We’ve previously reported on efforts to create an “artificial pancreas,” a device consisting of a continuous glucose monitor and an insulin pump that work together to prevent high or low blood glucose without requiring input from the user. JDRF (formerly the Juvenile Diabetes Research Foundation) is funding artificial pancreas trials at 13 sites around the world, and several other studies are being funded by medical device manufacturers. This week, we’d like to give you an update regarding two milestones reached in the development of an artificial pancreas.
Successful Inpatient Trial in Adolescent
The first update concerns Elle Shaheen, a 12-year-old girl with Type 1 diabetes, who was chosen to take part in a trial of an artificial pancreas at Massachusetts General Hospital. For three days she stayed in the hospital, where she was outfitted with an artificial pancreas hooked up to a laptop that monitored her blood glucose levels and responded accordingly. According to researcher Steven Russell, MD, PhD, “For three days, the device did the work Elle’s pancreas can no longer do. It went very smoothly — her blood sugar control was really very, very good, and we were really very pleased by what we saw with Elle.”
For the duration of the trial, Elle did not have to check her blood glucose levels, and she was able to eat more carbohydrate than usual at each meal. “We’re extraordinarily impatient for access to the device. I think it will revolutionize the way she lives,” her mother noted.
Russell and his research partner Edward Damiano, PhD, recently visited the offices of the Food and Drug Administration to present their prototype for an artificial pancreas, which consists of two tiny pieces that go under the skin — one to measure glucose levels and the other to administer insulin or glucagon (a drug that can raise glucose levels) — and a small device that can be carried in a pocket or clipped to a belt. The investigators are hoping to have permission for trial participants to walk the grounds of the hospital while wearing the device by the fall and to give the artificial pancreas to children attending a summer camp by the summer of 2013.
FDA Approves Artificial Pancreas for Outpatient Trial
The second update regards the Food and Drug Administration’s approval of outpatient trials for another artificial pancreas, this one developed at the University of Virginia School of Medicine. The handheld device, which was created by reconfiguring a smart phone, monitors blood glucose levels and administers insulin as needed. Previous inpatient trials of this artificial pancreas, conducted in both France and the University of Virginia, along with an outpatient trial under way in Italy and France, have shown good results; the first eight people involved in the outpatient trial were able to keep their blood glucose levels in a safe range using the device during a night outside the hospital.
“Conducting the first US tests of a portable artificial pancreas running on a cell phone in a real-world setting is an important step toward evaluating its effectiveness and how it may impact treatment for Type 1 diabetes patients in the United States,” notes lead researcher Boris Kovatchev, PhD.
For more information about Elle’s experience with the artificial pancreas, see the article “Artificial Pancreas Gives Girl a Vacation From Diabetes.” And to learn more about the FDA’s approval of outpatient testing of the device, read “Type 1 Diabetes: Artificial Pancreas Approved for Outpatient Testing.”