Fresh hope has emerged this month that diabetes patients may one day soon be totally free of insulin, thanks the development of an implantable robotic pancreas currently undergoing FDA trials.
The pancreas is an organ near the liver which secretes insulin to control the concentration of glucose in the blood. In patients with type 1 diabetes the pancreas makes no insulin of its own, so those with the disease must work hard to manually replace that organ’s function. This means several times a day the patient must prick a finger to test blood sugar, making complicated calculations and estimates to account for meals, physical activity and time of day.
After half a century of work, a solution may be just around the corner: the artificial pancreas.
“It is a classic problem in control technology, which is the methodology used in process control,” says Ahmad Haidar, a researcher at the Institut de Recherches Cliniques de Montréal (IRCM). Haidar’s group is one of a number of academic and corporate teams vying to create a closed-loop system for an artificial pancreas, whereby a computerized control system determines how much insulin to inject and how often to inject it. It completely takes patient judgement out of the loop.
“Each patient is represented by a set of differential equations,” Haidar says, “parameterized based on physical information—body weight and total daily insulin dose, for instance.” From there computer processors and software algorithms do the rest.
The research is bearing fruit, with partial versions being rolled out now, and more advanced versions in clinical trials.
The reason this relatively simple concept is only just hitting the market is thanks to advances in sensors, actuators, algorithms, and insulin that are just now coming together to create the artificial pancreas.
“The thing that was cool about it was that it works,” says Herrick, 27, who directs strategic communications at the Juvenile Diabetes Research Foundation (JDRF). Together with a colleague, he spent several days and nights in a controlled setting, surrounded by doctors and engineers.
So far trials of fully automatic devices have mainly looked at nighttime control, which is vital, because the patient may not wake in time to handle a bout of low blood sugar. “My mother is still fearful of my sleeping at night, even though I've got my fiancée sleeping next to me,” said one patient involved in the trial.
The information provided by the new, fully automated meter, can also be used to prove to insurers that money spent on health care is producing results. “Health care providers are more and more being paid for outcomes,” one company executive was quoted as saying “Payers want patients to stay on the system; now they can make sure that patients do.”
While not quite yet on the market the FDA looks set to approve fully automated machines within the next two years from a host of companies.
It is estimated that within five years nearly all machines sold, especially those covered by insurance, will be fully automated devices.