Sufferers of Type 1 diabetes spend a lifetime having to cope with impaired function of the pancreas — a crucial organ of the digestive system. But a first-generation artificial pancreas could offer hope to the millions of people who are at risk — a prospect that became all the more real, after a very successful clinical trial on humans.
Results from the first feasibility study of an artificial pancreas has shown that it successfully works in humans. The device, called the Hypoglycemia-Hyperglycemia Minimizer (HHM) System, is able to automatically predict a rise and fall in blood glucose levels in Type 1 diabetes sufferers, enabling it to increase or decrease insulin delivery. The system is comprised of an implantable insulin pump, a glucose monitor, and special software used to predict changes in blood glucose. The developers say the successful completion of the study in a human clinical trial setting is an important step forward in the development of an advanced first-generation artificial pancreas system.
The trial was conducted by Animas Corporation and the Juvenile Diabetes Research Foundation to create a closed-loop artificial pancreas system specifically for patients with Type 1 diabetes.
The feasibility study involved 13 patients each with Type 1 diabetes in the United States. The HHM system was monitored for about 24 hours for each participant during periods of open and closed loop control by using a control algorithm with a safety module connected to a laptop. Patients had their insulin and food modified over the course of study to both challenge and assess the system.
By the end of the study, the researchers were pleased to see that the algorithm worked; it was successfully able to predict a rise and fall in glucose above or below set thresholds, and as a result, was able to send messages to the pump to increase, decrease, or resume insulin infusion accordingly. The HHM system was also able to safely keep glucose levels within a target range.
Animas Corporation was given the green light to proceed with the study by the U.S. Food and Drug Administration in June of 2011. This breakthrough will now allow them to further develop the procedure and the device.
Image via Shutterstock.com/Creations.