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Post by uvula on Nov 25, 2024 12:48:38 GMT -5
The "goal" is an a1c of 7, not because it is ideal but because it is achievable and won't cause too many hypos. 80% of people with an AID can hit this goal.
If the goal was set to 5.5 (i.e. normal for people w/o diabetes), would 80% of AID users be able to hit this? Would Afrezza br superior to AIDs at hitting this target?
In my nomedicalbackground opinion, for peds an A1C of 7 is bad but for adults it might not be that bad because it takes many years for the damage to happen.
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Post by agedhippie on Nov 25, 2024 17:40:01 GMT -5
Having watched my 8 y/o granddaughter live with a pump for the last year, I would say there is nothing easy about it. It's always there, connected to her body, sitting in a fanny pack that must always be worn. It hinders movement and must be removed for activities involving water.
Furthermore, with two savvy parents (both are veterinarians), and a medical team from a major children's hospital, BG control looks pretty bad to me. I'm not privy to everything that her parents are, but it sure seems like there are frequent highs and lows. The pump sometimes delivers "extended boluses" (an oxymoron) which mean that insulin is still present many hours later, and must be fed. Never-ending adjustments are necessary.
BG control aside, using Afrezza would appear to me to be far easier than an AID pump. Yes, my sample size is small, and I don't have a coterie of other diabetics as AH does, and I don't have real world experience with Afrezza. But there are legions of PWDs on the internet who have exquisite control with Afrezza, and I'm heartened by VDEX's apparent mastery of it. Maybe that kind of control is possible with an AID, but there can't be anything "easy" about it.
I would love to hear more from Bill McCullough or Sports about their experiences, and particularly whether follow-up doses are common once Afrezza is mastered. This is why Omnipod 5 is pretty much the pump of choice for kids as Mike commented on the UBS call. It's a patch pump so no fanny pack or tubes, and it's waterproof so you can swim, shower, and generally get wet with it. It sounds like she either has a Tandem or a Medtronic which don't have those properties. As to BG control I suppose the question is whether she has an AID pump, or one of the earlier pumps. If the former then the hospital really should be able to dial in the numbers, if an earlier pump then it's a lot harder. An extended bolus is essential for earlier pumps because it lets you spread out your insulin for food that is slower to digest without needing follow up doses (this is another reason why I suspect it's not an AID pump as they handle that transparently). If you think how fatty food makes you take a second dose with Afrezza because it clears before the food finishes digesting - that is what an extended bolus does. I would hesitate to use the internet as a representative sample, there are those (Flatliners) who keep their levels between 120 and 70 with pens! Anything is possible if you put in the work. The reason endos like the sort of study companies like Medtronic publish is because the large population size (thousands of users) lets them see what an average user can achieve.
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Post by agedhippie on Nov 25, 2024 17:46:45 GMT -5
The "goal" is an a1c of 7, not because it is ideal but because it is achievable and won't cause too many hypos. 80% of people with an AID can hit this goal. If the goal was set to 5.5 (i.e. normal for people w/o diabetes), would 80% of AID users be able to hit this? Would Afrezza br superior to AIDs at hitting this target? In my non-medical background opinion, for peds an A1C of 7 is bad but for adults it might not be that bad because it takes many years for the damage to happen. The problem with kids, and why they are treated separately from adults is because their bodies are changing hugely and that makes stability tricky because of the associated hormones. They will be kids so eating (or not) and dosing, or violent exercise are all expected, and all out of the sight of their parents.
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Post by longliner on Nov 26, 2024 1:15:10 GMT -5
It's really difficult in todays environment to find minimum wage daycare folks willing to stick needles in children.
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Post by longliner on Nov 26, 2024 1:42:43 GMT -5
Pediatrics and gestational are going to open the floodgates, welcome aboard parents of diabetic children! Lets put an end to kids being excluded from daycare due to the need for mealtime injections. Show me the pregnant women that would prefer injections to inhalations and I will laugh you off the board! Power in numbers folks, positive change is a tsunami! Why do you suppose pregnant women are going to feel that way. Seems only small numbers of people are so needle phobic that they don't very quickly get over using modern insulin pens. I'm curious what you are basing what appears to be a very strong conviction. Granted I'm not a woman and will never be pregnant, but I'm pretty sure it wouldn't bother me in the least to use injected insulin if the medical situation warranted. I think there may be arguments that Afrezza would have benefits for gestational use, just not the mere fact it's not an injection. Though as usual, success will depend on convincing PBMs to cover it. You pose a fair question. Let's have people weigh in. Would a pregnant woman prefer for (appx. 6 months of her pregnancy) to get multiple shots daily (something she would arguably not be familiar with? nor her spouse.) Or simply inhale and enjoy each meal? Silly me! I go for occam's razor. Ha, ha, ha, ha, ha, ha, etc, etc, etc, ad nauseum!
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Post by ktim on Nov 26, 2024 9:06:30 GMT -5
Hmmm... still don't get it. How well are Ozempic and Wegovy selling? Though I guess we're both just looking at our own perspective. Using an insulin pen doesn't seem at all bothersome to me. I guess you believe that would be "unknown" "scary" or whatever... or that women would perceive it that way. I'm imagining a women isn't going to think a 32 gauge needle that can barely be felt would be the daunting part of pregnancy and child birth. Maybe the women in our lives are very different, lol.
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Post by agedhippie on Nov 26, 2024 9:46:53 GMT -5
... I'm imagining a women isn't going to think a 32 gauge needle that can barely be felt would be the daunting part of pregnancy and child birth. Maybe the women in our lives are very different, lol. Needles are an irrelevance, always have been since pens arrived. Maybe in the old days when you had to use syringes but even then it was more about having to draw up the insulin. These days using a pen with 4mm 34 gauge needles it's a non-event. Afrezza is never going to breakthrough on the idea that needles matter as we have seen. I entirely understand how needles look to a non-diabetic, they looked like that to me pre-diagnosis, but you rapidly realize they don't matter. The reason you would want to use Afrezza during pregnancy is that it gives better control. A key aim in diabetes is to keep a range of 80 - 125 most of the time. This can be done with pens, but it means changing your diet by going low carb and even then is a lot of work. Afrezza would still be a lot of work, but the fast onset will make it easier to limit excursions that could get away from you with RAA.
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Post by daisyz on Nov 26, 2024 10:07:38 GMT -5
AID's will be replaced if the patient is not at GOAL. Remember Mike said 70% are NOT. Any sane doctor will consider it if the DATA is strong. Afrezza's BIGGEST PROBLEM was DOSING. That has been corrected. That's why MNKD needs a Partner will brains and muscle. NOVO?? Sanofi?? I can see a Afrezza/Tresiba COMBO. Keep things easy for diabetics. That patient data is out of data. For the Medtronic 780G in the real world across 4,000+ users 79% are at goal . From the paper, " There were 77.3% and 79.0% of users who achieved a TIR >70% and a GMI of <7.0%, respectively" (GMI is equivalent to HbA1c but taken from a CGM rather than estimated from the blood test). That is typical for the current generation of AID pump. An AID pump lets you have less injections with less work than the Afrezza/Tresiba combo. The pump is definitely easier. If you don't want to use a pump for some reason (and there are a few!) then it's a different story. How would you know that a pump is easier than Afrezza? You have never used Afrezza, correct?
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Post by casualinvestor on Nov 26, 2024 12:40:14 GMT -5
... I'm imagining a women isn't going to think a 32 gauge needle that can barely be felt would be the daunting part of pregnancy and child birth. Maybe the women in our lives are very different, lol. Needles are an irrelevance, always have been since pens arrived. Maybe in the old days when you had to use syringes but even then it was more about having to draw up the insulin. These days using a pen with 4mm 34 gauge needles it's a non-event. Afrezza is never going to breakthrough on the idea that needles matter as we have seen. I entirely understand how needles look to a non-diabetic, they looked like that to me pre-diagnosis, but you rapidly realize they don't matter. The reason you would want to use Afrezza during pregnancy is that it gives better control. A key aim in diabetes is to keep a range of 80 - 125 most of the time. This can be done with pens, but it means changing your diet by going low carb and even then is a lot of work. Afrezza would still be a lot of work, but the fast onset will make it easier to limit excursions that could get away from you with RAA. My wife uses pens for bi-weekly medication. She hates it. Also, the way it looks to us non-diabetics is the same way it's going to look to a woman who just got told she has gestational diabetes and has to take this medication for several months. Is the biggest benefit tight control (high and lows) or less hypos?
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Post by sayhey24 on Nov 26, 2024 13:25:50 GMT -5
Having watched my 8 y/o granddaughter live with a pump for the last year, I would say there is nothing easy about it. It's always there, connected to her body, sitting in a fanny pack that must always be worn. It hinders movement and must be removed for activities involving water.
Furthermore, with two savvy parents (both are veterinarians), and a medical team from a major children's hospital, BG control looks pretty bad to me. I'm not privy to everything that her parents are, but it sure seems like there are frequent highs and lows. The pump sometimes delivers "extended boluses" (an oxymoron) which mean that insulin is still present many hours later, and must be fed. Never-ending adjustments are necessary.
BG control aside, using Afrezza would appear to me to be far easier than an AID pump. Yes, my sample size is small, and I don't have a coterie of other diabetics as AH does, and I don't have real world experience with Afrezza. But there are legions of PWDs on the internet who have exquisite control with Afrezza, and I'm heartened by VDEX's apparent mastery of it. Maybe that kind of control is possible with an AID, but there can't be anything "easy" about it.
I would love to hear more from Bill McCullough or Sports about their experiences, and particularly whether follow-up doses are common once Afrezza is mastered. This is why Omnipod 5 is pretty much the pump of choice for kids as Mike commented on the UBS call. It's a patch pump so no fanny pack or tubes, and it's waterproof so you can swim, shower, and generally get wet with it. It sounds like she either has a Tandem or a Medtronic which don't have those properties. As to BG control I suppose the question is whether she has an AID pump, or one of the earlier pumps. If the former then the hospital really should be able to dial in the numbers, if an earlier pump then it's a lot harder. An extended bolus is essential for earlier pumps because it lets you spread out your insulin for food that is slower to digest without needing follow up doses (this is another reason why I suspect it's not an AID pump as they handle that transparently). If you think how fatty food makes you take a second dose with Afrezza because it clears before the food finishes digesting - that is what an extended bolus does. I would hesitate to use the internet as a representative sample, there are those (Flatliners) who keep their levels between 120 and 70 with pens! Anything is possible if you put in the work. The reason endos like the sort of study companies like Medtronic publish is because the large population size (thousands of users) lets them see what an average user can achieve. One thing I will say is you sure do like pumps. I know a lot of people 20 years ago who loved their "land lines" who only have cell phones now. One thing about the kids trial is if afrezza was not working well or the kids did not like it we should be seeing large drop out rates. I doubt the moms would be sticking with a trial for their kids if they did not see a benefit. Based on Mike's comments it does not seem like they are seeing a large drop out rate. IMO, a 50% drop out rate with the kids would be a success because these moms are not going to be wanting worse care for their kids and are not going to continue the trial if things are not working out well. IDK but it sure does not seem they are even close to 50%. On the subject of drop out rates I did see this article which I thought was interesting and may just be the leverage for afrezza in the T2 market. I knew it was high but this surprised me - nearly 60% of the people taking GLP1 drugs – including Ozempic and Mounjaro for diabetes and Wegovy and Zepbound for obesity – stop treatment before 12 weeks. I think its time for "Inhale 4" - the afrezza/glp1 study. I would be more than willing to pick up 60% of the GLP1 market and with better meal time BG control. www.cnn.com/2024/11/16/health/after-ozempic-maintaining-weight-loss/index.html
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Post by mpg54 on Nov 26, 2024 15:30:57 GMT -5
... I'm imagining a women isn't going to think a 32 gauge needle that can barely be felt would be the daunting part of pregnancy and child birth. Maybe the women in our lives are very different, lol. Needles are an irrelevance, always have been since pens arrived. Maybe in the old days when you had to use syringes but even then it was more about having to draw up the insulin. These days using a pen with 4mm 34 gauge needles it's a non-event. Afrezza is never going to breakthrough on the idea that needles matter as we have seen. I entirely understand how needles look to a non-diabetic, they looked like that to me pre-diagnosis, but you rapidly realize they don't matter. The reason you would want to use Afrezza during pregnancy is that it gives better control. A key aim in diabetes is to keep a range of 80 - 125 most of the time. This can be done with pens, but it means changing your diet by going low carb and even then is a lot of work. Afrezza would still be a lot of work, but the fast onset will make it easier to limit excursions that could get away from you with RAA. Hmmm… with the potential for scar tissue buildup over years. How can they be irrelevant? Pens wouldn’t eliminate that? Maybe lessen it a bit. Jabbing yourself several times a day like a human pin cushion, no thanks. I’d want to reduce that in anyway I could and I’m not needle phobic.
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Post by hopingandwilling on Nov 26, 2024 15:38:38 GMT -5
You State:
"One thing about the kids trial is if afrezza was not working well or the kids did not like it we should be seeing large drop out rates."
If you are seeing high dropout rates,then you just stop the trial---you can't run a clinical trial with any value if you are constantly refilling the patients in the trial. A valid trial must not game the system with just adding new patients.
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Post by prcgorman2 on Nov 26, 2024 16:15:05 GMT -5
Now its a party.
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Post by agedhippie on Nov 26, 2024 17:38:09 GMT -5
... An AID pump lets you have less injections with less work than the Afrezza/Tresiba combo. The pump is definitely easier. If you don't want to use a pump for some reason (and there are a few!) then it's a different story. How would you know that a pump is easier than Afrezza? You have never used Afrezza, correct? Because Afrezza is MDI and I want something that is less work than MDI. I started on an Omnipod pump last week so I will see if my assessment was right.
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Post by agedhippie on Nov 26, 2024 17:40:44 GMT -5
My wife uses pens for bi-weekly medication. She hates it. Also, the way it looks to us non-diabetics is the same way it's going to look to a woman who just got told she has gestational diabetes and has to take this medication for several months. Is the biggest benefit tight control (high and lows) or less hypos? Tighter control, which implies less hypos. It's being able to keep in that 70 - 125 band as much as possible.
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