Thursday, October 22, 2015
Workshop A: Business Opportunities in Diabetes Technology
Panel 1: Investing in Diabetes Technology
08:00 Moderators
James Scott, JD Paul Radensky, MD, JD
Applied Policy, Alexandria, Virginia McDermott Will & Emery LLP, Washington, DC
08:05 21st Century Technology and Early 20th Century Reimbursement
Bruce Quinn, MD, PhD
FaegreBD Consulting, Washington, DC
08:20 What a Venture Capitalist Looks For?
John Ryan, MBA
ONSET Ventures, Menlo Park, California
08:35 Investment Opportunities
Karen Drexler
Hygieia, Los Altos, California
08:50 What a Large Corporate Partner Looks For?
James Petisce, PhD
BD Diabetes Care, Andover, Massachusetts
09:05 Q & A
09:30 Break
Panel 2: Reimbursement
09:55 Moderators
Bruce Quinn, MD, PhD John Ryan, MBA
FaegreBD Consulting, Washington, DC ONSET Ventures, Menlo Park, California
10:00 Competitive Bidding for Insulin Pumps: Medicare’s National Expansion of Flawed Payment Rates
James Scott, JD
Applied Policy, Alexandria, Virginia
10:15 Healthcare Insurance Reimbursement for Continuous Glucose Monitoring: Getting it Right!
Mary Ann Hodorowicz, RD, LDN, MBA, CDE, Certified Endocrinology Coder
Mary Ann Hodorowicz Consulting, LLC, Palos Heights, Illinois
10:30 Reimbursement Update
Paul Radensky, MD, JD
McDermott Will & Emery LLP, Washington, DC
10:45 Coding, Coverage, and Reimbursement for CGM
Meredith Dyer
The Endocrine Society, Washington, DC
11:00 Q & A
11:25 End of workshop/Lunch
Workshop B: New Treatment Paradigms
Panel 1: Do It Yourself
08:00 Moderators
Alicia Warnock, MD Yogish Kudva, MD
Walter Reed National Military Medical Center, Bethesda, Maryland Mayo Clinic, Rochester, Minnesota
08:05 Patient-Powered: How Technology is Changing the “Patient” Paradigm
Patricia Salber, MD, MBA
Health Tech Hatch & The Doctor Weighs In, Larkspur, California
08:20 Regulatory Aspects
Courtney Lias, PhD
U.S. Food and Drug Administration, Silver Spring, Maryland
08:35 N-of-1 Studies for Novel Technology
Richard Kravitz, MD, MSPH
University California Davis, Sacramento, California
08:50 Patient Perspective on DIY Artificial Pancreas
Bryan Mazlish
Bigfoot Biomedical, Inc., Milpitas, California
09:05 Q & A
09:30 Break
Panel 2: Big Data and Precision Medicine for Diabetes
09:55 Moderators
Guillermo Arreaza-Rubin, MD
National Institute of Diabetes, Digestive, and Kidney Diseases | NIH, Bethesda, Maryland
10:00 Mobile Technologies to Collect Data for Precision Medicine for Diabetes
William Riley, PhD
National Institutes of Health, Bethesda, Maryland
10:15 Diabetes Care Desperately Needs Precision Medicine
Rodney Hayward, MD
University of Michigan, Ann Arbor, Michigan
10:30 Diabetes Data Analytics using Electronic Health Records and Patient Social Media
Hsinchun Chen, PhD
University of Arizona, Tucson, Arizona
10:45 Precision Medicine Driven by Big Data, Genomics and Personalized Digital Health Tracking: Overpromised Hype or Impending New Era for Health, Wellness and Preventive Medicine?
Robert Cuddihy, MD
Janssen Pharmaceuticals, Raritan, New Jersey
11:00 Q & A
11:25 End of workshop/Lunch
Workshop C: Glucose Measurement Errors and Insulin Dosing Errors
Panel 1: Metrics of BGM & CGM Accuracy
12:25 Moderators
George Cembrowski, MD, PhD Joan Lee Parkes, PhD
Alberta Health Services, Edmonton, Alberta, Canada Joan Lee Parkes Consulting Inc., Bristol, Indiana
12:30 Accuracy and Precision of Blood Glucose Meters and Continuous Glucose Monitors (CGM)
David Rodbard, MD
Biomedical Informatics Consultants LLC, Potomac, Maryland
12:45 Does MARD Convey the Real Measurement Performance of a CGM Device?
Luigi Del Re, PhD
Johannes Kepler University Linz, Linz, Austria
13:00 Metrics of BGM & CGM Accuracy and Their Limitations
Rolf Hinzmann, MD, PhD
Roche Diagnostics GmbH, Mannheim, Germany
13:15 Metrics of Accuracy
Marc Breton, PhD
University of Virginia, Charlottesville, Virginia
13:30 Q & A
13:55 Break
Panel 2: How to Avoid Insulin Dosing Errors
14:20 Moderator
Patricia Beaston, MD, PhD
U.S. Food and Drug Administration, Silver Spring, Maryland
14:25 Reference Systems to Improve the Accuracy of Testing in Diabetes Management
Hubert Vesper, PhD
Centers for Disease Control and Prevention, Atlanta, Georgia
14:40 Variability of Insulin Absorption
Tim Heise, MD
Profil GmbH, Neuss, Germany
14:55 Dark Side of Insulin Therapy: Insulin Dosing Errors and Unexpected Insulin Absorption
Eda Cengiz, MD, MHS
Yale School of Medicine, New Haven, Connecticut
15:10 Substances that Interfere with BG Testing
Barry Ginsberg, MD, PhD
Diabetes Technology Consultants, Wyckoff, New Jersey
15:25 Q & A
15:50 End of workshop
16:00–18:30 Poster session and inauguration of the 2015 Diabetes Technology Meeting
18:30–20:00 Posters remain on display for viewing
Workshop D: A Reassessment of Markers of Glycemia
Panel 1: New Developments in Hemoglobin A1C
12:25 Moderator
David Sacks, MD
National Institutes of Health, Bethesda, Maryland
12:30 Modeling HbA1c to Explore Relationship of HbA1c and the Blood Glucose Concentration
Piotr Ładyżyński, PhD, DSc
Biocybernetic Institute, Polish Academy of Sciences, Warsaw, Poland
12:45 Estimated A1C
Boris Kovatchev, PhD
University of Virginia, Charlottesville, Virginia
13:00 Mismatches Between HbA1c and Blood Glucose - Mechanisms
Robert Cohen, MD
University of Cincinnati, Cincinnati, Ohio
13:15 What is the Value of Home A1C Testing?
James Anderson Jr., MD, FFPM, FACE
PTS Diagnostics, Indianapolis, Indiana
13:30 Q & A
13:55 Break
Panel 2: Novel Markers
14:20 Moderators
David Sacks, MD Alicia Warnock, MD
National Institutes of Health, Bethesda, Maryland Walter Reed National Military Medical Center, Bethesda, Maryland
14:25 A Multi-Dimensional Combined Endpoint for Understanding Glycemic Control
Robert Vigersky, MD
Medtronic Diabetes, Washington, DC
14:40 Detection of Hypoglycemia using EEG
Lykke Blaabjerg, MSc, PhD
Hypo-Safe A/S, Kongens Lyngby, Denmark
14:55 Combining Data Obtained by Heart Rate Variability and Continuous Glucose Monitoring Enables Prediction and Improves Detection of Hypoglycemic Events
Jesper Fleischer, PhD
Aarhaus University Hospital and Aarhus University, Aarhus, Denmark
15:10 Service Dogs for Detecting Hypoglycemia
Jaclyn Shepard, PsyD
University of Virginia Health System, Charlottesville, Virginia
15:25 Q & A
15:50 End of workshop
16:00–18:30 Poster session and inauguration of the 2015 Diabetes Technology Meeting
18:30–20:00 Posters remain on display for viewing
Friday, October 23, 2015
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 Speech: Cybersecurity
Daniel Prieto
The White House, Washington, DC
Session 2: DTSec (DTS Cybersecurity Standard for Connected Diabetes Devices project)
08:25 Moderator
David Klonoff, MD, FACP, FRCP (Edin), Fellow AIMBE
Mills-Peninsula Health Services, San Mateo, California
University of California, San Francisco, San Francisco, California
08:30 Identifying and Addressing Potential Cybersecurity Legal Liability Risks for the Diabetes Device Community
Bryan Cunningham
Cunningham Levy LLP, Los Angeles, California
08:45 Panel Discussion
Seth Carmody, PhD Food and Drug Administration, Silver Spring, Maryland
Bryan Cunningham
Cunningham Levy LLP, Los Angeles, California
Barry Ginsberg, MD, PhD
Diabetes Technology Consultants, Wyckoff, New Jersey
David Kleidermacher
BlackBerry Limited, Santa Barbara, California
Jeffery Reynolds, PhD
Bayer Diabetes Care, Tarrytown, New York
Margie Zuk
The MITRE Corporation, Boston, Massachusetts
09:45 Q & A
10:10 End of session/Break
Session 3: How Good Does CGM Need to be for a Primary Indication to Replace SMBG?
10:35 Moderators
Courtney Lias, PhD
U.S. Food and Drug Administration, Silver Spring, Maryland
Andrea Facchinetti, PhD
University of Padova, Padova, Italy
10:45 Diabetes Technology Society Leadership Award
10:50 Regulatory Considerations for Non-Adjunctive CGM Indications
Alain Silk, PhD
U.S. Food and Drug Administration, Silver Spring, Maryland
11:05 CGM Technology: Is It Ready to Replace Traditional Blood Glucose Monitoring?
Grazia Aleppo, MD, FACE, FACP
Northwestern University, Chicago, Illinois
11:20 How Good Does CGM Need to be for a Primary Indication to Replace SMBG?
Marc Breton, PhD
University of Virginia, Charlottesville, Virginia
11:35 Non-Adjunctive Use of CGM: Future Directions
Jessica Castle, MD
Oregon Health and Science University, Portland, Oregon
11:50 Q & A
12:10 – 13:10 End of session/Lunch
| Scientific Sessions | Clinical Sessions |
|---|---|
| Scientific 4: Best Approach to Type 1 Diabetes: Biological or Bioengineered? | Clinical 4: Debate: Is There a Role for Blinded CGM in Addition to Real Time CGM? |
| 13:10 Moderators Gerold Grodsky, PhD University of California San Francisco, San Francisco, California John Pickup, MD, PhD King’s College London, London, United Kingdom |
13:10 Moderator Stuart Weinzimer, MD Yale University School of Medicine, New Haven, Connecticut |
| 13:15 Biological Approach Matthias Hebrok, PhD University of California San Francisco, San Francisco, California |
13:15 Overview of CGM Stuart Weinzimer, MD Yale University School of Medicine, New Haven, Connecticut |
| 13:30 Bioengineered Approach Roman Hovorka, PhD University of Cambridge, Cambridge, United Kingdom |
13:35 No Steve Edelman, MD University of California San Diego, San Diego, California |
| 13:45 Panel Discussion Speakers and Moderators |
13:55 Yes Ian Blumer, MD, FRCPC University of Toronto, Ontario, Canada |
| 14:05 Q & A | 14:15 Rebuttals 14:25 Q & A |
| 14:30 Break | 14:40 Break |
| Scientific Sessions | Clinical Sessions |
|---|---|
| Scientific 5: Artificial Pancreas: What is Needed? | Clinical 5: Developments in Insulin Pump Therapy |
| 14:55 Moderators Jeffrey Joseph, DO Thomas Jefferson University Philadelphia, Pennsylvania Geoff Chase, PhD University of Cantebury Christchurch, New Zealand |
15:05 Moderator Eda Cengiz, MD, MHS Yale School of Medicine, New Haven, Connecticut |
| 15:00 Artificial Pancreas Award | 15:10 How to Use Insulin Pumps John Pickup, MD, PhD King’s College London, London, United Kingdom |
| 15:05 Need for Better Algorithms Claudio Cobelli, PhD University of Padova, Padova, Italy |
15:35 A Practical Approach to Insulin Pump Therapy in Type 2 Diabetes Juan Pablo Frias, MD, FACE National Research Institute, Los Angeles, California |
| 15:20 Artificial Pancreas: Need for Better CGMS Garry Steil, PhD Harvard Medical School, Cambridge, Massachusetts |
16:05 Which Treatment Will Dominate: New Insulin or Insulin Pumps? Stuart Weinzimer, MD Yale University School of Medicine, New Haven, Connecticut |
| 15:35 Artificial Pancreas: Need for Glucagon Ahmad Haidar, PhD McGill University, Montreal, Quebec, Canada |
16:30 Q & A |
| 15:50 Need for Commercializing Actual Products Moshe Phillip, MD Schneider Children’s Medical Center of Israel, Tel-Aviv, Israel |
16:40 Adjourn 16:45–19:15 Poster session 19:15–20:45 Posters remain on display for viewing |
| 16:05 The Challenges of Using Model-Based Control for the Artificial Pancreas Eyal Dassau, PhD Harvard University, Cambridge, Massachusetts |
|
| 16:20 Q & A | |
| 16:45 Adjourn | |
| 16:45–19:15 Poster session | |
| 19:15–20:45 Posters remain on display for viewing |
Saturday, October 24, 2015
| Scientific Sessions | Clinical Sessions |
|---|---|
| 07:00 Continental Breakfast | 07:00 Continental Breakfast |
| Scientific 6: Novel Insulins | Clinical 6: Nutrition & the Microbiome |
| 08:00 Moderator Dorian Liepmann, PhD University of California Berkeley Berkeley, California |
08:00 Moderator Frank Greenway, MD Louisiana State University Baton Rouge, Louisiana |
| 08:05 Synthetic Glucose-Responsive Insulin Matthew Webber, PhD Massachusetts Institute of Technology Cambridge, Massachusetts |
08:05 The Diabetes Breakthrough for Successful Weight Loss Osama Hamdy, MD, PhD Joslin Diabetes Center, Boston, Massachusetts |
| 08:20 Dance 501, a New Novel Inhaled Insulin Delivery System John Patton, PhD Dance Biopharm, San Francisco, California |
08:35 Altering the Microbiome to Treat Diabetes Frank Greenway, MD Louisiana State University Baton Rouge, Louisiana |
| 08:35 Biosimilar Insulin, Reflection or Mirage? Alan Carter, PharmD MRIGlobal, Kansas City, Missouri |
09:05 Meal Timing: Can It Protect Against Diabesity? Amir Zarrinpar, MD, PhD University of California San Diego San Diego, California |
| 08:50 Stability of Insulin and Global Warming Andreas Pfützner, MD, PhD Pfützner Science & Health Institute Frankfurt, Germany |
09:35 Q & A 09:45 End of session/Break |
| 09:05 Timing of Meal Insulin and Its Relation to Diabetes Outcomes Karishma Datye, MD Monroe Carrell Jr. Children’s Hospital at Vanderbilt, Nashville, Tennessee |
|
| 09:20 Q & A | |
| 09:45 End of session/Break |
| Scientific Sessions | Clinical Sessions |
|---|---|
| Scientific 7: Importance of Hypoglycemia as an Endpoint in Clinical Trials | Clinical 7: The Social Media Phenomenon |
| 10:10 Moderator David Price, MD Dexcom, San Diego, California Rebecca Gottlieb, PhD Medtronic Diabetes, Northridge, California |
10:10 Moderator Patricia Salber, MD, MBA Health Tech Hatch & The Doctor Weighs In, Larkspur, California |
| 10:15 Diabetes Technology Society (DTS) Student Research Award | 10:15 In Defense of Your Patients: How to Identify and Prevent Online Bullying (aka – Dia-Bullying) Kevin McMahon, B.Sc. MediSelf Press, Sausalito, California |
| 10:20 Presentation by DTS Student Research Award Winner | 10:40 The Reluctant Tweet(er) Pratik Choudhary, MD, MbbD, MRCP King’s College London, London, United Kingdom |
| 10:35 Panel Discussion Timothy Dunn, PhD Abbott Diabetes Care, Alameda, California Alexander Fleming, MD Kinexum, Harpers Ferry, West Virginia Campbell Hutton, MSPH JDRF, New York, New York Boris Kovatchev, PhD University of Virginia, Charlottesville, Virginia John Pickup, MD, PhD King’s College London, London, United Kingdom |
11:05 Social Media for Physicians Patricia Salber, MD, MBA Health Tech Hatch & The Doctor Weighs In, Larkspur, California |
| 11:45 End of session/Lunch | 11:30 Q & A |
| 11:45 End of session/Lunch |
| Scientific Sessions | Clinical Sessions |
|---|---|
| Scientific 8: Mobile Apps | Clinical 8: What’s Next in Diabetic Limb Salvage and Prevention |
| 12:45 Moderators Richard Williams, MD National Aeronautics and Space Administration Washington, DC Judith Fradkin, MD National Institutes of Health, Bethesda, Maryland |
12:45 Moderator Stephen Twigg, MBBS(Hons-1), PhD, FRACP University of Sydney, Sydney, Australia |
| 12:50 Mobile Apps in Diabetes: Quantity vs. Quality Ellie Strock, ANP-BC, CDE Voluntis, Inc., Plymouth, Minnesota |
12:50 Gait Balls of Fire: Dosing Activity Like We Dose a Drug Bijan Najafi, PhD University of Arizona, Tucson, Arizona |
| 13:05 Linking CGM Data with an Electronic Health Record Rajiv Kumar, MD Stanford University, Stanford, California |
13:15 New Treatments for Diabetic Foot Disease Using Technology Stephen Twigg, MBBS(Hons-1), PhD, FRACP University of Sydney, Sydney, Australia |
| 13:20 Regulation of Mobile Apps Bakul Patel, MBA, MSc U.S. Food and Drug Administration, Silver Spring, Maryland |
13:40 How to Treat Pain Due to Diabetic Neuropathy: Facts and Controversies Rodica Pop-Busui, MD, PhD University of Michigan, Ann Arbor, Michigan |
| 13:35 Q & A | 14:05 Q & A |
| 14:00 End of session/Break | 14:30 End of session/Break |
| Scientific Sessions | Clinical Sessions |
|---|---|
| Scientific 9: New Developments in CGM | Clinical 9: SMBG & Bolus Calculators |
| 14:25 Moderator Stayce Beck, MD Food and Drug Administration, Silver Spring, Maryland |
14:55 Moderator Pratik Choudhary, MD, MbbD, MRCP King’s College London, London, United Kingdom |
| 14:30 CGM Systems Rebecca Gottlieb, PhD Medtronic Diabetes, Northridge, California |
15:00 Benefits and Limitations of SMBG – The Implications and Assessment of Device Accuracy Timothy Bailey, MD, FACE, CPI AMCR Institute, Escondido, California |
| 14:42 Dexcom G5® Mobile: CGM on Your Smartphone Apurv Kamath, MS Dexcom, Inc., San Diego, California |
15:25 Benefits and Limitations of SMBG Maurice J. O’Kane, MD Altnagelvin, Londonderry, Northern Ireland |
| 14:54 New Developments in Professional Sensor Glucose Monitoring Scott Harper, BS Abbott Diabetes Care, Alameda, California |
15:50 Getting the Most Out of Blood Glucose Monitors Kathleen Dungan, MD, MPH The Ohio State University, Columbus, Ohio |
| 15:06 Time Delay of CGM Sensors: Causes and Countermeasures Guenther Schmelzeisen-Rekeker, PhD Roche Diabetes Care GmbH, Mannheim, Germany |
16:15 Q & A |
| 15:18 BREAK | 16:40 End Session |
| 15:30 Accuracy and Longevity of an Implantable Continuous Glucose Sensor in the Precise Study: A Prospective Multi-Center Pivotal Trial Jort Kropff, MD Academic Medical Centre at the University of Amsterdam, Amsterdam, Netherlands |
|
| 15:42 A Novel CGM Sensing Technology Shinjiro Sekimoto, MS Arkray Inc., Kyoto, Japan |
|
| 15:54 Application of a Second-Generation Long Term Implantable Continuous Glucose Monitoring System in Human Subjects Joseph Lucisano, PhD GlySens Inc., San Diego, California |
|
| 16:06 Q & A | |
| 16:35 End Session | |
| Scientific & Clinical 10: Live Demonstrations | |
| 16:40 Moderator John Pickup, MD, PhD King’s College London, London, United Kingdom |
|
| 16:45 The mySugr Ecosystem – Consistent All-Round Care Viamobile Tools, Education, Motivation and Coaching Fredrik Debong mySugr GmbH, Vienna, Austria |
|
| 16:55 Meeting Summary | |
| 17:00 Adjourn Meeting |