Tia Geri can’t wait to bring her new golden retriever, Nonna, home to Los Altos this month. Her diabetic alert dog will not only become a new family friend, but also a lifesaving companion if her blood sugar drops too low.
Geri, 14, suffers from Type 1, or juvenile, diabetes. She and her parents live with the fear of hypoglycemia – low blood sugar. Waking up to a diabetic who has become comatose during the night because of low blood sugar is not just scary, it can be life-threatening. Research shows that between 2 and 6 percent of Type 1 diabetics under the age of 40 who die, pass away from low blood sugar while sleeping.
“If a patient eats the same food and does the same activities every day, then they may possibly have reasonable control, but life isn’t like that,” said Dr. Trang Ly, a pediatric endocrinologist, of the unpredictable swings in glucose levels that even the most disciplined juvenile diabetic may experience.
Unlike those with Type 2 diabetes, the more prevalent form, juvenile diabetes sufferers face life without a fully functioning pancreas, the organ that produces insulin, a hormone that metabolizes food into the energy needed for survival. Because pancreas transplants aren’t an option for most Type 1 diabetics, blood sugar testing, insulin injections and carbohydrate counting become integral to their everyday routines.
Since Geri’s diagnosis six years ago, the soccer-loving teen has accepted the responsibilities of managing her disease, which include up to 10 pinpricks daily to test her blood glucose levels.
Although an alert dog may make Geri feel safer, managing her diabetes remains a challenge. With the advent of insulin pumps that can be programmed to deliver insulin via a cannula, a small tube inserted beneath the skin, and glucose monitors that continuously read blood glucose levels, patients have found some relief in diabetes management. But without a system to synchronize multiple medical technologies, the machines are prone to error and the unpredictability of the human body.
New technology offers hope
With the rapid development of the artificial pancreas, young diabetics like Geri see promise in the near future.
“It would take away most highs, it would bring you down so you don’t have to do it yourself,” said Geri of how an artificial pancreas could make controlling blood sugar levels easier.
The artificial pancreas uses algorithms to program devices that monitor glucose levels and respond in a way that closely mimics a working pancreas.
“For a long time, as we introduced technology, it has made life harder and harder,” said Dr. Bruce Buckingham, a pediatric endocrinologist at Stanford University who has been involved in artificial pancreas and sensor research for more than 10 years, in reference to the urine tests, blood tests and insulin pumps that have simultaneously improved and complicated diabetes management for patients. “With this technology, we’re trying to reduce and bring the burden down, help diabetics get a good night’s sleep, make better calculations and protect them from prolonged lows and highs (of glucose levels).”
Four days, three nights in the name of science
To be part of the solution, Geri sacrificed part of her summer to participate in an artificial pancreas study sponsored by Stanford University and the University of Virginia last month. Unlike previous studies limited to a controlled laboratory or medical facility, Geri and six other Type 1 diabetics between the ages of 10 and 16 spent four days and three nights together at a hotel in Newark testing the artificial pancreas system.
“I’d done lots of other studies at Stanford, but I got really excited about the closed-loop study because I’d heard about it and wanted to test it out,” said Geri, pointing to the technology she was wearing on day three of the study.
Connected to a barrage of small devices and tiny tubes, the artificial pancreas may look confusing at first glance. A continuous glucose monitor and transmitter, approximately the size of a small flash drive, sits on her right arm, measuring her blood sugar levels from interstitial body fluids every five minutes. Tubes extend from a small tube inserted in her left arm to a pager-sized insulin pump that delivers insulin as directed by the system’s “brains” – an accelerometer attached to an android phone programmed with algorithms that receive and transmit signals to the devices. As not all devices are elegantly integrated into one product, another small device is needed to convert some signals to Bluetooth format to be read by the phone. Despite having six separate devices attached to her at all times, Geri made sense of it all.
“Everything talks to the phone, and the phone talks to the pump so that it can either give you insulin or shut it off,” she explained.
Unlike the restrictions under most controlled research, Geri and the other participants swam, shopped at the mall and ate at restaurants during the study.
Preparing for mass distribution
According to Buckingham, testing the capabilities and vulnerabilities of a closed-loop artificial pancreas system in homelike settings will help scientists improve the artificial pancreas and prepare it for mass distribution.
To ensure that risk was minimized and the study met the rules of the U.S. Food and Drug Administration, 14 clinicians and technical support staff remained on-site to monitor glucose levels with remote tablets and phones. The phone has red, yellow and green indicator lights built into its control panel. If the red light began to flash and sound an alert, researchers were on hand to troubleshoot technical problems or help the patient intervene with the administration of insulin, if needed.
“At some point, it will be a pretty cool tool for people to wear, it will really make managing diabetes easier,” said Geri of the artificial pancreas. “Right now, there are some definite problems with the system, but they’re fixable.”
After data were collected and patient questionnaires reviewed, Buckingham said the study revealed more highs than lows: The system reduced glucose levels efficiently and quickly without many incidents of hyperglycemia, there were no major safety issues and the study proved that the device was ready for more studies. Another 24 children are scheduled to test the system at camps for Type 1 diabetics this summer, inching the technology toward home studies that could further validate its viability.
The artificial pancreas is not flawless, but Buckingham identifies its imperfections as the reason such studies exist – to improve medical devices in a setting that is safe for participants.
“They came in to volunteer to move the field forward. They did a great job – we learned a lot,” Buckingham said. “We’ll come back to them in another nine months or year with another device. It will get better.”