The room was packed with clinicians, researchers, patients, and industry – and from what we have heard there were a lot more people watching on-line.  This is just more evidence of how much interest is out there about artificial pancreas systems.  For those of you watching in person or on-line – tell us what you think about what you heard by commenting below.  For those of you who missed it, we’re told FDA will be posting the webcast soon.

In the meantime, let me give you a brief overview.  The FDA assembled the who’s who of the diabetes community for this workshop.  In fact, many of the participants are members of a clinical recommendations panel that JDRF convened to discuss and make recommendations to the FDA on the best ways to conduct studies of artificial pancreas systems, especially those outside of a hospital.  The experts on the panel and in the audience made this a stimulating discussion that we hope will advance the field in important ways.

The important take-aways were:

• The clinicians, researchers, and patients in the room were
  overwhelmingly in favor of low glucose suspend systems (those that turn
  off insulin when a person gets to certain low level or is predicted to
  go below a certain level) being available to patients.
• The experts agreed that it is most appropriate to test these systems outside of the hospital.
• There was a debate about whether to use CGM data to measure if a system
  is effective.  Most external experts agreed that CGM should be used
  while FDA expressed concerns about this because of accuracy.
• The patient voice came through loud and clear with 5 patients and
  parents sharing their experience and struggles managing type 1 diabetes
  and support of speeding development and availability of artificial
  pancreas systems.

And speaking of patients, we want to hear from you.  Click here to tell us why an artificial pancreas would be important to you.

I applaud the FDA for bringing together the right experts and hope they will take advantage of the input and recommendations provided, incorporate it into regulatory decision-making and into public guidance for researchers and industry to use as they develop these important new tools for patients with type 1 diabetes.  Having clear and reasonable guidelines from FDA is sure to stimulate the field even more and encourage more interest and innovation.