A recent study measured the amount of intact insulin in vials to find that none met standard insulin concentrations.

Insulin vials and cartridges are supposed to have 95 U/ml when they are sent out from the manufacturer–the FDA strictly requires this. During the journey to you, they require proper handling and temperatures in order to maintain their quality.

To check on this, researchers quantitatively measured the levels of intact insulin in randomly acquired multi-dose human insulin vials using standard analytical methodologies.

They randomly picked up eighteen 10 ml vials of insulin from two different manufacturers in the US and discovered that the insulin concentration which was intact ranged from 13.9 to 94.2 U/ml, with a mean of 40.2 U/ml. No vial was at the minimum FDA-required standard of 95 U/ml.

The bottom line is your insulin vial may not contain enough insulin.

Eighteen vials is a small subject size but the results are still somewhat startling. To pay so much and potentially get inadequate effectiveness is not acceptable for patients relying on insulin as a life-sustaining medication for a condition that is already hard enough to manage.

How Does This Happen?

Researchers stated in their abstract that “These results imply the cold supply chain impacts insulin concentrations to a larger extent than anticipated. Patients are paying high prices for insulin and should expect to receive insulin vials with adequate insulin content in return.”

Cold supply chain refers to the chain of activities that are involved in moving insulin from the manufacturer to the consumer. Every step along the way, insulin needs to be maintained within a certain temperature range. Just one of these steps involving insulin warming a little too much can affect the insulin’s quality and thus affect the way it works for the patient.

The researchers on this study, Dr. Alan Carter and Dr. Lutz Heinemann, are according to Medscape News, “working with the Diabetes Technology Society and trying to obtain funding to broaden this research to test larger samples and include insulin analogs and biosimilars.”

Sometimes patients with diabetes feel certain their insulin isn’t working adequately. It’s a hard thing to pinpoint with so many factors involved but in some cases perhaps they did receive poor quality insulin. Hopefully, future studies will help us to learn more soon.