Researchers are scheduled to begin long-term clinical trials of an artificial pancreas early this year.  The artificial pancreas is designed to regulate blood sugar levels in people diagnosed with type 1 diabetes mellitus. If the trials work, then it is hoped that this could lead to commercial trials and eventual regulatory approval in the U.S and abroad.

The artificial pancreas system will be tested for six months in about 240 people with type 1 diabetes. These people will be drawn from nine locations across Europe and the United States. According to the researchers, the results of this system will be compared to the current insulin pump diabetes management system. One hundred eighty of the patients will then be followed for another six months.

The artificial pancreas is a wearable system that was developed by researchers from Harvard and Virginia Universities. It is being funded by the U.S. National Institute of Health and will cost about $13 million.

The wearable device works by monitoring blood sugar levels in the body and providing a shot of insulin when levels are low. The current treatment of type 1 diabetes involves manual insulin injections which are not very effective in terms of ensuring the patient doesn’t miss an injection. Therefore, this would be a better alternative if the trials are successful.

The co-principal investigator of the project, Francis Doyle III of Harvard University, said that the idea is to improve the quality of life for the individual with type 1 diabetes rather than a solution to the disease.

The system will have patients fitted with a wearable device that contains an insulin pump placed under the skin, as well as a blood sugar monitor and an app that will tell the patient how much insulin is required.

According to Doyle, the biggest challenge in designing the artificial pancreas is “the inherent uncertainty in the body.” For instance, the body constantly experiences changing levels of stress, hormones, and anxiety that alter the chemical balance of the body on an ongoing basis. This means that the body will respond to insulin-controlling glucose differently depending on the condition of the body. The trials will cover a long period of time so that researchers will have the ability to address these factors. Doyle says the long window will give researchers time to study patterns and fine tune the algorithms for the system. This will eventually lead to improved glucose control.

Statistics from the U.S. Centers for Disease Control and Prevention indicate that about 1.25 million Americans suffer from type 1 diabetes. In people living with the disease, the body’s immune system erroneously destroys insulin-producing beta cells in the pancreas so that there isn’t enough insulin to control blood sugar levels. Diabetics have to constantly monitor their blood sugar levels and if possible replace the lost insulin either via a thin tube inserted under the skin and connected to an insulin pump or through multiple insulin injections.