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Human Guinea Pigs: How to Tell if Your Insulin Still Works
Question: How can you tell if the insulin in any given vial is still good before injecting it?
Answer: You can’t! You have to “test” it on yourself by injecting and awaiting the blood sugar results.
Isn’t that crazy?!
A reader emailed me a week or so ago asking why there is no litmus test — like a strip of test paper where
applying a few drops of insulin would yield either green for “good” or red for “bad” — to tell whether the insulin is active or not active.
Well, why isn’t there? I thought. It’s got to be either a cost issue (too expensive to produce and market), or not yet scientifically possible. I find the latter hard to believe.
So what did I do? I queried the big three manufacturers of insulin in this country, that’s what. Here’s how the various heads of PR answered my query:
ELI LILLY
There are chemistry tests that can be run in a lab to determine insulin activity, but it’s not something that can be appropriately replicated outside a lab setting, and there currently are no such tests available for patients. The best advice we can provide is that anytime a person has a question about his/her insulin, call the physician and the call center associated with the product (for Lilly insulins, it’s 1-800-LILLYRX). The call center can direct the person to the appropriate resources, and step them through the product complaint process if necessary.
Also, one of our physicians, Dr. Sherry Martin, added this:
“As a practical note, physicians tell patients to take a dose from a new vial or pen (the patient should have one backup on hand): if the blood glucose improves, they have the answer they need in a matter of hours. Then, they can discard the old vial/pen. If it doesn’t improve, call your HCP and hold on to all insulin you have.”
NOVO NORDISK
Novo Nordisk has conducted extensive stability studies on our insulin products to ensure that they maintain potency throughout their entire lifetime, from manufacture through shipping and storage until the labeled expiration date.
If your insulin is kept in accordance with the guidelines on the label, the product should maintain expected potency. Novo Nordisk cannot evaluate specific cases outside of the recommended storage. If you chose to administer insulin that may have been improperly stored, then it is important to monitor your blood glucose to ensure your readings are within the goals determined by you and your healthcare professional. Prior to injecting your insulin, the insulin should be inspected for changes, such as clumping, frosting, precipitation, or change in color or clarity that may indicate a loss in potency. However, a lack of visual changes is not a guarantee of the potency of improperly stored insulin.
Novo Nordisk is continuously evaluating changes in packaging that may help identify insulin that has been improperly stored or to protect it from changes in the storage environment.
I have sent your reader’s idea to our product design department in Denmark for consideration.
SANOFI-AVENTIS
Unfortunately, the tests currently available for determining insulin activity are not practical for home use. In the absence of such a test, Sanofi-Aventis’ goal is to ensure that the insulin that reaches the patient has the expected activity through good manufacturing, testing, and shipping practices. At home, proper storage and regular inspection before use are key to maintaining and delivering insulin with the expected potency.
It is important to note that both of the insulins we manufacture are clear and colorless, so if you are using a Sanofi-Aventis insulin product and your insulin appears cloudy or colored, or if you have any other questions about your insulin, please contact your treating healthcare provider or our Medical Information Services at 1-800-633-1610.
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The upshot is: there is no such test. We’re on our own (especially suck-ish in the summer heat). But at least they’ve all made note of my query. It never hurts to be the squeaky wheel. So if a test like this seems important to you, email me and I’ll point you where to lobby. Human guinea pigs, unite!
Explore posts in the same categories: Diabetes Essentials, Miscellaneous
It would be neat if they could put a little sticker on the vial that changes color if the insulin has reached a temperature that would cause it to go bad (at either high or low temp.), or if it’s been opened longer than what is recommended. It wouldn’t actually let you know if the insulin is bad, but it would provide a visual indicator that it “might” be bad, so you could use at your own risk. They have something similar on the packages of fish where I buy groceries. There is a sticker on the package that changes colors the longer the fish has been in the package. It’s supposed to help you gauge whether or not the fish is fresh.
Posted by: amber | July 9th, 2008 at 8:16 amwhat a bunch of CYA in those responses! Feh.
Posted by: lendie | July 9th, 2008 at 8:46 amI think that, even more useful, would be a blood test to measure how much is actually in my body. That would be incredibly useful.
Also, I had a vial I suspected was bad. I requested Lilly to check it out; they did and it was okay. I was still suspicious but later discovered the source of my problem, which was not the insulin.
-Anne
Posted by: anne | July 9th, 2008 at 9:59 amwow…
what a fantastic idea! Some of the responses from the companies certainly reflect a lack of understanding on living with diabetes every day. Particularly for pumpers we can experience highs not just because the insulin is bad, but also because our catheter may be kinked. Before replacing infusion sets multiple times, it would be nice to know if the insulin itself is the culprit.
It was nice to see SANOFI-AVENTIS and to a lesser extent NOVO NORDISK at least acknowledge how useful it would be for diabetics to know if their insulin is still good without having to resort to trial and error…
Posted by: chris | July 9th, 2008 at 10:00 amLooks like the Novo Nordisk response was written by the legal department — more concern about potential liability than customer service. Makes me so happy to be using their product.
Posted by: Jonathan | July 9th, 2008 at 11:01 amNot to be too cynical, but these companies make a lot of money from the common practice of “if in doubt, throw it out.” Having this kind of litmus test would save us some money and eliminate one variable when we’re troubleshooting. I love the idea. Insurance companies should like it too.
This seems like a job for a more entrepreneurial (i.e. hungry) biotech company. Could you send the same query to that group? Maybe JDRF or NIH would offer a grant for R&D in this area.
Posted by: Pearce | July 10th, 2008 at 5:33 amUnfortunately, an absolute “yes” or “no” probably isn’t sufficient, given the concentration of the insulin and the sensitivity people have to slight fluctuations. Most BG meters allow for a swing of plus or minus 20% (isn’t that why the acceptable range on the “control solution” is so great?) and I imagine there would be some sort of range with insulin and/or insulin-litmus-tests as well.
A test would be great though. As insulin users, we all know the importance of handling and storing insulin properly, but U.S. consumers also strongly encouraged by our healthcare providers to fill recurring prescriptions by mail instead of by local pharmacy. For me, it took a lot of courage and blind faith to accept insulin shipments by mail, but we really have no idea what environments the insulin is subjected to before finding the box left on our front doorstep.
Posted by: Scott | July 10th, 2008 at 6:02 amWhat a timely post Amy! I’ve been having some stubborn highs over the past 24 hours and I suspect that the insulin in my pump has gone “bad.”
The summer heat makes a huge difference, in my experience. I tend to wear more skirts in the summer that require me to wear the thigh holster for my pump. The insulin undoubtedly gets warmer than usual and thus has the tendency to go bad more often.
I suppose one workaround would be to fill the pump reservoir more often, using less insulin, so that the insulin doesn’t sit in the reservoir too long.
What a pain!
Posted by: Kelsey | July 10th, 2008 at 4:39 pmHere is the the email communication I had with Dr Jens Brange in Denmark who is an authority on Insulin storage and stability.
Dear Dr. Brange:
As a person living with Type 1 diabetes since 1967 I have seen a lot of changes in the types of insulins that are used to treat the disease and to control blood sugar.
I would be interested in any information that you have on the stability of Insulin at various storage temperatures. Most manufactures give basic information about insulin storage temperatures to preserve maximum activity. They generally say that the insulin is stable and active until the expiration date when stored at refrigerator temperatures and should be discarded after 30 days at room temperature. What is the “real story” on insulin storage and stability. I seem to be wasting a lot of insulin that I use because of the instructions to discard it after 30 days at room temperature. Lilly, Novo Nordisk, and Sanofi Aventis, are not much help. Where can I find the information that I am looking for. Thanks for your help; I look forward to hearing from you soon.
Dear Florian Menninger,
Posted by: Florian | July 10th, 2008 at 6:18 pmThe real story is that the manufacturers of insulin have all reasons (FDA) to be on the safe side and not to promise too much. The true story is that even after 1 (one) year at 25 degrees the biological potency (blood sugar lowering capacity) of any insulin is still about 90-95% of its initial potency. During storage at room temperature degradation products of insulin are formed at a rate of a few percent per month, but the largest amount of these products have nearly full biological effect. The formation of such products is very much lowered in the fridge and insulin kept that way will retain its effectivity even after many years. I hope that it is what you needed to know in order not to discard too much insulin.
Best regards
Jens Brange, D.Sc.
I have been type 1 for 23+ years. During that time I have lived in central Illinois, North Carolina, Indiana, and Washington during different parts of my life. Most of that time especially when I was a kid was without air conditioning (and using the old pig/cow insulin originally and then humalog/novalog later on). Up until 6 months ago (when I switched to the pod) I have always carried insulin bottles around with me through out the year at temperatures up to >100 degrees on a really regular basis. In addition I have carried insulin with me around the jungle in central america in a baggy in my pocket without issue. I will also admit there have certainly been times (a lot of the time??) where I have left my basal (NPH, UL, and finally Lantus) sitting out on a table during these period of heat.
I never really had issues with the potency of the insulin I was using, in most cases where I thought their might be an issue I would find some other reason for the high (as the insulin was proved effective at a later date).
The only thing I would suggest not to do is let it sit in direct sun(so the rays are able to pass through the glass and degredade the insulin directly), but as far as potency in all my years with Type 1 I have never had an issue with insulin going bad and I have left open bottles in room temps (high and low) for most of these years without fail.
Posted by: Aaron | July 11th, 2008 at 9:43 amMe too, Aaron–in my nearly 30 years of using insulin I’ve kept my vials of Novolog, Humalog, Humulin, Regular, Ultralente, and NPH in use at room temperature summer and winter (only avoiding direct sun and parked cars in summer heat) and as far as I can tell none has ever gone bad. I’ve also generally used a vial of insulin for well over the 30-day limit rather than throw it out, watching blood sugars carefully when it gets old, and haven’t run into any problems as far as I know.
BUT just this month (for a pump “vacation”) I’ve started using Lantus for the first time ever. Have any of you noticed that Lantus is more fragile than any other insulin? Do you actually throw out your nice, pricey, half-full Lantus vial after 30 days?
Posted by: Laura G. | July 14th, 2008 at 8:05 am