What it Takes to Get Started in Closed Loop Artificial Pancreas Trial

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Participating in an artificial pancreas medical trial is not as simple as signing on the dotted line, hooking yourself up to the equipment and pressing go.

“Medical trials are strictly regulated and monitored by the FDA and the FDA has very strict rules concerning individuals eligible to participate in the study.  After submitting my name for the trial in early December, I had a lengthy telephone conference with Dr. Sue Brown who went through a whole list of exclusion criteria to make sure I qualified for the trial.  I had not heard of 99% of the various ailments that Dr. Brown rattled off, so I assumed that I didn’t suffer from them.  After the telephone conference, I had a physical performed and various blood tests done to make sure I was a perfectly healthy diabetic.

I finally heard on December 23rd that I was accepted to the trial.  I started the actual trial on January 1.  The trial involves several weeks of at home “control” studies followed up with the control admission at the University of Virginia.  Since January 1, I have been documenting and keeping track of the food I eat, when I eat, what I am doing during the day and what time I work out.  The goal is to replicate, as much as possible, those activities while in Virginia.  Many of my coworkers think there is no way to replicate my life here without bringing them along to Virginia where it’s supposed to be in the low 50s.

There were three days in the middle of January where I had to follow a schedule given to me by the University and eat designated foods.  I was allowed certain prepackaged meals for dinner and Panera for breakfast and lunch.  Let’s just say I am not in the mood to enjoy the power steak breakfast at Panera any time soon.  Those three days were the most challenging for me because I follow the paleo diet and low carb diet as much as possible to keep my A1Cs in the mid to upper 5s.  My breakfast options were limited and there is no such thing as a paleo/low carb friendly prepackaged meal in the various options I was given.

Since the beginning of January, I also have been wearing two Dexcom G4 continuous glucose monitors, using my regular Animas Ping pump, and using a One Touch blood glucose monitor provided by the University of Virginia.  The reason I have been wearing two CGMs is because one is mine and one was provided by the University of Virginia.  I thought it would be fun to compare the two.  Tomorrow I will be disconnecting my own CGM and adding a second CGM from the University of Virginia.  I believe the reason for two CGMs is merely for safety during the trial and not because the final system will require two CGMs.  Stayed tuned for my update on Monday because Sunday night I go live on closed loop artificial pancreas out in Virginia!”

To hear more from Melissa on her journey click HERE.

 

For more information on the artificial pancreas project, check out the following links:

https://www.jdrf.org/blog/2013/the-artificial-pancreas-does-its-homework

http://artificialpancreasproject.com

http://news.virginia.edu/content/uva-s-artificial-pancreas-project-receives-34-million-grant