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Smart insulin WOW!!

Discussion in 'Parents of Children with Type 1' started by BrokenPancreas, Nov 26, 2009.

  1. BrokenPancreas

    BrokenPancreas Banned

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    This is old news, but it's "new news to me"
    I searched this site and couldn't find any threads.

    Does anyone know about this?
    How long would this "practically a cure" insulin be ready for the market?

    If there were past threads, please post, I would love to read anything and everything about this!

    http://www.smartinsulin.com/news/articles2009/05_2009_NewTypeofInsulin.pdf
     
  2. My_Dana

    My_Dana Approved members

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    This would really simplify life!
    I didn't know about it.
     
  3. BrokenPancreas

    BrokenPancreas Banned

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    Today was the first I heard about it, I had a really great Thanksgiving thinking about this all day!!!:):)
     
  4. Darryl

    Darryl Approved members

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    From their website... sounds they are still moving along.


    September 25, 2009 ? SmartCells, Inc. Awarded Phase II SBIR by NIH/NIDDK

    SmartCells, Inc. received notice that it has been awarded $1,578,278 in first year funding for a Phase II SBIR grant from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH). The grant was awarded to support IND-enabling toxicology and safety pharmacology studies of SmartInsulin, the company?s glucose-regulated insulin formulation. The second year of the Phase II grant allocates $337,365 in additional funding.
     
  5. BrokenPancreas

    BrokenPancreas Banned

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    Darryl,
    In a nutshell, what does this mean
    Also, if all goes well, how long would a drug like this take to get to our kids? How many years?
     
  6. Lisa P.

    Lisa P. Approved members

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    I was really skeptical when I first heard of this, but my sister (who is not a medical doctor or researcher but has her PHD in chemistry and had done work on body chemistry, etc., whatever you'd call it) says she thinks it sounds like solid science and potentially really do-able. For what it's worth.
     
  7. Toni

    Toni Banned

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    I would be very surprised if you would see this come to market before ten years are up. I would hate to think it would be longer than that, but it could be longer than that.
     
  8. buggle

    buggle Approved members

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    If they're in SBIR grants, they're very, very early on and a long way from human clinical trials. They're still at the proof of concept point, which means they're looking at whether this will actually work and likely trying to get the polymer perfected and get it to deliver consistently. Phase II SBIRs are usually for a few years of work. We could look up the grant, since they're public record and see how long they have the project planned.

    If they do make it to human clinical trials, new drugs usually take around 20 years on average and about a billion dollars of investment. There's a lot of money to be made if this works, because the delivery system concept would work for lots of other drugs besides insulin. But it's likely many years away before this makes it to market.

    I wonder about these polymers and what effect they'll have on peoples' health. So, lots of questions to still be answered. But hopefully, this concept has some promise and will actually make it to market some day and be safe.
     
  9. momma_fish2007

    momma_fish2007 Approved members

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    I saw a brief article about it but it didn't give any definitive answers as to when it would be available. The sooner the better!
     
  10. Darryl

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    I don't know any more... I think that the qeuestion was answered in a post before this.

    Even if this works, I think there will still be a need for frequent testing. This insulin could theoretically prevent hypo's resulting from excess insulin, but would not prevent hypo's or ketones due to lack of carbohydrates, say during exercise. Until they can pair smart insulin with smart glucagon, they have only addressed half of the problem.
     
  11. carbz

    carbz Banned

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    Hello gang, I just registered here mainly to reply to this topic. I am not a child nor parent of a diabetic but a long time veteran to type 1. I have been following these guys (smartcells) since back in 2003 when they became public to the net. As far as my understanding at this point the drug has been tested in many large animals with no signs of any hypoglycemia giving them much more dosage then needed. The only thing that hasn't been mentioned is what actually happens to the leftover insulin that doesn't get used and of course knowing the long term safety of using it. But If everything goes without any setbacks I think they are scheduled to start human trials by the second or third quarter of 2010. Someone I met online that has spoke to Dr Zion directly claims he stated the drug could make it too the market by the end of 2014 if if if... You know the story there. Anyway here is a video of Dr Zion showcasing some info about the drug from back in April. It seems encouraging and very realistic. I am praying for this one though it wouldn't be a cure (which may eventually happen) it would at least be a huge advancement in living with D until a cure like treatment happens....(Faustman,Exsulin) cough cough... At 44 years old and 35 years diabetic I deserve a break already.

    http://jdrfne.blogspot.com/2009/04/tenth-annual-spring-research-briefing_21.html
     
    Last edited: Nov 27, 2009
  12. buggle

    buggle Approved members

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    Would they be able to fast-track it? I don't how they could get through the bureaucracy of FDA human clinical trials in just 4 years. But, I haven't listened to the presentations you posted yet.

    Welcome, carbz. :) We have several adult T1s who are regulars here and I really enjoy the input and perspective of people who've been living with diabetes for years.

    ETA: Smart insulin and that cool tattoo that changes color with BG would be great things if they work and get released.
     
  13. carbz

    carbz Banned

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    Buggle,

    Your guess is as good as mine. From my understanding they actually have the product but whether they run into setbacks due to any unexpected problems is anyones guess. I will assume if they don't and have it tested in the human setting for a good couple of years and it shows safe and effective there is no valid reason for the FDA to delay it to the people that need it (most of us). This disease is not to make light of and something needs to be done sooner or later. Though smartinsulin would really be just another band-aid it would be a huge breakthrough and not making living diabetes that difficult to live with. Its very discouraging all the setbacks that come with these potential breakthroughs. I remember reading an article back in 99 when the Edmonton protocol broke through and they suggesting that by 2010 diabetes would not be an untreatable disease and no big deal to be diagnosed with. I thought to myself how can a cope with this another ten years?? Well its basically 2010 and I am still injecting up to 10 times a day with not much sign of relief in the near future. Just a little bout myself the lows are not a problem for me its the elevated levels and spikes that drive me crazy. I am way more uncomfortable (anxiety, irritable) at a slightly elevated sugar then most people claim to be running 250 to 300. I am still in one piece without any major diabetes comps but the swings are killer for me and make it difficult to enjoy being alive. :(
     
  14. BrokenPancreas

    BrokenPancreas Banned

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    Carbz,
    Thank you SOOOO Much for the update.;)
    Please, please update this forum from time to time when you hear about anything?

    Do you know who would be eligible for the clinical trials, how to get involved, and what the age limit would be?
    Thanks again for this wonderful news!!!
     
  15. buggle

    buggle Approved members

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    Here's the SBIR Phase II grant abstract.

    http://crisp.cit.nih.gov/crisp/CRIS...e=57&p_audit_numfound=1&p_keywords=smartcells

    It sounds like things are coming along, but they still have a long way to go before they can even think about the FDA drug approval process with human clinical trials.

    There's a protocol that all drugs must go through before they can be released. There's a fast track process for certain drugs, but they must be tested in FDA clinical trials. If they can get fast tracked, it will cut way back on the standard 15-20 years. I think they still have a few years of work before they can even apply to the FDA. I don't know how long it takes the FDA to approve the applications and then how fast they could get through the approval process.



    We've only been at this 1.5 years, so I know I have a completely different perspective than someone with your first-hand experience who has dealt with type 1 for many years. But, the single thing that has improved our lives so much is the Navigator CGM. It has changed how I feel about managing my son's diabetes and it's improved my level of calmness and my comfort level aggressively treating his variable BGs and constantly changing insulin dosing. We started on the pump last July and it's really helped too, though CGM is the most important thing from our perspective. Have you considered CGM or a pump? They're a pain too, but I think they're so much better than our experience without them.
     
  16. BrokenPancreas

    BrokenPancreas Banned

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    Rella,
    So it's not at all a reality with his 2014 post regarding distribution?:confused:
     
  17. buggle

    buggle Approved members

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    I don't really know. The SBIR grant looks like it's two years. Depending on how it goes, I suppose it's conceivable that the fast track could have it through within a few more years -- especially if they get a big pharma investor.

    I'll want to see it actually being used for a few years before I'd start Brendan on it too.
     
  18. BrokenPancreas

    BrokenPancreas Banned

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    Another WOW!
    I just read on their website that it deals with Thyroid issues also!
    My dd has Hashimoto's, would this get her off her synthoid that she needs to take for the rest of her life?
    All I can say about SmartInsulin... WOW WOW WOW WOW WOW!!!!!!!
     
  19. Daxdog

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    If it administers insulin only when you are high, you would be high before the insulin ever goes into effect. What is their high threshold? If it is 150, you would remain around 140 or higher all the time, because it would not consider 140 "high." How long does it take to act? A lot of the time if I am already over 150 when I take my insulin, I'm headed up very fast and not even Apidra can keep me out of the 300's.

    I just don't think it offers me the level of control a pump does.
     
  20. Ali

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    Re Daxdog post. Even if it does not kick in till a BG of 140 you could use it as a back up for MDI or the pump and never go over 140. that means for all those times you can not meet the carb needs of your meal for any reason or the basal changes of your body due to hormones, exercise, growth hormones, stress, etc. the smart insulin could kick in and help. I may be way off base but it could really help as a background insulin on top of your pump or MDI if it worked this way. ali
     

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