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Re: [IP] Might the DCCT have been flawed?



Jim,
Hi.  As this may be an emotional issue for many of us I would like to
explain in brief exactly what the DCCT was.

Here is what we basically agreed to; 1441 randomized into 2 groups. One was
the 'Experimental' (MDI/Pump), the other was 'Control' (standard of care).
Both groups agreed to follow specific protocols for the duration of the
trial.  At the end to the trial we were informed of the data. The DCCT was
stopped before its intended duration timeline concluded.  This was due to
the significant results reported by both groups.

Also the DCCT was monitored by: it's Principal Investigator(s), Numerous
Trial Coordinators, the Medical Ethics Review Board of all participating
institutions and the National Insitue of Health.

I have a lot of questions about this thread:
> David Spiegel, M.D. (psychiatrist) of Stanford did a follow-up study of a
> breast cancer (profesionaly facilitated) support group that he was involved
> in during the early 80s.  The follow up study showed that the patients in
> the "supportive/expressive" support group lived twice as long as the
> control group that they were compared with.  Both groups had conventional
> treatment and the only identifiable difference for the longer living group
> was the SUPPORT GROUP membership...
>
> What makes it interesting is that they did not exclude people who signed up
> and never attended the group - and still the longevity of the experimental
> group as a whole....

Is Dr. Spiegel extrapolating these conclusions to other dieases?  I realize
that both Cancer and DM are quite severe, however I would certainly not
equate them either in their psychological impact, or their morbidity.

> The specific part of the quote about the experimental DCCT group that got
> my attention is:  "...cared for by an experienced team including a nurse, a
> dietitian and a diabetologist, among others. They received intensive
> diabetes education and nutritional instruction, were monitored by telephone
> every week and visited their clinic monthly."
>
> This is an amazing amount of long-term support that few "regular" people
> are able to afford or even find

Please remember that this was a CLINICAL TRIAL, that was rigourously
monitored by Pricipal Investigators, Trial Coordinators, and the NIH.
>
> If the DCCT did not account for the psychological variables in the groups,
> might their "proof" that it is all "BG control" be flawed?

I do not believe that the DCCT ever said that "it is all BG control".  Also
both groups had access to, and scheduled appointments with Psychologists.

> I found the following quote that is a sample chapter from the book:
>
>  Confronting Diabetes
>  by Frank Davis, DPM, and Jere Matlock
>
>
> "The 1441 people in the trial were randomly assigned to two groups, each
> group getting about half of                                  the people.
> The first group of people received "normal", conventional treatment for
> their diabetes. They
> used the same regimen followed by the majority of people with Type I
> diabetes--they took one or two                                  insulin
> injections a day, did daily self-monitoring of their blood glucose, and had
> a program of diabetes                                  education that
> included nutritional instruction. They visited their clinic every three
> months.

Incorrect (IMHO).  The Control Group recieved 'The Standard of Care' for DM,
established in Trial Protocols.  This (unfortunately) is not the regime
followed by a 'majority of people with Type 1 diabetes".  The first group
were following the protocols that they had agreed to follow.

> The second group, however, received a more intensive kind of care. The
> people in that second group                                  were cared for
> by an experienced team including a nurse, a dietitian and a diabetologist,
> among others.                                  They received intensive
> diabetes education and nutritional instruction, were monitored by
> telephone                                  every week and visited their
> clinic monthly. They checked their blood glucose four or more times a
> day                                  and injected insulin three or more
> times a day (or used an insulin pump). They adjusted their
> own                                  insulin dosages. (These people were
> confronting and controlling their diabetes--with a vengeance!)

Again, Please remember that this was a CLINICAL TRIAL, niether of the groups
(in my experience and further investigation) recieved more or less
instruction or encouragement.  The second group were following the protocols
that they had agreed to follow.

Also the Control Group met with the same 'experienced team including a
nurse, a dietitian and a diabetologist, among others' at each visit.  We
also received 'diabetes education and nutritional instruction'.

>
> At the end of ten years of this, you might ask, what was the difference in
> the two groups?
>
> A person in the intensively managed group was 40% to 75% less likely to
> have gotten the                                  complications of diabetic
> retinopathy, neuropathy (nerve disease), and nephropathy (kidney disease).
>
> With regard to their blood glucose levels, the people in the second group
> were able to average 155                                  mg/dL, and
> averaged a glyco hemoglobin level of about 7.2%.
>
> The people in the first, conventional treatment group averaged blood
> glucose levels of 231 mg/dL, and                                  averaged
> a glyco hemoglobin level of 9.0%. (They weren't being pressured to confront
> their diabetes                                  as often or control it as
> well as the second group.) "

Who drew this conclusion?  Mr. Davis and Mr. Matlock?  What is their
intent/agenda?  I do not have enough information to understand this
conclusion.

Like I said these are a few questions (and several points ;-)) to get the
discussion going.  As I was in the DCCT Control Group I have rather strong
opinions about the study and its conclusions and applications.
- --
Frank W. Tegethoff, Jr.
DCCT Control Group, MM507
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End of insulin-pumpers-digest V5 #142
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