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Artificial Pancreas: FDA Releases Guidance

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Artificial Pancreas: FDA Releases Guidance

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In the past several weeks over 110,000 diabetes advocates signed onto a petition asking the FDA to issue draft guidance by December 1 that would advance the testing and development of artificial pancreas systems. We wanted to share the news that FDA has just published this important draft guidance and based on an initial review JDRF is encouraged that it appears to lay a foundation for accelerating the development and availability of artificial pancreas technologies.  Read more in this JDRF statement just released.

What’s Next?

  • In the coming weeks, our scientific and regulatory experts will review the draft guidance in detail and provide comments to FDA.
  • We will be back in touch with you about additional steps you can take! 

Continue to follow along and update your family and friends by sharing this post on Facebook or Twitter (use hashtag #AP100k).

Talk to you next week,

Hasan

 


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  • Great News!!!!!!!!!  :)

  • IDDM since 1967 (13 years old) & have had at least 2 strange issues -1-since age 13 I have always taken a minimum of 20 total units of long-acting & short acting insulin, at times more than 30. At some point my insulin requirements dropped significantly ( many things going on- none that should deal with this) & nobody has a clue why. Currently I take between2-5 units of Lantus & 0-3 units of humalog - at times my daily total may be 3 units. My A1c's run in the low 7's & my weigh remains as it always does! Don't more people develop insulin resistance &need more insulin?

     The other thing is - for the 1st 25-30 years, I would have around 2-6 insulin reactions a year where someone else had to bring me out of, whether it was my parents, siblings, wife,kids or my doctor (many years ago) or EMT's.  If I got down in the 50's I was already getting very confused.Now for at " least" 15+ years I haven't had an insulin reaction that I couldn;t deal with & even having bloodsugars as low as 17 (double checked with another glucometer from a different sight). At times at night I might wake up feeling okay, go to the bathroom & always check my sugar - as I said, it might be 28! Most of the time when I wake up, I'm asymptomatic, but somehow I wake up. I've had T1Dfor 45 years, see  an endocrinologist regularly & nobody has a clue! Wouldn't be great if we figured out why I  no longer have reactions! For years I prayed to not have a reaction in school!  Plus to figure out why my insulin requirements dropped (A BUNCH)

                               Bud Miller  & Max (my best buddy-a Golden Retriever)   517-881-2507

  • Couldn't find a way to sing petition. Very exited for my grandson and all others who suffer from Type 1 Diabetes.

  • Please continue your research to develop the artificial pancreas for all the Type 1's out there. I was diagnosed at 18 and am now 38. Twenty years with diabetes is long enough. Come on everyone, get involved.

  • This is wonderful news for anyone with type 1.  My hope is that one day soon my son can get this in place.

  • I have had Type 1 Diabetes since 9 years old and I am now 27. So it is time to have an option like this.

  • I would love to give my son the gift of life with the blessings of an artificial pancreas!!

  • Dear FDA,

    Please approve the Artificial Pancreas as soon as possible, for juvenile diabetics.  Thank you.

    J.K.

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