Two  Breakthrough T1D-funded pilot trials  in human subjects represent significant advances in the development of a safe and effective artificial pancreas system for the treatment of type 1 diabetes (T1D). One study demonstrated, for the first time,  the feasibility of a wearable artificial pancreas in a “real-world” setting. The second study showed that a hypoglycemia-hyperglycemia minimizer (HHM)  system could predict changes in blood-glucose levels and adjust insulin  delivery accordingly. Results  from both trials  were announced at the American Diabetes Association’s 72nd Scientific Sessions in Philadelphia in June 2012.

Artificial pancreas systems require three primary components: a continuous glucose monitor, an insulin pump, and a software algorithm that automatically regulates insulin  delivery in response to blood-glucose levels. A fully automated, closed-loop artificial pancreas would safely  maintain blood glucose within a close-to-normal range with no to minimal input from the user.

The Breakthrough T1D Artificial Pancreas  Project supports research to accelerate the development, regulatory approval, and clinical acceptance of commercially viable artificial pancreas systems for patients with T1D. Such systems could rapidly and dramatically improve the lives of millions of people living with T1D.

The first outpatient study of an artificial pancreas system was led by Eric Renard,  M.D., Ph.D., of the Montpellier University Hospital (France) in collaboration with investigators at the University of Padova (Italy), the University of Virginia, and Sansum Diabetes Research  Institute (United States). The system comprised a blood- glucose monitor and insulin  pump wirelessly linked to a smartphone running an algorithm that was capable of monitoring glucose levels and controlling insulin  delivery.

Two  study participants with T1D wore the closed-loop system outside of a hospital for 18 hours.  They ate dinner, stayed overnight in a hotel, had breakfast, and took a short walk  around town. One subject stayed within the target glucose range  (70-250 mg/dl) for the entire study period. The other subject remained within range 78 percent of the time.  The subjects were  remotely monitored by the study investigators, and neither required medical assistance.

This groundbreaking study demonstrates the safety and feasibility of testing artificial pancreas systems in real-world settings outside the confines of a clinic  or laboratory. Further, it sets the stage  for larger clinical trials  in the United States and Europe, a necessary step on the path to regulatory approval.

The second study, directed by Henry Anhalt, D.O., chief  medical officer of Animas Corporation, evaluated the HHM system for the first time in human subjects with T1D. Thirteen study participants wore the system in a clinical research center for about 24 hours  each. The system was able to predict when  blood-glucose levels would rise above or fall below a predetermined target range  and then respond by increasing, decreasing, stopping, or resuming insulin  delivery to maintain glucose control. No significant adverse events, such as diabetic ketoacidosis or severe hypoglycemia, occurred in any of the subjects.

This successful pilot trial  of the HHM system marks  a crucial step toward the realization of an advanced first- generation artificial pancreas system. The results of this trial  will  guide ongoing development and refinement of the software algorithm.

Artificial pancreas systems will reduce the daily  burden of diabetes management for people with T1D. Breakthrough T1D is supporting additional outpatient studies in the United States with the intent to move toward larger efficacy trials  of artificial pancreas systems in the near future.

Aaron Kowalski, Ph.D., Breakthrough T1D assistant vice president of treatment therapies, is encouraged by the outcomes of these pilot studies. “Researchers have achieved an important milestone with the study showing that the artificial pancreas is safe and feasible in a real-world environment,” he states. “Moreover, an artificial pancreas system that can detect and predict high  and low blood-glucose levels and automatically adjust insulin  delivery would be a major advance.”

Key point: A first-of-its-kind clinical pilot study has demonstrated the safety and feasibility of an artificial pancreas system in an outpatient, “real-world” setting. A second clinical
study has shown that  a hypoglycemia- hyperglycemia minimizer system can predict when  blood-glucose levels are about to rise or fall and make appropriate adjustments in insulin delivery. These Breakthrough T1D-supported studies represent critical steps on the path  to a functional artificial pancreas for the benefit of people living with T1D.