Researchers Eye Artificial Pancreas
Device Considered Promising but a Decade Away
Sept. 27, 2006 -- Engineers in the increasingly high-tech world of diabetes
treatment are moving toward a quantum leap they hope will free some diabetes
patients from the daily torment of finger pricks and insulin injections.
Several centers around the U.S. and in the United Kingdom are gearing up to
test the feasibility of the first artificial pancreas to control patients'
Marketing of a self-contained artificial pancreas is probably a decade away,
researchers say. But if this proves realistic, it could greatly improve blood
sugar control for diabetics.
The artificial pancreas would not resemble a natural organ in the way an
artificial heart approximates the shape of a human heart.
Instead, it would combine two existing technologies -- computerized blood
glucose monitors and insulin pumps -- into a machine capable of sampling blood
glucose, then delivering an appropriate insulin dose.
Type 1 diabetes affects approximately 2 million Americans. Only 44% of them
achieve long-term control of their blood sugar with insulin, according to the
National Institutes of Health.
Both the monitors and pumps have been credited with improving average blood
sugar control in patients who use them.
What researchers don't know is whether they can "close the loop"
between the two machines so they mimic a true pancreas.
Researchers at Yale University School of Medicine recently tested a
prototype artificial pancreas under laboratory conditions and found the machine
effectively controlled sugar levels in teenagers.
That study was small -- only 18 patients -- and limited to 36 hours in a
hospital. That's hardly a real-world setting complete with varying diet,
exercise, movement, and stress.
But, "Based on this, it's feasible," says Stuart Weinzimer, MD, a
Yale pediatric endocrinologist who participated in the trial. He called the
results "very, very preliminary."
Weinzimer and other researchers at Yale and other centers are starting a new
series of trials to test artificial pancreas systems under a variety of
One protocol will test how well a "closed loop" functions when
patients exercise or sleep, though the study will still be performed under
"The long-term goal is for broad patient access and a thriving
competitive market," Arnold Donald, president of the Juvenile Diabetes
Research Foundation, told lawmakers at a Capitol Hill hearing Wednesday.
The group devoted $5.5 million to fund the new round of studies this
Work to Be Done
Mathematical algorithms that govern the link between blood sugar levels and
insulin doses are yet to be perfected. Researchers are also working on backups
that won't leave patients in danger if a sensor or pump fails.
After that, a manufacturer must show that the system is reliable enough in
the real world to gain approval from the FDA.
Whether insurers will show an interest in paying for the device is another
"I really don't think it's going to be any sooner than 10 years,"
Weinzimer tells WebMD.
"It all comes down to 'are there enough fail-safes that if the hardware
fails you're not walking around with no insulin without knowing it?'" he