Chuck Bednar for redOrbit.com – @BednarChuck
As part of a unique real-world experiment being conducted this weekend at the Yale University Pediatric Specialty Clinic, a group of teenagers are taking a “vacation” from diabetes in order to test-drive an “artificial pancreas” in real-world conditions.
Five participants between the ages of 14 and 17 are scheduled to take part in the study, according to the researchers. They will be using an automated system that continually monitors blood sugar levels and administers the correct dosage of insulin as needed over a four-day period.
While Yale scientists have been studying such devices for the last decade, this will mark the first time that they will be tested in pediatric patients outside of the hospital, they noted. The device is a two-part system that combines an insulin pump with a continuous glucose sensor, adjusting the delivery of insulin automatically in response to what the body needs at any given time.
Currently, the standard treatment for children and teenagers with Type 1 diabetes is to either give them multiple injections of insulin each day or to use a manually operated insulin pump. In the last 10 years, though, experts at the Yale School of Medicine and industry partners have teamed up to combine insulin pumps and continuous glucose sensors in an “artificial pancreas.”
Hoping for a “major advance” in diabetes care
Separately, both components of the “artificial pancreas” have been approved by the US Food and Drug Administration (FDA). However, the Yale team indicates that a closed-loop system using a sensor to control the function of the insulin pump would be “a major advance” in treating Type 1 diabetes, which affects as many as three million Americans, according to the JDRF.
“The ability of the system to self adjust automatically in the background while patients go about their daily lives would really be transformative in the lives of people with diabetes,” explained Dr. Stuart Weinzimer, lead investigator of the study, associate professor of pediatrics at the Yale School of Medicine, and associate clinical professor of nursing at the Yale School of Nursing.
As part of the current study, five teenagers will sleep at a hotel in New Haven, Connecticut and participate in a variety of activities, including hiking and laser tag. They will also eat their meals together, all while under the supervision of Yale medical officials. The teenagers will have their blood sugar levels monitored regularly, both directly and remotely using mobile devices.
Previous outpatients studies have indicated that the device can achieve good glucose control in adults, but doing so can be more difficult in teens. Dr. Weinzimer said that his team ultimately plans to study a total of 15 teenagers, which he says is a large enough group to gauge the safety and effectiveness of the device. If successful, they plan to conduct larger-scale studies involving multiple sites before submitting the device to the FDA for approval.
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