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


The book quote gave me the impression that there was a lot more contact 
between the experimental group and the "resources" that I wondered out loud 
- - psychological impact?

At 01:46 PM 05/18/2001 , you wrote:
>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.

Not arguing at all about the over-sight....  Just wondering if there was 
enough statistical evaluation to guarantee that there was not a 
psychological component to the outcome that was not accounted for.....

>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.

I did the extrapolation from my personal experiences which will not go into 
right now.

Dr. Spiegel was involved as a professional in a group at Stanford (was 
research) to make the remaining time for end-stage breast cancer patients 
easier in the early 80s.  End of intended study......   In the late 80s 
(think 89) he wondered what happened to the "experimental" group members 
and found some limited funding to follow up....

Gathered information, talked to family members, and ran statistical 
analysis.  The results were so unarguable that they were "afraid" to 
publish....  Then spent time reevaluating the results and having peer 
reviews - No one was able to come up with any "holes"....   The only 
difference they could find in the "experimental" group was that they were 
in the "make dying easier" group - and that population as a group lived 
twice as long as the matched samples....


>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.

Maybe not BUT that is the way it has been presented.   At one time, I asked 
an email group acquaintance (in the DCCT intensive therapy group) about the 
psychologists... The reply as I remember it, was they were mainly to keep 
people from dropping out of the study..... (individual perception skewed by 
my memory - and may have been as far back as before the DCCT results were 


>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.

Didn't argue that.

> > 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.

How about simply more or less personal contact?

>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'.

Again not arguing with the agreement...  Only asking if there was enough 
analysis of the psychological to exclude it as a variable affecting the 

REMEMBER - Back in that time frame there was only anecdotal evidence of the
mind-body connection and it was more arguing a direct cause/effect NOT 
I believe that Dr. Spiegel's follow on study was one of the first 
rigorously reviewed scientific studies that showed the mind-body 
connection.  AND the study was not general knowledge  until Dr. Spiegel was 
included in the Bill Moyer's Healing and the Mind special.  (1993?)

I seem to remember the mention of psychological testing - how thorough was it?

> > 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

Don't know the book - I think I remember the review as saying the book was 
about managing diabetes.  The quote was some "history" as to why it is 
better to "control" the blood sugars....

>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.

And unless you were thoroughly briefed about the experimental group's 
"people contact protocol" it is difficult to know if there were 

>Frank W. Tegethoff, Jr.
>DCCT Control Group, MM507

My response from the American Diabetes Association was:

         While we do not have statistics on this topic, you can contact the 
National     Diabetes Information Clearinghouse 
at   www.niddk.nih.gov/health/diabetes/ndic.htm to inquire further about 
this matter.

Hope this doesn't turn out to be a question similar to:  "Aren't the 
Emperor's new clothes beautiful?"   <vbg>

Thinking it may be time to dust off the flak jacket and asbestos 
underwear  ;-),

Jim S.
email @ redacted
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