Page Menu

UMass Diabetes Center of Excellence Patients Participated in "Artificial Pancreas" Study

Date Posted: Tuesday, December 20, 2016

The bionic pancreas system developed by Boston University (BU) investigators proved to work better than either conventional or sensor-augmented insulin pump therapy.  The clinical trial, led by Steven Russell, MD, PhD, of the Massachusetts General Hospital (MGH) Diabetes Unit, managed the blood sugar levels for 11 days of people living with type 1 diabetes (T1D). 

“For study participants living at home without limitations on their activity and diet, the bionic pancreas successfully reduced average blood glucose, while at the same time decreasing the risk of hypoglycemia,” says Dr. Russell. “This system requires no information other than the patient’s body weight to start, so it will require much less time and effort by health care providers to initiate treatment. And since no carbohydrate counting is required, it significantly reduces the burden on patients associated with diabetes management.”

Developed by Edward Damiano, PhD, and Firas El-Khatib, PhD, of the BU Department of Biomedical Engineering, the “bionic pancreas” controls blood sugar using both insulin and glucagon.  A 2010 clinical trial confirmed the original version of the device could maintain near-normal blood sugar levels for more than 24 hours in adult patients.  Two follow-up trials were reported in a 2014 New England Journal of Medicine paper, showing an updated version of the system successfully controlled blood sugar levels in adults and adolescents for five days.  Another follow-up trial published in 2016 in The Lancet Diabetes and Endocrinology showed it could do the same for children as young as 6 years old.

Participants in the 2014 trials spent nights in controlled settings and were accompanied at all times by either a nurse (for the adult trial) or at a diabetes camp (for adolescent and pre-adolescent participants). The current trial had no such restrictions placed upon the participants, who were able to pursue normal activities at home or work, with no limitations on diet or exercise.

The bionic pancreas system, the same one used in the 2014 studies, consists of an iPhone 4S which wirelessly communicates with two pumps, delivering either insulin or glucagon.  Every five minutes the smartphone received a reading from an attached continuous glucose monitor, which was used to calculate and administer either insulin or glucagon as needed.  Algorithms controlling the system were updated for the current trial to better respond to blood sugar variations.

The device allows participants to enter information into an App, about each upcoming meal, to deliver an anticipatory insulin dose, however it's optional in the current study.  If blood sugar dropped to dangerous levels, or if the monitor or one of the pumps was disconnected for more than 15 minutes, the system would automatically alert staff, who would contact the participants.

Participants in the study were adults who had been diagnosed with T1D for at least a year, and used an insulin pump for at least six months.  Each of 39 participants who finished the trial completed two 11-day study periods.  First, they used the bionic pancreas, then their usual insulin pump and CGM.  In addition to the automated monitoring of glucose levels and administered doses of insulin or glucagon, participants completed daily surveys regarding any episodes of symptomatic hypoglycemia.  They also recorded what carbohydrates they consumed to treat those episodes, as well as any nausea they may have experienced.

On days when participants were on the bionic pancreas, their average blood glucose levels were significantly lower (141 mg/dl as opposed to 162 mg/dl) then when on their standard treatment.  Hypoglycemia (less than 60 mg/dl) occurred 0.6% of the time participants were using the bionic pancreas, versus 1.9% on standard treatment.  Participants reported fewer episodes of symptomatic hypoglycemia while on the bionic pancreas, and no episodes of severe hypoglycemia.

The bionic pancreas system performed even better overnight, when the risk of hypoglycemia is particularly concerning.  “Patients with type 1 diabetes worry about developing hypoglycemia when they are sleeping and tend to let their blood sugar run high at night to reduce that risk,” explains Russell, an assistant professor of Medicine at Harvard Medical School. “Our study showed the bionic pancreas reduced the risk of overnight hypoglycemia to almost nothing, without raising the average glucose level. In fact, the improvement in average overnight glucose was greater than the improvement in average glucose over the full 24-hour period.”

Dr. Damiano’s work on this project is inspired by his own 17-year-old son’s T1D.  He is a professor of Biomedical Engineering at Boston University, and co-author of the Lancet report.  “The availability of the bionic pancreas would dramatically change the life of people with diabetes by reducing average glucose levels,“ he said.  “Thereby reducing the risk of diabetes complications including hypoglycemia, which is a constant fear of patients and their families, and reducing the emotional burden of managing T1D.”

The BU patents covering the bionic pancreas have been licensed to Beta Bionics, a startup company co-founded by Drs. Damiano and El-Khatib. The company’s latest version of the bionic pancreas, called the iLet, integrates all components into a single unit, which will be tested in future clinical trials.  

Dr. El-Khatib is the lead author of the Lancet paper.  Co-authors include UMass Diabetes Center of Excellence co-director David Harlan, MD, as well as Bruce Buckingham, MD, from Stanford University, and John Buse, MD, from the University of North Carolina at Chapel Hill.  

Support for the study includes National Institute of Health grants R01DK097657 and DP3DK101084 and National Center for Advancing Translational Sciences awards UL1TR001453, UL1TR001085 and UL1TR001111.

Additional Resources
click to open search panel