read an AGP and its really hard arguing with an AGP and ignoring the numbers. The beauty of what VDex is doing is their control group is the general population, what better control group. Assuming each is using some form of CGM they have the PWDs BG profile history and progression. The numbers are the numbers and all the Step program BS stops. Does VDex need to convince the doctors, IMO no. All they need to do is run some radio ads on the Rush Limbaugh show. As I understand it Rush's dad was diabetic. If they take a trip to Palm Beach, explain to Rush their findings and become a sponsor, I suspect the treatment for T2s may change almost over-night. |
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Post by goyocafe on Dec 30, 2017 10:47:15 GMT -5
There are two problems you run into almost immediately with that approach. The first is that doctors will say that VDex results are the result of intensive management and if they could spend that amount of time they could get similar results (as an aside this is a known problem with trials - the higher level of attention from the medical support staff produce better results regardless which makes the control arm important). Secondly that you cannot simply publish practice results and expect to be taken seriously. As VDex said the Medical Board will have problems with that and rightly so. You cannot take a self-selected well motivated group and expect that to translate to the wider population. To prove a protocol you need control groups and blind tests. I suspect that the VDex protocol would hold up, however that sort of trial is expensive and there is not much gain in it for VDex. Lets take your problem one - doctors are short changing the patients and not spending enough time but if they did they could get similar results. Given the fact doctors are following the current Step program, there is ZERO chance they will get the same results. We have early insulin intervention studies since UpJohn's Orinase and they all same the same thing, early insulin intervention works. What we have not had prior to afrezza is an insulin which can stop the meal time spike and when not taking a basal has little chance of producing a hypo. Stopping the spike is huge in stopping progression. Its also what DeFronzo found with the GLP-1/TZD combo. Nothing stops the spike better than afrezza. Your problem two is VDex will not be taken seriously is old school thinking. 2017 was the year of the CGM and AGPs. Endo's are now seeing the value of the AGP and spending more time with PWDs reviewing them. The reality is no one needs an Endo to read an AGP and its really hard arguing with an AGP and ignoring the numbers. The beauty of what VDex is doing is their control group is the general population, what better control group. Assuming each is using some form of CGM they have the PWDs BG profile history and progression. The numbers are the numbers and all the Step program BS stops. Does VDex need to convince the doctors, IMO no. All they need to do is run some radio ads on the Rush Limbaugh show. As I understand it Rush's dad was diabetic. If they take a trip to Palm Beach, explain to Rush their findings and become a sponsor, I suspect the treatment for T2s may change almost over-night. For those of you scratching your head about yet another abbreviation: AGPAmbulatory Glucose Profile (AGP) is a single page, standardized report for interpreting a patient's daily glucose and insulin patterns. AGP provides both graphic and quantitative characterizations of daily glucose patterns. First developed by Drs. Roger Mazze and David Rodbard,[1] with colleagues at the Albert Einstein College of Medicine in 1987, AGP was initially used for representation of episodic self-monitored blood glucose (SMBG). The first version included a glucose median and inter-quartile ranges graphed as a 24 hour day. Dr. Mazze brought the original AGP to the International Diabetes Center (IDC) in the late 1980's and since that time, IDC has built the AGP into the internationally recognized standard for glucose pattern reporting [2]. |
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Post by agedhippie on Dec 30, 2017 12:45:25 GMT -5
Lets take your problem one - doctors are short changing the patients and not spending enough time but if they did they could get similar results. Given the fact doctors are following the current Step program, there is ZERO chance they will get the same results. We have early insulin intervention studies since UpJohn's Orinase and they all same the same thing, early insulin intervention works. ... The beauty of what VDex is doing is their control group is the general population, what better control group. Assuming each is using some form of CGM they have the PWDs BG profile history and progression. The numbers are the numbers and all the Step program BS stops. Does VDex need to convince the doctors, IMO no. All they need to do is run some radio ads on the Rush Limbaugh show. As I understand it Rush's dad was diabetic. If they take a trip to Palm Beach, explain to Rush their findings and become a sponsor, I suspect the treatment for T2s may change almost over-night. In my experience doctors would love to spend more time with their patients. However the insurers have strict ideas on how long a consultancy will last and that prevents doctors from going into things in depth. I suspect that VDex does not take insurance directly so they do not have this problem, it is certainly how Integrated Diabetes works. This limits the service though and only those who are prepared to pay out of pocket will use the service. VDex most definitely are not using a general population group for their sample. They are using a self-selecting group. This is the same as people who listen to Russ Limburgh being asked on air by him to vote in a poll in his show - the result is easily predictable. VDex has a very motivated and focused patient group who are prepared to expend what is probably a fair bit of money - that is not the general population (sadly). Radio ads by VDex will have to tread very carefully or they will upset their medical board. You will need trial data to support assertions or you will need to phrase things in a particularly squirrelly way (thinking of weight loss pills, etc.) I doubt that is somewhere a serious operation like VDex wants to be. |
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Post by sayhey24 on Dec 30, 2017 14:06:39 GMT -5
Lets take your problem one - doctors are short changing the patients and not spending enough time but if they did they could get similar results. Given the fact doctors are following the current Step program, there is ZERO chance they will get the same results. We have early insulin intervention studies since UpJohn's Orinase and they all same the same thing, early insulin intervention works. What we have not had prior to afrezza is an insulin which can stop the meal time spike and when not taking a basal has little chance of producing a hypo. Stopping the spike is huge in stopping progression. Its also what DeFronzo found with the GLP-1/TZD combo. Nothing stops the spike better than afrezza. Your problem two is VDex will not be taken seriously is old school thinking. 2017 was the year of the CGM and AGPs. Endo's are now seeing the value of the AGP and spending more time with PWDs reviewing them. The reality is no one needs an Endo to read an AGP and its really hard arguing with an AGP and ignoring the numbers. The beauty of what VDex is doing is their control group is the general population, what better control group. Assuming each is using some form of CGM they have the PWDs BG profile history and progression. The numbers are the numbers and all the Step program BS stops. Does VDex need to convince the doctors, IMO no. All they need to do is run some radio ads on the Rush Limbaugh show. As I understand it Rush's dad was diabetic. If they take a trip to Palm Beach, explain to Rush their findings and become a sponsor, I suspect the treatment for T2s may change almost over-night. For those of you scratching your head about yet another abbreviation: AGPAmbulatory Glucose Profile (AGP) is a single page, standardized report for interpreting a patient's daily glucose and insulin patterns. AGP provides both graphic and quantitative characterizations of daily glucose patterns. First developed by Drs. Roger Mazze and David Rodbard,[1] with colleagues at the Albert Einstein College of Medicine in 1987, AGP was initially used for representation of episodic self-monitored blood glucose (SMBG). The first version included a glucose median and inter-quartile ranges graphed as a 24 hour day. Dr. Mazze brought the original AGP to the International Diabetes Center (IDC) in the late 1980's and since that time, IDC has built the AGP into the internationally recognized standard for glucose pattern reporting [2]. Thanks - sorry. AGP is one of the 2017 buzzwords. Endos are finally starting to figure out what we have been talking about for years on this board, A1c is no way to treat diabetes. You need to understand the 24/7 BG profile and correlate that to meals and "special" activities, like exercise or in my case taking a few fingers of bourbon. Its a standard report but a licensed product. Dexcom licensed the report this year. www.agpreport.org/agp/aboutIMO the licensed report is not as important as the profile you can make in your favorite graphing tool like excel and I really don't like the word "Ambulatory". |
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Post by sayhey24 on Dec 30, 2017 14:43:12 GMT -5
Lets take your problem one - doctors are short changing the patients and not spending enough time but if they did they could get similar results. Given the fact doctors are following the current Step program, there is ZERO chance they will get the same results. We have early insulin intervention studies since UpJohn's Orinase and they all same the same thing, early insulin intervention works. ... The beauty of what VDex is doing is their control group is the general population, what better control group. Assuming each is using some form of CGM they have the PWDs BG profile history and progression. The numbers are the numbers and all the Step program BS stops. Does VDex need to convince the doctors, IMO no. All they need to do is run some radio ads on the Rush Limbaugh show. As I understand it Rush's dad was diabetic. If they take a trip to Palm Beach, explain to Rush their findings and become a sponsor, I suspect the treatment for T2s may change almost over-night. In my experience doctors would love to spend more time with their patients. However the insurers have strict ideas on how long a consultancy will last and that prevents doctors from going into things in depth. I suspect that VDex does not take insurance directly so they do not have this problem, it is certainly how Integrated Diabetes works. This limits the service though and only those who are prepared to pay out of pocket will use the service. VDex most definitely are not using a general population group for their sample. They are using a self-selecting group. This is the same as people who listen to Russ Limburgh being asked on air by him to vote in a poll in his show - the result is easily predictable. VDex has a very motivated and focused patient group who are prepared to expend what is probably a fair bit of money - that is not the general population (sadly). Radio ads by VDex will have to tread very carefully or they will upset their medical board. You will need trial data to support assertions or you will need to phrase things in a particularly squirrelly way (thinking of weight loss pills, etc.) I doubt that is somewhere a serious operation like VDex wants to be. According to Mr. VDexdiabetes who posted above 80% of their patience are covered by insurance. Their model is very different than Gary Scheiner's, although I do know Scheiner has been spotted speaking on the wonders of afrezza and is now using it himself. Gary is a CDE. VDex is a specialized clinic with prescribing doctors. Could Gary evolve into a VDex, maybe but his focus is T1s and coaching on the use of old school insulins. Assuming Tresiba provides an almost flat line baseline and afrezza stops the spike and gets the T1 back to baseline fast and the T1 has a CGM, a lot of what Gary currently does is OBE. The big market for VDex is taking the T2 off the hands of the PCP as soon as they are found to be diabetic or better yet "Prediabetic". Now, today's doctors could spend all day long with their new PWD and what would be the end result? - take the medformin, loose a few pounds, take a walk and maybe try and cut back on the carbs, then come back in 5 years and we will probably have to give you the needle. Maybe in five years VDex will be OBE and every doctor will be following the VDex protocol but while that would surprise me, I would be pleasantly surprised. I think VDex's population group is anyone walking into their clinic who can pay them via insurance or cash. I do not think they are only taking those who fit a certain profile. The thing about human insulin is its been working pretty darn good in the body for a long time. There are few PWDs who would not benefit from it. In fact if they had enough in their body they would not be diabetic. I don't know much about Limbaugh's polls. In fact I did not know he ran polls but I do know he has about 15M listeners and most have some type of health insurance. Additionally, when he gets into a controversial topic like a fight with a pissed off medical board because one of his sponsors has developed a protocol using an FDA approved drug to stop and in some cases reverse T2 diabetes, Limbaugh gets covered on every other news station in what they use to call "earned" advertising. I think if Limbaugh could create a stir in the medical community it would be a victory for VDex, MNKD and PWDs around the world. |
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Post by agedhippie on Dec 30, 2017 16:30:32 GMT -5
According to Mr. VDexdiabetes who posted above 80% of their patience are covered by insurance. ... I think VDex's population group is anyone walking into their clinic who can pay them via insurance or cash. I do not think they are only taking those who fit a certain profile... I am pretty certain that the 80% they are talking about is Afrezza coverage, not service coverage. If you have out of network cover you could probably claim back partial coverage for the costs. You are confusing selection. Yes I would expect VDex to talk to anyone who approached them and not only certain profiles. That is the point of self-selection - only people who want to go beyond the normal care their PCP would give will approach them. Those are the self-motivated and proactive section of the population, not the general population. The vast majority of the population wants to do the bare minimum which is why we have drugs at all initially when this could happily be handled by diet and exercise. |
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Post by peppy on Dec 30, 2017 17:12:30 GMT -5
According to Mr. VDexdiabetes who posted above 80% of their patience are covered by insurance. ... I think VDex's population group is anyone walking into their clinic who can pay them via insurance or cash. I do not think they are only taking those who fit a certain profile... I am pretty certain that the 80% they are talking about is Afrezza coverage, not service coverage. If you have out of network cover you could probably claim back partial coverage for the costs. You are confusing selection. Yes I would expect VDex to talk to anyone who approached them and not only certain profiules. That is the point of self-selection - only people who want to go beyond the normal care their PCP would give will approach them. Those are the self-motivated and proactive section of the population, not the general population. The vast majority of the population wants to do the bare minimum which is why we have drugs at all initially when this could happily be handled by diet and exercise.The vdex testimonials I have seen have been type one. if type one could be handled by diet and exercise, you would have done that. There is out of network. There is referral. Their are people seeking out Afrezza. Vdex seems to be a program. A teaching program with tools to help manage and learn Afrezza; a continuous glucose monitor, instructions and support. |
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Post by agedhippie on Dec 31, 2017 6:20:30 GMT -5
I am pretty certain that the 80% they are talking about is Afrezza coverage, not service coverage. If you have out of network cover you could probably claim back partial coverage for the costs. You are confusing selection. Yes I would expect VDex to talk to anyone who approached them and not only certain profiules. That is the point of self-selection - only people who want to go beyond the normal care their PCP would give will approach them. Those are the self-motivated and proactive section of the population, not the general population. The vast majority of the population wants to do the bare minimum which is why we have drugs at all initially when this could happily be handled by diet and exercise.The vdex testimonials I have seen have been type one. if type one could be handled by diet and exercise, you would have done that. There is out of network. There is referral. Their are people seeking out Afrezza. Vdex seems to be a program. A teaching program with tools to help manage and learn Afrezza; a continuous glucose monitor, instructions and support. Does getting your PCP to refer you to an out of network provider mean that provider is now covered for your treatment? My insurance doesn't require referrals, but if a referral will get me cover for an out of network provider I will start getting them! I think Sayhey and I were talking about Type 2 since Type 1 cannot be be reversed or halted (it self-limits). You are quite right though that diet and exercise will not help with Type 1 unlike Type 2. Historically diet was the treatment for Type 1 and nobody really lived past a year. I would suspect that the vast majority of VDex's patients sought them out. That alone is impressive. |
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Post by sportsrancho on Dec 31, 2017 9:34:57 GMT -5
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Post by sayhey24 on Dec 31, 2017 10:24:06 GMT -5
The vdex testimonials I have seen have been type one. if type one could be handled by diet and exercise, you would have done that. There is out of network. There is referral. Their are people seeking out Afrezza. Vdex seems to be a program. A teaching program with tools to help manage and learn Afrezza; a continuous glucose monitor, instructions and support. Does getting your PCP to refer you to an out of network provider mean that provider is now covered for your treatment? My insurance doesn't require referrals, but if a referral will get me cover for an out of network provider I will start getting them! I think Sayhey and I were talking about Type 2 since Type 1 cannot be be reversed or halted (it self-limits). You are quite right though that diet and exercise will not help with Type 1 unlike Type 2. Historically diet was the treatment for Type 1 and nobody really lived past a year. I would suspect that the vast majority of VDex's patients sought them out. That alone is impressive. My understanding is VDex is getting insurance to pay for the office visits and the afrezza. Getting paid for the office visits for follow-up diabetic care I would think would be an easier charge than getting the insurance to cover the afrezza. It would be nice to have Mr. VDexdiabees weigh in on this. Unlike Scheiner who is simply a CDE, VDex is not. They are acting in several roles including afrezza diabetes education and prescribing medical clinic. They are also working in conjunction with PCPs by off loading the new T2s. What the exact business model is, is not clear. I am assuming and maybe incorrectly they are building handshake relationships where the PCP benefits from having an "enhanced" level of care for their PWDs, maintains the PWD as their client yet doesn't have to deal with the details. Now, T1 versus T2 is a separate topic but one of my favorites. As best as I have determined the term T2 was originated by UpJohn segregating diabetics into two classes for sale of their product; candidates for Orinase; and non-candidates. The reality we have in the world of diabetes is those under an active immune attack and those who are not. The question in the latter is how much beta cell damage has been done. Where the damage has been limited there seems to be a great chance of stopping further damage and in some seeing beta cell regeneration. The key seems to be stopping the post meal spike and getting the "T2" back into a non-diabetic range asap. The open question in the former "T1" is what role can keeping that PWD in a very tight range have on limiting the attack? My guess is if we can get early stage LADAs on afrezza we may start getting some good answers. Unfortunately until the CGM IWatch or similar devices are being widely used identifying these people prior to massive beta cell damage is a challenge. A year ago we were talking about the coming of technology with CGMs and cloud monitoring and going beyond A1c and why this was so crucial for the survival of afrezza. 2017 has been a great year in advancing technology adoption and now with the beginning adoption of AGPs as the way to analyze diabetes, 2018 is now set to be the year of afrezza (and not the dog) and "Stopping the Spike". Its been a long long road but finally, it appears all the supporting pieces have come together for afrezza and MNKD. Its all up to Mike and team. IMO, VDex seems to be sitting in the sweet spot providing the missing link between the PWD and the monitoring companies like Onduo and One Drop. Best wishes to all for a great 2018! |
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Post by liane on Dec 31, 2017 11:11:27 GMT -5
Does getting your PCP to refer you to an out of network provider mean that provider is now covered for your treatment? My insurance doesn't require referrals, but if a referral will get me cover for an out of network provider I will start getting them! I think Sayhey and I were talking about Type 2 since Type 1 cannot be be reversed or halted (it self-limits). You are quite right though that diet and exercise will not help with Type 1 unlike Type 2. Historically diet was the treatment for Type 1 and nobody really lived past a year. I would suspect that the vast majority of VDex's patients sought them out. That alone is impressive. The answer is no - Out of Network is Out of Network. The exception might be if there is no provider in network to meet the patient's needs - and I think that would be a tough case to make in managing diabetes. And yes, I know that the protocol promoted by Vdex cannot necessarily be found anywhere else. But the insurance company will likely only view it as diabetes management with no concern for the specific protocol. |
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Post by agedhippie on Dec 31, 2017 12:32:22 GMT -5
Unlike Scheiner who is simply a CDE, VDex is not. They are acting in several roles including afrezza diabetes education and prescribing medical clinic. They are also working in conjunction with PCPs by off loading the new T2s. What the exact business model is, is not clear. I am assuming and maybe incorrectly they are building handshake relationships where the PCP benefits from having an "enhanced" level of care for their PWDs, maintains the PWD as their client yet doesn't have to deal with the details. Now, T1 versus T2 is a separate topic but one of my favorites. As best as I have determined the term T2 was originated by UpJohn segregating diabetics into two classes for sale of their product; candidates for Orinase; and non-candidates. The reality we have in the world of diabetes is those under an active immune attack and those who are not. The question in the latter is how much beta cell damage has been done. Where the damage has been limited there seems to be a great chance of stopping further damage and in some seeing beta cell regeneration. The key seems to be stopping the post meal spike and getting the "T2" back into a non-diabetic range asap. The open question in the former "T1" is what role can keeping that PWD in a very tight range have on limiting the attack? My guess is if we can get early stage LADAs on afrezza we may start getting some good answers. Unfortunately until the CGM IWatch or similar devices are being widely used identifying these people prior to massive beta cell damage is a challenge. Integrated Diabetes Services is a lot more than just Gary Scheiner who in turn is a lot more than "simply a CDE".  When people talk about thought leaders he is one of them in the Type 1 arena and if Mannkind could get IDS to recommend Afrezza it would be significant. Gary Scheiner has been in this area for years and wrote the books that endos recommend. T1 and T2 were identified as separate diseases over 1500 years ago in India. More recently although they were known to be different diseases they were universal treated with insulin. Orinase was the first treatment for Type 2 although metformin was discovered about then as well and used not very widely in Europe (it was another 40 years before the FDA approved it!) The basis for metformin in French Liliac which had been a folk remedy for Type 2 for hundreds of years. I dislike the Type system as it has a lot of shortcomings, but it is widely used. It is a huge over-simplification. Tight control is irrelevant in auto-immune attacks like T1 and LADA. The immune system is targeting the beta cells themselves and levels are irrelevant to that process. During the honeymoon phase you have non-diabetic numbers, but in the background your immune system is still happily wiping out your beta cells. The deciding factor in the differential diagnosis between Type 2 and LADA is antibodies - LADA has them (usually GAD65 and ICA antibodies), Type 2 doesn't. Those antibodies see beta cells as the enemy. |
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Post by sayhey24 on Jan 1, 2018 10:46:53 GMT -5
Unlike Scheiner who is simply a CDE, VDex is not. They are acting in several roles including afrezza diabetes education and prescribing medical clinic. They are also working in conjunction with PCPs by off loading the new T2s. What the exact business model is, is not clear. I am assuming and maybe incorrectly they are building handshake relationships where the PCP benefits from having an "enhanced" level of care for their PWDs, maintains the PWD as their client yet doesn't have to deal with the details. Now, T1 versus T2 is a separate topic but one of my favorites. As best as I have determined the term T2 was originated by UpJohn segregating diabetics into two classes for sale of their product; candidates for Orinase; and non-candidates. The reality we have in the world of diabetes is those under an active immune attack and those who are not. The question in the latter is how much beta cell damage has been done. Where the damage has been limited there seems to be a great chance of stopping further damage and in some seeing beta cell regeneration. The key seems to be stopping the post meal spike and getting the "T2" back into a non-diabetic range asap. The open question in the former "T1" is what role can keeping that PWD in a very tight range have on limiting the attack? My guess is if we can get early stage LADAs on afrezza we may start getting some good answers. Unfortunately until the CGM IWatch or similar devices are being widely used identifying these people prior to massive beta cell damage is a challenge. Integrated Diabetes Services is a lot more than just Gary Scheiner who in turn is a lot more than "simply a CDE". When people talk about thought leaders he is one of them in the Type 1 arena and if Mannkind could get IDS to recommend Afrezza it would be significant. Gary Scheiner has been in this area for years and wrote the books that endos recommend. T1 and T2 were identified as separate diseases over 1500 years ago in India. More recently although they were known to be different diseases they were universal treated with insulin. Orinase was the first treatment for Type 2 although metformin was discovered about then as well and used not very widely in Europe (it was another 40 years before the FDA approved it!) The basis for metformin in French Liliac which had been a folk remedy for Type 2 for hundreds of years. I dislike the Type system as it has a lot of shortcomings, but it is widely used. It is a huge over-simplification. Tight control is irrelevant in auto-immune attacks like T1 and LADA. The immune system is targeting the beta cells themselves and levels are irrelevant to that process. During the honeymoon phase you have non-diabetic numbers, but in the background your immune system is still happily wiping out your beta cells. The deciding factor in the differential diagnosis between Type 2 and LADA is antibodies - LADA has them (usually GAD65 and ICA antibodies), Type 2 doesn't. Those antibodies see beta cells as the enemy. Aged - Gary is not only now using afrezza he is also speaking on it. He started soon after his review integrateddiabetes.com/my-review-of-afrezza-fast-acting-inhaled-insulin/ came out. Gary goes way back with Al Mann as he was one of the first Minimed pump users when he was at Joslin. He waited a few years on afrezza to see if the lung FUD was an issue and came to the conclusion it was a lot of FUD. Back in 1920 Goat's Rue was about all they had. When insulin was discovered it 1921 it quickly became obsoleted. Because of the disaster of Orinase and the rest of the T2 meds Goat's Rue was more or less reborn as Metformin. In the U.S. we have guys like Ralph DeFronzo to thank and now 25 years later what does Ralph say about metformin? “The most waste in type 2 diabetes is to continuously put people on metformin and sulfonylureas (glyburide, glimepiride, etc.). These drugs have no protective effect on the beta cell, and by the time you figure out what you’re doing, there are no beta cells left to save.” – Dr. Ralph DeFronzo (University of Texas Health Science Center) diatribe.org/the-diatribe-foundation-and-tcoyd-11th-annual-forumNow, I don't know the answer to tight control in LADAs. There is growing evidence ALL diabetes is caused by some type of immune attack on the beta cells but its a matter of degree. In a very minor attack we see the aftermath as people who do not recover typically because they are insulin insensitive (obese, non-active, etc.) and we call them T2s who never recover as they spiral out of control over years. Their bodies need a lot of insulin, their pancreas can no longer meet the demands after beta cell damage, works over time and wears out. Metformin does nothing to stop the root cause of the high BG which is the out of control after meal spike due to not having enough insulin. You get the picture, high blood sugar leads to more high blood sugar which requires the remaining beta cells no rest and no time to recover and in the end makes a big mess. We are testing a lot more now than ever before for antibodies and guess what we are finding? Yes more LADAs who a few years ago we would have called T2s. Now, if we test all T2s and had better testing would more and more T2s show some level of some anitbodies? - my guess is yes but it really doesn't matter. What we do know is if we get these people asap when they still have beta cell function and put them on afrezza and keep them in a non-diabetic range for 3 - 6 months most will see positive beta cell results. That's pretty much what VDex is doing. Get them early and get them on afrezza. What do they say "afrezza first, afrezza always"? I am very interested is seeing their clinical findings. Hopefully they will have them available soon. |
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When people talk about thought leaders he is one of them in the Type 1 arena and if Mannkind could get IDS to recommend Afrezza it would be significant. Gary Scheiner has been in this area for years and wrote the books that endos recommend.