Event Details
Agenda
Event Details
Meeting Objectives
Current evidence demonstrates that when glycemic control is not optimized, diabetes imposes additional burdensome care requirements, health care costs, and high risk of disabling complications. It is expected that close to physiological glucose-metabolic control provided by an artificial pancreas will reduce the incidence of acute and chronic complications and significantly improve the quality of life of the individuals affected. As a consequence, further morbidity and mortality also may be prevented. The purpose of this workshop is to have a multidisciplinary discussion of advances and prospective areas of research that would accelerate the development and delivery of a wearable, automated artificial pancreas for individuals with diabetes. It will be focused on the following topics:
- State of the art: designs, results and challenges from the latest closed loop studies;
- Learning algorithms with more inputs and fault detection;
- Improved sensors;
- New hormones and delivery for improved kinetics;
- Innovative approaches in closing the loop;
- Elements for a new generation of devices/technologies.
Organizing Committee
FDA Arleen Pinkos, M.T.
JDRF Marlon Pragnell, Ph.D.
NIH Guillermo Arreaza, M.D.
Meeting Chairs
Rich Bergenstal, M.D., Park Nicollet Health Services
Claudio Cobelli, Ph.D., Padova University, Italy
Barry Ginsberg, M.D., Ph.D., Diabetes Technology Consultants
David Klonoff, M.D., Mills Peninsula Health Services
Robert Vigersky, M.D., Walter Reed National Military Medical Center
Kenneth Ward, M.D., Legacy Research Institute
Mike Weiss, M.D., Case Western Reserve University and Thermalin, Inc.
Natalie Wisniewski, Ph.D., Medical Device Consultancy
Todd Zion, Ph.D., Akston Biosciences Corporation
Howard Zisser, M.D., Sansum Diabetes Research Institute
Agenda
April 9, 2013
Welcome and Introductory Remarks
- 8:00 a.m.
- Griffin Rodgers, M.D., Director, National Institute of Diabetes, Digestive, and Kidney Diseases (NIDDK), National Institutes of Health (NIH)
- 8:05 a.m.
- Alberto Gutierrez, Ph.D., Director, Office of In Vitro Diagnostic Device Evaluation and Safety, U.S. Food and Drug Administration (FDA)
- 8:10 a.m.
- Aaron Kowalski, Ph.D., Vice President, Treat Therapies, JDRF
State of the Art: Designs, Results, and Challenges From the Latest Clinical Studies
Chairs: Robert Vigersky, M.D., Walter Reed National Military Medical Center Rich Bergenstal, M.D., Park Nicollet Health Services
- 8:15 a.m.
- Introduction and Overview of Session
- 8:20 a.m.
- Predictive Pump Shut-off Approaches
Bruce Buckingham, M.D., Stanford University
- 8:40 a.m.
- The Diabetes Assistant Mobile Artificial Pancreas Platform
Boris Kovatchev, Ph.D., University of Virginia
- 9:00 a.m.
- Time to Go Home
Roman Hovorka, Ph.D., University of Cambridge, United Kingdom
- 9:20 a.m.
- Preliminary Results of a Bihormonal Bionic Pancreas in an Outpatient Setting: The Beacon Hill Study
Edward Damiano Ph.D., Boston University
- 9:40 a.m.
- AP@home: Lessons Learned From Clinical Studies on the Way to Daily Life Usage
Lutz Heinemann, Ph.D., Profil Institut für Stoffwechselforschung, Germany
- 10:00 a.m.
- Coffee Break and Posters
- 10:30 a.m.
- The DREAM Way to Control Overnight Glucose Using the MD-Logic Artificial Pancreas System
Moshe Phillip, M.D., Schneider Children's Medical Center of Israel
- 10:50 a.m.
- Multivariable Adaptive Closed-loop Control of an Artificial Pancreas Without Meal and Activity Announcement
Ali Cinar, Ph.D., Illinois Institute of Technology
- 11:10 a.m.
- Human Factors That May Influence Clinical Efficacy of Closed-loop Technologies
Linda Gonder-Frederick, Ph.D., University of Virginia Health System
- 11:30 a.m.
- FDA Challenges and the Artificial Pancreas
Arleen Pinkos, FDA
- 11:40 a.m.
- Roundtable Discussion
- 12:30 p.m.
- Lunch and Posters
New Developments in Modeling, Algorithms, and Technology
Chairs: David Klonoff, M.D., Mills Peninsula Health Services, Claudio Cobelli, Ph.D., Padova University, Italy
- 1:20 p.m.
- Introduction/Overview of Session
- 1:25 p.m.
- The Type 1 Diabetic Simulator: New Developments for the Artificial Pancreas
Claudio Cobelli, Ph.D., Padova University, Italy
- 1:40 p.m.
- Personalized Model-based Algorithms for Controlling the Artificial Pancreas
Frank Doyle, Ph.D., University of California, Santa Barbara
- 1:55 p.m.
- Carbohydrate Physiology, Accelerometry Input, and Meal Detection to Personalize a Closed-loop Control System
Ananda Basu, M.D., and Yogish Kudva, M.D., Mayo Clinic
- 2:15 p.m.
- Algorithms to Detect Glucose Sensor and Infusion Pump Anomalies
Wayne Bequette, Ph.D., Rensselaer Polytechnic Institute
- 2:30 p.m.
- Operating System and Remote Monitoring of the Diabetes Assistant Mobile Artificial Pancreas
Patrick Keith-Hynes, Ph.D., University of Virginia Center for Diabetes Technology
- 2:45 p.m.
- m-Health
David Klonoff, M.D., Mills Peninsula Health Services
- 3:00 p.m.
- Roundtable Discussion
- 3:45 p.m.
- Coffee Break and Posters
Improving Insulin and Non-insulin Hormone Replacement
Chairs: Howard Zisser, M.D., Sansum Diabetes Research Institute, Mike Weiss, M.D., Case Western Reserve University and Thermalin, Inc.
- 4:00 p.m.
- Introductions and Overview of Topic
- 4:05 p.m.
- Developing Ultra-rapid Insulin Analogs for Closed-loop Applications
Michael Weiss, M.D., Case Western Reserve University and Thermalin, Inc.
- 4:20 p.m.
- Ultra-rapid Insulin Use in Closed-loop Artificial Pancreas: Preliminary Clinical Results
Howard Zisser, M.D., Sansum Diabetes Research Institute
- 4:35 p.m.
- Microneedle Intradermal Delivery Enables Rapid Insulin Uptake and Effect
Ron Pettis, Ph.D., BD Technologies
- 4:50 p.m.
- Next Generation Insulin Delivery CSII Catheters: Optimized Insulin Delivery Using a Continuous Subcutaneous Insulin Infusion (CSII) Catheter
Jeffrey Joseph, D.O., Thomas Jefferson University Hospital
- 5:05 p.m.
- Site Delivery Warming to Improve Rapid Acting Insulin Pharmacokinetics and Pharmacodynamics
Eda Cengiz, M.D., Yale University
- 5:20 p.m.
- Novel Glucagon Formulations
Steve Prestrelski, Ph.D., Xeris Pharmaceutics
- 5:35 p.m.
- Use of Adjunctive Pramlintide to Improve Mealtime Glycemic Excursions During Closed-loop Glucose Control
Stuart Weinzimer, M.D., Yale University
- 5:50 p.m.
- Roundtable Discussion
- 6:30 p.m.
- Adjourn, First day—Posters
April 10, 2013
Future Devices and Other Innovative Approaches to Optimize a Closed-loop System
Chairs: Kenneth Ward, M.D., Legacy Research Institute, Barry Ginsberg, M.D., Ph.D., Diabetes Technology Consultants
- 8:00 a.m.
- Introductions and Overview of Topic
- 8:05 a.m.
- Medtronic's Current and Next Generation Sensing and Delivery Devices
Rajiv Shah, Ph.D., Medtronic
- 8:20 a.m.
- Current and Future Dexcom CGM Systems for Artificial Pancreas Applications
Tom Peyser, Ph.D., Dexcom
- 8:35 a.m.
- BD's Novel Sensors and Insulin Delivery
Kerstin Rebrin, M.D., Ph.D., BD Medical
- 8:50 a.m.
- Pathway to Commercializing Closed-loop Systems
John Mastrototaro, Ph.D., Medtronic
- 9:05 a.m.
- Intelligent Catheters That Combine Hormone Delivery With Amperometric Glucose Sensing
Kenneth Ward, M.D., Legacy Research Institute
- 9:20 a.m.
- Coffee Break and Posters
- 9:45 a.m.
- Afferent Limb Solution: Real-time Blood Glucose via a Noninvasive Sensor
Robert Peura, Ph.D., Grove Instruments
- 10:00 a.m.
- Miniaturized Implantable Sensors
Fotios Papadimitrakopoulos, Ph.D., University of Connecticut
- 10:15 a.m.
- Long-term, Fully Implanted, Self-contained Subcutaneous Glucose Sensor: Results from Clinical Evaluation and Applicability for Closed-loop Systems
Joe Lucisano, Ph.D., GlySens, Inc.
- 10:30 a.m.
- Non-glucose Oxidase-based Sensing Technologies
Natalie Wisniewski, Ph.D., Medical Device Consultancy
- 10:45 a.m.
- Feasibility of the Peritoneal Cavity as a Site for Glucose Sensing
Dan Burnett, M.D., Theranova, LLC
- 11:00 a.m.
- Contribution of Insulin Sensing to Optimize a CLS
Tania Konry, Ph.D., Massachusetts General Hospital/Harvard Medical School
- 11:15 a.m.
- Modeling the Relative Impacts of Protein Biofouling and Cellular Metabolic Effects on Glucose Sensor Performance
William M. Reichert, Ph.D., Duke University
- 11:35 a.m.
- Roundtable Discussion
- 12:50 p.m.
- Lunch and Posters
Elements for a New Generation of Devices/Technologies
Moderators: Todd Zion, Ph.D., Akston Biosciences Corporation, Natalie Wisniewski, Ph.D., Medical Device Consultancy
- 1:30 p.m.
- Introduction and Overview of Topic
- 1:35 p.m.
- Closed-loop Insulin Delivery in Diabetic Pigs Using a Smart Biomaterial Device
Margaret Joan Taylor, Ph.D., De Montfort University, United Kingdom
- 1:50 p.m.
- Engineering a Cell-based Glucose Monitor
Eric Schreiter, Ph.D., Janelia Farm Research Campus, Howard Hughes Medical Institute
- 2:05 p.m.
- Microchip-based Sensing and Delivery
Robert Farra, M.S., MicroCHIPS, Inc.
- 2:20 p.m.
- Advancement of the Artificial Pancreas Through the Development of Data and Communication Standards
Joseph Cafazzo, Ph.D., Toronto General Hospital and the University of Toronto
- 2:35 p.m.
- Bioartificial Pancreas: Challenges and Opportunities
Cheryl Stabler, Ph.D., University of Miami
- 2:50 p.m.
- Hybrid Flexible Electronics
Eric Forsythe, U.S. Army Research Laboratory (Invited)
- 3:05 p.m.
- Break
- 3:15 p.m.
- Roundtable Discussion: Perspectives for the Future
- 4:15 p.m.
- Adjournment
