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  After FDA released the artificial pancreas draft guidance document on December 1st our initial review was that the guidance is encouraging and seems to incorporate suggestions from clinical experts.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All of this work is leading up to our official comments on the draft guidance document to FDA.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.