The first human trials of the latest design of an artificial pancreas for people with type 1 diabetes found that the drive works without causing low blood sugar (hypoglycemia).
In the best case, this type of automated device finally released people with type 1 diabetes need injections that many each day and the constant need to check levels of blood sugar and monitor their food as appropriate.
The device, produced through a collaboration of experts from Boston University, Massachusetts General Hospital and Harvard Medical School has two hormones that are deficient among Type 1 diabetic, insulin, which prevents levels blood sugar get too high after a meal, and glucagon, a hormone that occurs naturally that prevents blood sugar levels fall too far.
Because the device does not depend on a human will provide information, it is called a “closed loop.”
“A closed-loop system bihormonal is possible and can help maintain a good average blood sugar readings,” said Edward Damiano, one of the designers of the device, associate professor of biomedical engineering at Boston University and father of a child with type 1 diabetes.
“What we developed is an automated software that makes decisions and uses mathematical formulas to inject various amounts of insulin and glucagon when necessary,” he said.
Type 1 diabetes is a disease in which the body’s immune system that normally protects against infections and other diseases attacking healthy cells. In type 1 diabetes, the immune system attacks the pancreatic beta cells, which in effect destroys the body’s ability to produce insulin and control blood sugar levels.
However, many people do not know beta cells are not the only ones affected by the autoimmune attack. The alpha cells, which produce the hormone glucagon, also damaged. Dr. Steven Russell, of Harvard and Damiano colleague said “there is a deficiency in alpha-cell function in type 1 diabetes, so do not act as they should. No glucagon secreted properly, so you lose a level Additional safety and body compensates with hypoglycemia, a condition that can cause big scares and even put life at risk. ”
For that reason, decided to add artificial pancreas glucagon to provide an additional level of protection, said Russell.
In the current version of the device, the researchers tracked the blood glucose through a special sensor placed inside a vein. Future versions will use the device monitors blood glucose continuous (CGM, for its acronym in English) that are already available, but for this test, the researchers wanted an extremely accurate way to measure blood sugar levels, so the only variable was the mathematical formulation used to program the administration of insulin and glucagon.
Eleven people with type 1 diabetes participated in the initial tests and experiments were performed in 27 hours. During that time, were connected to artificial pancreas and ate foods high in carbohydrates (carbohydrates are converted into glucose in the body).
The device responded to the increase in blood sugar levels with insulin administration. In six, the device reached a level of average blood glucose of 140 milligrams per deciliter (mg / dl), which is within the range established guidelines for the care of the American Diabetes Association. However, five insulin absorbed much more slowly than expected, which led to severe drops in blood sugar, so it was necessary to use extra food.
The researchers were surprised by the significant difference in the rates of absorption of blood sugar, so turned back, the mathematical formula adjusted and re-test the device in a second experiment. This time, reached a level of average blood glucose of 164 mg / dl, which is slightly above the target of the ADA. However, there were no cases of hypoglycemia that needed intervention.
The researchers said that people who use the pump is freed from daily injections. On the other hand, might need to change the pump site every three days and the place of glucose monitoring once a week. Yet integration has been developed in one place for the administration of hormones and glucose monitoring, although the ultimate goal.
In the following essay, researchers hope to give at least some insulin before a meal, which is the standard treatment. Damiano noted that this could be achieved with a button before the meal and the user could choose whether the carbohydrate meal will be short, medium or large.
The next series of trials will also evaluate a device that includes only insulin, it is likely to be available faster. The reason is that now glucagon is only approved by the FDA in a freeze-dried injection as rescue medication. But not to be administered via an insulin pump in small doses, as in the case of the artificial pancreas. Both Damian and Russell believe it is possible to have a closed-loop system only insulin to patients within five years or so.
“The goal of artificial pancreas is to try to restore normal physiology as closely as possible to the real organ, and this study shows that this technology is a reality and it works on real people,” said Aaron Kowalski, assistant vice president for research Glucose Control and director of the Artificial Pancreas Project of the Juvenile Diabetes Research Foundation (JDRF). “Many years ago we talked about the theoretical potential of closed-loop system and now we see the real potential. These technologies will become real systems and have the potential to transform the management of diabetes.”
The study results are published in the April 14 edition of Science Translational Medicine.
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