Heat Stable Insulin and ‘Miniature’ Insulin Pumps: Major Breakthroughs in the Storage and Delivery of Insulin for Diabetes

Diabetes is a group of diseases that affects a person’s ability to properly process food for energy use, which results in too much sugar (glucose) in the blood. A person who has diabetes cannot either make enough or create its supply of insulin (Type 2 and Type 1 respectively). Insulin (which normally needs to be refrigerated, no has a Non-refrigerated insulin alternative) is a chemical produced in the pancreas, a small organ near the stomach, that helps the body integrate glucose to travel from the blood and into the body’s cells. Without the presence of insulin, levels of glucose in the blood will continue to rise, which can cause serious health conditions such as heart disease, kidney disease, vision loss, nerve damage, and death. Diabetes was the 7th leading cause of death in the United States and the 9th globally in 2019 in studies done by the Centers for Disease Control (CDC) and the World Health Organization (WHO).

Non refrigerated insulin may be right around the corner

There are three major types of diabetes: type 1, type 2, and gestational (diabetes while pregnant), all of which may require the introduction of insulin into the blood (less common types of diabetes include monogenic and cystic fibrosis-related diabetes). While people diagnosed with type 2 or gestational diabetes may not need to take insulin, type 1 diabetes occurs when the pancreas stops producing insulin altogether. People diagnosed with type 1 diabetes need to take insulin daily for the rest of their lives to properly regulate the level of glucose in their bloodstream.

Insulin is administered via injection into the body in either the abdomen (the preferred site of injection as it can absorb the most insulin), arm, or thigh. The most common methods of injection include syringes, insulin pens, insulin pumps, and jet injectors, all of which have fluctuating degrees of use and effectiveness concerning one’s body and reaction to insulin injections. Syringes remain the most popular method of insulin injection, as they are readily available and covered by most major insurance companies.

For people who have more serious cases of diabetes or those who may require multiple injections a day, an insulin pump may be a more viable treatment option. An insulin pump delivers a continuous supply of insulin into the bloodstream via a catheter inserted into the fatty tissue under the skin of the abdomen. While it still needs to be cleaned, monitored, and maintained by the individual, the bypassing of self-injections can be beneficial for many, especially young children and people with vision impairment.

No matter what type of diabetes a person may have, or which injection method they choose, the storage of insulin has proven to be challenging for many, including the millions suffering from diabetes in countries in which electricity may be unavailable. Currently, the American Diabetes Association (ADA) recommends insulin be stored in a refrigerator (approximately 37-41℉) when not in use; once opened, vials are to be used within 28 days and then discarded. Such strict storage conditions have sparked demand for insulin that is effective without refrigeration.

Non-refrigerated insulin

Heat-stable insulin is currently being developed by two independent organizations: Médecins Sans Frontières (MSF), an international humanitarian medical organization based in Switzerland (referred to as Doctors Without Borders in the United States), and Thermalin, an Ohio based company focused on engineering new forms of insulin.

A joint study between MSF and the University of Geneva, published in Plos One, has shown that a variety of readily available insulins can be kept at temperatures between 77-99℉ for four weeks of utilization. When first tested in the Dadaab refugee camp in northern Kenya, where the temperature regularly hovers around 100℉, researchers found that the soaring tropical temperatures did not affect the shelf life or safety of many existing insulins without any changes to the medication or its storage needs. The study also tested in-use insulin (vials that had been opened) and found similar results.

For the hundreds of millions of people living in areas without access to electricity and the proper refrigeration needed to store insulin, this study has now proven to be a major discovery. Upon releasing this data hospitals around the refugee camp immediately started to change their approach in treating patients with diabetes. For the first time, patients were given their supply of insulin, and were taught how to safely inject themselves from the comfort of their own home; saving many from multiple trips to the clinic (in some cases patients had even relocated to be closer to treatment centers).

While the insulin tested in the joint study showed that existing insulin could be stored at higher temperatures than prescribed, it is important to note that the insulin had not been modified to withstand temperatures above normal refrigeration. While it was able to be stored above normal storage temperatures, researchers say the cooler nighttime temperatures kept the insulin safe for use. Problems such as this are what currently keep insulin from truly being “refrigeration free”, and where companies like Termalin are focusing their efforts.

Thermalin is currently developing a new insulin analog named T-1123. T-1123 is a new type of ultra-rapid insulin that can rival the speeds of some of the fastest-acting insulins available today. (ultra-rapid refers to the speed at which insulin can lower glucose levels; one of the fastest to date is Nordisk, which can lower glucose levels in 15-20 minutes). Thermalin plans to use this insulin analog as the basal (base) for all of its insulin still in research; including new, refrigeration-free insulin. The heat-stable base will help eliminate cold chain distribution, making it ideal for mail order shipping, and people without access to refrigeration. While still early in testing, Thermalin believes their heat-stable insulin could last over a year without refrigeration. The insulin is set to finish its development by mid to late 2021, and begin clinical trials in 2022.

Thermalin is also testing a new type of insulin pump that would be possible thanks to its shelf-stable insulin. The pump, named the StampPump, would be “one quarter the size of any existing or planned automated insulin management system” (resembling the size of a postage stamp) according to Thermalin. The pump would be applied via a skin adhering patch, similar to existing nicotine patches, come prefilled with T-1123, and be controlled by a phone app. Thermalin says the patch would be able to be worn for a week and be fully disposable; compared to the two to three days of normal insulin pumps. Like T-1123, the StampPump is still in testing, but if conception turns creation, it could greatly improve the lives of many who use a pump to treat their diabetes.

Currently, insulin is still recommended to be stored in a refrigerator until use, and then can be kept at room temperature for up to 28 days after opening. While studies have shown that insulin can survive higher temperatures, it’s important to follow the advice of medical professionals regarding insulin storage. For questions regarding diabetes and other diabetes-related concerns including non-refrigerated insulin, contact a specialist for further advice.

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