Patient Perspective on FDA APP Meeting

We asked one of the patients who spoke at the FDA meeting, Ali Umberger, to give us her perspective on the meeting.  Here is what she had to say:

“Last Wednesday I had the opportunity to make a few comments before an FDA panel during a public workshop on the Clinical Development of the Artificial Pancreas.  The specific session that I participated in was titled, “Clinical Expectations for the Low Glucose Suspend Device Systems.”  It was eye opening for me to listen to the exchanges among the scientists and FDA officials on the panel.  I walked into the workshop expecting dry power point presentations full of scientific jargon and a glazed over audience, but instead I heard the scientists passionately advocating for reasonable study parameters and the FDA officials countering with concerns over the accuracy and reliability of the data available.  I was honored to be able to provide an adult type 1 perspective to the panel and to encourage the participants to work together to move diabetes technology forward.

As type 1 patients I believe it is our responsibility to keep up with the treatment developments happening around the country and the world.  We need to show the FDA as well as the companies developing new or enhanced diabetes devices that there is a demand for such advances.  While case studies can illustrate the challenges of successful diabetes management, our stories of day to day life with diabetes have a much larger impact.  I encourage others to share their stories as well; you can explain why an artificial pancreas would be important to you on the APP Tell Your Story page.  We all work hard to manage our disease and we deserve the best treatments available.”