Re: Personal Care Approach moves T2s from Horrible control to Lousy control



throop@xxxxxxxxxxxxx (David R. Throop) wrote in news:e3p8nj$le9$1
@beechbone.cs.utexas.edu:


[D]on't tweak the last tenth of a percent in those already under good
control, you go after those who are sky-high and truly out of
control.

OK, so both Tim and Charley Coughran point out that other, established
approaches can cut a full 2% off of an out of control A1c.

I don't expect researchers to try and reach the 5% club the way
posters on a.s.d. and s.m.d do. I just expect them to use a protocol
that -in the placebo or non-intervention arm - does as well as
established protocols do. That is, the control group from this
current study should have been doing at least as well as the
intervention group did in the UKPDS or the DCCT trials did. In fact,
the intervention arm in this group only got about 1/3 as much
improvement as DCCT or UKPDS.

That's lousy control, by my book. There might be some rationale for
it, if the study population were more recalcitrant or difficult to
treat than those earlier studies. But that's not what the abstract
seems to be saying.

Really, how can a human subjects board pass on a protocol that, even
when it 'succeeds', is this much worse than interventions that are
already a decade old?

Or am I missing something?

DRT



I don't have access to the actual article without getting up to the med
school library and it is always problematic to base much on the abstract
alone. That being said, here is what I think is going on.

When I proposed the UKPDS rather than the DCCT as being apples to apples,
I was wrong. The UKPDS and DCCT are apples. This study is, indeed, an
orange. I will talk about the DCCT because I know more about it, but I
am sure everything I say has a parallel in the UKPDS.

In the DCCT, the intensively treated group had 24/7 access to diabetic
educators and diabetic nutritionists. They could call to discuss any
problem they might encounter. They could fax their log books in to get
feedback on patterns that they didn't understand. They could change
their insulin MDI regimens with full support and training on request in
order to experiment around to find what worked best for them. This
included switching to, and from, pumping on request. They got monthly
A1c values for feedback. They could see an endo anytime on short notice.
They could test as much as they wanted without argument.

I have never seen a cost figure for the care received by an intensive
care DCCT subject, but it is much higher than that for any of us out in
the wild, independent of the quality of our insurance. I don't know of
anyone who gets anything like DCCT intensive quality care.

Even with this amazing amount of care, the intensive group only managed
to average 1% above the high end of normal, 6%. The intensive group's
average A1c of 7% was then translated into the target for the more
general population. I think a good case could be made that this is an
unrealistic goal absent much more support and education than is offered
to most diabetics, but that is another topic.

The conventional DCCT group received conventional treatment, but this was
conventional treatment only in the sense that the insulin regimens and
dietary and exercise advice were conventional. This does not mean that
they received the same level of treatment that would be called common in
the general population from their DCCT physicians who were top notch
across the board.

The study at issue compares "structured personal care" and "routine
care". My guess is that "routine care" is much more like the care a
standard patient actually receives. My guess is that it was a single
center study and the structured group was diverted to special care and
the routine group just entered the general patient population.

We can, and I do often, decry the reality of care as opposed to the care
level recommendations based on research like the DCCT and UKPDS and the
difference between target standards and achieved A1cs. We need, however,
to keep those differences in mind when interpreting studies and results.

--
-------
Charly Coughran
ccoughran@xxxxxxxxxxxxxxxxxxxxxxxxxx
.



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