The wearable bionic device, showcased recently at the American Diabetes Association meeting in San Francisco, Calif., uses iPhone app that lets patients enter information immediately prior to eating. Every five minutes the app receives a blood sugar reading from an attached continuous glucose monitor, which it uses to calculate and administer a dose of either insulin or glucagon.
Researchers from Boston University (BU) and Massachusetts General Hospital (MGH) reported the results from two clinical trials in The New England Journal of Medicine. The study included one trial for adults and one for adolescents. Both trials imposed minimal restrictions on patients’ activities.
Type 1 diabetes is usually diagnosed in children and young adults. According to the U.S. Centers for Disease Control and Prevention, 29.1 million people, or 9.3 percent of the population, have diabetes. The American Diabetes Association states that five percent of people with diabetes have type 1 diabetes.
In type 1 diabetes, the body does not produce insulin, a hormone needed to convert sugar, starches, and other food into energy needed for daily life.
Study Compared Device with Patients' Use of Insulin Pumps
Both studies compared data showing five days on the bionic pancreas system with five days of participants' usual care using their own insulin pumps. The adult trial enrolled 20 participants who lived at home and managed their own care during the usual-care period. The adolescent trial enrolled 32 participants, ages 12 to 20, attending a camp for youngsters with type 1 diabetes, who followed the same activity and meal schedule as other campers during both phases of the trial.
Pointing out that his 15-year-old son was diagnosed with diabetes when he was 11 months old, Edward Damiano, Ph.D., associate professor at the BU Department of Biomedical Engineering, principal investigator of the project, and a senior author of the NEJM report, told Healthline, "The benefit to patients of a device like this is to offer them much better glucose control that will keep them healthier for many years. The glucose control we saw, that this device was able to achieve, is consistent with a level of glucose control that should stave off long-term complications of diabetes, and at the same time protect them from the dangers of low blood sugars."
Diabetics Face Problems
Noting that diabetics face two problems, Damiano said, "There are long-term complications of running your blood sugars too high and then people strive to lower them with standard care therapies. But the challenges there become, as you add more insulin to do that, you run the risk of exposure to low blood sugars. Our device achieves very safe long-term blood sugars, and at the same time reduces episodes of the low blood sugars."
Emphasizing that the device used in the studies is an investigational device, Damiano said, "The final version of the device will run on a dedicated piece of medical device hardware. We are just using the iPhone as a portable computer for the purposes of this study."
Damiano also said the device conveys "an enormous emotional benefit in unburdening the stress that goes along with constantly having to manage this relentless disease. Diabetics are constantly in fear of low blood sugar, especially at nighttime."
Co-lead author of the report, Firas El-Khatib, Ph.D., of the BU Department of Biomedical Engineering, said in a press statement, "One of the key virtues of this device is its ability to start controlling the blood sugar instantly, based only on the patient's weight, and continually adapt its decision-making regarding insulin and glucagon dosing to handle a wide range of dosing requirements."
Damiano and El-Khatib published a 2010 Science Translational Medicine report in which a first-generation system was successful in controlling the blood sugar of adults for 27 hours. That study was conducted in a controlled hospital inpatient environment where participants remained in bed for the whole period and ate prescribed meals.
"The key element with the current version of this device is that it's wearable, allowing participants to stay in something close to their usual environments, exercise, and eat whatever they want," said Dr. Steven Russell, Ph.D., of the MGH Diabetes Unit, who led the current clinical trials.
Two follow-up trials are already underway. One of these trials is a home-study-only, and it requires participants to stay within an hour's drive of the study site. That trial will compare 11 days on the bionic pancreas with 11 days of usual care. The second study will enroll children ages six to 11, and is currently enrolling participants already registered at the camps. Information on both of those trials is available at http://www.bionicpancreas.org/.