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Post by cgiscgis on Sept 28, 2016 15:34:12 GMT -5
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Post by liane on Sept 28, 2016 15:36:48 GMT -5
Link please.
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Post by sla55 on Sept 28, 2016 15:38:56 GMT -5
www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm522974.htmThe U.S. Food and Drug Administration today approved Medtronic’s MiniMed 670G hybrid closed looped system, the first FDA-approved device that is intended to automatically monitor glucose (sugar) and provide appropriate basal insulin doses in people 14 years of age and older with type 1 diabetes. The human pancreas naturally supplies a low, continuous rate of insulin, known as basal or background insulin. In patients with diabetes, the body’s ability to produce or respond to insulin is impaired. “The FDA is dedicated to making technologies available that can help improve the quality of life for those with chronic diseases – especially those that require day-to-day maintenance and ongoing attention,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “This first-of-its-kind technology can provide people with type 1 diabetes greater freedom to live their lives without having to consistently and manually monitor baseline glucose levels and administer insulin.” The MiniMed 670G hybrid closed looped system, often referred to as an “artificial pancreas,” is intended to adjust insulin levels with little or no input from the user. It works by measuring glucose levels every five minutes and automatically administering or withholding insulin. The system includes a sensor that attaches to the body to measure glucose levels under the skin; an insulin pump strapped to the body; and an infusion patch connected to the pump with a catheter that delivers insulin. While the device automatically adjusts insulin levels, users need to manually request insulin doses to counter carbohydrate (meal) consumption. According to the U. S. Centers for Disease Control and Prevention, approximately 5 percent of people with diabetes have type 1 diabetes. Also known as juvenile diabetes, type 1 diabetes is typically diagnosed in children and young adults. Because the pancreas does not make insulin in people with type 1 diabetes, patients have to consistently monitor their glucose levels throughout the day and have insulin therapy through injection with a syringe, an insulin pen or insulin pump to avoid becoming hyperglycemic (high glucose levels). In addition, management of type 1 diabetes includes following a healthy eating plan and physical activity. “As part of our commitment to improving diabetes care, the FDA worked interactively with Medtronic from the earliest stages of development to assist in making this technology available to people with type 1 diabetes as quickly as possible,” said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “We encourage companies to work closely with the agency to ensure scientifically sound, highly efficient clinical study designs, helping to expedite the FDA’s evaluation and subsequent approval of novel devices that can make a difference for patients.” The FDA evaluated data from a clinical trial of the MiniMed 670G hybrid closed looped system that included 123 participants with type 1 diabetes. The clinical trial included an initial two-week period where the system’s hybrid closed loop was not used followed by a three-month study during which trial participants used the system’s hybrid closed loop feature as frequently as possible. This clinical trial showed that the device is safe for use in people 14 years of age and older with type 1 diabetes. No serious adverse events, diabetic ketoacidosis (DKA) or severe hypoglycemia (low glucose levels) were reported during the study. Risks associated with use of the system may include hypoglycemia, hyperglycemia, as well as skin irritation or redness around the device’s infusion patch. This version of this device is unsafe for use in children 6 years of age or younger and in patients who require less than eight units of insulin per day. As part of this approval, the FDA is requiring a post-market study to better understand how the device performs in real-world settings. While the device is being approved today for use in people 14 years of age and older with type 1 diabetes, Medtronic is currently performing clinical studies to evaluate the safety and effectiveness of the device in diabetic children 7-13 years old. The MiniMed 670G hybrid closed looped system is manufactured by Medtronic, headquartered in Dublin, Ireland. The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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Post by dg1111 on Sept 28, 2016 15:44:41 GMT -5
Without knowing too much about how this works, I am not sure that it would have a huge of an impact on Afrezza or other insulin. This artificial pancreas would be analogous to Lasik eye procedures. Afrezza and other insulins would be analogous to eyeglasses contacts. While Lasik is fairly common, you still see a lot of people wearing traditional eyeglasses.
Some people may opt for (and be able to pay for) this artificial pancreas. A lot of diabetics either may choose not to get it or may not be able to afford it.
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Post by mannmade on Sept 28, 2016 15:49:58 GMT -5
My opinion/understanding is the following:
1. It will be expensive
2. Still rather bulky and inconvenient
3. Results still not that much better than a CGM, AFREZZA and a basil, (yes I know this depends on how diligent one is)
4. If T1's are looking to drop pump (and many are able to do so with an Hba1c in the mid 5's to low 6's) why get hooked to an AP?
5. More moving parts and chances for something to go wrong. I have a friend whose son almost died because his pump was not calibrated properly
6. Oh yeah... didn't the Samsun trials in Santa Barbara for an AP use AFREZZA?
Can't get a Dexcom approved very easily how will insurance look at an AP?
Just my initial thoughts... AFREZZA is simpler, less expensive, almost as able to get same results, and likely to some degree more convenient... But I am not diabetic so would love to hear from someone who is...
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Post by audiomr on Sept 28, 2016 16:17:54 GMT -5
Key sentence: "While the device automatically adjusts insulin levels, users need to manually request insulin doses to counter carbohydrate (meal) consumption." Patients still have to intervene for mealtime insulin, and Afrezza is the best.
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Post by peppy on Sept 28, 2016 17:35:47 GMT -5
Key sentence: "While the device automatically adjusts insulin levels, users need to manually request insulin doses to counter carbohydrate (meal) consumption." Patients still have to intervene for mealtime insulin, and Afrezza is the best. have ignition? Continues Glucose monitors now indicted for insulin infusion in diabetes, per FDA.?
afrezza technosphere insulin, keep post meal blood glucose between the lines.
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Post by sayhey24 on Sept 28, 2016 18:24:17 GMT -5
If you believe the JDRF it should actually increase afrezza use. afrezza was the best way they controlled meal time spikes at about the 2:50m and 4:30m mark. youtube.com/watch?v=GGgGjtM5ipg Now the bigger problem is afrezza works so well why do you need the AP at all if a shot of Tresiba and afrezza work as well.
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Post by chyaboi on Sept 28, 2016 19:45:55 GMT -5
My opinion/understanding is the following: 1. It will be expensive 2. Still rather bulky and inconvenient 3. Results still not that much better than a CGM, AFREZZA and a basil, (yes I know this depends on how diligent one is) 4. If T1's are looking to drop pump (and many are able to do so with an Hba1c in the mid 5's to low 6's) why get hooked to an AP? 5. More moving parts and chances for something to go wrong. I have a friend whose son almost died because his pump was not calibrated properly 6. Oh yeah... didn't the Samsun trials in Santa Barbara for an AP use AFREZZA? Can't get a Dexcom approved very easily how will insurance look at an AP? Just my initial thoughts... AFREZZA is simpler, less expensive, almost as able to get same results, and likely to some degree more convenient... But I am not diabetic so would love to hear from someone who is... Maybe the shorts will finally move to greener pastures! |
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Post by mannmade on Sept 28, 2016 19:56:11 GMT -5
The below 3 paragraphs pulled from an article on Yahoo today explain exactly why an AP is nothing without AFREZZA. Conversely a CGM, basal 1 to 2x day and AFREZZA are almost as good if not better in some respects than an AP. Oh the irony that it is from Medtronics... This may actually be good for AFREZZA.
However, figuring out exactly how much insulin to give is no easy task. Both too much and too little insulin can have dangerous, even deadly consequences.
And that’s where this new technology will help. The device has a continuous glucose monitor that constantly measures blood sugar levels. A sophisticated computer algorithm then figures out if someone’s blood sugar levels are too low or too high, and when too high, will give the correct insulin dose to bring the blood sugar level down.
The device does this via a small catheter inserted beneath the skin and attached to a tube that’s attached to an insulin pump. This insulin delivery site needs to be changed approximately every three days.
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Post by mannmade on Sept 28, 2016 19:56:54 GMT -5
If only the medical world truly understood AFREZZA.... sigh!! I hope Dexcom now understands the importance and real world benefits of AFREZZA now... Maybe some competition from Medtronics will spur them to partner with AFREZZA for a trifecta of CGM, Basal, and AFREZZA as a "poor man's AP,' that may just have a more benefits with almost as good results for less cost to insurance etc... One can dream...  |
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Post by figglebird on Sept 28, 2016 19:59:28 GMT -5
So yet to read the part about the guy who invented the insulin pump sells it to medtronic - just thought that it was important in terms of horizonal thinking al mann is the curative profitable thinker of this sector while institutional obstacles of less meaningful and compelling adherence habits pry up walls to obstruct acess and obliterate realized transformation - make do doubt they will fall
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Post by gonetotown on Sept 28, 2016 20:07:59 GMT -5
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Post by mannmade on Sept 28, 2016 20:21:44 GMT -5
The below two paragraphs are pulled directly from the article at the above link... Tell me AFREZZA would not be better in most cases for the reasons I have previously stated...
"... Before going into the study my A1C was 7.6%. After the first six months, I came out with a 6.5%. It’s the device that is really being studied, not me. But learning about the technology and how it works allowed me to manage a lot better. This was a big eye-opener in taking better care of myself!
Any other surprises you’ve found with this technology?
One thing that I’ve noticed that many people like to refer to this as an 'artificial pancreas,' as if it were fully automated. It really isn’t, in my opinion. It provides you a lot of the benefits of continuous micro-boluses, but you still have to manage your diabetes on a daily basis in order for the device to work as it needs to. You’re still thinking about diabetes just as much -- at least that’s what I have found..."
Now AFREZZA:
1. AFREZZA is getting PWD as low as 4.8 and generally within mid 5's to low 6's for those that learn how to tritarate properly. (His is a 6.2 although may be better since article)
2. No carb counting
3. As Gus B and many others say, they live like they don't have diabetes anymore... (He is still thinking about it all day)
There are more comparisons to be made but for not I think I have made my point... Very disturbing that such a great drug is virtually ignored and a new piece of technology that is admittedly imperfect is getting such attention and phase...
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Post by agedhippie on Sept 28, 2016 20:26:25 GMT -5
It's interesting but has to many shortcomings for me: It works by continually altering the basal to hold you in range and cannot do a single shot bolus if you are high. It's average target is higher than I would like and I cannot see a way to tune that. I still have to manually bolus for meals (using the pump) It is insulin only, I want a dual hormone AP. And it's made by Medtronics which means it will be clunky and vaguely dated (prejudiced? Me?) More seriously there are going to be a lot of APs out next year and for the most part they look like they will be better. If I get the 670G it's 4 years before I can get another pump from my current insurer. I doubt there will be any problems with insurance companies since except for UHC they all let you pick the pump you want. |
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