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Artificial pancreas trial successful in 11 Type 1 diabetes patients

Type 1 diabetes, which affects approximately a million people in U.S., is an autoimmune disease in which the insulin-producing beta cells of the pancreas are destroyed by the immune system, requiring insulin treatment to regulate blood sugar levels.

American researchers announced on Wednesday that in the first human trial of an artificial pancreas that watches sugar levels carefully and delivers both insulin and regulatory hormone called glucagon, the device helped about a dozen people with type 1 diabetes achieve near-normal blood sugar levels for at least 24 hours.

With the latest automated device, lives of people suffering from type 1 diabetes from the insulin injections will be easier. They would rid themselves of the need for daily injections and also get relief from the constant need to check blood sugar levels and watch carefully the food they eat.

Researchers from the Boston University (BU), Massachusetts General Hospital and Harvard Medical School, U.S., produced the “artificial pancreas” which delivers two hormones that are deficient in type 1 diabetes, first being insulin, which keeps blood sugar levels from going up after a meal, and glucagon, a naturally occurring hormone that prevents blood sugar levels from going too down.

As the device basically mimics the workings of a healthy pancreas, human input is not needed, which is called a "closed-loop" system.

One of the author of the study, Edward Damiano, Ph.D., an associate professor of biomedical engineering at Boston University, and the father of a son with type 1 diabetes, said, "A bi-hormonal closed-loop system is feasible and it can give you good average blood sugar readings."

Type 1 diabetes
Type 1 diabetes, which affects approximately a million people in U.S., is an autoimmune disease in which the insulin-producing beta cells of the pancreas are destroyed by the immune system, requiring insulin treatment to regulate blood sugar levels.

Few people realize that beta cells aren't the only ones damaged by the autoimmune attack, but Alpha cells, which produce the hormone glucagon, are also damaged. Together, these two hormones help the body in the delicate balancing act of maintaining blood sugar levels that are neither too high nor too low.

Aaron Kowalski, a vice president of the Juvenile Diabetes Research Foundation and molecular biologist, said, "The latest research have made major advances in controlling blood sugar levels with continuous monitors and insulin pumps, but one of the challenges is that we have an accelerator but not a brake, which means blood sugar levels can fall too much."

According to Kowalski, intervention is necessary as low blood sugar (hypoglycemia) can cause seizures and even be deadly. For Individuals who have been on insulin for long periods, the risk of hypoglycemia increases over time. The recent research which is published in the April 14 Science Translational Medicine, may provide that intervention.

Surprise findings
Study authors, Edward Damiano, and Steven Russell, MD, PhD, of the MGH Diabetes Unit, USA and team invented a ‘computer algorithm’ that responds to changes in blood sugar and computes how much insulin or glucagon to inject.

Soon after Damiano found that the ‘automated system’ worked in pigs suffering from diabetes, Dr. Russell advised human trails. They conducted their first trials on 11 adults with type 1 diabetes, who were kept in hospitals for 27 hours for the tests. During the trials, patients were hooked up to the artificial pancreas and ate three standardized, high-carbohydrate meals.

The device responded to the increase in the blood sugar levels by injecting insulin. In six patients, the device achieved an average blood glucose level of 140 milligrams per deciliter, which is well within the American Diabetes Association (ADA) guidelines for care, however, five adults experienced hypoglycemia significant enough that they needed a dose of orange juice to raise their blood sugar.

The scientists were taken aback by the significant difference in blood sugar absorption rates, but they went back and altered the mathematical formulation, and again tested the device in a second experiment. However, next time, they achieved an average blood glucose level of 164 mg/dl, which is slightly higher than the American Diabetes Association goal.

However, there were no cases of low blood sugar that needed intervention.