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Re: holdmfoldm post# 36862

Wednesday, 09/28/2016 8:58:49 PM

Wednesday, September 28, 2016 8:58:49 PM

Post# of 97093

Prior to May 1, 2016: Get a discounted price of $3,500. This reflects a 55% discount off the retail price of $7,899. These customers are also eligible for the $400 exchange credit, so the total out-of-pocket for this group with a pump exchange is $3,100.
New Transmitter cost, too! Be aware that users wishing to upgrade will also have to buy a Guardian Link Transmitter Kit, as the existing transmitters from older models will not work with the new MiniMed 630G system. The Guardian Link Transmitter Kit can be purchased at a "discounted cash price" of $511.21.



I suppose every diabetic in the world (especially 3rd world countries) will be digging deep into their pockets and purchasing this system...

Ya think?

AND

Yes, you were correct in your thinking that it was not expected until "next year sometime", as it will not be available (on a limited basis) until next Spring.

AND

Since it has been tested on only a few (123 people) do you think there will be any complications upon further testing among the few fortunate (or unfortunate) enough to be human Guinea Pigs?

Also

How about those under 14 years old for whom this system is not approved?

AND

unsafe for use in children 6 years of age or younger and in patients who require less than eight units of insulin per day.



The FDA evaluated data from a clinical trial of the MiniMed 670G hybrid closed looped system that included 123 participants with type 1 diabetes. The clinical trial included an initial two-week period where the system’s hybrid closed loop was not used followed by a three-month study during which trial participants used the system’s hybrid closed loop feature as frequently as possible. This clinical trial showed that the device is safe for use in people 14 years of age and older with type 1 diabetes. No serious adverse events, diabetic ketoacidosis (DKA) or severe hypoglycemia (low glucose levels) were reported during the study.

Risks associated with use of the system may include hypoglycemia, hyperglycemia, as well as skin irritation or redness around the device’s infusion patch. This version of this device is unsafe for use in children 6 years of age or younger and in patients who require less than eight units of insulin per day.



http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm522974.htm


I highly doubt test strips are going to go the way of the dinosaur.