Researchers at Boston University recently developed an artificial pancreas which maintains the glucose levels of type 1 diabetes patients, via a control mechanism. Edward Damiano, of Boston University, and his team conducted the clinical trial of their mechanism at Massachusetts General Hospital on 11 adults, all of whom have type 1 diabetes. The system is the first of its kind -- combining both insulin and the blood sugar-raising hormone glucagon. The artificial pancreas injects both insulin and glucagon using a mechanism that combines a blood glucose monitor and insulin pump. When tested, the artificial pancreas failed to cause hypoglycemia, also a first.

"It showed that, by delivering both hormones in response to frequent blood sugar tests, it is possible to control blood sugar levels without hypoglycemia, even after high-carbohydrate meals," states Steven Russell (MD, PhD of Massachusetts General Hospital Diabetes Unit), research partner of Damiano.

The immune system of type 1 diabetes patients kills the beta cells of the pancreas which are responsible for producing insulin. Insulin treatment is necessary for patients to maintain a safe blood sugar level. Blood sugar testing and insulin administration can delay complications such as kidney failure or cardiovascular disease, but is a tedious daily job. Insulin pumps are another option, but place patients at a risk for hypoglycemia.

Hypoglycemia is characterized by a drop in blood sugar, caused by too much insulin. So far, any administration of insulin by pump or artificial pancreas has come with the risk of hypoglycemia. Therefore, Damiano and fellow researches developed a system that would potentially eliminate that risk. Glucagon, a hormone employed to raise blood sugar, is also administered along with insulin.

The clinical study was designed to test the software that controls the artificial pancreas. Glucose levels were monitored via a sensor planted in the vein of the patient, relating information to a monitor. All patients were monitored for 27 hours, throughout their overnight stay in the hospital and their three standardized high-carbohydrate meals. Six of the patients kept a reasonable glucose levels, however five experienced hypoglycemia and were given the mighty treatment of orange juice. 

Researches conducted another study with the same patients after they diagnosed the problem with their artificial pancreas. Because not all patients absorb insulin at the same rate, those who absorbed insulin slower received extra doses, causing their hypoglycemia. After adjusting the controlling software to a slower insulin absorption rate and conducting another study, none of the participants needed a glass of orange juice to combat hypoglycemia.

In 2007, diabetic pigs were tested with this same mechanism – FDA later approved this human trial. Later this spring, a 48 hour study will be conducted, both with children and adults. The vision of the researchers: a wearable pump the size of a cell phone, that will wirelessly communicate with a sensor placed underneath the skin.

"A system like this...wouldn't be a cure, but it has the potential to be the ultimate evolution of insulin therapy for type 1 diabetes," comments Damiano.