Patients with type 1 diabetes may be on the verge of getting an artificial pancreas system as a new treatment for their chronic condition. Two new clinical trials will soon be underway to test the effectiveness of this new artificial pancreas system that’s designed to take the guesswork out of monitoring glucose levels.
Diabetes mellitus is one of the most common chronic disorders that is characterized by the body’s inability to regulate blood glucose levels. In type 1 diabetes, insulin is not made in enough quantities because the insulin producing cells (islet cells) are attacked and destroyed by the body’s own immune system. As a result, the body is unable to regulate blood sugar levels normally, and diabetics must take great care in monitoring their activity, diet, and glucose levels. This involves daily blood checks and even insulin injections.
Researchers hope the artificial pancreas will eliminate these steps completely. There are two parts to this artificial system: an implanted insulin pump that receives blood sugar levels every five minutes, and a smartphone that’s programmed to automatically deliver the correct amount of insulin. In addition to the ability to react to body changes, the system is also touted to be clever enough to predict glucose levels in advance. Thus, though the system is not a replica of the biological organ, it should function just like the real thing – regulating blood sugar levels at all times.
"The idea is that this can lead to an improved quality of life for individuals with this disease -- not a solution to diabetes, but a means to really extend the quality of their healthful living. - Francis J. Doyle III, Harvard co-principal investigator and engineering lead on the project.
The system was developed through a collaboration between the University of Virginia (UVA) School of Medicine and the Harvard John A. Paulson School of Engineering and Applied Sciences (SEAS). The teams secured $12.7 million in NIH funding to test this artificial construct in two six-month clinical trials, one of the largest-ever long-term clinical trials for diabetes research.
In the first trial, researchers will test the effectiveness of the artificial pancreas system at controlling blood sugar levels in comparison to a traditional insulin pump in 240 patients with type 1 diabetes.
In the second trial, researchers aim to test an adaptive algorithm function of the artificial pancreas, essentially asking whether the system can predict and regulate blood sugar within an acceptable range. For this trial, they will follow 180 patients who completed the first study for an additional six months.
"The biggest challenge in the design of the artificial pancreas is the inherent uncertainty in the human body. Day to day, hour to hour, the various stresses that impact the human body change the way it responds to insulin-controlling glucose. Physical stresses, anxiety, hormonal swings will all change that balance. To be able to control for those factors we need to see longer intervals of data. This is the first trial where we'll be looking at multi-month intervals of time with cohorts of subjects where we can actually see a long enough window to learn those patterns, to adapt and fine-tune the algorithms, and to improve the overall level of glucose control." – Francis J. Doyle
Sources: Harvard press release