Fourth Artificial Pancreas Workshop: Testing and Adoption of Current and Emerging Technologies

Event Details

Event Details

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 automated glucose responsive hormone delivery system (artificial pancreas) will reduce the incidence of acute and chronic complications and significantly improve the quality of life of affected individuals and caretakers. As a consequence, further morbidity and mortality may also be prevented.

Meeting Objectives

The purpose of this workshop is to discuss in a multi-disciplinary forum the actual and potential future challenges for the testing of current and emerging systems and their components, including integration strategies, clinical testing modalities, psychosocial and usability factors, regulatory and reimbursement considerations, and prospective areas of research to accelerate the availability of a wearable, affordable, and user-friendly artificial pancreas (AP) for individuals with diabetes. Some of the topics to be discussed are:

• Testing of automated glucose control systems (AGCS): lessons and challenges
• Personalization of AP platforms
• Psychosocial drivers and barriers
• Interoperability of platforms/components: What is needed for plug-and-play capability?
• Data management and cybersecurity
• Emerging technologies to improve sensing and hormone delivery
• Strategies to facilitate the development of a viable commercial platform

This workshop has been organized in coordination with the Diabetes Mellitus Interagency Coordinating Committee (DMICC)

Organizing Committee

Guillermo Arreaza-Rubín, M.D.
Director, Diabetes Technology Program
Division of Diabetes, Endocrinology, and Metabolic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
National Institutes of Health

Stayce Beck, Ph.D., M.P.H.
Chief, Diabetes Diagnostic Devices Branch
Office of In Vitro Diagnostic Devices and Radiological Health
Center for Devices and Radiological Health
U.S. Food and Drug Administration

Andrew Bremer, M.D., Ph.D.
Program Director
Division of Diabetes, Endocrinology, and Metabolic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
National Institutes of Health

Vincent Crabtree, Ph.D.
Director, Research Business and New Technology Development
JDRF

Campbell Hutton
Senior Director, Regulatory Affairs
JDRF

David C. Klonoff, M.D.
Medical Director, Diabetes Research Institute
Mills-Peninsula Health Services

Aaron Kowalski, Ph.D.
Chief Mission Officer and Vice President, Research
JDRF

Courtney Lias, Ph.D.
Director, Division of Chemistry and Toxicology Devices
Office of In Vitro Diagnostic Devices and Radiological Health
Center for Devices and Radiological Health
U.S. Food and Drug Administration

David Panzirer
Trustee
The Leona M. and Harry B. Helmsley Charitable Trust

Sean Sullivan, Ph.D.
Senior Program Officer, Type 1 Diabetes
The Leona M. and Harry B. Helmsley Charitable Trust

Yiduo Wu, Ph.D.
Artificial Pancreas Team Lead
Office of In Vitro Diagnostic Devices and Radiological Health
Center for Devices and Radiological Health
U.S. Food and Drug Administration

Registration Deadline

July 5, 2016

Agenda

July 6, 2016

8:15 a.m. – 8:30 a.m.

Welcome and Introductory Remarks

Griffin P. Rodgers, M.D., Director, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH)

Alberto Gutierrez, Ph.D., Director, Office of In Vitro Diagnostic Device Evaluation and Safety, U.S. Food and Drug Administration (FDA)

Aaron Kowalski, Ph.D., Chief Mission Officer and Vice President, Research, JDRF

8:30 a.m. – 9:40 a.m.

Testing of Automated Glucose Control Systems (AGCS). Real-world Experience, Challenges, Lessons, and Opportunities
Chairs: Rebecca Gottlieb, Ph.D., Medtronic Diabetes, and Boris Kovatchev, Ph.D., University of Virginia

Testing of a Hybrid System and Transition to a Fully Automated System

• Academic Perspective: Boris Kovatchev, Ph.D., University of Virginia
• Industry Perspective: Rebecca Gottlieb, Ph.D., Medtronic Diabetes

Single-hormone Systems
Roman Hovorka, Ph.D., University of Cambridge, United Kingdom (UK)

Dual/Multi-hormone Systems
Steven Russell, M.D., Massachusetts General Hospital, Harvard Medical School

9:40 a.m. – 10:30 a.m.

Panel Discussion

10:30 a.m. – 11:00 a.m.

Break and Posters

11:00 a.m.– 12:00 p.m.

Psychosocial Drivers and Barriers. Real-world Experience
Chairs: Katharine Barnard, Ph.D., BHR Limited, and Linda Gonder-Frederick, Ph.D., University of Virginia Health System

Why Psychosocial Issues Are Crucial. Use of New Measures
Katharine Barnard, Ph.D., BHR Limited

Potential Psychological Impact of a Long-term Artificial Pancreas (AP) System
Linda Gonder-Frederick, Ph.D., University of Virginia Health System

Impact on Quality of Life. Need for Standard Measurements for Patients and Caretakers
Lori Laffel, M.D., Joslin Diabetes Center, Harvard Medical School

12:00 p.m. – 12:50 p.m.

Panel Discussion

12:50 p.m. – 2:00 p.m.

Lunch and Posters

2:00 p.m. – 3:20 p.m.

Personalization of AP Platforms and Adaptation to Specific Subpopulations
Chairs: Eyal Dassau, Ph.D., Harvard School of Engineering, and Claudio Cobelli, Ph.D., University of Padova, Italy

Towards an Adaptive Artificial Pancreas: from In Silico to Outpatient Free-Living
Claudio Cobelli, Ph.D., University of Padova, Italy

Physiological Inputs beyond Glucose. Relevance for Novel Simulation Systems and More Personalized Systems
Marc Breton, Ph.D., University of Virginia

Real-world Testing in Children and Adolescents
Bruce Buckingham, M.D., Stanford University

Real-world Testing during Pregnancy
Helen Murphy, Ph.D., University of East Anglia, UK

Real-world Testing in Older Adults
Rich Bergenstal, M.D., Park Nicollet Health Services

3:20 p.m. – 4:00 p.m.

Panel Discussion

4:00 p.m. – 5:00 p.m.

Posters

5:00 p.m.

Adjournment

July 7, 2016

7:55 a.m. – 8:00 a.m.

Summary of the First Day, Introduction to the Second Day
David Klonoff, M.D., Mills Peninsula Health Services, Journal of Diabetes Science and Technology (DST)

8:00 a.m. – 9:30 a.m.

Regulatory Considerations for Component AP Systems
Chairs: Courtney Lias, Ph.D., FDA, and Stayce Beck, Ph.D., FDA

Overview and Vision
Courtney Lias, Ph.D., FDA, and Stayce Beck, Ph.D., FDA

Challenges and Opportunities for Rapid Innovation of an Interoperable AP Ecosystem
Howard Look, Tidepool Project

Current Tools to Address These Challenges and Gaps
Melanie Yeung, M.H.S., Centre for Global eHealth Innovation, University of Toronto

9:30 a.m. – 10:00 a.m.

Panel Discussion

10:00 a.m. – 10:20 a.m.

Break and Posters

10:20 a.m. – 11:20 a.m.

Interoperability, Data Management, and Cybersecurity
Chairs: Melanie Yeung, M.H.S., University of Toronto, and David Klonoff, M.D., Mills Peninsula Health Services, DST

Industrial Automation Interoperability Experiences—A Learning Opportunity for AP?
Lane Desborough, Ph.D., BigFoot

Closed-loop Data Management and Big Data Resources
Pratik Agrawal, Medtronic Diabetes

Mobile Systems and Remote Monitoring
Patrick Keith-Hynes, Ph.D., University of Virginia, TypeZero

Cybersecurity Considerations for an Integrated System
David Klonoff, M.D., Mills Peninsula Health Services, DST

11:20 a.m. – 11:50 a.m.

Discussion

11:50 a.m. – 12:50 p.m.

Lunch and Posters

12:50 p.m. – 2:10 p.m.

Emerging Technologies to Improve Sensing and Hormone Delivery Integration to Automated Glucose Control Systems (AGCS)
Chairs: Tom Peyser, Ph.D., Mode AGC, Insulet, and Natalie Wisniewski, Ph.D., Profusa, Inc.

Emerging Sensing Technologies. What Is Needed for a High-performance Miniaturized AGCS?
Kenneth Ward, M.D., Pacific Diabetes Technologies

Recent Advances in Hormone Delivery Technologies. What Is Needed for a High-performance Miniaturized AGCS?
Eyal Dassau, Ph.D., John A. Paulson School of Engineering and Applied Sciences, Harvard University

Progress on Novel Insulin Formulations and Delivery
Bruce Frank, Ph.D., Thermalin, Inc.

Progress on Novel Glucagon Formulations and Delivery
Steve Prestrelski, Ph.D., Xeris Pharmaceuticals

2:10 p.m. – 2:40 p.m.

Panel Discussion

2:40 p.m. – 3:10 p.m.

Break and Posters

3:10 p.m. – 5:00 p.m.

What Is Needed to Facilitate the Development of a Viable Commercial Platform and to Deliver Artificial Pancreas Systems to People with Type 1 Diabetes (T1D) in the Near, Medium, and Long Term?
Chairs: Aaron Kowalski, Ph.D., JDRF, and John Pickup, M.D., King’s College London, UK

Open Panel with regulatory agencies, payers, patients, advocate organizations, funding agencies, and researchers.

1. Patient advocates and representatives
   Adam Brown, Alecia Wesner
2. Industry representatives
   Animas (Nicholas Benetatos), Bigfoot (Lane Desborough), Senseonics (Lynne Kelley), DoseSafety (Richard Mauseth), DreaMed (Moshe Phillip), Insulet/Mode AGC (Jennifer Schneider), Medtronic (Robert Vigersky)
3. Regulatory agencies
   Stayce Beck, Alberto Gutierrez, Courtney Lias, Yiduo Wu
4. Payers’ representatives
   Amanda Bartelme, Dominic Galante
5. T1D-Exchange
   Henry Anhalt
6. Funding agencies/associations
   American Diabetes Association (Jane Chiang), DST (David Klonoff), Helmsley (Sean Sullivan), JDRF (Vincent Crabtree, Marjana Marinac), NIH (Guillermo Arreaza-Rubín, Andrew Bremer, Judith Fradkin)
7. Jaeb Center
   Roy Beck, John Lum, Judy Sibayan
   
8. Investigators
   All present

5:00 p.m.

Adjournment