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14th Annual Diabetes Technology Meeting
Bethesda, Maryland, November 6–8, 2014
Thursday, November 6, 2014
PRE-MEETING WORKSHOPS
Workshop A: Reimbursement for Diabetes Technology
Panel 1: Clinical & Industry Perspective
08:00 Moderator
James Scott, JD
Applied Policy, Alexandria, Virginia
08:05 Guideline Driven Care
Robert Vigersky, MD, Colonel, Medical Corps
Walter Reed National Military Medical Center, Bethesda, Maryland
08:20 Economics of Continuous Glucose Monitoring
Claudia Graham, PhD, MBA, MPH
Dexcom, San Diego, California
08:35 Issues in Accurately Estimating the Cost of New Technologies: The Case of
Continuous Glucose Monitors
Michael O'Grady, PhD
NORC/University of Chicago | O'Grady Health Policy LLC,
Chevy Chase, Maryland
08:50 Trends in Reimbursement
Paul Radensky, MD, JD
McDermott Will & Emery LLP, Washington, DC
09:05 Q & A
09:30 Break
Panel 2: Payer Perspective
09:55 Moderator
John Ryan, MBA
ONSET Ventures, Menlo Park, California
10:00 Medicare Reimbursement for Diabetes Technologies: Is Competitive Bidding
Sustainable?
James Scott, JD
Applied Policy, Alexandria, Virginia
10:15 Payer Perspectives on Reimbursement for Diabetes Technology
Daniel Crowe, MD, CDE
Superior HealthPlan | Centene, Austin, Texas
10:30 Diabetes Benefits
Albert Tzeel, MD, MHSA, FACPE
Humana – North Florida, Jacksonville, Florida
10:45 Diabetes Technology from an Industry Perspective: How to Create Value in a
Constrained Reimbursement Environment
Peter Ehrhardt
Simon-Kucher & Partners LLC, Cambridge, Massachusetts
11:00 Q & A
11:25 End of workshop/Boxed lunch provided
Workshop B: Technology for Detection and Prevention of Hypoglycemia
Panel 1: Clinical Diagnosis/ Analytical Diagnosis
08:00 Moderators
Bruce Buckingham, MD
Stanford University, Stanford, California
Darrell Wilson, MD
Stanford University, Stanford, California
08:05 Nocturnal Hypoglycemia: Common and Dangerous
Anthony McCall, MD, PhD
University of Virginia, Charlottesville, Virginia
08:20 Performance of Blood Glucose Monitors at the Low-End
Guido Freckmann, MD
Institute for Diabetes Technology, Ulm, Germany
08:35 Performance of Continuous Glucose Monitoring Devices at the Low-End
Yogish Kudva, MD
Mayo Clinic, Rochester, Minnesota
08:50 Diagnosing Hypoglycemia in Neonates
Matthew Signal, PhD
University of Canterbury, Christchurch, New Zealand
09:05 Q & A
09:30 Break
Panel 2: Prevention/ Treatment
09:55 Moderators
Guillermo Arreaza-Rubin, MD
National Institute of Diabetes, Digestive and Kidney Diseases | NIH, Bethesda,
Maryland
Asimina Mitrakou, MD
University of Athens Medical School, Athens, Greece
10:00 Hypo- and Hyperglycemia Alarms: Devices and Algorithms
B. Wayne Bequette, PhD
Rensselaer Polytechnic Institute, Troy, New York
10:15 The Use of Technology to Prevent Hypoglycemia
Pratik Choudhary, MD, MbbD, MRCP
King's College London, London, United Kingdom
10:30 Social Media Surveillance for Hypoglycemia Risk
Elissa Weitzman, ScD, MSc
Boston Children’s Hospital | Harvard Medical School,
Boston, Massachusetts
10:45 A Review of New Glucagon Therapies
W. Kenneth Ward, MD
Oregon Health and Science University | Pacific Diabetes Technologies,
Portland, Oregon
11:00 Q & A
11:25 End of workshop/Boxed lunch provided
Workshop C: Regulatory Science; New Performance Guidances & the New
Surveillance Error Grid
Panel 1: New FDA Glucose Guidelines
12:25 Moderator
Robert Vigersky, MD, Colonel, Medical Corps
Walter Reed National Military Medical Center, Bethesda, Maryland
12:30 On-Label, Off-Label, and Clinical Laboratories Improvement Amendments
William Clarke, PhD, MBA, DABCC
John Hopkins School of Medicine, Baltimore, Maryland
12:45 FDA Elevation of Blood Glucose Meters: 2014 Draft Guidance Documents
Katherine Serrano
U.S. Food and Drug Administration, Silver Spring, Maryland
13:00 How Accurate Do We Need Blood Glucose Monitors to Be in the Hospital?
Marie McDonnell, MD
Boston University, Boston, Massachusetts
13:15 How Accurate Do We Need Blood Glucose Monitors to Be in the Outpatient
Setting?
Marc Breton, PhD
University of Virginia, Charlottesville, Virginia
13:30 Q & A
13:55 Break
Panel 2: The New Surveillance Error Grid
14:20 Moderator
Patricia Beaston, MD, PhD
U.S. Food and Drug Administration, Silver Spring, Maryland
14:25 Introduction to the Surveillance Error Grid
David Klonoff, MD, FACP, FRCP (Edin), Fellow AIMBE
Mills-Peninsula Health Services, San Mateo, California
University of California, San Francisco, San Francisco, California
14:40 FDA Perspective on the Surveillance Error Grid
Courtney Lias, PhD
U.S. Food and Drug Administration, Silver Spring, Maryland
14:55 Analyzing Performance Data Using the Surveillance Error Grid
Boris Kovatchev, PhD
University of Virginia, Charlottesville, Virginia
15:10 An Industry Perspective
David Simmons, MD
Bayer Diabetes Care, Whippany, New Jersey
15:25 Q & A: Panelists and Christian Wakeman
15:50 End of workshop
16:00–18:30 Poster session and inauguration of the 2014 Diabetes Technology Meeting
18:30–20:00 Posters remain on display for viewing
Workshop D: Improving Adherence to Diabetes Technology Devices
Panel 1: Increasing Motivation to Use Technology
12:25 Moderator
Judith Fradkin, MD
National Institutes of Health, Bethesda, Maryland
12:30 Improving Adherence to Self Monitoring of Blood Glucose and Continuous Glucose
Monitoring
Susana Patton, PhD, CDE
University of Kansas, Kansas City, Kansas
12:45 Strategies to Increase Adherence to Technology
Bruce Buckingham, MD
Stanford University, Stanford, California
13:00 Improving Health Literacy
David Kerr, MD
Sansum Clinic, Santa Barbara, California
13:15 Techniques for Children to Improve Adherence to Diabetes Therapy
Alan Delamater, PhD
University of Miami, Miami, Florida
13:30 Q & A
13:55 Break
Panel 2: Improving Human Factors to Increase Adherence
14:20 Moderator
David Kerr, MD
Sansum Clinic, Santa Barbara, California
14:25 Better Lancing Technology
Lutz Heinemann, PhD
Science & Co., Düsseldorf, Germany
14:40 Digital Medicines
Naunihal Virdi, MD, MBA, FACP
Proteus Digital Health, Inc., Redwood City, California
14:55 Human Factors Review Priority for Insulin Delivery Devices
QuynhNhu Nguyen, MS
U.S. Food and Drug Administration, Silver Spring, Maryland
15:10 Hardware to Improve Adherence
William Fisher, PhD
Western University, London, Canada
15:25 Q & A
15:50 End of workshop
16:00–18:30 Poster session and inauguration of the 2014 Diabetes Technology Meeting
18:30–20:00 Posters remain on display for viewing
Friday, November 7, 2014
07:00 Continental Breakfast
Session 1: Welcome & Keynote Presentation
08:00 Welcome/Opening Remarks
David Klonoff, MD, FACP, FRCP (Edin), Fellow AIMBE
Mills-Peninsula Health Services, San Mateo, California
University of California, San Francisco, San Francisco, California
08:05 Keynote Speaker
Toward a More Physiologic Insulin Therapy
Alfred Mann, MS
MannKind Corporation, Valencia, California
Session 2: Wearable Devices for Diabetes
08:25 Moderators
Karl Friedl, PhD
Physiology Associates LLC, Frederick, Maryland
Dorian Liepmann, PhD
University of California Berkeley, Berkeley, California
08:30 Wearable Devices and Network Platforms for Artificial Pancreas and Advanced
Glucose Management
Patrick Keith-Hynes, PhD
University of Virginia, Charlottesville, Virginia
08:45 Google Glass for Diabetic Foot Surgery
Nicholas Giovinco, DPM
University of Arizona College of Medicine, Tucson, Arizona
09:00 Wearable Devices to Assess Exercise and Diet
Kong Chen, PhD, MSCI
National Institutes of Health, Bethesda, Maryland
09:15 Q & A
09:40 End of session/Break
Session 3: Big Data for Diabetes Management
10:05 Moderators
Roy Vigneulle, PhD
U.S. Army, Frederick, Maryland
Elissa Weitzman, ScD, MSc
Boston Children’s Hospital | Harvard Medical School,
Boston, Massachusetts
10:10 Diabetes Technology Society Leadership Award
10:15 Big Data Technologies and Diabetes Management: A Challenging Opportunity
Riccardo Bellazzi, PhD
University of Pavia, Pavia, Italy
10:30 We No Longer Live in the 1990’s: Social Media is Diabetes Technology
Joyce Lee, MD, MPH
University of Michigan, Ann Arbor, Michigan
10:45 Bringing Together Data from Disparate Sources for Diabetes
James Maisel, MD
Zydoc, Hicksville, New York
11:00 Q & A
11:25 End of session/Lunch
Session 4: Performance of Cleared Blood Glucose Monitors - What is Needed?
12:25 Moderator
David Klonoff, MD, FACP, FRCP (Edin), Fellow AIMBE
Mills-Peninsula Health Services, San Mateo, California
University of California, San Francisco, San Francisco, California
12:30 Panel Discussion
Alan T. Cariski, MD, JD, FACP, FACE
LifeScan, Inc., Fremont, California
Guido Freckmann, MD
Institute for Diabetes Technology, Ulm, Germany
Rolf Hinzmann, MD, PhD
Roche Diagnostics GmbH, Mannheim, Germany
Boris Kovatchev, PhD
University of Virginia, Charlottesville, Virginia
Aaron Kowalski, PhD
JDRF, New York, New York
Areta Kupchyk
Nixon Peabody LLP, Washington, DC
Courtney Lias, PhD
U.S. Food and Drug Administration, Silver Spring, Maryland
Markus Ott, MBA
Bayer, Basel, Switzerland
Riccardo Perfetti, MD, PhD
Sanofi, Bridgewater, New Jersey
Robert Ratner, MD, FACP, FACE
American Diabetes Association, Alexandria, Virginia
Steve Scott
Abbott Diabetes Care, Alameda, California
Robert Vigersky, MD, Colonel, Medical Corps
Walter Reed National Military Medical Center, Bethesda, Maryland
13:45 Break
Session 5: Controversies in Developing the Artificial Pancreas
14:10 Moderators
Jeffrey Joseph, DO
Thomas Jefferson University, Philadelphia, Pennsylvania
Boris Kovatchev, PhD
University of Virginia, Charlottesville, Virginia
14:15 Artificial Pancreas Award
14:20 Panel Discussion
Ali Cinar, PhD
Illinois Institute of Technology, Chicago, Illinois
Claudio Cobelli, PhD
University of Padova, Padova, Italy
Edward Damiano, PhD
Boston University, Boston, Massachusetts
Eyal Dassau, PhD
University of California Santa Barbara, Santa Barbara, California
Roman Hovorka, PhD
University of Cambridge, Cambridge, United Kingdom
16:00 Adjourn
16:00–18:30 Poster Session
18:30–20:00 Posters remain on display for viewing
Saturday, November 8, 2014
07:00 Continental Breakfast
Session 6: Novel Treatments & New Technology for Insulin Delivery
08:00 Moderators
Gerold Grodsky, PhD
University of California San Francisco, San Francisco, California
Richard Williams, MD
National Aeronautics and Space Administration, Fredericksburg, Virginia
08:05 Short-Action and Long Acting Insulins in the Pipeline
Lutz Heinemann, PhD
Science & Co., Düsseldorf, Germany
08:20 A Novel Approach to Rescue Islets in Type 1 Diabetes: The Role of Non-Immune
Cells
Eli Lewis, PhD
Ben-Gurion University of the Negev, Beer-Sheva, Israel
08:35 Insulin Pump Therapy in Type 2 Diabetes
Bruce Bode, MD, FACE
Atlanta Diabetes Associates, Atlanta, Georgia
08:50 Controlled Skin Temperature to Improve Insulin Absorption
Andreas Pfützner, MD, PhD
Pfützner Science & Health Institute, Mainz, Germany
09:05 Using Simulation Technology to Teach Diabetes Care Management Skills and
Insulin Dosing
JoAnn Sperl-Hillen, MD
SiMCare Health, Minneapolis, Minnesota
09:20 Q & A
09:45 End of session/Break
Session 7: Is Diabetes Technology Better in the U.S. or Europe?
10:10 Moderators
Timothy Bailey, MD, FACE, CPI
AMCR Institute, Escondido, California
John Pickup, MD, PhD
King’s College London, London, United Kingdom
10:15 Diabetes Technology Society (DTS) Student Research Award
10:20 Presentation by DTS Student Research Award Winner
10:35 Panel Discussion
Hans De Vries, MD
Academic Medical Center, Amsterdam, Netherlands
Barry Ginsberg, MD, PhD
Diabetes Technology Consultants, Wyckoff, New Jersey
David Kerr, MD
Sansum Clinic, Santa Barbara, California
David Maahs, MD
University of Colorado Denver, Denver, Colorado
11:35 End of session/Lunch
Session 8: Role of mHealth in Managing Diabetes
12:35 Moderator
Marshall Porterfield, PhD
National Aeronautics and Space Administration, Fredericksburg, Virginia
12:40 Mobile Technology, “Making” Health, and the Future of Diabetes Technology
Joyce Lee, MD, MPH
University of Michigan, Ann Arbor, Michigan
12:55 User Experience and Behavior Change in mHealth Interventions: Human Factors
Engineering
Joseph Cafazzo, PhD
Centre for Global eHealth Innovation | University of Toronto, Toronto, Ontario,
Canada
13:10 FDA’s Role in mHealth and Diabetes Management
Beth Stephen, PhD
U.S. Food and Drug Administration, Silver Spring, Maryland
13:25 Diabetes mHealth: The Last Mile
Aaron Neinstein, MD
University of California San Francisco, San Francisco, California
13:40 Q & A
14:05 End of session/Break
Session 9: New Technology in Continuous Glucose Monitoring
14:30 Moderators
Alberto Gutierrez, PhD
U.S. Food and Drug Administration, Silver Spring, Maryland
John Pickup, MD, PhD
King’s College London, London, United Kingdom
14:35 New Technology in Continuous Glucose Monitoring
Rajiv Shah, MS
Medtronic, Northridge, California
14:47 New Technology in Continuous Glucose Monitoring
Jacob Leach
Dexcom, San Diego, California
14:59 New Glucose Sensor Technology
Steve Scott
Abbott Diabetes Care, Alameda, California
15:11 New Sensor Technology: Improved Performance for Higher Reliability
Matthias Axel Schweitzer, MD, MBA
Roche Diagnostics GmbH, Mannheim, Germany
15:23 Sensing Technology: Employing a Direct Electron Transfer Principle
Shinjiro Sekimoto, MS
Arkray Inc., Kyoto, Japan
15:35 Performance of an Implanted Continuous Glucose Sensor in a Multi-Site Study
Mark Mortellaro, PhD
Senseonics, Inc., Germantown, Maryland
15:47 Q & A
Session 10: Product Demonstrations
16:15 Moderator
John Pickup, MD, PhD
King’s College London, London, United Kingdom
16:20 Product Demonstration: Flash Glucose Monitoring
Steve Scott
Abbott Diabetes Care, Alameda, California
16:35 Product Demonstration: Software to Help Patients Manage Diabetes and
Behaviors
Neal Kaufman, MD, MPH
DPS Health | UCLA School of Medicine, Los Angeles, California
16:50 Meeting Summary
17:00 Adjourn Meeting