FDA: Don't Delay Life-Saving Diabetes Care Developments
- by: JDRF
- recipient: US Food & Drug Administration
An 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, significantly reducing the risk of life-threatening glucose fluctuations giving them a much better chance at a happy, healthy life.
How quickly an artificial pancreas reaches patients in the US will be determined by crucial guidance issued by the U.S. Food and Drug Administration by December 1st.
But there is a real risk that the FDA may throw obstacles in the path of researchers, scientists and manufacturers who are poised to launch outpatient clinical trials required to demonstrate the safety and effectiveness of an artificial pancreas.
We need to tell the FDA to keep their promise to the children and families affected by type 1 diabetes. Let the FDA know that delays are not acceptable. The health and even the lives of our loved ones are at stake.
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.
