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Re: [IPk] NICE Guidelines

In message <email @ redacted>,
Steven J Sexton <email @ redacted> writes
>I am very wary of setting criteria to define when existing pump user should 
>switch back to MDI for a trial period. How long should that trial period be 

But criteria are needed, or people will be switched back in

Given the criteria we've come up with here, is there _anyone_ on this
group who would be switched to a glargine trial?

Remember, that means someone who: has a near-flat basal rate, and only
very occasionally uses temp basal, suspend, profiles or basal rate %
variation, and never uses square or dual bolus.

>I would argue very strongly that for existing pump users that previous 
>HbA1c's and medical history should be used and that should include quality 
>of life issues.

Er, that's a criteria based decision. Or was your point that 'previous
HbA1c's and medical history should be assessed against criteria', with
the stress on the past, rather than new evidence against the criteria?
As I read it, they expect consultants to do exactly as you say, use the
past to make a judgement as to whether a glargine trial is likely to
give a good hba1c, without 'disabling hypos'.
>Presumably for most pump users who are currently funded by their Trust 
>there was a "clinical" case for the PCT/Trust to fund them. Hopefully with 
>the FAD in its current form they would continue to receive funding, as the 
>clinical case had previously been made.

What NICE is getting at is that when many people were put on pumps,
while there was a clinical case then, glargine wasn't around then, and
so everyone should go and have a trial with glargine before being
allowed back on a pump.  

The patent stupidity of that for anyone with varying basal rates (for
example) needs to be spelled out in the criteria.
>For those of use who are self funded, I would hope that our previous 
>history would be sufficient to demonstrate that it would be extremely 
>difficult to achieve an HBA1c of less than 7.5 on MDI without disabling 
>hypos occurring.

No, it won't be enough, unless you have tried glargine.
>The difficult area would be for those people who switched to a pump through 
>personal choice but previously had HBA1c's of less than 7.5 when they were 
>on MDI.
Again, if they got their under 7.5s with glargine, but had 'disabling
hypos', however that gets defined eventually, they are fine.  If this
was with another basal insulin, even if they had a string of ambulance
admitals, they could be forced to go and try glargine.

>The way I am reading it at the moment is that people would be recommended 
>for CSII where MDI has failed ie people cannot maintain an HBA1c of less 
>than 7.5% without disabling hypos occurring. MDI would be any combination 
>of short/medium/long acting insulins.

The way I read it, 'any 2 combinations, one of which must involve
>One query regarding the treatment of disabling hypos by third parties, is 
>does third parties include anybody capable of treating a person with a hypo 
>ie family, friends, work colleagues, passers by etc or would be restricted 
>to medically qualified people?

I suggest we don't poke at this one for the moment - if we can get it
changed so that any significant hypo is a 'disabling hypo' - whether or
not it's self treated, unqualified treated, or medically qualified
treated, this won't be an issue.  If it goes through in the current
form, we need the vagueness, so that enlightened doctors can interpret
it as generously as possible (e.g. 'asked my husband to make me dinner
as I was feeling a bit shaky two hours later' could count as

If we push against this now, NICE may come down with the tight decision
of 'treatment by the medically qualified'.

Best wishes,

Pat Reynolds
email @ redacted
   "It might look a bit messy now, but just you come back in 500 years time" 
   (T. Pratchett)
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