Modular Design Facilities Artificial Pancreas Software Development and Testing

Drs. Marc Breton and Boris Kovatchevs team at the University of Virginia are employing a novel approach to design, test and implement progressive improvements of artificial pancreas software based on a modular architecture concept. This approach would allow the various components, such as a software module focused on avoiding hypoglycemia or one that keeps glucose within a target range, to be seamlessly integrated in systems that can be implemented and tested in a stepwise fashion in clinical studies. The advantages of this module-based approach were demonstrated in two inpatient clinical trials. Each trial used software packages in which different modules were used: a standard control to range software module (sCTR) and a more sophisticated enhanced control to range (eCTR) software module. Both inpatient trials compared sCTR and eCTR vs. standard pump therapy and included meals, overnight rest and 30 minutes of exercise. The studies were conducted in 11 adolescents and 27 adults with T1D at the Universities of Virginia, Padova and Montpellier. sCTR was found to significantly increase the time spent in the normal blood glucose range while reducing hypoglycemia. eCTR was found to further improve mean blood glucose from 139 to 120 mg/dl without increasing hypoglycemia and reduced variability overnight. In addition to demonstrating improved glucose control and reduced hypoglycemia with both sCTR and eCTR these studies highlighted the efficient use of modules in the design, testing and implementation of artificial pancreas algorithms.

Reference:

Fully Integrated Artificial Pancreas in Type 1 Diabetes: Modular Closed-Loop Glucose Control Maintains Near Normoglycemia, Diabetes. 2012 Sep;61(9):2230-7. Epub 2012 Jun 11.

Investigators and Institutions:

Marc Breton1, Anne Farret2, Daniela Bruttomesso3, Stacey Anderson1, Lalo Magni4, Stephen Patek1, Chiara Dalla Man, Jerome Place2, Susan Demartini1, Simone Del Favero4, Chiara Toffanin4, Colleen Hughes-Karvetski1, Eyal Dassau6,7, Howard Zisser6,7, Francis J. Doyle III6 , Giuseppe De Nicolao4, Angelo Avogaro3, Claudio Cobelli5, Eric Renard2 and Boris Kovatchev1, on behalf of the International Artificial Pancreas (iAP) Study Group. 1University of Virginia, Charlottesville Virginia; University Hospital of Montpellier, University of Montpellier, Montpellier France; 3University of Padova, Padua Italy, 4University of Pavia, Pavia, Italy, 6University of California Santa Barbara, Santa Barbara, 7Sansum Diabetes Diabetes Research Institute, Santa Barbara California

Ramifications for Individuals with Type 1 Diabetes:

The modular approach described by Drs. Marc Breton and Boris Kovatchev has accelerated the development and testing of control-to-range artificial pancreas software by facilitating the stepwise development and testing of discrete software modules. Control-to-range systems are now being tested in outpatient pilot studies and a larger pivotal trial to assess efficacy is in the planning stages for 2013. Most importantly, these systems can be developed with todays available technologies, and set the stage for the development of future generation AP systems and advanced devices.

JDRF Involvement:

JDRF funded this research through a grant to Dr. Boris Kovatchev at the University of Virginia. Dr. Kovatchev is a member of the JDRF Artificial Pancreas Consortium.