U.S. News
Advances Made in Regulating Type 1 Diabetes
Software Potentially Could Better Manage Disease Through Automated Insulin Pump, Glucose Monitor
June 15, 2014 9:08 p.m. ET
Medical researchers reported progress in
developing software that potentially could better manage Type 1 diabetes
through an automated insulin pump and glucose monitor, lowering
patients' risk of sudden death or long-term medical complications from
the disease.
In two small clinical
studies presented at a meeting of the American Diabetes Association in
San Francisco on Sunday, researchers said patients with Type 1 diabetes
were able to better control their blood sugar when using an insulin-pump
system controlled by an algorithm, or mathematical formula, which was
embedded in a smartphone application, than when the patients determined
the timing and dosage of injections themselves.
The
studies, which also were published online Sunday in the New England
Journal of Medicine, were conducted by doctors and biomedical engineers
from Boston University and Massachusetts General Hospital, and were
funded by the National Institutes of Health.
It
will take years before such a setup is available to consumers, and
there are challenges to making a commercial-grade version of the
automated insulin pump.
Independent
experts, however, said the results represent an important
proof-of-concept for a technology that could provide significant
benefits to families grappling with Type 1 diabetes.
"It's a leap ahead in treating diabetes, but it's a research leap—not a leap where patients can now use this," said
Anne Peters,
director of the clinical diabetes program at the University of Southern California, who wasn't involved in the studies.
Type
1 diabetes, a disease in which the pancreas doesn't produce enough
insulin to clear excess sugars from the blood, is typically diagnosed in
childhood and affects about 1.5 million to 2 million Americans.
Diabetes
management today requires patients and their families to spend hours
each week tracking food intake, blood-sugar levels and physical exercise
to calculate when and how much insulin to inject into the body.
Wearable
devices, such as insulin pumps and continuous glucose monitors, help
eliminate some of the guesswork, Dr. Peters said, but the process is
still largely a manual one.
If a
patient's insulin dosage isn't just right, their blood-sugar levels can
rise too high, which over time can cause heart disease and kidney
damage. Diabetic patients also are at risk of dying in their sleep if
their blood sugar falls too low because of an insulin overdose, a
phenomenon known as dead-in-bed syndrome.
In the studies presented Sunday, researchers installed the software algorithm on an Apple Inc. iPhone
and wirelessly synced it with insulin pumps and glucose monitors,
creating what they call a bionic pancreas capable of determining when
and how much insulin to pump.
The system
also was able to automatically inject glucagon, an antidote to low
blood sugar, which could help reduce the risk of dead-in-bed syndrome,
said
Edward Damiano,
an associate professor of biomedical engineering at Boston
University and one of the lead developers of the algorithm.
"What
we're providing is a smart pump that overtakes your diabetes management
completely," said Mr. Damiano, who has a financial stake in the
device's success through patents assigned to Boston University.
In
the clinical studies, Mr. Damiano and his colleagues used commercially
available devices and pumps and connected them through wireless
Bluetooth technology to their iPhone
application. But to bring such a device to the market, the researchers
will have to develop their own single, self-contained unit. Mr. Damiano
said he hopes to have such a device ready for a large clinical trial by
2016.
Insulin pump systems cost upward
of $7,000 retail. There are no estimates as to how this development
could affect the price tag.
Medical
device firms have for years sought to develop a fully automated insulin
pump system, sometimes called an artificial pancreas. The U.S. Food and
Drug Administration last year approved a device made by
Medtronic Inc.,
MDT -1.10%
capable of suspending the flow of insulin if patients' blood
sugar fell too low, but not of automatically determining insulin
injections.
Write to Joseph Walker at joseph.walker@wsj.com
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insulin.
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You are not rich. Neither am I.
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Father Devises A 'Bionic Pancreas' To Help Son With Diabetes
8 min 27 sec
Ed Damiano and his son David, 15, play
basketball at home in Acton, Mass. Ed has invented a device he hopes
will make David's diabetes easier to manage.
His son, David, has Type 1 diabetes. The 15-year-old sleeps hooked up to a monitor that sounds an alarm when his blood sugar gets too low. If it drops sharply, David could die in his sleep.
"The fear is that there's going to be this little cold limb, and I screwed up. It's all on me," Damiano says.
But when he touches David's hand, he's warm. He's OK. Damiano says, "That's the moment of relief."
The father has been doing this night after night since his son was diagnosed with when he was 11 months old.
But Damiano has done more than nightly monitoring to try to protect his son. He's an associate professor of at Boston University, and has shifted the focus of his career to developing a better way to care for people with Type 1 diabetes.
"It's intimidating when you start considering the list of things that influence blood sugar," he says. "Emotions and physical activity, if you're healthy. You can't possibly take into account and balance all those things. And sometimes you get it right. And often you get it wrong."
Damiano has developed a system he calls a "bionic pancreas" designed to help people better manage their blood sugar. He's racing to get it approved by the Food and Drug Administration before his son leaves for college in three years.
In tests with 52 teenagers and adults, the device did a better job controlling blood sugar than the subjects typically did on their own. The were reported Sunday at an American Diabetes Association meeting in San Francisco and also in the New England Journal of Medicine.
At the moment, Damiano's system is basically a sophisticated app that runs on an iPhone. The iPhone is connected wirelessly to the kind of that many people with diabetes wear taped to their abdomens.
Ed tests tubing for his son's insulin pump.
"The bionic pancreas is a device that automatically takes care of your blood sugars 24/7," Damiano says. "It's a device that comes to know you."
David wears a transmitter on his abdomen that sends data on his glucose levels to a monitoring unit.
Diabetes specialists at the National Institutes of Health and the Juvenile Diabetes Research Foundation, both of which have provided funding for Damiano's research, say his system is promising. But it remains unclear which approach will work best, they say. Damiano's could, for example, turn out to be too complicated.
"Because it's more complex, using a pump for each hormone, it may also make it more challenging for the people using it if there is a failure of the system," says , a program director at the National Institute of Diabetes and Digestive and Kidney Diseases. In the worst-case scenario, someone could die from severe hypoglycemia if the device failed.
Based on the results of the last round of testing, Damiano has gotten approval to launch a new round of testing. Dozens of adult and adolescent volunteers will use the system on their own for 11 days. The first volunteers start Monday.
"This thing is going to take the worries about my blood sugar off my hands," says Ariana Koster, 24, one of the volunteers. Koster has been struggling with diabetes since she was 11.
This pump uses the hormone glucagon to help provide better blood sugar control.
"I can already see how awesome it is," Koster said.
There are not yet companies involved in developing the device. Damiano hopes to win the FDA's approval just in time for his son David's first night alone in his dorm room. For his part, David is confident his dad's bionic pancreas will be ready in time.
Ed and David work through problems for an
algebra final. Both father and son hope the bionic pancreas will be
approved for use by the time David goes to college.
Story produced for broadcast by Rebecca Davis.
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