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Post by shawnonafrezza on Dec 13, 2019 17:53:28 GMT -5
"Aged - it doesn't matter if its one PWD or 1000 PWDs, afrezza with a CGM and second dosing when needed will always win."
Uhhhh, those are some fighting words that I promise you can't back up. We can get the whole JAEB study for DIY loop and compare it to a few Twitter posts if you want. Can do the T1GRIT study too.
There's a good 8 hour chunk (1/3 of the day) of the day people are asleep and can't dose at all. I mean in this thread we have a picture of an afrezza user at 270mg/dl! Just that one excursion put them out of range for 12.5% of the day and every T1 knows how that drop from 270-110 in 60 minutes is going to leave them feeling for the next 12 hours.
"Who wants to be a human pin cushion?"
Ironic since the CGM is still a wire in you... Have you seen the gushers people get from the dexcom?!
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Post by lennymnkd on Dec 13, 2019 18:00:58 GMT -5
Sens? No wires.." what now
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Post by shawnonafrezza on Dec 13, 2019 18:04:18 GMT -5
Sens? No wires.." what now Instead you get 7-14 days of inaccurate readings post insertion, failure in sunlight, scaring, less accurate than the G6, unable to change by yourself, and yet another thing that most insurance companies won't cover. I know of 4 people who tried it, all went back to the G6. Really curious on the overlap of MNKD vs SENS investors. One is a pretty awesome idea, the other is "eh" and not necessary and if anything worse. EDIT - Just found out you can't use local pain killers for the incision too. Good luck with kids.
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Post by sportsrancho on Dec 13, 2019 19:13:06 GMT -5
Because Laura K swears by both products.
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Post by rfogel on Dec 13, 2019 19:20:11 GMT -5
Sens? No wires.." what now Instead you get 7-14 days of inaccurate readings post insertion, failure in sunlight, scaring, less accurate than the G6, unable to change by yourself, and yet another thing that most insurance companies won't cover. I know of 4 people who tried it, all went back to the G6. Really curious on the overlap of MNKD vs SENS investors. One is a pretty awesome idea, the other is "eh" and not necessary and if anything worse. EDIT - Just found out you can't use local pain killers for the incision too. Good luck with kids. Where did you see you can't you can't use a local anesthetic for insertion of the SENS CGM? Just published a few weeks ago in "Diabetes Technology and Therapeutics": www.senseonics.com/~/media/Files/S/Senseonics-IR/documents/publications/DTT_Longitudinal_Analysis_Real-WorldPerformance_110719.pdf"Longitudinal Analysis of Real‐World Performance of an Implantable Continuous Glucose Sensor Over Multiple Sensor Insertion and Removal Cycles" There it says: "In a 6‐month time period, the 180‐day Eversense System is inserted and removed once whereas a short‐term, 14‐day device would need to be inserted and removed 12 times. The office‐based insertion and removal procedure on average takes less than 5 to 10 minutes and only requires local injection of lidocaine and a small, 5 mm incision that is closed without sutures." There is also no mention of scarring. Indeed, how much scarring could there be from a single 5 mm incision closed without sutures? As far as patients abandoning the device: "Patients have shown their preference for Eversense in two prior clinical studies, where surveys showed that over 80% of patients, 45% of whom had used other CGM systems, wanted to be re‐inserted with another sensor, demonstrating the acceptance and usability of the Eversense System (14, 25). In free‐form responses using the CGM satisfaction scale, many patients cited freedom from having to replace the CGM weekly as a positive attribute (14). In addition, in a large registry of the long‐term safety of Eversense over multiple sensor insertion and removal cycles, only 11% of patients had discontinued the Eversense System by the last follow up reported, with the predominant reasons for discontinuation cited as lack of medical reimbursement or temporary discontinuation of prescription order." Imagine what afrezza script numbers would look like if only 11% of patients discontinued it. For how well it performs: "PERFORMANCE SUMMARY Time in Range – 63-64% of time spent between 70-180 mg/dL demonstrating promising and durable time in range throughout multiple sensor wear cycles Estimated A1c* – 7.0-7.1 over 4 sensor cycles demonstrating sustained real-world glycemic control Wear Time – 83.2% to 85.8% median wear time across all 4 sensor cycles confirming patient adherence to the device over a multi-cycle wear periods including almost 1300 patient-years of real-world follow-up. Sustained Excellent performance – demonstrating sustained accuracy from sensor 1 through sensor 4 with no deterioration over time. These data show the ability of Eversense to consistently perform over multiple cycles of sensor wear for up to 2 years duration." Studies have already demonstrated the device is every bit as accurate as anything Dexcom has to offer and the FDA has approved it for patients to use in determining their insulin dose. For cost, every few months SENS releases further info about more approvals -- e.g.: www.senseonics.com/investor-relations/news-releases/2019/10-14-2019-210445457"Senseonics Announces a Positive Coverage Decision for Eversense CGM from Health Care Service Corporation - Blue Cross Blue Shield of Illinois, Montana, New Mexico, Oklahoma and Texas" And SENS has a program to support those without coverage: www.mobihealthnews.com/content/senseonics-launches-program-low-cost-eversense-cgm-systems"Senseonics launches program for low-cost Eversense CGM systems The new program, geared toward patients with high deductible insurance plans or plans that don't cover the full cost of Eversense CGM, can purchase the system for $99." As far as sunlight, the solution is as simple as covering it -- per Amy Tenderich: www.healthline.com/diabetesmine/eversense-implantable-cgm-alerts-insertion-cost-trials#1"Eversense Implantable CGM Updates: Alerts, Insertion, Cost, Clinical Trials...if you know you’ll be out in bright light, you can simply double-up white adhesive patches to give the sensor more shade."
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Post by shawnonafrezza on Dec 13, 2019 19:52:16 GMT -5
I mean, you can post all you want but I'm part of the FB group and many d forums. As normal happy people are less likely to post but like Afrezza the numbers don't lie. If the eversense was that great and the patients loved it why are they struggling? Look at real world use, not the studies.
The 99$ thing is for a one time bridge, so 3 months in the US. Whoopie.
Sunlight? Oh, beach doesn't count, can't wear tanks (I live in SoCal) either. Ok.
If it's so good I expect to google "SENS stock" and see how well it's being received right? If it's doing well and patients love it shouldn't that be positive? Down to 34% of what it started the year with. Like with Afrezza you can point to all you want but then you go talk to the PWD out there and this is the reality. The cost/convince just isn't there. I don't really care one way or another, I take it you probably have money in them too so I'm sorry about that. But I'll still speak my mind and my overall reflection on how the community reacts/reacted to the device.
They get cheaper/more insurance and fix the sunlight thing as well as getting the 180 or 365 day version in the US and they'll have an actual selling point IMO. Also pump integrations. I've said it all over this board but partnerships and integrations matter. People stay on the tslim because of the g6 integration. Companion medical is pulling in people with their G6 integration. Tidepool is built around it and both Dexcom, Insulet, and Medtronic will benefit. You all are fighting uphill with two lone wolves.
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Post by akemp3000 on Dec 13, 2019 20:05:24 GMT -5
This is a excellent thread showing the paradigm shift in real time that's moving diabetics toward CGMs and Afrezza. I can't wait for pediatric approval. This is the biggest and most monumental and transitional period for diabetics in decades. Let the negativity and bashers continue with their arguments. The science already shows they can't win. The challenge to get the message out remains but it's now down to a matter of time.
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Post by sellhighdrinklow on Dec 13, 2019 20:58:03 GMT -5
"Aged - it doesn't matter if its one PWD or 1000 PWDs, afrezza with a CGM and second dosing when needed will always win." Uhhhh, those are some fighting words that I promise you can't back up. We can get the whole JAEB study for DIY loop and compare it to a few Twitter posts if you want. Can do the T1GRIT study too. There's a good 8 hour chunk (1/3 of the day) of the day people are asleep and can't dose at all. I mean in this thread we have a picture of an afrezza user at 270mg/dl! Just that one excursion put them out of range for 12.5% of the day and every T1 knows how that drop from 270-110 in 60 minutes is going to leave them feeling for the next 12 hours. "Who wants to be a human pin cushion?" Ironic since the CGM is still a wire in you... Have you seen the gushers people get from the dexcom?! If you arent floating for hours at 270, the drop back into range quickly has no negative impact on how one feels. Afrezza is a no brainer. Mr. Flynn. Tou are a Type 1?
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Post by shawnonafrezza on Dec 13, 2019 21:43:20 GMT -5
"Aged - it doesn't matter if its one PWD or 1000 PWDs, afrezza with a CGM and second dosing when needed will always win." Uhhhh, those are some fighting words that I promise you can't back up. We can get the whole JAEB study for DIY loop and compare it to a few Twitter posts if you want. Can do the T1GRIT study too. There's a good 8 hour chunk (1/3 of the day) of the day people are asleep and can't dose at all. I mean in this thread we have a picture of an afrezza user at 270mg/dl! Just that one excursion put them out of range for 12.5% of the day and every T1 knows how that drop from 270-110 in 60 minutes is going to leave them feeling for the next 12 hours. "Who wants to be a human pin cushion?" Ironic since the CGM is still a wire in you... Have you seen the gushers people get from the dexcom?! If you arent floating for hours at 270, the drop back into range quickly has no negative impact on how one feels. Afrezza is a no brainer. Mr. Flynn. Tou are a Type 1? Yes. For 15 years and an afrezza user. We established that earlier when I said you pulled a dick move.
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Post by rfogel on Dec 13, 2019 22:13:57 GMT -5
I mean, you can post all you want but I'm part of the FB group and many d forums. As normal happy people are less likely to post but like Afrezza the numbers don't lie. If the eversense was that great and the patients loved it why are they struggling? Look at real world use, not the studies. The 99$ thing is for a one time bridge, so 3 months in the US. Whoopie. Sunlight? Oh, beach doesn't count, can't wear tanks (I live in SoCal) either. Ok. If it's so good I expect to google "SENS stock" and see how well it's being received right? If it's doing well and patients love it shouldn't that be positive? Down to 34% of what it started the year with. Like with Afrezza you can point to all you want but then you go talk to the PWD out there and this is the reality. The cost/convince just isn't there. I don't really care one way or another, I take it you probably have money in them too so I'm sorry about that. But I'll still speak my mind and my overall reflection on how the community reacts/reacted to the device. They get cheaper/more insurance and fix the sunlight thing as well as getting the 180 or 365 day version in the US and they'll have an actual selling point IMO. Also pump integrations. I've said it all over this board but partnerships and integrations matter. People stay on the tslim because of the g6 integration. Companion medical is pulling in people with their G6 integration. Tidepool is built around it and both Dexcom, Insulet, and Medtronic will benefit. You all are fighting uphill with two lone wolves. First, as to as going to the beach, is it really all that difficult to "double-up white adhesive patches"? And if you want "real world" data: www.senseonics.com/~/media/Files/S/Senseonics-IR/documents/publications/DTT_RealWorldData_FirstUS_Users_082819.pdf"Real-World Data from the First U.S. Commercial Users of an Implantable Continuous Glucose Sensor... ...In conclusion, the 90-day implanted Eversense CGM system appears to be a valuable and safe tool for management of diabetes with patients reinserting and using the device the majority of the time. Its use was associated with low rates of hypoglycemia and glycemic variability as measured by CV, and a favorable time in the target range in these initial patients. The Eversense CGM should be considered as an appropriate CGM system for those patients and providers wishing to improve diabetes outcomes." And Dexcom? Well, let's compare. Dexcom was founded 20 years ago; SENS only 8 years ago. Dexcom went public 14 years ago at around $10 a share. Three years later it was trading at $2.00 a share -- an 80% loss for those who sold. It didn't even get back to its offering price until three more years after that. SENS went public at $3 a share just 3 years ago. Trading at $1 now translates into a 67% loss -- at least a little better than where Dexcom stood at 3 years. Also, so far SENS has partnered with Geo-med, Beyond Type 1, Glooko, Beta Bionics, and R2Integrated. And not to be forgotten is the distribution agreement with Roche -- "a global leader in integrated diabetes management." How many partners did Dexcom have three years after its IPO? Then consider, three years after its IPO, Dexcom was reporting around 2 million in revenues a quarter. Three years after its IPO SENS is reporting about 5 million a quarter. In regards the bridge program, for $99 plus the cost of placing the device, you get 90 days of Eversense CGM service. How much would 90 days G6 service cost? Well a transmitter plus a month's supply of sensors costs $500; then you need $700 for two more months worth of sensors so the total cost of 90 days is $1,200. Dexcom does offer assistance to the tune of saving you a whopping $140 -- https://dexcom.pskw.com So the net would be $1,060. I'd say SENS deserves the kudos in terms of cost. It might also be worthwhile to review some of the threads on tudiabetes the past couple of weeks: "G6 adhesive not as good as before? Medicare No Longer Covers Test Strips for G6 Users The dread G6 session-restart block is here Just started Dexcom G6 - all readings incorrect Dexcom Share servers are down Dexcom’s latest comment regarding Medicare patients staying on the G5 [now mandatory to upgrade to the G6]" Don't exactly sound like a group of satisfied customers.
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Post by agedhippie on Dec 14, 2019 9:52:10 GMT -5
... In regards the bridge program, for $99 plus the cost of placing the device, you get 90 days of Eversense CGM service. How much would 90 days G6 service cost? Well a transmitter plus a month's supply of sensors costs $500; then you need $700 for two more months worth of sensors so the total cost of 90 days is $1,200. Dexcom does offer assistance to the tune of saving you a whopping $140 -- https://dexcom.pskw.com So the net would be $1,060. I'd say SENS deserves the kudos in terms of cost. It might also be worthwhile to review some of the threads on tudiabetes the past couple of weeks: "G6 adhesive not as good as before? Medicare No Longer Covers Test Strips for G6 Users The dread G6 session-restart block is here Just started Dexcom G6 - all readings incorrect Dexcom Share servers are down Dexcom’s latest comment regarding Medicare patients staying on the G5 [now mandatory to upgrade to the G6]" Don't exactly sound like a group of satisfied customers. It is possible to run a Dexcom at a lot lower cost provided you don't use their app. I use xDrip and restart both sensors and transmitters. The transmitter lasts around 6 months like that, and the sensors last between 14 and 20 days. The FDA don't approve of this because you cannot tell exactly when either the transmitter or sensor will die so the FDA fix that by making it shutdown when it's half used (Dexcom don't mind because they sell twice as many). My last transmitter lasted 187 days rather than the 90 days Dexcom and the FDA say it should. That session restart block has already been hacked in xDrip and you can bypass it. Cost aside restart makes sense as there is a period of a couple of days where inflammation from the insertion makes the readings less reliable - Dexcom have routines in the CGM to compensate for the trauma. There is some talk of them using the trauma to detect restarts - if there is no trauma then it's a restart so kill the sensor. Common painkillers have long been a problem. The G6 is the first Dexcom sensor that doesn't react badly to Tylenol, and the Libre reacts badly to aspirin. They give inaccurate readings for several hours afterwards. I am not sure if the Sens has any issues in that area. I do have one friend who is staying on the G5 because they get better results. This is a good example of all diabetics not being the same (I get far better results with the G6).
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Post by agedhippie on Dec 14, 2019 9:55:30 GMT -5
This is a excellent thread showing the paradigm shift in real time that's moving diabetics toward CGMs and Afrezza. I can't wait for pediatric approval. This is the biggest and most monumental and transitional period for diabetics in decades. Let the negativity and bashers continue with their arguments. The science already shows they can't win. The challenge to get the message out remains but it's now down to a matter of time. There is an old trader saying; the market can remain irrational longer than you can remain solvent. Just because something should does not mean it will.
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Post by sayhey24 on Dec 14, 2019 11:39:08 GMT -5
"Aged - it doesn't matter if its one PWD or 1000 PWDs, afrezza with a CGM and second dosing when needed will always win." Uhhhh, those are some fighting words that I promise you can't back up. We can get the whole JAEB study for DIY loop and compare it to a few Twitter posts if you want. Can do the T1GRIT study too. There's a good 8 hour chunk (1/3 of the day) of the day people are asleep and can't dose at all. I mean in this thread we have a picture of an afrezza user at 270mg/dl! Just that one excursion put them out of range for 12.5% of the day and every T1 knows how that drop from 270-110 in 60 minutes is going to leave them feeling for the next 12 hours. "Who wants to be a human pin cushion?" Ironic since the CGM is still a wire in you... Have you seen the gushers people get from the dexcom?! Mr. Flynn - I sense there is some confusion on your part. afrezza is a 2 hour insulin. Looking at the results of a single dose past 2.5 hours is meaningless but after 2 hours its done. Lets say your FG is 100 at 5pm, you eat and dose afrezza the question is whats your BG at 7pm? In an ideal world it would back to your baseline 100. The assumption with the T2 is the pancreas has enough function to keep it at that until the next meal. If the next meal is 8am the next morning then the BG should be no higher than 100 but in a non-diabetic will be at 87+-. Could it be lower than the 100 sure if the pancreas is producing enough insulin. If the T2 is not making enough insulin to offset liver sugar production thats a whole other ball of wax. At that point they have really transitioned to a T1. In reality diabetes is on a continuum and the terms T1 and T2 are pretty meaningless. What has to be known is how much insulin is being produced during fasting and that will change on an individual basis. This is what Ralph DeFronza was talking about in his quote. The goal with afrezza is to get the T2 back to baseline within 2 hours. If they are not then second dose. If the baseline is 100 then they should be back to baseline. Worst case they are down under 140 because thats when vascluar degeneration starts happening. The studies you reference are about T1's who are not producing enough insulin during the fasting period, let alone for meals. The goal of the loop is to keep the T1 at a steady baseline. What complicates things is when they eat. So, the loop tries to release more RAA for the meals. Well, the problem is the RAA is too damn slow. As a result the best results which have been gotten is using afrezza for meals and the loop after the 2 hours when afrezza is gone. The thing is whats the real value of a complex loop when l you really need is afrezza and a patch pump? I think the Yale study is proving this again.
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Post by agedhippie on Dec 14, 2019 12:27:22 GMT -5
Mr. Flynn - I sense there is some confusion on your part. afrezza is a 2 hour insulin. Looking at the results of a single dose past 2.5 hours is meaningless but after 2 hours its done. ... The studies you reference are about T1's who are not producing enough insulin during the fasting period, let alone for meals. The goal of the loop is to keep the T1 at a steady baseline. What complicates things is when they eat. So, the loop tries to release more RAA for the meals. Well, the problem is the RAA is too damn slow. As a result the best results which have been gotten is using afrezza for meals and the loop after the 2 hours when afrezza is gone. The thing is whats the real value of a complex loop when l you really need is afrezza and a patch pump? I think the Yale study is proving this again. What you are doing here is looking at the component of the system. I can have the best brakes in the world on a car, but if the tires are bad then it really doesn't matter. Your argument is that Afrezza is really good over two hours and it's unfair to consider beyond that, but in the real world you must consider beyond that because it's part of a bigger system. So now you are introducing the need for second and possibly third doses. That's a lot of work and you see the result reflected in studies like STAT - people only took a single dose because they had other things to do. T1 diabetics by definition never produce enough insulin to hold them during a fasted state, that's why we have basal insulin. so I am not sure what the point is. The loop continually dispenses RAA to cover that basal requirement based on the CGM. The algorithm looks ahead to see what the need is and by using very small doses avoids going off course (it's easy to correct small variances). As to the impossibility of a loop system outperforming Afrezza the Medtronics 670G already does that today. If you compare the best group from STAT (two doses per meal) they fall short of the Medtronics results, and that's the entire 670G group with no cherry picking. The Medtronics 780G that is released next year had an 80% TIR in trials, again with big groups and long term trials. The idea that technology cannot compensate for RAA speed of action is simply out-dated. Would faster insulin be even better - definitely, but it is not necessary. Finally (sighs of relief from the readers), You need Afrezza, a patch pump (I assume you mean like a Omnipod), and a CGM at which point you have most of the components of a loop, just add a phone and drop the Afrezza - job done.
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Post by lennymnkd on Dec 14, 2019 13:06:07 GMT -5
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