FDA approves inhaled insulin

haoleboy
By haoleboy Latest Reply 2014-07-03 21:57:26 -0500
Started 2014-06-27 18:57:30 -0500

A rapidly acting inhaled formulation of human insulin was approved by the Food and Drug Administration on June 27 for adults with type 1 and type 2 diabetes …
read the whole story: http://goo.gl/gkOF7q


25 replies

MoeGig
MoeGig 2014-07-03 16:51:09 -0500 Report

The owner of Mankind (his name) put $1 billion of his own money to keep the company afloat while they FDA forced them to cycle through additional tests. The main benefit I can see is that when (everybody does) fall off the wagon and test a high blood sugar, then inhaling it will be absorbed a lot quicker. When I run high, a shot of humalog takes several hours to have an effect. I would see that as the major benefit. I also wondered if you could do the reverse for a low, and inhale a carb substance that would instantly bring you back…maybe I'll apply for a patent…:>)

jaydoubleyou23
jaydoubleyou23 2014-06-30 20:15:32 -0500 Report

Eek..I don't know. I have a problem with inhalants in general. I'd definitely rather inject personally. But it would be a cool alternative to have.

evaziem
evaziem 2014-06-30 09:42:04 -0500 Report

Does anybody know about any independent review of these meters?
Which meter is more accurate than the others?
I would appreciate this info?

IronOre
IronOre 2014-06-28 13:44:55 -0500 Report

No doubt this is good news.
Of course price is a concern. I guess we will have to wait and see.
Honestly tho, I don't know if I would do this or not. Taking insulin really that bad for me. It's the testing, which shows nothing in the near future for changes.
.
So in this case would an insulin pump be a hose to your mouth ? (just being sarcastic here)

evaziem
evaziem 2014-06-28 09:37:35 -0500 Report

Wow!
I wonder if it would deliver a precise dose…

haoleboy
haoleboy 2014-06-28 09:50:39 -0500 Report

I'd like to think that accuracy of delivery would be one of the requirements for approval

evaziem
evaziem 2014-06-28 10:31:22 -0500 Report

Approval…
The FDA lost credibility in my eyes when I discovered how inaccurate the glucose meters are.

I had NO idea that my glucose meter measurements may NOT be what the numbers show until my insurance changed me from Accu-chek to Prodigy.

I had some strips left so I used both and to my astonishment I discovered that from the SAME puncture my numbers vary between from a few to over 40 mg/dL of glucose!!!!!!!!!!!

The difference is not constant, it varies.
See this:
http://www.conexbridges.com/BGLtable.pdf
http://www.conexbridges.com/BGLplot.pdf
http://www.conexbridges.com/Differen.pdf

If you look at my numbers (2 hours after dinner), according to Accu-chek I am fine, but the Prodigy's values scare me…

I know about this "new" initiative
http://diabetestechnology.org/surveillance.html
to improve the situation but have very little hope.
I contacted these people how can I help with my data or be part of it but received no reply…

I do not know how this organization is demanding the FDA would evaluate and pull the wrong meters from the market. Does anybody know?

haoleboy
haoleboy 2014-06-28 12:12:10 -0500 Report

I honestly think you are tilting at windmills here ,,,
home testing by its very nature will always be inaccurate unless you can guarantee that testing is done in a 'perfect" environment … meter and strips are kept sterile and at a controlled temperature. test site is always the same and free of contaminants … and on and on.
Even if we could get all the variables in line … what would the cost of a laboratory grade meter and strips be? Who could afford them? Would insurance cover them for type 2's that are in good control?
I honestly do not see the concern (or a reasonable solution)

Steve

evaziem
evaziem 2014-06-28 12:18:29 -0500 Report

Both of these meters and strips I keep in the same place AND I use the same puncture. Therefore what environmental variables are we talking about? :=)

haoleboy
haoleboy 2014-06-29 14:44:22 -0500 Report

You are looking for lab grade accuracy in a household item that is subject to heat, humidity, exposure to sunlight … all of which can affect accuracy. Not just at home but throughout the entire distribution chain.
While I am sure you take very good care of your meters and test strips I can tell you from personal experience not all of us do … and having worked in retail most of my life I can tell you horror stories about how merchandise is handled (I once worked in the 'adult beverage' industry for a number of years and NEVER drink anything from a can).
My point is not that we should have inaccurate meters but that the amount of effort (cost) that the manufacturers are likely to expend is limited by the realities of the market … how much would you be willing to pay for dead on accuracy? Or more to the point how much is the average diabetic willing to pay?
Which one of your meters that you are comparing is accurate? If neither your testing really proves very little empirically, and is really just anecdotal evidence that meters have an "accepted" range of accuracy.
If you were FDA czar … what accuracy standards would you require?

namaste
-Steve

evaziem
evaziem 2014-06-30 09:38:29 -0500 Report

The home meters are not accurate. This is a know fact and that is why we have this initiative:
http://diabetestechnology.org/surveillance.html

See this article updated March 2014 that says: "Just because a blood glucose meter meets the current federal standards doesn't mean it's the best; as of March 2014, those standards allow the devices to be wrong by as much as 20 percent."
http://www.consumersearch.com/blood-glucose-m...

The 20% is too much. I would accept +/-5%. With such an error margin, THERE IS REASON TO MEASURE.

If we go to the store and a cashier would say: "Your bill is with +/- error," I would not pay!

Nick1962
Nick1962 2014-07-02 19:26:51 -0500 Report

As a very anal retentive and obsessive person, I can understand your frustration with the accuracy issue. It took me a while to come to grips with the fact that these meters were never meant to be a “medical diagnostic tool” for the average Joe or Josephine. Merely a step above peeing on a stick. Even “hospital grade” stuff has an error factor and unless you test a blood sample from a vial, accuracy within 5% is impossible.

At the end of the day, you can’t control your BG within +/- 5% and you are realistically only looking at one very brief snapshot test with any meter. Blood isn’t equally mixed in your system either, so if you want that form of accuracy, you’d really need to get on a CGM, and I’ve read that even with those there can be a large discrepancy between the CGM and the meter you calibrate it against.

I personally don’t know my meter’s true accuracy, but after I tally up my readings and do the math, my A1c comes within .2 of my doctor’s vial test. Well within what I’m comfortable with (now).

To tie this back to the original post though, I’m sure there are many out there who would be willing to use a +/- 20% accurate insulin – seems like an ideal thing for someone active.

evaziem
evaziem 2014-07-03 09:00:31 -0500 Report

I do not take insulin yet, but it's my understanding that people who do calculate their amount if insulin based on what the glucose meter shows.

If this is true, the wrong base for this calculation can be dangerous, maybe even deadly.

This where my concern comes from…

Nick1962
Nick1962 2014-07-03 11:07:32 -0500 Report

I agree, however, my goal (like most people I think) is to keep my levels comfortably between the recommended high and low. If you are consistently flirting with the high or low end where that 20% makes a life threatening difference, you have other serious issues that need to be addressed, meter or no meter. Again, it was not meant to be a precision medical diagnostic tool.

evaziem
evaziem 2014-07-03 11:26:53 -0500 Report

I does not say anywhere in the instructions that these numbers are only FOR INFORMATIONAL PURPOSES ONLY.
What I am reading implies that the numbers is what it is expected to be. They pretend to be accurate because if not, what is the purpose of the meter.

Imagine that your electric meter at home could be 20% wrong and you are paying for electricity you did not use?

Science is science and number and numbers. They must be correct.

Many people try to correct this inaccuracy problem and that is why there is this "new" initiative:
http://diabetestechnology.org/surveillance.html

jigsaw
jigsaw 2014-06-28 20:13:14 -0500 Report

Simply your perception and interpretation. Not meant to be a criticism, but you're free to believe and interpret things, any way you like! Isn't it nice to be so priviledged! A closed mind is a dangerous thing. The older I get, the more I realize how little I really know. Funny thing, the more I know, the more I realize how much more there is to learn!!! Holy mackeral baby!

Trudie Ann
Trudie Ann 2014-06-28 02:56:45 -0500 Report

I hope I never have to take insulin but if I do I think I would much rather inhale it. I really don't like needles so if it's safe they get my vote.

Chevy Vega
Chevy Vega 2014-07-03 07:54:57 -0500 Report

I'm just the opposite. (Although I already shoot insulin, so I know what it is like. I find it very easy to do, even in public.) The thought of inhaling insulin doesn't appeal to me at all.

Trudie Ann
Trudie Ann 2014-07-03 21:57:26 -0500 Report

I hate needles, I might could do it if I had to but OMG, that is a hurdle I would have to jump when I get to it.

Gabby
GabbyPA 2014-06-27 19:47:39 -0500 Report

I have asthma and it might be right for me, but I would be willing to give it a try to see how well it works. No more needles sounds great.

Next Discussion: last doctors appr »