2015 Diabetes Technology Meeting Agenda

Abstract

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 21^st 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 & A09:45 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