FDA: Build-A-Pancreas

Jan.17,2011

Dearest FDA,

I've been thinking,lately,of how despised you must be (not just among the D-Community,but among the entire medical community) Everyone wants a cure, yesterday. Your job is to protect us from those drugs & devices out there that (properly or improperly used) have the ability to injur,maim, and kill. I get that,I really do.( & I'm glad that you exist)

But I have diabetes...and sometimes,it feels like everything is "five years away." A Cure. Inhaled Insulin. Smart Insulin. An Artificial Pancreas. And on the subject of the later,the minds at JDRF & the clinical test sites know much more then I do about how it will play out. But they are dependent on us,those of us who live with diabetes..without us,it goes nowhere. At the end of the latest research study,my "Big Picture" got a little bigger.


Right now,it's in phase 2.(still very stuck in the clinical setting) They say phase 3(moving to outpatient,probably a hotel) is still a couple years away. In the meantime, research continues as to how to best incorporate various features for each & every user, a "build-a-pancreas" as you were.( not everyone needs,or wants,the same features)

And so, this led to an hour long discussion (via phone) as to what features would be most important to me. It was not the standard "I need the darn thing to shut off at 80 mg/dl so that it doesn't OD & kill me" type of conversation( because,not everyone needs that) it was more of the nitty-gritty,get your hands dirty kind.

Because an artificial pancreas is to be MORE then a glorified CGM.(& mine,is not too glorious at the moment) So you need to know if you're high or low...a CGM will alarm,& tell you that. The real issue here is the accuracy of said CGM & you can't really trust your life to it, it's lagging behind actual blood glucose by 15-20 minutes. Blood
Glucose calibration is still necessary, as are "safety parameters".(below or above certain bgs,an alarm would sound) That would be largely user defined...hence the need for initial data collection before setting those parameters. Still, I would really like for it to do SOMETHING automatically(initially), for I'm doing everything anyway & it couldn't be any more disastrous then what I've got now. (right now,even an integrated pump-CGM would make me deliriously happy) The action of the fastest acting insulin is still not fast enough to prevent a postmeal spike.(outside controls & ability to override system is a must) Technology is just not to the "slap it on and forget about it" stage...it's a work in progress.

All I ask,is for you to give it a chance.There is so much potential in it,& it blows the socks off what we have now. The moments that I didn't have to worry about my blood sugar are the moments I will treasure forever.( I,and everyone else would like more of those moments)


Cordially,


Heidi

(type 1 for 12 years and counting)


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