[Previous Months][Date Index][Thread Index][Join - Register][Login]
[Message Prev][Message Next][Thread Prev][Thread Next]

[IP] minimed panel -- other details

hi everyone

wanted to send some other quick details about Minimed panel, in addition to
Linda's great post.  that must've been fun to be there Linda!  

as the news showed, the panel voted to approve with some conditions (related
to calibration, postmarketing studies for minority populations, and a couple
of others). from what i can tell (i was listening via telephone) meeting
seemed to end on pretty upbeat note.  i am very excited to use the sensor to
see 3 days worth of data -- 288 tests per day should give a lot better
information to fine-tune basel rates than does my 6-8 tests per day!  i just
hope it doesn't take forever to get the "official" approval from the FDA and
then to get it out to the doctors.  

early on in the panel meeting, two concerns from the panel did emerge, which
were as follows, for those that are interested: 

1.  algorithm issues -- the FDA statisticians seemed to be highly involved
and appear not to have been totally satisfied with the fact that the studies
used just one calibration per day.  they asked the minimed to go back and do
a test showing 4 calibrations.  this implies to me that the correlations
using just one finger stick may not be considered fully adequate.  by the
end of the day, however, this issue seemed to be not as major (would you
agree Linda?  seemed funny to me what a big deal the panel made of it early

2.  performance issues -- second area of concern to me seemed actual
performance of sensor and related engineering/ manufacturing issues.  there
did seem to be a number of questions on the varying performance of the
sensors -- the sensors were compared with a hospital lab meter and an
Accucheck meter.  when the sensor values were compared with finger stick
values, for example only 25% of time did the two values match at least 90%
of the time or more.  for perspective, i believe the FDA historically has
required 80% accuracy for typical finger-stick tests.  the data showed that
about 45% of the sensor values matched the other values 80% of the time or
more.   (sorry, i know this is a strange way to report data -- but i think
this is what it showed.)

take care!

--kelly (email @ redacted)

Insulin Pumpers website http://www.insulin-pumpers.org/
for mail subscription assistance, contact: HELP@insulin-pumpers.org