Wednesday, April 15, 2009

APIDRA - What's the BIG DEAL

Some Details: This spot concerns those who use Apidra in an insulin pump and exercise fairly often. Realise that most of this data is from personal experience, that linked and quoted data is tested and factual according to each of the respective companies.

   I saw my endo this last week and my wife got to meet her for the first time also. It was a good sit down. We were looking at my bg's and trending along with correlative food intake. What the endo wanted to know was if I was having high, almost uncontrollable glucose levels at certain times of usage from the pump. When I say "certain times" I'm referring to how many days worth of insulin I put in the cartridge and when those problems highs were starting in...I fill it for a 3 day usage. So, it turns out it was almost always like day 2 or 3 of a cartridge when I started having uncontrolled high Glucose. I could take two times the normal amount of insulin and the glucose would barely budge. So, here's the issue. Apridra, made by Sanofi Aventis, has a 77 degree threshold, after which the effectiveness of the insulin degrades. They also state, "Infusion sets (reservoirs, tubing, and catheters) and the Apidra in the reservoir should be discarded after 48 hours of use or after exposures to temperatures that exceed 98.6 degrees F (37 degrees C)".

   So, "control we have a problem". We're talking about users of a product ranging from the not so energetic to the very energetic. Those very energetic are going to get their outside body tempts above 98.6. Let's face it normal body temp is 98.1 degrees and add a good run to that on a sunny June afternoon......forget using that cartridge of Apidra attached to you hip, according to Aventis. I sleep very comfortably during the winter under a wonderful down comforter also. The temps under that thing are great for the body, but horrible according to Aventis for your Apidra. NO WONDER I 'VE HAD PROBLEMS GETTING THOSE SUGARS DOWN SOMETIMES.

Let's do a little comparison here with Apidra, Novolog, and Lantus.

Production: Apidra and Lantus are manufactured by Sanofi Aventis. Novolog is manufactured by Novo Nordisk.

Insulin Recommended Storage (Pump/Tubing/Etc)

Apidra Infusion sets (reservoirs, tubing, and catheters) and the Apidra in the reservoir should be discarded after 48 hours of use or after exposures to temperatures that exceed 77 degrees F (37 degrees C)".

Lantus The opened (in-use) cartridge system in OptiClik® should NOT be refrigerated but should be kept at room temperature (below 86°F [30°C]) away from direct heat and light.

Novolog NovoLog® in the pump reservoir should be discarded after at least every 48 hours of use or after exposure to temperatures that exceed 37°C (98.6°F).


   So, here we have a confused intersection of details. Pump companies, let's just use Minimed, say to change your infusion sets and cartridges every 2-3 days. Insulin pharmecos say to change insulin every 48 hours regardless and sooner if the insulin is exposed to temps greater than a range of 77 to 98.6 degrees.

   I will state the following from self-observance. I've never had uncontrollable upswings from Novolog during high intensity exercise, summer months, sleeping under a very warm comforter, or even going 4 days (I know, I know) on the same cartridge of insulin. I can only state that I have done most of these things with Apidra and am having issues with uncontrollable high glucose about every 2-3 cartridge changeovers. I think if I were more closely analysed this, it would be revealed that the insulin is going bad from temps exceeding 77 degrees.

Test Solution:
I've started to fill the cartridge for 1.5 days worth of insulin. Let's see how this goes, until July when temps will force me to use Novolog for safety again.


Food For Thought:
It's summed up in three alphanumerics "TT1". They use Apidra and they use the Omnipod, which is attached to your body, not clipped to your hip. How long do they use their insulin pods for? Even more importantly, what does the sustained external body temperature get to for one of their cyclist users?


What Say you?








1 comment:

  1. Hi, Mike,
    I can tell you that a similar topic has come up among Triabetes team captains. The discussion was really about whether an infusion site really must be changed after 3 days. The conclusion seemed to be that after three days the insulin is degraded whether the infusion site is still good or not.
    I am going back over meter readings, daily insulin totals, and timing of infusion site changes to see if I find a pattern.

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