Issue 104 Item 9 Trial of Artificial Pancreas “Bina” Set for Launch

First closed loop artificial pancreas set to begin trial Clinical trials will begin next month for a prototype artificial pancreas that should enable patients with type 1 diabetes to have more controlled levels of blood glucose with fewer episodes of hypoglycemia than are achievable with insulin pumps, say scientists at City University here.

"Our prototype artificial pancreas administers continuous subcutaneous insulin that maintains glucose at a constant level. It has the potential to reduce the most dangerous aspects of diabetes such as hypoglycemia, amputations, and blindness," said Dr. Roman Hovorka, from City University.

The prototype is made up of three parts: a sensor placed on the skin takes a blood sample to measures glucose levels; a hand-held computer analyses the information using a control algorithm; a small pump infuses glucose into the body.

"It will be small enough for men to fit it on their belts or women to place it inside their bras," said Dr. Hovorka. He hopes the product will be on the market in 5 years.

Funded by the European Commission and insulin pump manufacturer Dietronic, the project is believed to be at a further stage than similar versions in the US. Dr. Hovorka said that US competitors have still not begun clinical trials.

The first randomized controlled trial for the prototype takes place next month in a hospital in Austria. Twelve subjects will be maintained in the hospital for 24 hours on two occasions. They will first be given treatment via insulin pumps currently used in Europe, and will then use the artificial pancreas.

Since January 2000, Dr. Hovorka has tested the prototype on over 20 volunteers in Austria and Italy, achieving "very promising results." Their glucose levels were maintained at an average of 6.2 mmol/L (125 mg/dL). The normal is about 5.5 mmol/L (111 mg/dL) around 5.5, and most insulin-dependent diabetics can only maintain an average of 8.9 mmol/L (179 mg/dL) using the methods currently available, he noted.

A unique computer model of the disease, on display at City University on Friday, has also aided research. Nicknamed Bina, the computer holds data of a number of diabetic profiles. The scientists were able to test various components of the prototype without the need for animal testing using the computer model.

"We believe this product will have a significant and important effect on the lives of people with type 1 diabetes. But the technology is expensive, so we will not be able to help everyone," added Dr. Hovorka.