Studies show that insulin vials can be stored for 4 weeks without loss of effectiveness after opening to 37 ° C.

Diabetes requires a very accurate form of daily treatment, which causes the patient to inject several insulins daily. Therefore, patients need to maintain an insulin supply and, according to pharmaceutical protocols, should respect the cold chain from manufacturing to injection. However, in some parts of the world, such as sub-Saharan Africa, not all homes have a refrigerator.

This forces people to live with Diabetes I go to the hospital every day. Faced with this problem, Médecins Sans Frontières (MSF) collaborated with the University of Geneva (UNIGE) in Switzerland to test. Insulin Store under actual conditions for 4 weeks at temperatures in the range of 25 ° C to 37 ° C. This corresponds to the time it normally takes a diabetics to complete one vial of insulin.Survey results published in the journal PLOS ONE, It shows that the stability of insulin stored under these conditions is the same as the stability of refrigerated insulin without affecting its effectiveness. This allows people with diabetes to manage their illness without having to go to the hospital multiple times each day.

Type 1 diabetes is characterized by elevated blood sugar levels and can have very serious consequences, including coma, blindness, amputation, and even death. Currently, it is possible to treat type 1 diabetes successfully, but you need to inject insulin daily to help sugar enter the cells of the body.

“Current pharmaceutical protocols require storage at 2-8 ° C until the insulin vial is opened, after which most human insulin can be stored at 25 ° C for 4 weeks,” said MSF’s Noncommunicable Diseases Advisor. One Philippa Boulle explains. “This is obviously a problem Refugee camp The family doesn’t have a fridge, at hotter temperatures. ”

Therefore, people with diabetes need to go to the hospital every day for insulin injections, which can interfere with their work or travel long distances. “We commissioned Professor Leonardo Scapozza’s team to perform a detailed analysis of the temperature conditions under which insulin can be stored without diminishing its effectiveness,” says Dr. Boule.

Real life situation

MSF teams at the Daga Harry refugee camp in northern Kenya have found that house temperatures fluctuate between 25 ° C at night and 37 ° C during the day. The researchers then carefully reproduced these conditions in a laboratory setting to test insulin storage. “Insulin vials can be used for four weeks after opening, so we performed measurements in the same time frame, first with the temperature-preserved vials found in Daga Haley and then with the refrigerated’control’vials,” Leonardo said. Explains. Scapozza is a professor of pharmacy at UNIGE’s Faculty of Science. The UNIGE team analyzed insulin using high performance liquid chromatography. “The risk is that the protein insulin precipitates under the influence of heat. In other words, it will begin to form flakes.” Insulin is no longer in solution and cannot be injected. “

There is no difference between the two storage methods

Research results show that, as encountered in the field, all insulin preparations stored at varying temperatures recorded a loss of efficacy of less than 1%, similar to those stored refrigerated for the required 4 weeks. I will. “Pharmaceutical regulations allow losses of up to 5%, which is well below that,” says Professor Scapozza.

Importantly, UNIGE researchers also observed that insulin activity was fully maintained. To verify this, they tested the action of insulin proteins on cells compared to the action of intentionally inactivated insulin. “Finally, with the help of Professor Michelangelo Foti’s group, I studied insulin vials that came directly from the Daga Hailey camp and always came to the same conclusion. Insulin was completely available,” said Professor Scapozza. I will add.

Results that may change the daily lives of thousands of people

For the first time, this scientific study shows that insulin vials can be used for 4 weeks in hot weather without refrigeration. “These results can serve as a basis for changing diabetes management practices. Low resource settingsPatients don’t have to go to the hospital every day for insulin injections, “says Dr. Boule. In addition, diabetics are no longer discriminated against and can lead a normal life and work. “Of course, this needs to work with patient education, support, and follow-up provision so that diabetics can measure their blood glucose levels and inject the right amount of insulin,” says Dr. Boule. This allows people to manage their illness correctly and more independently. To support this goal, we hope that a consensus statement will be developed and approved by WHO focusing on the home use of insulin in hot environments where refrigeration is not available. ”