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On 14 Sep 98 at 8:40, email @ redacted wrote:

> Recently many parents have complained to me about the fact that on the
> Humalog, site changes have to be much more frequent then they were while using
> Velosulin or Humulin R.  We haven't figured out if it's due to lower basal
> rates that cause the clogs in the Tender/ComfortDisconnect/Silouettes.
> This IP list is 500 strong.  We have a voice.  I for one will call Eli Lilly
> today and voice a request that some buffering agent be investigated to make
> the Humalog not clog at low basal rates and to last longer even in the heat of
> warm weather.  Will you join me in this calling campaign?  1-888-88Lilly.  

Some things come to mind about this - 

1.  Humalog isn't approved for use in the pump.  A big push to get it 
approved for that use would be a step in the right direction, but to 
demand that they reformulate Humalog to enable it to be used in an 
"unapproved" manner is likely to meet with opposition.  Any change in 
the formulation would require a whole new round of clinical trials 
and they probably won't like that idea.  According to the CDE's I've 
talked to, Humalog isn't even approved for pediatric use (anyone 
under 18!) and isn't approved for use during pregnancy either.  

2. A serious study would need to be done to actually quantify the 
problem.  That means several hundred users, some on V, some on H, 
with a mix of the infusion sets, including the needles, to determine 
exactly what combinations give trouble under what conditions.  
Getting funding for this type of study would be problematic because 
of the current research environment. 

3.  The infusion set suppliers themselves rate three days as a 
maximum for an soft infusion set and two days for a metal needle.  I 
know some people have done OK with longer intervals between changes 
but the suppliers will fall back on their "recommended useage" 
guidelines.  Lilly can refer to these guidelines and say that for 
most people there is no indication of any problem.  

4. It might be better to ask them to formulate it in U-40 
concentrations - that way the volume of liquid infused could be 
increased while keeping the insulin amount the same.  A higher 
volume of fluid should reduce the clogging if the clogging is caused 
by the low rate...  and this option might be met with a more positive 
response since it would be easier for them to meet... the problem 
would be convincing them that there is a big enough demand.
Randall P. Winchester
* The views expressed here are mine and do not necessarily *
* reflect the official position of anyone in particular.            *
* There's no guarantee on anything said here...
* If I say I understand something completely the only thing
* we can both be assured of is that I must have completely
* misunderstood something. 
Insulin-Pumpers website http://www.bizsystems.com/Diabetes/