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Post by hellodolly on Nov 7, 2023 17:41:59 GMT -5
When I am talking about aggressive I mean aggressive. Since all the PWDs will be wearing a CGM I doubt any will go low during fasting. I would also be surprised if we have a lot of "rookies" in this trial. ... I wouldn't expect many rookies either which is why you are not going to get aggressive basal dosing. People tend to get irritable when their CGM wakes them up in the middle of the night to eat glucose tablets because they dosed basal "aggressively". You dose the correct dose, this is really 101 stuff. You also need newer trial data. That article looked at 2014 to 2021, pumps have come a long way in the last couple of years and that's what endos will be comparing with. Yes, the pumps have come a long ways in the last couple of years and to that I say, their improvements really couldn't have come at a better time for MNKD and this study. |
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Post by JEvans on Nov 7, 2023 19:21:37 GMT -5
I wouldn't expect many rookies either which is why you are not going to get aggressive basal dosing. People tend to get irritable when their CGM wakes them up in the middle of the night to eat glucose tablets because they dosed basal "aggressively". You dose the correct dose, this is really 101 stuff. You also need newer trial data. That article looked at 2014 to 2021, pumps have come a long way in the last couple of years and that's what endos will be comparing with. Yes, the pumps have come a long ways in the last couple of years and to that I say, their improvements really couldn't have come at a better time for MNKD and this study. I have two friends on new pumps and are always having issues with them. One goes to the hospital once every couple months it seams. I personally know nothing about them.... |
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Post by agedhippie on Nov 7, 2023 23:08:22 GMT -5
I have two friends on new pumps and are always having issues with them. One goes to the hospital once every couple months it seams. I personally know nothing about them.... I would be curious as to which pumps and what the issues are. I had a meeting today with my endo and he was pushing pumps very heavily, especially the Medtronic 780G. I am procrastinating about going back to a pump after several years, but if they are still problematic... |
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Post by cretin11 on Nov 7, 2023 23:17:27 GMT -5
I have two friends on new pumps and are always having issues with them. One goes to the hospital once every couple months it seams. I personally know nothing about them.... I would be curious as to which pumps and what the issues are. I had a meeting today with my endo and he was pushing pumps very heavily, especially the Medtronic 780G. I am procrastinating about going back to a pump after several years, but if they are still problematic... Perhaps… time to give Afrezza a try, even as part of your regimen? You’ve explained it multiple times, I respect that and apologize for suggesting something that’s none of my business. Just selfishness on my part as I can’t help wondering what your experience and feedback would be if you tried it. |
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Post by sayhey24 on Nov 8, 2023 6:18:33 GMT -5
When I am talking about aggressive I mean aggressive. Since all the PWDs will be wearing a CGM I doubt any will go low during fasting. I would also be surprised if we have a lot of "rookies" in this trial. ... I wouldn't expect many rookies either which is why you are not going to get aggressive basal dosing. People tend to get irritable when their CGM wakes them up in the middle of the night to eat glucose tablets because they dosed basal "aggressively". You dose the correct dose, this is really 101 stuff. You also need newer trial data. That article looked at 2014 to 2021, pumps have come a long way in the last couple of years and that's what endos will be comparing with. If you have better data than 2021, please share. Here is what we know from yesterday "We're using the latest CGM technology with G7 and we're also including 20% of people whose A1c is less than 7". I think my overall 7.3 number is probably pretty good based on Mike's comment. He also said "The INHALE-3 trial is a groundbreaking trial in our mind. It's one of the largest switch trials done, and it's got the new dosing regimen, and I didn't talk about that. But one of the things we got the FDA to agree to is we could basically double the dose up front, and we're testing the first dose in the office to ensure patients' safety and comfort. And we're hopefully able to see, and we've already run those presentations that we are CRUSHING the first two hours of postprandial control." Given that it all comes down to Tresiba dosing. It will also be interesting to see if afrezza cuts down on issues during the middle of the night since the bolus RAA is no longer in the picture. If not I have no problem having them set the alarm at 85 and waking them up. The more they almost go low the better our A1c and we WIN! BTW - didn't we discuss CGMs becoming the standard in these type of trials a few years back and you told me it was never going to happen? I think I remember that. |
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Post by sayhey24 on Nov 8, 2023 6:24:46 GMT -5
I have two friends on new pumps and are always having issues with them. One goes to the hospital once every couple months it seams. I personally know nothing about them.... I would be curious as to which pumps and what the issues are. I had a meeting today with my endo and he was pushing pumps very heavily, especially the Medtronic 780G. I am procrastinating about going back to a pump after several years, but if they are still problematic... Aged - your endo probably heard of the INHALE-3 and how everyone wanted to jump off the pump and get in on this trial. Maybe your endo is getting concerned they won't be selling enough pumps and the free Bahama trips will be ending. Have they mentioned afrezza causing ELS (Exploding Lung Syndrome) lately? What are they saying now about afrezza's lung safety? |
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Post by mango on Nov 8, 2023 8:36:09 GMT -5
We've been saying Time in Range will become the new Gold Standard for years here. A1C is just proxy. You can have a good A1C but terrible TIR. The RAA manufacturers rely on hypoglycemic events to get that low A1C. It's a clever trick, but the cat has been out of the bag for a while.
We've been saying here for years that CGMs will become commonplace in trials to assess glucose homeostasis which is accurately reflected in Time in Range measurements, not A1C. A lot of the past data with RAAs are really misleading because that good A1C was at the expense of patient harm—knowing the hypoglycemic events will be used as an advantageous position for the drug makers' clinical outcomes, which in turn gets funneled into the SoC.
It has all been a clever game, but CGMs are their worst threat because you can see how bad their insulin are with multiple daily injections. We know how bad the Metformin triple therapy TIR is thanks to CGMS. Or is it quadruple therapy now? I've lost count.
Looking forward to the superior Afrezza results in this trial that will change the SoC.
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Post by agedhippie on Nov 8, 2023 18:14:24 GMT -5
I would be curious as to which pumps and what the issues are. I had a meeting today with my endo and he was pushing pumps very heavily, especially the Medtronic 780G. I am procrastinating about going back to a pump after several years, but if they are still problematic... Perhaps… time to give Afrezza a try, even as part of your regimen? You’ve explained it multiple times, I respect that and apologize for suggesting something that’s none of my business. Just selfishness on my part as I can’t help wondering what your experience and feedback would be if you tried it. I am curious, but I know I wouldn't be able to stick with the regimen in the long term. People can tolerate different degrees of interaction with their diabetes and I am at the lower end. |
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Post by agedhippie on Nov 8, 2023 18:27:08 GMT -5
If you have better data than 2021, please share. Look at this paper - Real-World Performance of the MiniMed™ 780G System: First Report of Outcomes from 4120 Users. Those TIR numbers are interesting because they are in the real world and not a trial (trials usually get better results than the real world). Trust me, people will have an issue with being woken up in the middle of the night on a regular basis. The suggestion to aggressively dose basal shows a lack of practical understanding about how basal works and it's implications. |
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Post by agedhippie on Nov 8, 2023 18:28:35 GMT -5
Aged - your endo probably heard of the INHALE-3 and how everyone wanted to jump off the pump and get in on this trial. Maybe your endo is getting concerned they won't be selling enough pumps and the free Bahama trips will be ending. Have they mentioned afrezza causing ELS (Exploding Lung Syndrome) lately? What are they saying now about afrezza's lung safety? I take it this is just trolling because it can't be serious. |
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Post by JEvans on Nov 8, 2023 18:46:10 GMT -5
I would be curious as to which pumps and what the issues are. I had a meeting today with my endo and he was pushing pumps very heavily, especially the Medtronic 780G. I am procrastinating about going back to a pump after several years, but if they are still problematic... Aged - I just texted them and asked them. If/when they respond I will let you know.... |
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Post by JEvans on Nov 8, 2023 21:11:32 GMT -5
Aged - I just texted them and asked them for there pump issues. If/when they respond I will let you know.... Alison, is a dressage trainer approx 39 yrs young - she says My old pump was the most problematic. It had multiple malfunctions in the insulin delivery mechanism. As well as buttons sticking, going out at certain altitudes (on planes) or getting misreads of how much insulin was left in the reservoir. There were also several times I had to get a replacement pump because of cracking of the out plastics in n the pump. My current pump is from Tandem and although it is MUCH MUCH BETTER THAN THE MEDTRONIC, it still has some flaws. Neither pumps adjust after you treat lows and it takes some time for them to register that you have treated the low blood sugar. So they keep sending alerts to say you are low. Oh and a few pretty Big ones for me personally are the efficacy of the insulin through scar tissue. After being on a pump for over 20 yrs I have so much scar tissue on my stomach, thighs, and upper arms that the insulin isn't as effective and the rate of absorption is slowed down immensely. Causing my pump to give me more insulin when it may not be needed. You run out of areas to put your pump port. It has to be changed every three days and the CGM every ten. The build up of scar tissue is pretty bad. You are always attached to tubes. They get caught on everything and will pull out. There are some other pumps that are tubeless but they are quite clunky and would not stay on long with my work, and you have to wear a Fanny pack to hold all your wireless transmitters. The adhesives don’t stay on well at all and require me to buy other out covers to try to help them stay on. Even then it is still so easy to get caught on clothing etc. The cost of all of these things is insane but I think that is all healthcare |
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Post by agedhippie on Nov 8, 2023 21:40:32 GMT -5
...Neither pumps adjust after you treat lows and it takes some time for them to register that you have treated the low blood sugar. So they keep sending alerts to say you are low. ... You run out of areas to put your pump port. It has to be changed every three days and the CGM every ten. The build up of scar tissue is pretty bad. You are always attached to tubes. They get caught on everything and will pull out. There are some other pumps that are tubeless but they are quite clunky and would not stay on long with my work, and you have to wear a Fanny pack to hold all your wireless truild ansmitters. The adhesives don’t stay on well at all and require me to buy other out covers to try to help them stay on. Even then it is still so easy to get caught on clothing etc. The cost of all of these things is insane but I think that is all healthcare Thanks for the post. I was wondering about the Tandem because it only does corrections every hour and it sounds like that lag is problematic. The absorption issue is an area I would have heavily focused on if I was selling Afrezza. People fixate on the needles and speed, but predictable absorption beats those hands down from a real world point of view. If you are getting variable absorption your CGM could be significantly off from where you are about to be (there may or may not be a 60pt drop out there...) I would have to go with tubeless pumps although the ability to physically disconnect the pump with a tubed pump is nice. But catching the tubing on a door handle and having it attempt to rip out the site... That hurts. I have had a pump before (an Animas back when J&J made them) and my reason for getting that was the build quality of the Medtronic pumps. The 780G is meant to be better and that's the one insurers like you taking as Medtronic rebates part of the cost to the insurer if you don't hit certain metrics. |
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Post by harryx1 on Nov 30, 2023 10:23:53 GMT -5
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Post by hellodolly on Nov 30, 2023 10:59:57 GMT -5
This thread is the INHALE-3 for adults, I think your link is to the juvenile study. Was that intentional? Just checking. Link headline : Ultra-fast-acting inhaled insulin, Afrezza, trialed at Norton Children’s Endocrinology. Regardless, a good read. INHALE-3 is a 17-week randomized controlled trial with a 13-week extension. The study will randomly assign participants over 18 years of age with T1D who are using MDI, an automated insulin delivery (AID) system, or a pump without automation to either continue their usual care or adopt an insulin regimen of basal injections plus Afrezza. Both arms will utilize continuous glucose monitoring to assess mealtime control and A1c levels.
“People living with diabetes deserve options and innovation that can reduce burdens and provide impactful glucose control,” said Dr. Irl B. Hirsch, Professor of Medicine and Diabetes Treatment and Teaching Chair at the University of Washington. “As protocol chair for the INHALE-3 study, I am looking forward to working with leading clinical sites across the country to collect meaningful data regarding the use of inhaled insulin.”
Approximately 120 patients will be randomized in the study conducted in collaboration with the Jaeb Center for Health Research and 20 sites across the country, including the Joslin Diabetes Center, the Barbara Davis Center for Diabetes, the University of Washington Diabetes Institute, Northwestern University, Mayo Clinic, and University of North Carolina Diabetes Care Center. |
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