Happy New Year! I know many of you have been following developments with the artificial pancreas guidance from FDA, so I wanted to give you an update about what’s been going on. After FDA released the artificial pancreas draft guidance document on December 1st our initial review was that the guidance is encouraging and seems to incorporate suggestions from clinical experts. Specifically, those recommendations were that the guidance (1) commit to the use of CGM for system evaluation; (2) lay out a reasonable study progression; (3) allow for flexibility in selection of a patient population and endpoints; and (4) encourage expeditious testing and incorporation of updated and improved components into the system.
Since December 1st we have been digging into the details more deeply. We are looking at the clinical and statistical implications of the FDA recommendations with experts who perform artificial pancreas studies. We are also considering the product development implications with the experts within the companies who work in this area.
All of this work is leading up to our official comments on the draft guidance document to FDA. We will be submitting our comments by the deadline of March 5th, but also plan to have them publically available a few weeks before the deadline so you can all see what we are suggesting to FDA.
The involvement of so many of you has brought us to this point and we hope you will continue to follow the developments. We want FDA to accept our comments and those of others and issue a final guidance document that will help provide a pathway for researchers and industry to quickly develop these much needed systems, perform the studies to demonstrate they are safe and effective, and make them available to people with type 1 diabetes.
Type 1 Diabetics shouldn't have to wait any longer for the opportunity to have a pancreas that works just like the rest of ours. Although it is an artificial pancreas, it will not only improve the lives, 24/7, of the Diabetic, prolong the lives of the Type 1 Diabetic and those who will one day receive the news that they too are insulin dependent due to pancreatic failure, but it would lower medical costs in our country, FDA, what are you waiting for...Does it take "A Act of Congress" to stop the suffering of those afflicted with this disease epidemic? These artificial pancreas study "kinks" have to be worked out NOW before they will work in the human body of the diabetic. Stop wasting time, and bring on the "Dr. DeBakey's" in the Endocrinology field. Let scientific technology progress. It is time for a cure.
I know that someday in my son's lifetime there will be a cure.
This train is on the right path, but we have to keep putting coal in the furnace and keep it moving. It's really up to all of us to keep pushing. We must: encourage expeditious testing and incorporation of updated and improved components into the system. It's up to us. We R the Cure! Thanks, JDRF, for all you do!