The development of an artificial pancreas is coming. This year, U.Va. researchers expect to begin a new phase of human clinical trials testing the closed-loop system outside of a hospital setting. A test in the real world with real Type 1D people like me.
This past December I was driving to Charlottesville for a new health screening, tied to my third clinical trial in the AP research project, when I got the classic “Good News, Bad News” phone call from U.Va. The Bad News: My new trial — “Pramlintide Combined with Model Predictive Control Algorithm” with Open and Closed Loop randomization — was being postponed. I would not be needed today.
The Good News: Successful AP clinical trials in outpatient settings in Europe were paving the way for next step trials in the United States! So instead of wasting my blood, sweat and tears in another inpatient trial, I am on the short list — fingers and toes are still crossed — of participants who will participate in unique, closely monitored trials using the Droid-like artificial pancreas device! (Hit the link below to read article and hear audio interview with U.Va.’s lead researcher Dr. Boris Kovatchev, courtesy of U.Va’s Health System News Service.)
These studies are the next critical step in ensuring that an artificial pancreas is safe and effective for all patients and will meet all FDA requirements. More than 300 Members of Congress, including Virginia Senators Mark Warner and Jim Webb, and organizations representing 6,000 clinical endocrinologists, and thousands of academic researchers and medical professionals urged the FDA to move forward at the end of 2011.
Hopefully, we’re now on a faster track that leads to rapid commercial development of the real deal — not just a fancy laboratory device. It’s time to climb the next mountain. And soon, very soon, the more than 3 million Americans who are living and coping with this chronic disease — and cheating destiny daily — will be able to show off their digital life-saving AP devices and say, “Diabetes, There’s an App for that!”