Doyle led a team at the University of California Santa Barbara in developing the artificial pancreas before joining Harvard in late 2015.
In the first study, 240 patients with type 1 diabetes using the device will go about their normal daily routines for six months in order to test how it integrates into their lives, and how it compares with a standard insulin pump. During the study, researchers will focus on control of blood sugar levels and risk of hypoglycemia to measure its efficacy and safety.
The second study will include 180 patients for another six months to test an advanced control algorithm that predicts a patient’s needed insulin levels and attempts to keep levels within a range, similar to the way an air conditioner regulates temperature in a building.
“The biggest challenge in the design of the artificial pancreas is the inherent uncertainty in the human body,” Doyle said. “Day to day, hour to hour, the various stresses that impact the human body change the way it responds to insulin-controlling glucose.
“Physical stresses, anxiety, hormonal swings will all change that balance. To be able to control for those factors we need to see longer intervals of data.
“This is the first trial where we’ll be looking at multi-month intervals of time with cohorts of subjects where we can actually see a long enough window to learn those patterns, to adapt and fine-tune the algorithms, and to improve the overall level of glucose control.”