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Posted - Oct 27 2011 : 12:11:07 PM
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ARTIFICIAL PANCREAS PETITION JDRF
Artificial Pancreas cartoonAn artificial pancreas represents the most revolutionary advance in treating type 1 diabetes since the discovery of insulin. This device, now under development, will dramatically change the lives of people with type 1, allowing them to maintain tight control of blood glucose levels, thereby significantly reducing the risk of life-threatening fluctuations and freeing them of much of the daily burden of managing their disease.
The speed with which an artificial pancreas reaches patients in the United States will be determined by crucial guidance to be issued by December 1st by the U.S. Food and Drug Administration. The FDA needs to hear from you that type 1 diabetes families are watching, we are waiting, and we are urging that the agency seize this moment to lead, and not stand in the way of bringing this innovative and life saving device to market.
Raising your voice now is critically important because recent FDA actions create a real risk that the agency may throw obstacles in the path of researchers, scientists, and manufacturers who are poised to launch the outpatient clinical trials required to demonstrate the safety and effectiveness of an artificial pancreas.
You need to tell the FDA that delays are not acceptable. You need to tell the FDA to keep their promise to the children and families affected by type 1 diabetes. You need to tell them that the health and even the lives of your loved ones are at stake. Sign the petition and check the box to receive emails from JDRF so you can stay up to date on our next steps for the AP.
PETITION:
Whereas, an artificial pancreas represents the most revolutionary advance in treating type 1 diabetes since the discovery of insulin,
Whereas FDA obstacles have kept a low glucose suspend device, the precursor to an artificial pancreas, from being available to patients in the U.S.
Whereas, availability of an artificial pancreas is a top priority for the type 1 diabetes community because of its potential to improve safety and transform the lives of people with the disease,
Therefore, we the undersigned, urge the FDA to issue guidance by December 1st adopting outside clinical recommendations allowing short term in-hospital evaluation of artificial pancreas systems followed by outpatient trials no more than three months long.
Your response has already been submitted once.
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