U.S. Department of Health and Human Services
Web Banner

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

7/6/2016 8:00 AM
7/7/2016 5:00 PM
Yes
No
​​Program Content

Guillermo Arreaza-Rubín, M.D.
Director, Diabetes Technology Program
DEMD, NIDDK, NIH
Phone: (301) 594-4724
Email: arreaza-rubing@niddk.nih.gov

Meeting Logistics

John Hare, M.S., CMP, CGMP
The Scientific Consulting Group, Inc.
Phone: (301) 670-4990
Email: jhare@scgcorp.com

Bethesda
 
Lister Hill Auditorium

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

Directions/Travel

Hotel Accommodations

Bethesda Marriott Hotel
5151 Pooks Hill Road
Bethesda, MD  20814
Phone: (301) 897-9400 or (800) 228-9290
Fax: (301) 897-0192

Website:  www.bethesdamarriott.com
(More hotel information can be obtained from this website.)

Government Room Rate

Travel arrangements are your own responsibility; three airports serve the Washington, DC, metropolitan area. A limited block of sleeping rooms for meeting participants has been reserved at the Bethesda Marriott Hotel. The rate is the prevailing government rate of $159 per night for single occupancy, plus tax (13%). To reserve a hotel room at the group rate, call reservations at (800) 228-9290 or (301) 897-9400 and identify yourself as a member of the NIDDK Artificial Pancreas group or online at aws.passkey.com/event/14988621/owner/3322307/home. The room block will be in effect at the Government rate only until Tuesday, June 7, 2016, or until full, whichever comes first. Any room reservations received after this date will be accepted on a space and rate-availability basis.

Reservation Dates

Book arrival on Tuesday, July 5, 2016, and departure on Thursday, July 7.

Check-in

Please be certain that the hotel provides you with a confirmation number for your reservation. After June7, 2016, the official room block will be released, and the hotel may charge significantly higher rates and may be sold out. When making a reservation, please provide your room and bedding preferences. The hotel will assign specific room types at check-in, based on availability. Please be advised that requests are not guaranteed. Check-in time is 4:00 p.m., and checkout time is 12:00 p.m.

Cancellations

If you need to cancel your reservation, please do so by 4:00 p.m. on the day prior to arrival, or you will be charged a no-show fee for 1 night on your credit card. If you plan to cancel your attendance, please alert the hotel, as well as John Hare (The Scientific Consulting Group, Inc.) at jhare@scgcorp.com.

NIH Visitor Information 

Information on visiting the NIH, campus maps, shuttle schedules, driving directions, security, and more can be found on the NIH Visitor Information page.​​

Minutes

Minutes are currently unavailable.

Attendees

Attendees are currently unavailable.

Abstracts

Abstracts are currently unavailable.

Location

Line
  • Building 38A
  • NIH Campus
  • MD 20894
Webinar

Contacts

Line ​​Program Content

Guillermo Arreaza-Rubín, M.D.
Director, Diabetes Technology Program
DEMD, NIDDK, NIH
Phone: (301) 594-4724
Email: arreaza-rubing@niddk.nih.gov

Meeting Logistics

John Hare, M.S., CMP, CGMP
The Scientific Consulting Group, Inc.
Phone: (301) 670-4990
Email: jhare@scgcorp.com