Cold Alert - Frozen Insulin

With recent temperatures changes that are breaking all historical records, more and more people are faced with polar temperatures and are ending up with frozen medicines such as insulin, which must then be destroyed because they lose all effectiveness when they are frozen.

Insulin should be stored at 2-8°C, and once opened can be kept for about a month at a temperature below 25°C. Very few people realize that cold is much more dangerous for insulin than heat, because when insulin is frozen, destruction is immediate, whereas with heat insulin gradually loses its effectiveness. Insulin must be protected not only against heat but also against the cold.

"I just went up the Kilimanjaro in early November with a group of diabetics to raise awareness for diabetes (and also because it was a really fun thing for me to do). We managed to raise 12071 US$ for a diabetes association and were super happy about that. On the other hand, one of my traveling companions found himself at 6000 meters with his insulin frozen, because the temperatureit was -20°C. Luckily we had some spare unfrozen insulin so the problem was solved easily enough. When insulin is frozen it develops crystals and is no longer usable" explains Uwe DIEGEL.

Hot or cold: The storage of insulin

A public health problem

Bad habits of diabetics regarding the storage and transport of their insulin are one of the main reasons for the bad control of their blood glucose. A recent study in India shows that insulin stored between 32 and 37°C for 28 days loses respectively 14 and 18% of its efficacy, and that patients using this "outdated" insulin do not show a significant decrease in blood sugar levels compared to those receiving insulin stored at 5°C. Insulin that has been exposed to heat no longer has the expected effect in the treatment of diabetes.

Several studies have shown that during its storage and use, insulin is degraded by hydrolysis reactions and its molecular weight is transformed and becomes higher. It is therefore recommended that insulin vials or pens be stored in the refrigerator between 2 and 8°C and protected from light. In a 2009 pilot study in India with 131 type-1 insulin-dependent diabetic patients, 59% of the patients were hyper-glycemic, showing poor diabetes control. Of these patients, 56% maintained their insulin at room temperature.

Uwe Diegel on top of the world, raising money for a diabetic association

For Uwe DIEGEL, this is now one of the biggest problems in managing diabetes; "A person who suffers from a chronic illness such as diabetes is defined by his lifestyle and everything that hinders that way of life is perceived as negative. Very often, I see diabetics going out for dinner and simply putting their insulin in their jacket pockets, because they do not want to go out with their diabetes kit, which is cumbersome and embarrassing. This is the worst thing for insulin, which is suddenly overheated by the heat of the body and rises to around 35°C. At this temperature insulin degrades very quickly and therefore affects glycemic control”.

Solutions for diabetics

MedActiv, a global leader in drug delivery solutions, has addressed the issue of insulin from a user's point of view and developed the iCool and EasyBag bags to protect insulin against heat and cold . To develop these bags, a team of diabetics worked together to rethink and develop traditional methods of insulin transport. MedActiv was created by two well-known brothers in the medical industry, Dr. Olaf and Uwe Diegel, following an incident where Dr. Diegel's insulin was compromised during the summer of the 2003 heatwave in France. For this reason the two brothers pay particular attention to the quality and finish of their products so that they are intuitive to use, practical and beautiful.

"As a diabetic and a personal user of solutions for insulin transport, I was consistently disappointed with a lot of products I bought through traditional sales channels. It was obvious to me that the people who designed these products were not themselves diabetic and did not understand our constraints. We were happy to redesign the transport kits to make them perfect. The iCool and EasyBag solutions are designed by diabetics for diabetics "says Dr. Diegel.

Intuitive designs combined with a perfect understanding of constraints

iCool bags use a new generation of eutectic freezer-packs that do not perspire and have a longer defrosting point than traditional packs. Available in three different versions (Weekender, Prestige and MediCube), iCool bags keep insulin between 2 and 8°C for 12, 24 and 36 hours respectively. They also serve as storage for all diabetes accessories, such as glucometers and strips.

The EasyBags use a specially developed polymer that keeps insulin fresh for 5 days without electricity and that protects it against accidental freezing. To activate the EasyBags, simply immerse them in water for 60 seconds. The crystals in the EasyBag become a gel that stays cool for five days, relying on a process of evaporation. EasyBags will keep insulin at a temperature between 16 and 25°C for 5 days. At this temperature, insulin can be kept for about a month without any adverse effects. The EasyBag have become the global standard for the daily transport of insulin.

The iCool and EasyBag bags are available on http://www.medactiv.com

A new technology for diabetes in Africa

Diabetes is growing rapidly in sub-Saharan Africa due to urbanization and an aging population. Although once considered as rare in this region, it is estimated that diabetes will affect over 13 million people in sub-Saharan Africa in 2012 and that 350,000 of these people will die of associated diseases, but that so far only 15% of all diabetes cases in sub-Saharan Africa are diagnosed. By 2030, there will be an estimated 24 million adults with diabetes in sub-Saharan Africa.

Treatment, insulin and equipment for diabetes are often lacking in developing countries, and in countries that have them, the costs for these diabetes supplies generally prove unaffordable for patients because access to subsidized healthcare in Africa is often limited or nonexistent.

If insulin is exposed to extreme temperatures, it is easily damaged and loses its effectiveness. The perfect storage temperature for insulin is between 2 and 8°C and when opened, it can be stored for up to three weeks at a temperature not exceeding 25°C.

In a large majority of sub-Saharan countries, less than 20% of the rural population has access to electricity (16.1% in Kenya, 18.8% in Zambia). There is therefore a lack of continuous and accessible refrigeration methods and it is now customary in rural Africa to bury insulin in the ground to try to keep it at a cooler temperature. However, this inadequate method of conservation is very unstable and can quickly damage insulin.

In a study published in 2009^*, 131 patients with type-1 diabetes were tested. 59% of these patients were hyper glycemic, showing poor control of diabetes. Of these patients, 56% maintained their insulin at room temperature. Inadequate storage temperature of insulin is a major reason for poor management of diabetes in developing countries.

MedActiv, a company created by diabetics in France, has developed the EasyBag, an isothermal bag that keeps insulin cool without electricity using gel crystals that cool when soaked in water. This new technology is ideal for countries where electricity is not available for diabetics.

To enable the EasyBag, it must simply be immersed in water for 40 seconds. The crystals in the panels of the EasyBag turn into a gel that stays fresh for between five to seven days based on an evaporation process that will keep the insulin at a temperature between 16 and 25°C (up to an ambient temperature 42°C). To "reload" the EasyBag, it must simply be immersed again in water for 40 seconds.

Over 80% of diabetes deaths occur in countries with low and middle income. In the 34 poorest African countries, the cost for a person with diabetes to manage his disease is twice the average wage. An estimated 6% of all deaths in sub-Saharan Africa in 2010 were probably caused by diabetes.

One of the defining points of healthcare systems in sub-Saharan Africa is that they focus nearly exclusively on the management of acute infections and thus have difficulty in providing the management and long-term treatment needed by patients with chronic diseases such as diabetes. Having access to insulin, syringes and testing equipment is vital, but it is not enough for a diabetic in Africa. A healthcare system with trained staff and adequate facilities is also essential. At the moment, healthcare systems in sub-Saharan Africa suffer from a serious shortage of accessible health facilities for the rural population and patients often have to travel long distances, with prohibitive transport costs to get tested and seek treatment.

The MedActiv EasyBag solution will help these patients to have better management of their diabetes, because it allows them to keep their insulin at an acceptable temperature without any electricity. The EasyBag reflects the corporate values of MedActiv, which are to create products that give patients something that is often denied to them: the freedom to take responsibility for their own health.

About MedActiv: MedActiv develops solutions for the storage and transport of thermo sensitive medications. Millions of people worldwide suffer from diseases that make them virtual prisoners of their medications. MedActiv develops solutions that allow them to travel anywhere safe in the knowledge that their medication is kept at the right temperature.

For more information, please contact:

HealthWorks France
6 rue de Castellane
75008, Paris, France
Tel: +33 (0) 1 42 66 15 59
http://www.medactiv.com

Press Contact:

Name: Uwe DIEGEL
Mail: udiegel@medactiv.com

^* Effect of temperature on the potency and Pharmacological action of insulin, Indian J Med Res 130, August 2009, pp 166-169