September 1: Cheyenne Crossing to Belle Fourche, South Dakota
Yesterday, I had my fill of headwinds and hills. There was none of that today. Instead, we had a cold rain and just the tiniest bit of sleet. I think I prefer headwinds.
The cold and rain was certainly annoying but we’re close enough to the finish now that I’m not sure anything short of an injury of some kind will keep us from finishing. So, I threw on a couple of base layers, topped it off with my raingear and I was quite comfortable. The only uncomfortable part was the cold rain on the face.
Highway 14A from Cheyenne Crossing parallels the Spearfish Creek so it’s a gentle descent all the way to Spearfish, South Dakota. It was a beautiful canyon even in the middle of the rain and clouds. The further down the road I got, the warmer it got. It was still only in the high 40’s when I got to Spearfish though, so I kept all my clothing layers on.
We arrived in Belle Fourche about the time the skies were clearing. After getting dried out and cleaned up, I had one more thing to do today. I had to make a 50 mile drive into Rapid City, South Dakota to visit a pharmacy where I had called in a refill on my insulin prescription. I haven’t written about this on the web site because of the cycling challenges I’ve had recently, but I’ve been having difficulties with my nighttime blood sugars again.
This is the third time I’ve suspected that my insulin supply has been compromised. The first time, it took several months to figure it out and I assumed we had not been keeping the insulin cold enough. The second time and now this time, I’m sure we’ve been keeping the insulin cold because I’ve been keeping a digital thermometer with the insulin. I know it was never above 46 degrees except for the short times I took it out to fill a new cartridge on my insulin pump. Was it being stored at temperatures that were too cold? The enclosure that comes with each bottle of insulin says long-term storage should be at 36-46 degrees, but I’ve always thought that as long as it wasn’t frozen (i.e., below 32 degrees), it was OK.
Each time I get a new supply of insulin, I’ve been asking the pharmacist about storage temperatures. Nobody seems to be able to tell me about storage at 33-35 degrees. I often find my digital thermometer reading in that range, but I didn’t know whether it was damaging to the insulin. So, this time I called the manufacturer. The enclosure that comes with each bottle has a 800 number you can call for assistance. I asked the person that answered about storage at 33-35 degrees. She said “Good question. Can I put you on hold?” Several minutes later she came back and said that they don’t have any clinical study data to demonstrate the effect of storing insulin at those temperatures. She added that storing it at those temperatures should be avoided in the same way that temperatures above 86 degrees should be avoided. They felt that the insulin is probably compromised and could not recommend that I continue to use it.
Sounds good to me. Now my challenge is to find some method of storing my insulin in the cooler, but preventing it from getting too cold.







September 1st, 2006 at 8:31 pm
Peter,
Since I work in the pharma/medical device industry I feel uniquely qualified to render my opinion on this subject. I find it very credible that they don’t have any “clinical” data on the stability of humulin at 33-35 deg. since those studies are not usually designed to capture this information. This information is usually captured at the “preclinical” stage. Stability is established during preclinical safety studies where it is much less expensive. Sending experimental product out for clinical studies without knowing whether your product is stable at typical storage conditions is very risky. How would the clinician tell the difference between an “adverse event” due to compromised humulin proteins (your case) and a manufacturing error.
I would recommend asking for “preclinical storage stability data” the next time you call the manufacturer. They might need to work to get it and might not like sharing it but the data is there.
Dirk