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Post by Clement on Jan 12, 2024 11:23:47 GMT -5
At the JP Morgan Healthcare Conference yesterday, slide 6 said that Inhale-1 "interim analysis met DSMB expectations on trial size and safety." So at least there are no delays or problems related to that.
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Post by agedhippie on Jan 12, 2024 16:29:23 GMT -5
At the JP Morgan Healthcare Conference yesterday, slide 6 said that Inhale-1 "interim analysis met DSMB expectations on trial size and safety." So at least there are no delays or problems related to that. I will translate that; so many people haven't dropped out that it has compromised the results, and nobody has died (literally!) The interim analysis is there to ensure that it is ethical to carry on with the trial.
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Post by peppy on Jan 12, 2024 16:40:15 GMT -5
At the JP Morgan Healthcare Conference yesterday, slide 6 said that Inhale-1 "interim analysis met DSMB expectations on trial size and safety." So at least there are no delays or problems related to that. I will translate that; so many people haven't dropped out that it has compromised the results, and nobody has died (literally!) The interim analysis is there to ensure that it is ethical to carry on with the trial. No one in the childhood trial has died, using a medication that adults have used for years. Also not too many people have dropped out. They are type one diabetes, drop out means back to subq. Perhaps their mothers have them in the study because their children do not like subq. ......
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Post by prcgorman2 on Jan 19, 2024 12:03:41 GMT -5
The picture is missing the finger sticks to draw blood to check blood glucose and/or to calibrate CGM (and pump?). I suppose Afrezza won’t get rid of those, but you could have a before and after picture that should probably resonate.
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Post by cedafuntennis on Jan 20, 2024 22:22:18 GMT -5
Unless you have a watch that monitors glucose levels, or a monitoring patch? These are becoming more and more common, and they will eliminate those pricks too.
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Post by prcgorman2 on Jan 22, 2024 8:31:42 GMT -5
Unless you have a watch that monitors glucose levels, or a monitoring patch? These are becoming more and more common, and they will eliminate those pricks too. Very interesting. Not to be disrespectful, but do you have any links to information that those do not require re-calibration using blood samples? I think that would be big.
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Post by agedhippie on Jan 22, 2024 21:17:45 GMT -5
Unless you have a watch that monitors glucose levels, or a monitoring patch? These are becoming more and more common, and they will eliminate those pricks too. Very interesting. Not to be disrespectful, but do you have any links to information that those do not require re-calibration using blood samples? I think that would be big. This is a sore point. The Dexcom G6 and G7, and the all of the Libre range do not require calibration in theory. My experience in practice (and this is my experience YMMV) is that the with Libre about 1 in 5 is accurate and you cannot calibrate to remove that error as they don't support calibration. The G6 is more like 50:50 but these days I always calibrate on start up anyway. The advantage of calibration is that when things are wrong you can fix them while with the Libre you have to remember to mentally adjust every reading. I never recommend Libre for that reason. This issue is more complex than it seems because of the catheter that the sensor inserts which creates a wound. The wound needs to stabilize and for the first couple of days the readings are prone to errors. Also, to prevent inflammation that catheter is coated but the body steadily erodes the coating leading to progressively worse accuracy. All of this is why I happily use calibration despite the adverts saying that it's unnecessary.
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Post by prcgorman2 on Jan 23, 2024 0:00:52 GMT -5
Very interesting. Not to be disrespectful, but do you have any links to information that those do not require re-calibration using blood samples? I think that would be big. This is a sore point. The Dexcom G6 and G7, and the all of the Libre range do not require calibration in theory. My experience in practice (and this is my experience YMMV) is that the with Libre about 1 in 5 is accurate and you cannot calibrate to remove that error as they don't support calibration. The G6 is more like 50:50 but these days I always calibrate on start up anyway. The advantage of calibration is that when things are wrong you can fix them while with the Libre you have to remember to mentally adjust every reading. I never recommend Libre for that reason. This issue is more complex than it seems because of the catheter that the sensor inserts which creates a wound. The wound needs to stabilize and for the first couple of days the readings are prone to errors. Also, to prevent inflammation that catheter is coated but the body steadily erodes the coating leading to progressively worse accuracy. All of this is why I happily use calibration despite the adverts saying that it's unnecessary. Pump loop would have same problem, yes?
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Post by agedhippie on Jan 23, 2024 16:23:30 GMT -5
This is a sore point. The Dexcom G6 and G7, and the all of the Libre range do not require calibration in theory. [Explaining CGM issues and why you want calibration] ...Pump loop would have same problem, yes? Yes, except they use the Dexcom G6 almost exclusively so you can recalibrate. The pump manufacturers have applied for approval for the G7 and Libre 2 Plus, but only Tandem with the t:slim pump has been approved, and the iLet Bionic Pancreas has been approved for the G7 (these went through last month). In reality CGM inaccuracies are less important to pumps than they are for humans because they dose in somewhere between 1 hour and 5 minute chunks whereas if you are dosing yourself you are working in 3 hour chunks (arguably 5 hour with RAA) at best. This short time horizon minimizes the impact of bad readings as a bad reading. TBH the same problem exists with test strips. It's a very long running complaint that meter readings between meters, and even of the same meter, vary from test to test when taken immediately. That's before you look at strip bias - for me OneTouch always tests lower than it should. As you can guess meter brands and their behavior are a source of hours of moaning amongst diabetics.
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Post by sayhey24 on Apr 19, 2024 6:00:44 GMT -5
Sports - I am assuming it is too late to get this girl into the trials but maybe VDex can do something for her? Novo discontinued Levemir and she can't wear a pump playing tennis and can't control her BG with the other basals. It could be some great earned advertising on shows like the View for VDex and afrezza, if afrezza works out for her. More important this girl can probably live a near normal life. www.foxnews.com/health/utah-mom-fights-daughters-access-discontinued-diabetes-medication-life-saving
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Post by agedhippie on Apr 19, 2024 6:29:19 GMT -5
Sports - I am assuming it is too late to get this girl into the trials but maybe VDex can do something for her? Novo discontinued Levemir and she can't wear a pump playing tennis and can't control her BG with the other basals. It could be some great earned advertising on shows like the View for VDex and afrezza, if afrezza works out for her. More important this girl can probably live a near normal life. www.foxnews.com/health/utah-mom-fights-daughters-access-discontinued-diabetes-medication-life-savingAfrezza is a meal time insulin, Levemir is a basal insulin. You cannot replace Levemir with Afrezza as they have different roles.
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Post by prcgorman2 on Apr 19, 2024 7:11:53 GMT -5
Sports - I am assuming it is too late to get this girl into the trials but maybe VDex can do something for her? Novo discontinued Levemir and she can't wear a pump playing tennis and can't control her BG with the other basals. It could be some great earned advertising on shows like the View for VDex and afrezza, if afrezza works out for her. More important this girl can probably live a near normal life. www.foxnews.com/health/utah-mom-fights-daughters-access-discontinued-diabetes-medication-life-savingAfrezza is a meal time insulin, Levemir is a basal insulin. You cannot replace Levemir with Afrezza as they have different roles. You got me thinking about basal versus bolus last night. I started to do some research but it was painful to find what I was looking for. What I wanted to know is if the pancreas essentially leaks insulin (basal) and somewhere it stores some of the leaking basal for a mealtime bolus. Is there an insulin bladder in the pancreas? Or are there some beta cells that hold on to their insulin and then release on demand? I assume all insulin is created equally and it is a simple matter of “background” versus bolus. I am absolutely certain that is too much of an oversimplification, but wondered if it was a directionally correct understanding (or perhaps just hopelessly wrong).
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Post by sayhey24 on Apr 19, 2024 7:37:50 GMT -5
Sports - I am assuming it is too late to get this girl into the trials but maybe VDex can do something for her? Novo discontinued Levemir and she can't wear a pump playing tennis and can't control her BG with the other basals. It could be some great earned advertising on shows like the View for VDex and afrezza, if afrezza works out for her. More important this girl can probably live a near normal life. www.foxnews.com/health/utah-mom-fights-daughters-access-discontinued-diabetes-medication-life-savingAfrezza is a meal time insulin, Levemir is a basal insulin. You cannot replace Levemir with Afrezza as they have different roles. Come on man! Her problem is control. Especially when playing tennis. She is not getting Levemir any more but she can probably use something like Tresiba and not try and control her highs and lows with the basal. Thats afrezza's job after she eats and then its gone. It would be nice to see what VDex could do with her. It would also be nice to get some earned advertising. Here we have a situation which the politicians said they fixed with the $35 insulin. Its clearly a huge issue. IDK but maybe the lady's on the View would have an interest in helping other kids.
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Post by sayhey24 on Apr 19, 2024 9:35:17 GMT -5
Afrezza is a meal time insulin, Levemir is a basal insulin. You cannot replace Levemir with Afrezza as they have different roles. You got me thinking about basal versus bolus last night. I started to do some research but it was painful to find what I was looking for. What I wanted to know is if the pancreas essentially leaks insulin (basal) and somewhere it stores some of the leaking basal for a mealtime bolus. Is there an insulin bladder in the pancreas? Or are there some beta cells that hold on to their insulin and then release on demand? I assume all insulin is created equally and it is a simple matter of “background” versus bolus. I am absolutely certain that is too much of an oversimplification, but wondered if it was a directionally correct understanding (or perhaps just hopelessly wrong). Let me suggest Think Like a Pancreas for you. www.amazon.com/s?k=think+like+a+pancreas&hvadid=598610639709&hvdev=c&hvlocphy=9009844&hvnetw=g&hvqmt=e&hvrand=5211065464376227869&hvtargid=kwd-560493185&hydadcr=15521_13558544&tag=googhydr-20&ref=pd_sl_8l10yb2dx2_eThe pancreas is releasing insulin all the time. At meals a lot more (1st phase release) - this is where afrezza fits. After meals "phase 2" less but more - this is the afrezza follow-up dose we talk about. During fasting periods a little amount in a pulsating fashion all the time until the next meal. This is where the "basal insulin" fits. The pancreas only makes one kind of insulin - human insulin just like afrezza. The basals are not human insulin. They are analogs.
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Post by agedhippie on Apr 19, 2024 10:08:57 GMT -5
Afrezza is a meal time insulin, Levemir is a basal insulin. You cannot replace Levemir with Afrezza as they have different roles. Come on man! Her problem is control. Especially when playing tennis. She is not getting Levemir any more but she can probably use something like Tresiba and not try and control her highs and lows with the basal. Thats afrezza's job after she eats and then its gone. ... This is discussion is beginning to feel like that old saying, if you have a hammer everything looks like a nail. Afrezza will not solve her problem at all. This is nothing to do with eating, it's to do with the interaction between basal insulin and exercise. When you exercise your body burns glucose but your basal insulin still takes the same amount of glucose so there is a deficit and you go low. What she is doing is using Levemir because it is the shortest lasting basal insulin (it lasts about 12 hours) so on days when she is going to play tennis she can take less basal insulin that morning and go back to normal that night (if she was a non-diabetic this would happen automatically). Tresiba would be the worst possible choice for her as it is the longest lasting of all basal insulins, she wants an intermediate basal like Levemir.
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