I was at JDRF retreat this weekend, and some lady from JDRF came and talked about the JDRF's new plans and stuff.
One of the things they're researching right now is Glucose Responsive Insulin. She described it as a shot once a day, maybe once a month, that it stored the insulin in your body and then it turned on when you need it turns off when you don't. To me it sounds like a good start on the way to a cure, or just making Diabetes less of a hassle. Merck is the company researching it
Yeah, I agree that smart insulin is even more exciting that artificial pancreases because it wouldn't require any equipment!! But, it's in the really early stages, so if it worked, unfortunately it's years out.
Yeah, I agree that smart insulin is even more exciting that artificial pancreases because it wouldn't require any equipment!! But, it's in the really early stages, so if it worked, unfortunately it's years out.
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they said that it's being tested in rodents right now.
The big difference between the U.S. and Europe is our FDA is slow and slows everything down.
Yeah, I agree that smart insulin is even more exciting that artificial pancreases because it wouldn't require any equipment!! But, it's in the really early stages, so if it worked, unfortunately it's years out.
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they said that it's being tested in rodents right now.
The big difference between the U.S. and Europe is our FDA is slow and slows everything down.
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then we'll have to wait years once it's approved by the US to get it in Canada =/
Well, I agree with you that it's slower here and I also feel your frustration with the pace of research. But, in Europe, they only have to show safety for approval. In the US they also have to show efficacy as well as safety. So, the FDA is using stricter criteria.
I heard about this a few years ago. Sounds awesome. To me this sounds way better than the artificial pancreas, if it really does end up working like this. Sounds good, but it's probably "5 years away". Where have I heard that before !?!?!?
Well, I agree with you that it's slower here and I also feel your frustration with the pace of research. But, in Europe, they only have to show safety for approval. In the US they also have to show efficacy as well as safety. So, the FDA is using stricter criteria.
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In most cases, yes, it is *better* to use efficacy as a guideline because why take an expensive new painreliever if 2 aspirin works just as well. However, neither safety or efficacy measures really get at a quality of life evaluation. Maybe(*) smart insulin will not reduce A1Cs or complications much compared to current MDI regimes. So it comes out of the study not looking safer or more effective. The FDA seems to struggle with cases where the improvement in the patients quality of life (less shots, eating more normally, etc.) is the real win because any way to monitor that is becomes at least somewhat subjective. So I hope smart insulin is on its way and I hope the FDA gets some common sense before it gets there.
*Just to note, my example is not because I know anything about the safety or efficacy about how smart insulin actually works and how it will go down at the FDA, just my imagination of why it could get stuck in the FDA for quite a while.
Well, I agree with you that it's slower here and I also feel your frustration with the pace of research. But, in Europe, they only have to show safety for approval. In the US they also have to show efficacy as well as safety. So, the FDA is using stricter criteria.
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In most cases, yes, it is *better* to use efficacy as a guideline because why take an expensive new painreliever if 2 aspirin works just as well. However, neither safety or efficacy measures really get at a quality of life evaluation. Maybe(*) smart insulin will not reduce A1Cs or complications much compared to current MDI regimes. So it comes out of the study not looking safer or more effective. The FDA seems to struggle with cases where the improvement in the patients quality of life (less shots, eating more normally, etc.) is the real win because any way to monitor that is becomes at least somewhat subjective. So I hope smart insulin is on its way and I hope the FDA gets some common sense before it gets there.
*Just to note, my example is not because I know anything about the safety or efficacy about how smart insulin actually works and how it will go down at the FDA, just my imagination of why it could get stuck in the FDA for quite a while.
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I'm not sure whether the FDA's approach is "better" (as you said) or worse. As you implied, it seems to depend somewhat on the device or medication. But, what I don't like is the anti-FDA tone in a lot of the T1 online community, including in this thread. The speed of research relates to a lot of things including science, funding, and the approval process. But, I feel they have good intentions and are not purposefully trying to delay a cure, even if they may be misguided. I know 2 of the endos who work over at FDA, and one of them has T1. Both feel they're doing their best to make sure the approved medications are safe, even if we all wish it would go MUCH faster.
And PS, I agree that everyone that I'd LOVE to see this smart insulin tomorrow, lol!