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RE: [IP] rediculous why we are not able to use artificial pancreas

The problem is that with this system the patient is not controlling it
either. With an insulin pump and CGM you make the decisions. For example if
the CGM tell you your BG is 40 and you are feeling fine you know to test
before you bolus. If you have a totally closed loop system the potential is
that the system could adjust itself and over or underdose you. With a
totally closed loop system more safeguards are needed because you have
eliminated the human factore. 

-----Original Message-----
From: email @ redacted
[mailto:email @ redacted] On Behalf Of BrentM
Sent: Saturday, November 26, 2011 10:26 PM
To: email @ redacted
Subject: Re: [IP] rediculous why we are not able to use artificial pancreas

I saw that as well and agree.   PEOPLE, not DOCTORS, should be in control of
their own healthcare day-to-day management with problem assistance from the
medical professionals when needed.    The FDA needs to loosen up the reigns
and let people manage/not manage their diseases as they see fit.


 From: "email @ redacted" <email @ redacted>
To: email @ redacted
Cc: email @ redacted
Sent: Saturday, November 26, 2011 6:33 PM
Subject: [IP] rediculous why we are not able to use artificial pancreas

i find this hurdle in the paragraph below to be stupid--- the fact that the
device would put us at risk bc it controls w out the oversight of a health
professional....um isn't that where we are at now w being on a pump ??? yes
helps to set pump up but I change my basals all the time / manual bolus
are they afraid of loosing out on the money made from our disease ????

"While the potential benefits are enormous, an artificial pancreas system is
considered a significant-risk device, meaning it presents a potential for
serious risk to the health, safety or welfare of a patient. If not properly
designed, use of an artificial pancreas device in an outpatient setting can
place patients at significant risk, because the device controls the
administration of insulin without the oversight of health care

Leigh Blackistone
email @ redacted
404 . 644 . 4737
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