Developments in Type 1 Diabetes.

Nine years in and counting.  It has been nine years since my then 3 year old grandson was diagnosed with Type 1 diabetes.  At the time of his diagnosis, I assured his anxious parents that relief was on the horizon.  Medical science was working feverishly to find both a cure for Type 1 diabetes and mechanical treatments that would more closely replicate the natural processes of the pancreas and keep blood sugars in a normal range.  While medical science continues to work feverishly on these two fronts, a really good solution seems still to be just out of reach.

What is diabetes? | CDC

Success in treating Type 1 diabetes is a holy grail for many companies and researchers.  There are an estimated 2 million people living with Type 1 diabetes in the United States today.  Approximately 200,000 of them are under 20.  The incidence of Type 1 diabetes is increasing for reasons that are not entirely clear.  It is estimated that by 2050 there will be 5 million people living with Type 1 in the United States.  Selling insulin to these people is already a huge money maker for Big Pharma.  Developing a cure would bring untold riches to the successful companies.  Developing an insulin pump which can effectively replicate the function of the cells that produce insulin and regulate blood sugar levels would also be a huge money maker.

Type 1 diabetes is an autoimmune disease.  For some unknown reason, the body’s immune system decides that the cells which produce insulin are a foreign invader and attacks them.  Insulin is a hormone that is essential to the body’s ability to use glucose to produce the energy the body needs in order to operate.  When enough insulin producing cells are destroyed, the body does not have enough insulin to survive.  Sugars in the blood reach out of control levels and, if insulin is not provided from the outside, the patient dies.  A little over 100 years ago, there was no outside source of insulin.  A little over 100 years ago my grandson would be dead by now.

There are two somewhat competing avenues of research for the treatment of diabetes.  The first is biological and seeks to restore the ability of the body to make insulin.  This avenue faces substantial obstacles created by the very process that caused the diabetes in the first place.  Any new insulin creating islet cells transplanted into the patient will be attacked by the immune system as were the original cells.  At present, islet cells are taken from a donor pancreas but there are not enough donors to supply everyone.  Anyone receiving such a transplant must take immunosuppressants for the rest of their life to protect the transplanted cells and immunosuppressants present problems of their own.  In spite of the use of immunosuppressants, the average life of an islet cell transplant is about two years.

Researchers are experimenting with novel ways to obtain islet cells for transplant and to protect them from destruction by the immune system.  Notwithstanding their best efforts, they appear to be quite a ways away from the time when a successful therapy can be rolled out to the public.

The second avenue of research and treatment is more advanced.  It is mechanical in nature.  It seeks to create what has been called “the artificial pancreas.”  The FDA has approved and companies already sell insulin pumps, which automatically deliver small amounts of insulin over the course of the day.  There are also sensors on the market that measure blood sugar and report it directly to the pump.  At present, the FDA has been unwilling to approve a pump that can take the data from the sensor and, using an algorithm, determine on its own how much insulin to deliver and when.  The greatest concern is that the pump might malfunction and deliver too much insulin, which causes a condition called hypoglycemia, or low blood sugar.  If blood sugar drops too low the patient becomes unconscious and can die.

The other failing of today’s pumps is that, unlike the human body, they can only deliver insulin.  In a non-diabetic, the body senses blood sugars and delivers insulin as blood sugar rises.  If blood sugar drops too low, the body will release stores of glucose to maintain appropriate levels.  The ability to sense the need for and to deliver glucose is a great defense against dangerous hypoglycemia.  Today’s pumps do not deliver glucose and will not in the foreseeable future, although some talented programmers have hacked insulin pumps to allow them to independently regulate blood sugar levels using both insulin and glucagon.

There is constant progress in the research and development of a cure and in the creation of an “artificial pancreas.”  In fact, the Wall Street Journal recently reported on a new pump being given fast track status by the FDA.  The pump does not need to be told how much insulin to deliver but makes the decision on its own and monitors the blood sugar levels.  That device may be approved in the next year or two.

If you, like me, have a loved one with Type 1 diabetes, you will continue to watch the developments and hope for significant breakthroughs.


Posted in drug companies, health, Medical Costs, Medical Devices, Type 1 Diabetes |