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Post by madog365 on Aug 18, 2016 12:28:07 GMT -5
"The FDA's efforts to help advance the development of an artificial pancreas device system are multifaceted. The agency refers to these devices as automated insulin delivery devices. An automated insulin delivery device automatically monitors blood glucose and provides appropriate insulin doses to patients with diabetes who use insulin. Dr Lias said types of automated insulin delivery systems include insulin only, bihormonal (eg, insulin and glucagon), hypo-/hyper-minimizers, “treat-to-target,” “hybrid” closed loop with which patients still require meal bolus, and fully closed-loop automated insulin delivery systems with which patients require little to no intervention." LinkObviously the ultimate goal is fully closed loop but it seems like "hybrid" closed loop systems are on their way to FDA approval (possibly this year?). “The FDA feels very strongly that automated insulin delivery device systems will provide people with diabetes significant benefits,” “The FDA's efforts include prioritizing the review of research protocol studies, providing clear guidelines to industry, setting performance and safety standards, fostering discussions between government and private researchers, sponsoring public forums, and finding ways to shorten study and review time.” This hybrid approach has been studied by JDRF and William Sansum Diabetes Center and from what we have heard during the AADE, has shown that Afrezza is a vital part of the system. See Study and tweet. So my question is, given that AP tech will gain major media exposure once it is available - will Afrezza also get to share in some of the spotlight? And how much could this possibly impact the total RX sales?
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Post by agedhippie on Aug 18, 2016 16:04:08 GMT -5
So my question is, given that AP tech will gain major media exposure once it is available - will Afrezza also get to share in some of the spotlight? And how much could this possibly impact the total RX sales? An AP? I want one and I want it NOW! Closed loop systems are out as soon as next year (allegedly). For some time this will be a Type 1 only market because the insurers are not going to pay for Type 2 so that leaves that market untouched for Afrezza. Then it's going to take a couple of years for the Type 1 market to spin up as people probably only swap as their pump hits end of life (the insurers tend not to pay for replacement DME until the old one is out of warranty). And of course there are the people who don't like being hooked up to things (that's me amongst others). In summary over the medium term it will hit Type 1 Afrezza sales but leave Type 2 sales alone. In the short term there's probably minimal impact. The area I can see it being used first is pediatric because of it's ability to handle hormone based glucose swings (food isn't the only thing that causes spikes) and I would expect newly diagnosed pediatrics would be moved straight to AP because of the reduced risk.
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Post by babaoriley on Aug 18, 2016 16:07:15 GMT -5
Seems to me, given the way things usually play out, that we will have a very, very good idea if we're going to survive and even thrive, well before the artificial pancreas can take a significant bite out of our sales. For example, no one could take a significant bite out of our sales now, just a tiny morsel would do us in. Let's hope that starts to get remedied as of tomorrow morning.
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Post by mannmade on Aug 18, 2016 16:18:03 GMT -5
If insurance will barely cover a cgm what makes us think they will cover an artificial pancreas for the masses? Also, the idea is to carry smaller and smaller less intrusive devices, witness Dexcom's collaboration with Google to develop such a cgm Lastly, in mho, just more moving parts to break. I could be way off on this... But once AFREZZA's real benefits are truly understood and the simplicity of it also becomes understood by the masses then in my mind it is no choice especially with the results we are seeing in early adopters... After all which instruction manual would you rather read? Now in the future we may have to get a digital inhaler that "talks" to the cgm to react and fine tune dosing plus collect data, but that is still a ways off and again imo way easier..
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Post by madog365 on Aug 18, 2016 16:29:43 GMT -5
Completely agree it will take time for insurers to get on board. Especially for T2.
My thinking is geared more towards the new rx Afrezza will gain by simply getting more positive media coverage for being associated with an approved Artificial Pancreas system. Once approved i think thousands of patients may hear the Afrezza name for the first time. They may not be able to get an AP due to cost right away- but using a savings card they could still get started with Afrezza and get the benefits of a better treatment option(which will hopefully have more coverage by then)
Here is the set up that JDRF was testing for their system: Drug: Investigational inhaled insulin (Technosphere)
by MannKind Corp. IND 61,729
Other Name: Technosphere® Insulin Inhalation System (Gen2C inhaler)
Device: Artificial Pancreas (AP) device (APS©)
Device includes:
OneTouch® Ping® Glucose Management System with modified Meter-Remote from Animas® Corp or the OmniPod® Insulin Management System from Insulet Corp.
Dexcom® G4® CGM System (CGM) from Dexcom® Corp
Control algorithm: zone-Model Predictive Control (zone-MPC) with safety Health Monitoring System (HMS)
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Post by mannmade on Aug 18, 2016 16:36:37 GMT -5
Yes agree, AFREZZA was part of trials in Santa Barbara at Samsun Institute. Also I think the bigger issue as you allude to with ref to AP is that now that Dexcom can be used for dosing officially, AFREZZA should become the bright new shiny object. Why would you care about wearing a cgm to dose umless you could find an insulin that worked in real time. Almost makes no sense. Will take some time for PWD to understand this but imo that is mostly due to educating them on AFREZZA's fast in / fast out qualities.
And frankly a cgm with Tresiba and AFREZZA seems to be a artifical pancreas of it's own so why be strapped to one? Can you swim with it, shower with it? Run? etc...
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Post by matt on Aug 18, 2016 16:53:22 GMT -5
It all comes down to how well any new technology works and whether the patients can afford it. Historically is has been easy to get a physician to change ONE OR TWO patients to a new therapy, then they sit on their hands for a while to see how it works. If the few patients who try it have a good experience, and the new product has mostly positive articles in the medical journals, then the physicians switch everybody over, but until then the old reliable methods are considered the best.
Afrezza has plenty of time to get traction in the market before artificial pancreas technology works properly. Virtually no first generation product works as well as it needs to, but second and third generations do. Just remember that device manufacturers can introduce a new generation of products with many fewer hurdles than a pharmaceutical company. We might see third generation AP devices within five years, but in five years either Afrezza will have gained traction and carved out a niche in the market, or else it will have gone the route of Exubera.
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Post by agedhippie on Aug 18, 2016 20:41:14 GMT -5
Yes agree, AFREZZA was part of trials in Santa Barbara at Samsun Institute. Also I think the bigger issue as you allude to with ref to AP is that now that Dexcom can be used for dosing officially, AFREZZA should become the bright new shiny object. Why would you care about wearing a cgm to dose umless you could find an insulin that worked in real time. Almost makes no sense. Will take some time for PWD to understand this but imo that is mostly due to educating them on AFREZZA's fast in / fast out qualities. And frankly a cgm with Tresiba and AFREZZA seems to be a artifical pancreas of it's own so why be strapped to one? Can you swim with it, shower with it? Run? etc... Ask any Type 1 (I can't speak for long term Type 2 but I expect it's the same) what they want and the answer definitely isn't better insulin, it's to go back to their pre-diabetes life. After all this time I want to be able to live my life without thinking about my diabetes and all it's little issues. Look up diabetes burnout and bear in mind that the description given is the fluffy one - sometimes people don't make it out the other side. I know of two, one was a student of mine, the other was a friend of a friend. Nuts (it's a family show so I toned that down) to whipping out my inhaler and meter/CGM every time I eat or drink something, figure out whether that's a 4u or an 8u, then check 90 minutes later to see if I need another. In the case of APs I really don't care how wonderful Afrezza is, it's still manual, it still gets in the way, and as soon as I can get an AP I'm so done with Afrezza, pumps, pens, the whole nine yards (personally speaking). Ok - rant over - back to the questions. Can you shower and swim with it? Yes - well you can with today's pumps so I don't see why not APs should be worse. Pumps are waterproof, ditto Dexcom (not the receiver!). By definition APs work in real time. They are continually altering doses and balancing glucagon against insulin - just like a real pancreas. If I get my hands on one and it works as advertised I really don't care what it costs and I'll pay if the insurance doesn't.
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Post by flatrock on Aug 18, 2016 22:25:19 GMT -5
If insurance will barely cover a cgm what makes us think they will cover an artificial pancreas for the masses? Also, the idea is to carry smaller and smaller less intrusive devices, witness Dexcom's collaboration with Google to develop such a cgm Lastly, in mho, just more moving parts to break. I could be way off on this... But once AFREZZA's real benefits are truly understood and the simplicity of it also becomes understood by the masses then in my mind it is no choice especially with the results we are seeing in early adopters... After all which instruction manual would you rather read? Now in the future we may have to get a digital inhaler that "talks" to the cgm to react and fine tune dosing plus collect data, but that is still a ways off and again imo way easier.. United Healthcare seems interested. UHC, Medtronic deal
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Post by audiomr on Aug 19, 2016 14:27:35 GMT -5
It's not really an artificial pancreas, though. It's really just an intelligent closed-loop monitor/pump system. Probably better than existing pump options, but it won't actually function the way a real pancreas does. Seems like Afrezza would be a better option for many patients.
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Post by agedhippie on Aug 19, 2016 14:48:06 GMT -5
It's not really an artificial pancreas, though. It's really just an intelligent closed-loop monitor/pump system. Probably better than existing pump options, but it won't actually function the way a real pancreas does. Seems like Afrezza would be a better option for many patients. Isn't "an intelligent closed-loop monitor/pump system" the definition of a pancreas?
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Post by audiomr on Aug 19, 2016 22:38:41 GMT -5
It's not really an artificial pancreas, though. It's really just an intelligent closed-loop monitor/pump system. Probably better than existing pump options, but it won't actually function the way a real pancreas does. Seems like Afrezza would be a better option for many patients. Isn't "an intelligent closed-loop monitor/pump system" the definition of a pancreas? A real pancreas has a better signaling system, a better insulin, and a superior (pumpless) path for delivering that insulin. The moniker "artificial pancreas" just seems to promise way more than is actually achieved.
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Post by mnholdem on Aug 20, 2016 0:09:15 GMT -5
The question of a true artificial pancreas was posed to Duane DeSisto a few years ago, when he was still CEO of Insulet. From a round table discussion of industry leaders that took place before Afrezza was approved by the FDA, DeSisto's thought on the AP was very unexpected: Moderator: "Duane, how far away are we from a true cutting edge artificial pancreas?” Duane: “Umm, I don’t think anyone in this room will live long enough to see it… CGM sensing is not accurate enough to deliver insulin by itself.” “If you’re really going to do this you’re going to need insulin that, basically, reacts more like your body, so it goes in almost instantaneously and has a very low tail. And if all that gets resolved, here’s the question. How does it know that you’re eating a pound of pasta because you’re going to run the Boston Marathon? It doesn’t! So it’s going to basically load you up with insulin and, by mile two, you’re going to look like me running… ” Read more: mnkd.proboards.com/thread/4630/why-duane-desisto-hired#ixzz4HqVxODgu
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Post by gamblerjag on Aug 20, 2016 0:36:18 GMT -5
Wow Mnholdem, The things you dig up!!
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Post by agedhippie on Aug 20, 2016 10:01:52 GMT -5
The question of a true artificial pancreas was posed to Duane DeSisto a few years ago, when he was still CEO of Insulet. From a round table discussion of industry leaders that took place before Afrezza was approved by the FDA, DeSisto's thought on the AP was very unexpected: Moderator: "Duane, how far away are we from a true cutting edge artificial pancreas?” Duane: “Umm, I don’t think anyone in this room will live long enough to see it… CGM sensing is not accurate enough to deliver insulin by itself.” “If you’re really going to do this you’re going to need insulin that, basically, reacts more like your body, so it goes in almost instantaneously and has a very low tail. And if all that gets resolved, here’s the question. How does it know that you’re eating a pound of pasta because you’re going to run the Boston Marathon? It doesn’t! So it’s going to basically load you up with insulin and, by mile two, you’re going to look like me running… ” Read more: mnkd.proboards.com/thread/4630/why-duane-desisto-hired#ixzz4HqVxODguWell he got the CGM call wrong! That FDA approval for Dexcom was precisely to allow dosing which is why it was so important for the AP products. Until that point commercial production of an AP was blocked by the lack of CGM with FDA approval for dosing. Next year there are at least three pivotal trials for APs which means likely release in 2018. The Medtronic 670G has completed trials and they filed for FDA approval in June so they are likely to be out 2017 (it's not perfect and I wouldn't use it - the 2017 trial devices are a lot better). The results were presented at ADA 2016. It's been posted before but this TEDx talk is well worth watch. The JDRF have just given them the money for a pivotal trial next year - The bionic pancreas | Edward Damiano | TEDxSacramento
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