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Post by agedhippie on Dec 18, 2018 17:26:46 GMT -5
There was never an expectation Dr. Kendall would get updates to the T2 section at this point. First up was the T1 section. I may be mistaken but isn't afrezza still included in the RAA class? If so this is clearly medically wrong and should be an easy fix the next time around.
As far as the T2s we currently have a Treat to Fail standards. Changes will come. Forget about the GLP1s in the T1 section they say they are not worth the risk.
Afrezza is a rapid acting insulin, but it's not an analog. If you read 9.1 and 9.2 together it becomes clearer. The 9.1 recommendation says diabetics should be treated with MDI or a pump, and 9.2 says a rapid acting insulin analog should be used to reduce hypos. I think that can be taken as Novolog/Humalog since 9.1 is injected insulin. Afrezza is in the rapid acting class, but it's not a rapid acting analog. I think that is the case. This should definitely be cleaned up.
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Post by bones1026 on Dec 18, 2018 19:49:55 GMT -5
Always glad to provide a service. Largely the SOC is a clean up and in-line with what I predicted. The bonus that I didn't predict was the STAT study inclusion. Since ryster seems to want the negatives here they are. First, look at the recommendations in each section, that's what most doctors are going to work from. Look at Section 9. The Type 1 recommendations do not mention inhaled insulin at all. I am not sure how that happened but look at the first two of the four recommendations for treat Type 1: That needs to be fixed because those are both class A recommendations so they are highly likely to be followed. Now on to Type 2 recommendations. This is what I was expecting after the ADA-EASD consensus statement: This is a new recommendation and it is reinforcing the use of GLP-1 ahead of insulin. This is a result of the CVD trials. You see this in recommendations 9.10 to 9.13 where they flat out say use SGLT-2 and/or GLP-1 if the person has chronic kidney disease progression, cardiovascular events, or both. They used to hedge that a bit, but now that hedging is gone. In the Type 2 treatment flowcharts you now have an additional step for GLP-1 inserted ahead of basal insulin. This delays the starting of RAA or Afrezza. In summary; read the Recommendations because that is what doctors are going to use. Generally the SOC is positive for inhaled insulin, but nothing earth-shattering. This is really about working to legitimize inhaled insulin in the eyes of the medical profession which gets my vote - laying the groundwork. There was never an expectation Dr. Kendall would get updates to the T2 section at this point. First up was the T1 section. I may be mistaken but isn't afrezza still included in the RAA class? If so this is clearly medically wrong and should be an easy fix the next time around.
As far as the T2s we currently have a Treat to Fail standards. Changes will come. Forget about the GLP1s in the T1 section they say they are not worth the risk.
“Next time around”? Wondering with the frequency is of SOC updates? Annual and that’s it?.
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Post by peppy on Dec 18, 2018 20:57:10 GMT -5
There was never an expectation Dr. Kendall would get updates to the T2 section at this point. First up was the T1 section. I may be mistaken but isn't afrezza still included in the RAA class? If so this is clearly medically wrong and should be an easy fix the next time around.
As far as the T2s we currently have a Treat to Fail standards. Changes will come. Forget about the GLP1s in the T1 section they say they are not worth the risk.
“Next time around”? Wondering with the frequency is of SOC updates? Annual and that’s it?. the frequency of changes can be intra year.
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Post by peppy on Dec 18, 2018 20:58:53 GMT -5
The Diabetes Control and Complications Trial (DCCT) demonstrated that intensive therapy with multiple daily injections or CSII reduced A1C and was associated with improved long-term outcomes (12–14). The study was carried out with short-acting and intermediate-acting human insulins. Despite better microvascular, macrovascular, and all-cause mortality outcomes, intensive therapy was associated with a higher rate of severe hypoglycemia (61 episodes per 100 patient-years of therapy). Since the DCCT, rapid-acting and long-acting insulin analogs have been developed. These analogs are associated with less hypoglycemia, less weight gain, and lower A1C than human insulins in people with type 1 diabetes (15–17). Longer-acting basal analogs (U-300 glargine or degludec) may convey a lower hypoglycemia risk compared with U-100 glargine in patients with type 1 diabetes (18,19). Rapid-acting inhaled insulin to be used before meals is now available and may reduce rates of hypoglycemia in patients with type 1 diabetes (20).
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Post by mango on Dec 18, 2018 21:13:16 GMT -5
The Diabetes Control and Complications Trial (DCCT) demonstrated that intensive therapy with multiple daily injections or CSII reduced A1C and was associated with improved long-term outcomes (12–14). The study was carried out with short-acting and intermediate-acting human insulins. Despite better microvascular, macrovascular, and all-cause mortality outcomes, intensive therapy was associated with a higher rate of severe hypoglycemia (61 episodes per 100 patient-years of therapy). Since the DCCT, rapid-acting and long-acting insulin analogs have been developed. These analogs are associated with less hypoglycemia, less weight gain, and lower A1C than human insulins in people with type 1 diabetes (15–17). Longer-acting basal analogs (U-300 glargine or degludec) may convey a lower hypoglycemia risk compared with U-100 glargine in patients with type 1 diabetes (18,19). Rapid-acting inhaled insulin to be used before meals is now available and may reduce rates of hypoglycemia in patients with type 1 diabetes (20).Sounds pretty clear to me peppy. Afrezza causes normal glucose, restores back to a healthy level, and has proven to cause less hypoglycemia than RAAs because it matches physiologic insulin. Good stuff
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Post by peppy on Dec 18, 2018 21:41:06 GMT -5
agedhippie. noninsulin Treatments for Type 1 Diabetes Injectable and oral glucose-lowering drugs have been studied for their efficacy as adjuncts to insulin treatment of type 1 diabetes. Pramlintide is based on the naturally occurring β-cell peptide amylin and is approved for use in adults with type 1 diabetes. Results from randomized controlled studies show variable reductions of A1C (0–0.3%) and body weight (1–2 kg) with addition of pramlintide to insulin (29,30). Similarly, results have been reported for several agents currently approved only for the treatment of type 2 diabetes. The addition of metformin to adults with type 1 diabetes caused small reductions in body weight and lipid levels but did not improve A1C (31,32). The addition of the glucagon-like peptide 1 (GLP-1) receptor agonists liraglutide and exenatide to insulin therapy caused small (0.2%) reductions in A1C compared with insulin alone in people with type 1 diabetes and also reduced body weight by ∼3 kg (33). Similarly, the addition of a sodium–glucose cotransporter 2 (SGLT2) inhibitor to insulin therapy has been associated with improvements in A1C and body weight when compared with insulin alone (34–36); however, SGLT2 inhibitor use is also associated with more adverse events including ketoacidosis. The dual SGLT1/2 inhibitor sotagliflozin is currently under consideration by the FDA and, if approved, would be the first adjunctive oral therapy in type 1 diabetes.The risks and benefits of adjunctive agents beyond pramlintide in type 1 diabetes continue to be evaluated through the regulatory process; however, at this time, these adjunctive agents are not approved in the context of type 1 diabetes (37). Get ready aged, you may be living too long.
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Post by sellhighdrinklow on Dec 18, 2018 21:56:07 GMT -5
As I recall not much was mentioned about CGM usage in SoC. However as their penatration grows and people start to better see the correlation between TIR and lower Hba1c w fewer hypos from a true real time management of diabetes Afrezza will most certainly have to become the clear choice imho. 100% proper/accurate imho. The revenue potential is huge and the players in the game to capture that are even "huge-er", valuation/market cap wise. The little wins to take the next % of market share give the big, big, huge-er players a chance to buy MNKD before they get crushed because (of course they wouldn't..mnkd will be bought at some point...?). We here know what's up with Afrezza(including and especially traderdennis and Agedhippie). The huge-er boys know also. That's my 2 IPA's rant.
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Post by slugworth008 on Dec 19, 2018 0:10:32 GMT -5
As I recall not much was mentioned about CGM usage in SoC. However as their penatration grows and people start to better see the correlation between TIR and lower Hba1c w fewer hypos from a true real time management of diabetes Afrezza will most certainly have to become the clear choice imho. 100% proper/accurate imho. The revenue potential is huge and the players in the game to capture that are even "huge-er", valuation/market cap wise. The little wins to take the next % of market share give the big, big, huge-er players a chance to buy MNKD before they get crushed because (of course they wouldn't..mnkd will be bought at some point...?). We here know what's up with Afrezza(including and especially traderdennis and Agedhippie). The huge-er boys know also. That's my 2 IPA's rant. I'm all for Huge-er. Preferrably while I still breathe
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Post by mnkdfann on Dec 19, 2018 0:38:43 GMT -5
As I recall not much was mentioned about CGM usage in SoC. However as their penatration grows and people start to better see the correlation between TIR and lower Hba1c w fewer hypos from a true real time management of diabetes Afrezza will most certainly have to become the clear choice imho. Actually, there was quite a bit about about CGMs in the SOC. But not in conjunction with Afrezza, if that's what you meant.
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Post by longliner on Dec 19, 2018 1:59:39 GMT -5
Yes mnkdfann, but isn't it nice to know that going forward we will hear formally what we have been privy to anecdotally in regards to CGM use and Afrezza? If that's what you meant.
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Post by sayhey24 on Dec 19, 2018 6:33:24 GMT -5
There was never an expectation Dr. Kendall would get updates to the T2 section at this point. First up was the T1 section. I may be mistaken but isn't afrezza still included in the RAA class? If so this is clearly medically wrong and should be an easy fix the next time around.
As far as the T2s we currently have a Treat to Fail standards. Changes will come. Forget about the GLP1s in the T1 section they say they are not worth the risk.
Afrezza is a rapid acting insulin, but it's not an analog. If you read 9.1 and 9.2 together it becomes clearer. The 9.1 recommendation says diabetics should be treated with MDI or a pump, and 9.2 says a rapid acting insulin analog should be used to reduce hypos. I think that can be taken as Novolog/Humalog since 9.1 is injected insulin. Afrezza is in the rapid acting class, but it's not a rapid acting analog. I think that is the case. This should definitely be cleaned up. That is the argument. Its medically a huge mistake which should be addressed asap but like everything else with the borg it will take time. Its a clear candidate for an interim update but doing so creates other issues and maybe why it was not yet updated in this release. ADA 2019 is going to be interesting.
It impacts 9.2 wording which will need to be changed to something like inhaled insulin or RAAs should be used to reduce hypos but inhaled insulin may provide better control. Putting afrezza first is a big jump. Its coming, there is no stopping it but will take time to move the borg.
My take is Dr. Kendall is clearly having an impact on the community and moving the ball. Lets see what he releases from the lost studies to support the T2s and what new studies may be need there.
Changing the current T2 "Treat to Fail" Standard which is a disgrace needs to change asap. The question is how many years is "asap" to the borg. When you include treatments for T2s which are not worth the risk for T1s I see big red flashing lights. The best word I have is "disgrace".
When you have to put together a Rube Goldberg chart to explain the "Treat to Fail Standard", that says it all and they should be ashamed of themselves.
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Post by peppy on Dec 19, 2018 6:37:46 GMT -5
Combination Therapy. (type two.)
Although there are numerous trials comparing dual therapy with metformin alone, few directly compare drugs as add-on therapy. A comparative effectiveness meta-analysis suggests that each new class of noninsulin agents added to initial therapy generally lowers A1C approximately 0.7–1.0% (46). If the A1C target is not achieved after approximately 3 months and the patient does not have ASCVD or CKD, consider a combination of metformin and any one of the preferred six treatment options: sulfonylurea, thiazolidinedione, dipeptidyl peptidase 4 (DPP-4) inhibitor, SGLT2 inhibitor, GLP-1 receptor agonist, or basal insulin; the choice of which agent to add is based on drug-specific effects and patient factors (Fig. 9.1 and Table 9.1). For patients in whom ASCVD, HF, or CKD predominates, the best choice for a second agent is a GLP-1 receptor agonist or SGLT2 inhibitor with demonstrated cardiovascular risk reduction, after consideration of drug-specific and patient factors (Table 9.1). For patients without established ASCVD or CKD, the choice of a second agent to add to metformin is not yet guided by empiric evidence. Rather, drug choice is based on avoidance of side effects, particularly hypoglycemia and weight gain, cost, and patient preferences (47). Similar considerations are applied in patients who require a third agent to achieve glycemic goals; there is also very little trial-based evidence to guide this choice. In all cases, treatment regimens need to be continuously reviewed for efficacy, side effects, and patient burden (Table 9.1). In some instances, patients will require medication reduction or discontinuation. Common reasons for this include ineffectiveness, intolerable side effects, expense, or a change in glycemic goals (e.g., in response to development of comorbidities or changes in treatment goals). See Section 12 “Older Adults” for a full discussion of treatment considerations in older adults.
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The standards of care seem to be hot on the SGLT2. I am not sure how it got the cardiac improvement. the only thing I can think of is an improvement in congestive heart failure due to the diuretic effect/water loss of SGLT2. Amazing to me is not mentioned, love your number miss your legs. The greater threat of amputation does not seem to be mentioned. Can we ask ourselves, how can this be? You go to the doctor, you are told you have a high blood glucose. Metformin started. Three months later SGLT2 started. initial weightloss. keep taking it. soon enough your toes are not getting enough oxygen and glucose to complete the Kreb's cycle. Next thing you know, more weight loss, your foot is gone. Be still my heart.
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Post by agedhippie on Dec 19, 2018 6:42:32 GMT -5
agedhippie . noninsulin Treatments for Type 1 Diabetes Injectable and oral glucose-lowering drugs have been studied for their efficacy as adjuncts to insulin treatment of type 1 diabetes. Pramlintide is based on the naturally occurring β-cell peptide amylin and is approved for use in adults with type 1 diabetes. Results from randomized controlled studies show variable reductions of A1C (0–0.3%) and body weight (1–2 kg) with addition of pramlintide to insulin (29,30). Similarly, results have been reported for several agents currently approved only for the treatment of type 2 diabetes. The addition of metformin to adults with type 1 diabetes caused small reductions in body weight and lipid levels but did not improve A1C (31,32). The addition of the glucagon-like peptide 1 (GLP-1) receptor agonists liraglutide and exenatide to insulin therapy caused small (0.2%) reductions in A1C compared with insulin alone in people with type 1 diabetes and also reduced body weight by ∼3 kg (33). Similarly, the addition of a sodium–glucose cotransporter 2 (SGLT2) inhibitor to insulin therapy has been associated with improvements in A1C and body weight when compared with insulin alone (34–36); however, SGLT2 inhibitor use is also associated with more adverse events including ketoacidosis. The dual SGLT1/2 inhibitor sotagliflozin is currently under consideration by the FDA and, if approved, would be the first adjunctive oral therapy in type 1 diabetes.The risks and benefits of adjunctive agents beyond pramlintide in type 1 diabetes continue to be evaluated through the regulatory process; however, at this time, these adjunctive agents are not approved in the context of type 1 diabetes (37). Get ready aged, you may be living too long. In Type 1 metformin is more useful for reducing the amount of insulin you need than in reducing A1c. It's still a gray area for Type 1 because of the idea that it can cause acidosis and so is not widely used. The acidosis risk is wrong though, but doctors are conservative so a lot of them still avoid it. My endo has used it for a long time for insulin resistant Type 1. I am torn over SGLT-2. I can see this being prescribed to people with existing heart or kidney issues in the first instance and it may well be good for that. I think the DKA risk is manageable by avoiding dehydration, but in some populations who tend to be dehydrated that will be an issue. On the plus side Type 1 should have keto test strips and know what DKA looks like. I have no intention of taking it any time soon anyway!
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Post by peppy on Dec 19, 2018 6:47:53 GMT -5
agedhippie . noninsulin Treatments for Type 1 Diabetes Injectable and oral glucose-lowering drugs have been studied for their efficacy as adjuncts to insulin treatment of type 1 diabetes. Pramlintide is based on the naturally occurring β-cell peptide amylin and is approved for use in adults with type 1 diabetes. Results from randomized controlled studies show variable reductions of A1C (0–0.3%) and body weight (1–2 kg) with addition of pramlintide to insulin (29,30). Similarly, results have been reported for several agents currently approved only for the treatment of type 2 diabetes. The addition of metformin to adults with type 1 diabetes caused small reductions in body weight and lipid levels but did not improve A1C (31,32). The addition of the glucagon-like peptide 1 (GLP-1) receptor agonists liraglutide and exenatide to insulin therapy caused small (0.2%) reductions in A1C compared with insulin alone in people with type 1 diabetes and also reduced body weight by ∼3 kg (33). Similarly, the addition of a sodium–glucose cotransporter 2 (SGLT2) inhibitor to insulin therapy has been associated with improvements in A1C and body weight when compared with insulin alone (34–36); however, SGLT2 inhibitor use is also associated with more adverse events including ketoacidosis. The dual SGLT1/2 inhibitor sotagliflozin is currently under consideration by the FDA and, if approved, would be the first adjunctive oral therapy in type 1 diabetes.The risks and benefits of adjunctive agents beyond pramlintide in type 1 diabetes continue to be evaluated through the regulatory process; however, at this time, these adjunctive agents are not approved in the context of type 1 diabetes (37). Get ready aged, you may be living too long. In Type 1 metformin is more useful for reducing the amount of insulin you need than in reducing A1c. It's still a gray area for Type 1 because of the idea that it can cause acidosis and so is not widely used. The acidosis risk is wrong though, but doctors are conservative so a lot of them still avoid it. My endo has used it for a long time for insulin resistant Type 1. I am torn over SGLT-2. I can see this being prescribed to people with existing heart or kidney issues in the first instance and it may well be good for that. I think the DKA risk is manageable by avoiding dehydration, but in some populations who tend to be dehydrated that will be an issue. On the plus side Type 1 should have keto test strips and know what DKA looks like. I have no intention of taking it any time soon anyway!yeah, I knew that. I wanted to point out what the medical industry, the blind trust we run, has in mind for your kind.
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Post by peppy on Dec 19, 2018 6:52:09 GMT -5
Standards of Care Type Two. First
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