2019 Standard of Care

[mnholdem]

Inclusion of inhaled insulin in the ADA Standard of Care is an important tool AND the sales reps will now be able to use it when they introduce doctors to Afrezza. Education of physicians is an essential component of any DTC campaign IMO.

[mango]

I think it's nice that the STAT study is in the 2019 SoC references. The STAT study is a powerful weapon in the MannKind arsenal, now in the ADA's SoC. Steady we go, and as we climb the mountain, the stronger we become.

Thank you Dr. Kendall!

[rockstarrick]

Dec 17, 2018 21:08:32 GMT -5 traderdennis said:

Dec 17, 2018 17:51:25 GMT -5 ryster505 said:

I wonder how long it will take aged or traderdennis to chime in with some negative shit on this fabulous update. Merry Christmas.

Merry Christmas to you!

If the company does not come out with a PR this is all just a nothing burger.

Actually, the new information in the SOC was PR”d last June when the stat study results were revealed.
But I sure do hope they say something !!  Even if they don’t, I believe we see more Drs prescribing Afrezza once they read the updates.  
Having a paragraph in the 2019 SOC, stating Afrezza works better at mealtime than injectable options with less Hypoglycemia, isn’t a nothing burger.
Its a big fat juicy Whopper.
😎

[agedhippie]

Dec 17, 2018 17:51:25 GMT -5 ryster505 said:

I wonder how long it will take aged or traderdennis to chime in with some negative shit on this fabulous update. Merry Christmas.

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:

9.1 Most people with type 1 diabetes should be treated with multiple daily injections of prandial and basal insulin, or continuous subcutaneous insulin infusion. A

9.2 Most individuals with type 1 diabetes should use rapid-acting insulin analogs to reduce hypoglycemia risk. A

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:

9.14 In most patients who need the greater glucose-lowering effect of an injectable medication, glucagon-like peptide 1 receptor agonists are preferred to insulin. B

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.

[mannmade]

Aged I am LOL because I absolutely agree with you in the above. I see it as a process and this is the start of that process. The ADA has included the language from the Stat study which in and of itself legitimizes the study which Dr. K and the sales people can use. Mnkd May need to do another larger study or perhaps the results from the One Drop Study or the Pediatric study will serve that purpose.

[peppy]

Dec 18, 2018 13:12:32 GMT -5 agedhippie said:

Dec 17, 2018 17:51:25 GMT -5 ryster505 said:

I wonder how long it will take aged or traderdennis to chime in with some negative shit on this fabulous update. Merry Christmas.

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:

9.1 Most people with type 1 diabetes should be treated with multiple daily injections of prandial and basal insulin, or continuous subcutaneous insulin infusion. A

9.2 Most individuals with type 1 diabetes should use rapid-acting insulin analogs to reduce hypoglycemia risk. A

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:

9.14 In most patients who need the greater glucose-lowering effect of an injectable medication, glucagon-like peptide 1 receptor agonists are preferred to insulin. B

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.

type ones are our/afrezza focus.
I saw how medicine was going to kill type twos.

[peppy]

Dec 18, 2018 13:24:13 GMT -5 mannmade said:

Aged I am LOL because I absolutely agree with you in the above. I see it as a process and this is the start of that process. The ADA has included the language from the Stat study which in and of itself legitimizes the study which Dr. K and the sales people can use. Mnkd May need to do another larger study or perhaps the results from the One Drop Study or the Pediatric study will serve that purpose.

additionally, the only reason the slightly greater hbA1c reduction with subq rapid acting is increase case of hypos.

inverse?

Afrezza, less hypos. 

[mango]

Dec 18, 2018 13:34:34 GMT -5 peppy said:

Dec 18, 2018 13:24:13 GMT -5 mannmade said:

Aged I am LOL because I absolutely agree with you in the above. I see it as a process and this is the start of that process. The ADA has included the language from the Stat study which in and of itself legitimizes the study which Dr. K and the sales people can use. Mnkd May need to do another larger study or perhaps the results from the One Drop Study or the Pediatric study will serve that purpose.

additionally, the only reason the slightly greater hbA1c reduction with subq rapid acting is increase case of hypos.

inverse?

Afrezza, less hypos. 

Yep. A1c is a proxy and does not assess glucose homeostasis. 

Treatment of the patient with diabetes: restore glucose homeostasis by matching physiologic insulin secretion

How does Afrezza behave? It matches physiologic insulin, stabalizes glucose.

Normal glucose with Afrezza

[mannmade]

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.

[hellodolly]

Quick takeaway from reading four pages of posts..."a start", "dialogue", "communication", a "beginning" and "tipping point". Base hits win ball games. There's nine innings to be played ladies and gents and if the MNKD Marauders keep getting base hits, the runs will cross the plate. Time for a beer and hot dog!

[peppy]

so mango I was reading in the supplement the formula for hba1c calculation based on glucose mg/dl.
heh.
HbA1c a 120 day average my assets.

[agedhippie]

Dec 18, 2018 13:59:36 GMT -5 peppy said:

so mango I was reading in the supplement the formula for hba1c calculation based on glucose mg/dl.
heh.
HbA1c a 120 day average my assets.

This one of those problems with HbA1c. It is possible to calculate an approximation based on average results, but it may not be the true value. To properly assess your HbA1c you need a blood test to measure the actual glycated haemoglobin.

This is where it gets interesting. If the aim to to simply measure the average of your levels then a CGM is the way to go. However, if the aim is to measure the tangible impact on the body then an HbA1c may be better since what you really care about is the impact of diabetes on the body, and that's what the HbA1c measures. The TIR or average are arbitrary measures which usually, although not always, reflect the probability of damage. What we really need to be able to do is measure the tangible damage over a period and there is no good way to do that.

[mango]

Dec 18, 2018 16:19:04 GMT -5 agedhippie said:

Dec 18, 2018 13:59:36 GMT -5 peppy said:

so mango I was reading in the supplement the formula for hba1c calculation based on glucose mg/dl.
heh.
HbA1c a 120 day average my assets.

This one of those problems with HbA1c. It is possible to calculate an approximation based on average results, but it may not be the true value. To properly assess your HbA1c you need a blood test to measure the actual glycated haemoglobin.

This is where it gets interesting. If the aim to to simply measure the average of your levels then a CGM is the way to go. However, if the aim is to measure the tangible impact on the body then an HbA1c may be better since what you really care about is the impact of diabetes on the body, and that's what the HbA1c measures. The TIR or average are arbitrary measures which usually, although not always, reflect the probability of damage. What we really need to be able to do is measure the tangible damage over a period and there is no good way to do that.

How is A1c the only measurement that assesses the impact of damange? That's not true, IMO. Measuring glucose levels via a CGM assesses the impact damage in real time. Knowing when and how many times you are going hitting 140 and above and/or 70 and below gives up measurements which reflects healthy levels versus damage.

microvascular damage begins at 140. A1c doesn't show us when and how many times that's happening a day, week, month, year, etc...everyone's normal A1c is gonna be different, it's limited and has many drawbacks.

[mannmade]

Also let’s not forget what the two graphs showed us w a diabetic on Afrezza and a diabetic on RAA the comparison was dramatic with much less variations between highs and lows. The number and rapidness of the fluctuations can’t be good for pwd.

[sayhey24]

Dec 18, 2018 13:12:32 GMT -5 agedhippie said:

Dec 17, 2018 17:51:25 GMT -5 ryster505 said:

I wonder how long it will take aged or traderdennis to chime in with some negative shit on this fabulous update. Merry Christmas.

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:

9.1 Most people with type 1 diabetes should be treated with multiple daily injections of prandial and basal insulin, or continuous subcutaneous insulin infusion. A

9.2 Most individuals with type 1 diabetes should use rapid-acting insulin analogs to reduce hypoglycemia risk. A

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:

9.14 In most patients who need the greater glucose-lowering effect of an injectable medication, glucagon-like peptide 1 receptor agonists are preferred to insulin. B

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.