2016 Diabetes Technology Meeting Agenda

Thursday, November 10, 2016

Workshop A: Implanted Sensors

Panel 1: Long-Term Implantable Glucose Sensors

08:00 Moderators

   Kong Chen, PhD, MSCI  David Kerr, MD, FRCPE

   National Institutes of Health  William Sansum Diabetes Center

   Bethesda, Maryland  Santa Barbara, California

08:05 Update of Clinical Experience with a Long-Term Fully-Implanted Continuous Glucose Monitoring System

   Joseph Lucisano, PhD

   Glysens Inc., San Diego, California

08:15 Tissue-Integrating Sensors

   Natalie Wisniewski, PhD

   Profusa, South San Francisco, California

08:25 Precise II Pivotal Trial: 90-Day Subcutaneously Implanted Glucose Sensor

   Mark Christiansen, MD

   Diablo Clinical Research, Walnut Creek, California

08:35 Long-Term Implantable Optical Continuous Glucose Monitoring System

   Jeffrey Joseph, DO

   Thomas Jefferson University, Philadelphia, Pennsylvania

08:45 Glucowizzard™: Preclinical Development and Transition to Human Testing

   Michail Kastellorizios, PhD

   Biorasis, Storrs Mansfield, Connecticut

08:55 An Implanted Osomotic Pressure Sensor

   Andreas Pfützner, MD, PhD

   Pfützner Science & Health Institute, Mainz, Germany

09:05 What Do Clinicians Want in an Implantable CGM?

   Jessica Castle, MD

   Oregon Health & Science University, Portland, Oregon

09:15 Q & A

09:35 Break

Panel 2: Market Opportunities, Financial Issues, and Exit Strategy

09:55 Moderators

   Jeffrey Joseph, DO  Matthew Maryniak, MBA

   Thomas Jefferson University  Fenix Group International, LLC

   Philadelphia, Pennsylvania  Wyomissing, Pennsylvania

10:00 Market Opportunities and Customer Preference Data for a Fully Implanted Long-Term CGM Solution

   William Markle, MBA

   Glysens Inc., San Diego, California

10:10 Tiny Sensor, Great Big World

   William McMillan, MS

   Profusa, South San Francisco, California

10:20 Next Generation Technology for New Market Challenges

   Tim Goodnow, PhD

   Senseonics, Inc., Germantown, Maryland

10:30 The Value Proposition of Implants

   Paul Strasma, MBA

   Capillary Biomedical, Inc., Irvine, California

10:40 Utilizing Start-Up Accelerators to Advance CGM Devices: Lessons Learned from Mass Challenge

   Fotios Papadimitrakopoulos, PhD

   Biorasis, Storrs Mansfield, Connecticut

10:50 Value Creation through Science or Distribution?

   Rune Frisvold, MBA

   Lifecare AS, Bergen, Norway

11:00 Investor Perspective on Implantable CGM

   Matthew Maryniak, MBA

   Fenix Group International, LLC, Wyomissing, Pennsylvania

11:10 Q & A

11:30  End of workshop/Lunch

Thursday, November 10, 2016

Workshop B: Biomarkers for Diabetes

Panel 1: Update on Established Biomarkers

08:00 Moderators

   George Cembrowski, MD, PhD  Julia Mader, MD

   Alberta Health Services  Medical University Graz

   Edmonton, Alberta, Canada  Graz, Austria

08:05 eA1C

   Boris Kovatchev, PhD

   University of Virginia, Charlottesville, Virginia

08:20 Blood Ketones – Measurement, Interpretation and Clinical Utility

   Andrew Drexler, MD

   University of California, Los Angeles, Los Angeles, California

08:35 A1C – Update on Measuring, Interpreting and Including POC tests

   Michelle Magee, MD, MBBCH, BAO, LRCPSI

   MedStar Health Research Institutes, Washington, DC

08:50 Metrics to Measure CGM

   Pratik Choudhary, MD, FRCP(UK)

   King’s College London, London, United Kingdom

09:05 Q & A

09:35  Break

Panel 2: Emerging biomarkers

09:55 Moderators

   Guillermo Arreaza-Rubin, MD  Gerold Grodsky, PhD

   National Institutes of Health  University of California, San Francisco

   Bethesda, Maryland  San Francisco, California

10:00 The Need for a New Definition of Hypoglycemia

   Brian Frier, MD, FRCP(Edin), FRCP(Glas)

   The Queen’s Medical Research Institute, University of Edinburgh, Edinburgh, Scotland

10:15 Noninvasive Glucose Measurement

   Avner Gal, MBA, MSCEE, MSc

   Integrity Applications, Ashkelon, Israel

10:30 C-Peptide and Proinsulin

   Andreas Pfützner, MD, PhD

   Pfützner Science & Health Institute, Mainz, Germany

10:45 Innovations in Novel Electrochemical Sensors, Methods, and Analytes

   Jeffrey La Belle, PhD, MS, MSEE, BSEE

   Arizona State University, Tempe, Arizona

11:00 Q & A

11:30  End of workshop/Lunch

Thursday, November 10, 2016

Workshop C: Coding, Coverage, Reimbursement, and Competitive Bidding

Panel 1: Coding and Coverage

12:30 Moderators

   Barry Ginsberg, MD, PhD  Claudia Graham, PhD, MBA, MPH

   Diabetes Technology Consultants  Dexcom

   Wyckoff, New Jersey  San Diego, California

12:35 An Overview of Coding & Coverage for Diabetes Products

   Bruce Taylor

   Roche Diabetes Care, Inc., Indianapolis, Indiana

12:50 How Reimbursement Coding & Coverage Affect Patient Choices

   Jerry Gomez, MBA

   ArkrayUSA, Inc., El Paso, Texas

13:05 Impact of Healthcare Reform on Reimbursement for New Technologies

   Patricia Telgener, RN, MBA

   Emerson Consultants, Inc., Excelsior, Minnesota

13:20 A New CPT Code for CGM: A Golden Opportunity or a Black Hole?

   Erika Miller, JD

   Cavarocchi ∙ Ruscio ∙ Dennis Associates, LLC, Washington, DC

13:35 Q & A

14:05  Break

Panel 2: Reimbursement and the   Competitive Bidding Process by CMS

14:25 Moderators

   Jane Chiang, MD  John Warren

   American Diabetes Association  McDermottPlus

   Alexandria, Virginia  Washington, DC

14:30 Patient Policy Advocacy Perspective

   Christel Marchand Aprigliano, MS Bennet Dunlap, MSHC

   Diabetes Patient Advocacy Coalition Diabetes Patient Advocacy Coalition

   Tampa, Florida Athyn, Pennsylvania

14:40 An Overview of the Competitive Bidding Process

   Timothy Trysla

   Alston & Bird LLP, Washington, DC

14:55 Diabetes Safety Monitoring in Medicare’s Competitive Bidding Program

   Gary Puckrein, PhD

   National Minority Quality Forum, Washington, DC

15:10 The Anticipated Impacts of Competitive Bidding on Diabetes Health Outcomes

   David Marrero, PhD

   University of Arizona Schools of Public Health and Medicine, Tucson, Arizona

15:25 How Will Trends in Federal Health Policy Affect Diabetes?

   Thomas Milam

   TrueLifeCare, LLC, Brentwood, Tennessee

15:40 Q & A

16:00  End of workshop

16:00–18:30 Poster session and inauguration of the 2016 Diabetes Technology Meeting

18:30–20:00 Posters remain on display for viewing

Thursday, November 10, 2016

Workshop D: Metrics for Diabetes

Panel 1: Metrics for Describing Performance of a Monitor

12:30 Moderators

   Vincent Crabtree, PhD  Courtney Lias, PhD

   Juvenile Diabetes Research Foundation  U.S. Food and Drug Administration

   New York, New York  White Oak, Maryland

12:35 Correct, Complete, and Still Comprehensible – How to Best Describe Accuracy of

Blood Glucose Meters?

   Rolf Hinzmann, MD, PhD

   Roche Diabetes Care, Mannheim, Germany

12:50 Best Metrics of Glycemia Measured by a BGM

   David Rodbard, MD

   Biomedical Informatics Consultants, LLC, Potomac, Maryland

13:05 The Relationship Between BGM and CGM

   David Simmons, MD

   Ascensia Diabetes Care, Parsippany, New Jersey

13:20 Borrowing from Big Data Technologies to Drive CGM Metrics Ubiquity

   Annika Jimenez, MPIA

   Dexcom, San Diego, California

13:35 Q & A

14:05  Break

Panel 2: New Metrics for Control

14:25 Moderators

   Guido Freckmann, MD  Frank Schwartz, MD

   Institute for Diabetes Technology  Ohio University

   Ulm, Germany  Athens, Ohio

14:30 The New Glucose Pentagon: Applying Novel Composite Metrics to Assess the Results of Glycemic Control in CGM-Based Studies

   Robert Vigersky, MD

   Medtronic Diabetes, Washington, DC

14:45 Composite Metrics for Clinical Trials – Can They Help Us?

   Alexander Fleming, MD

   Kinexum, Harpers Ferry, West Virginia

15:00 Is Calibration Necessary for CGMs?

   Andrea Fachinetti, PhD

   University of Padova, Padova, Italy

15:15 Long-Term Metrics

   Marc Breton, PhD

   University of Virginia, Charlottesville, Virginia

15:30 Q & A

16:00  End of workshop

16:00–18:30 Poster session and inauguration of the 2016 Diabetes Technology Meeting

18:30–20:00 Posters remain on display for viewing

Friday, November 11, 2016

07:00  Continental Breakfast

Session 1: Patient-Generated Health Data for the Precision Medicine Initiative

08:00 Moderators

   Judith Fradkin, MD  Karl Friedl, PhD, COL (US Army, ret.)

   National Institutes of Health  UCSF & ORISE

   Bethesda, Maryland  San Francisco, California

        Oak Ridge, Tennessee

08:10 The Connected Patient

   Howard Zisser, MD

   Verily Life Science, San Francisco, California

   University of California, Santa Barbara, Santa Barbara, California

08:25 Health Data Analytics Applied to Diabetes

   Shahram Ebadollahi, PhD

   IBM Watson Health, Yorktown Heights, New York

08:40 An Open Source Platform Enabling an Ecosystem of Diabetes Apps and Research

   Howard Look, BSCE

   Tidepool, Palo Alto, California

08:55 Leveraging Patient Generated Data and Decision Support to Deliver Personalized Recommendations

   Rick Altinger, MS EM, BSME

   Glooko, Mountain View, California

09:10 Q & A

09:25 Break

Friday, November 11, 2016

Session 2: Regulatory Initiatives in Diabetes Technology

09:45 Moderator

   David Klonoff, MD, FACP, FRCP(Edin), Fellow AIMBE

   Mills-Peninsula Health Services, San Mateo, California

09:50 Diabetes Technology Society Leadership Award

09:55 DTSec

   David Kleidermacher

   BlackBerry Limited, Santa Barbara, California

10:05 Insulin Pump Security

   Colin Morgan, CISSP, CISM, GPEN

   Johnson & Johnson, Fort Washington, Pennsylvania

10:15 Medical Device Cybersecurity: An FDA Perspective

   Suzanne Schwartz, MD, MBA

   U.S. Food and Drug Administration, Silver Spring, Maryland

10:30 The DTS-BGMs Surveillance Program: Results of the First Series of 18 BGMs Marketed in the USA

   Joan Lee Parkes, PhD

   Joan Lee Parkes Consulting, Inc., Bristol, Indiana

10:45 News from FDA on Glucose Monitoring Regulation

   Courtney Lias, PhD

   U.S. Food and Drug Administration, White Oak, Maryland

11:00 Privacy of Diabetes Apps

   Sarah Blenner, JD, MPH

   UCLA Fielding School of Public Health, Los Angeles, California

11:15 What’s New with HIPAA

   Iliana Peters, JD, LLM

   U.S. Department of Health and Human Services, Office for Civil Rights, Washington, DC

11:30 Q & A

11:55  End of session/Lunch

Session 3: Use of Mobile Apps to Increase Adherence

12:50 Moderators

   Riccardo Bellazzi, PhD  Bakul Patel, MBA, MSc

   University of Pavia  U.S. Food and Drug Administration

   Pavia, Italy  Silver Spring, Maryland

12:55 Digital Self-Management Support: Improving Outcomes for Patients with Diabetes

   Adam Kaufman, PhD

   Canary Health, Los Angeles, California

13:10 Integrating Real-Time Blood Glucose and Mobile Behavioral Data for Enhanced Problem Solving

   Shelagh Mulvaney, PhD

   Vanderbilt University, Nashville, Tennessee

13:25 A European Perspective

   Pratik Choudhary, MD, FRCP(UK)

   King’s College London, London, United Kingdom

13:40 Q & A

13:55  End of session/Break

Friday, November 11, 2016

Session 4: Artificial Pancreas – Recent Innovations in Algorithms

14:15 Moderators

   Jeffrey Joseph, DO  Marc Torjman, PhD

   Thomas Jefferson University  Thomas Jefferson University

   Philadelphia, Pennsylvania  Philadelphia, Pennsylvania

14:20 Artificial Pancreas Award

14:25 Model Predictive Control for AP: Cost Function Design to Improve Safety & Performance

   Ravi Gondhalekar, PhD

   Harvard University, Cambridge, Massachusetts

14:35 Combining Two Schools of Thought in One Algorithm

   Moshe Phillip, MD

   Institute for Endocrinology and Diabetes, Schneider Children's Medical Center of Israel

   Petah Tikva, Israel

14:45 Individually Adaptive Algorithm for Artificial Pancreas: In Silico & One-Month Outpatient Free-Living Conditions

   Claudio Cobelli, PhD

   University of Padova, Padova, Italy

14:55 inControl: a Closed Loop Control System for Type 1 Diabetes

   Patrick Keith-Hynes, PhD

   TypeZero Technologies, Charlottesville, Virginia

15:05 Multi-Module Multivariable Artificial Pancreas Control Systems

   Ali Cinar, PhD

   Illinois Institute of Technology, Chicago, Illinois

15:15 Integration of an Adaptive Bolus Calculator in an Artificial Pancreas

   Nick Oliver, FRCP

   Imperial College, London, United Kingdom

15:25 Translation of Hybrid Closed-Loop Technology Into Better Care for T1D

   William Tamborlane, MD

   Yale School of Medicine, New Haven, Connecticut

15:35 Q&A

16:00 End of Session

16:00–18:30 Poster Session Night Two

18:30–20:00 Posters remain on display for viewing

Saturday, November 12, 2016

07:00  Continental Breakfast

Session 5: New Drugs

08:00 Moderators

   Curtiss Cook, MD  Alicia Warnock, MD

   Mayo Clinic Arizona  US Navy; Walter Reed National Military Medical Center

   Phoenix, Arizona  Bethesda, Maryland

08:05 Student Presentation

08:25 Glucagon Formulations

   Jessica Castle, MD

   Oregon Health & Science University, Portland, Oregon

08:45 Optimizing Basal Insulin

   David Kerr, MD, FRCPE

   William Sansum Diabetes Center, Santa Barbara, California

09:05 Novel Rapid-Acting Insulins

   Tim Heise, MD

   Profil Institut für Stoffwechselforschung GmbH, Neuss, Germany

09:25 Biosimilar Insulin

   Lutz Heinemann, PhD

   Science & Co., Dusseldorf, Germany

09:45 Q & A

10:00 Break

Session 6: New Insulins and Delivery Systems

10:20 Moderators

   Deborah Greenwood, PhD, RN, BC-ADM, CDE, FAADE  Dorian Liepmann, PhD

   Sutter Health  University of California, Berkeley

   Sacramento, California  Berkeley, California

10:25 Infusion Set Advances

   Lutz Heinemann, PhD

   Science & Co., Dusseldorf, Germany

10:45 Patch Pumps

   John Pickup, MA, BM, DPhil, DSc, FRCPath

   King’s College London, London, United Kingdom

11:05 Apps for Insulin Dosing Software

   Signe Schmidt, MD, PhD

   Hvidovre University Hospital, Hvidovre, Denmark

11:25 OpenAPS

   Rachel Sandlain

   OpenAPS, Bel Air, Maryland

11:45 Q & A

12:00  End of session/Lunch

Saturday, November 12, 2016

Session 7: New Developments in Needle Sensor CGMs

13:00 Moderators

   Andrea Bell-Vlasov, PhD  Jeffrey Sutton, MD, PhD

   U.S. Food and Drug Administration  National Space Biomedical Research Institute

   Silver Spring, Maryland  Houston, Texas

13:05 New Data on Flash Glucose Monitoring

   Scott Harper, BS

   Abbott Diabetes Care, Alameda, California

13:20 Accuracy of a Novel CGM System Employing Transfer Technology

   Shinjiro Sekimoto, MS

   Arkray, Inc., Kyoto, Japan

13:35 Pushing the Boundaries in CGM Performance

   Peter Simpson, MEng

   Dexcom, San Diego, California

13:50 New Developments in Sensor Technology

   Brian Kannard, BS, MBA

   Medtronic Diabetes, Northridge, California

14:05 New Data on the Accu-Chek Insight CGM System

   Guenther Schmelzeisen-Redeker, PhD

   Roche Diabetes Care GmbH, Mannheim, Germany

14:20 Q & A

14:35 Break

Session 8: Social Media

14:55 Moderators

   Leslie Landree, PhD  John Pickup, MA, BM, DPhil, DSc, FRCPath

   U.S. Food and Drug Administration  King’s College London

   Silver Spring, Maryland  London, United Kingdom

15:00 Harnessing Social Media for Diabetes Research

   Joyce Lee, MD, MPH

   University of Michigan, Ann Arbor, Michigan

15:20 How Social Media Affects Adoption and Use of Technology

   Amy Tenderich, MA

   DiabetesMine, San Francisco, California

15:40 The Diabetes Village – People with Diabetes Need to Be Heard

   David Kerr, MD, FRCPE

   William Sansum Clinic, Santa Barbara, California

16:00 Q & A

16:20  End of session/Break

Saturday, November 12, 2016

Session 9: Live Demonstration

16:30 Moderator

   John Pickup, MA, BM, DPhil, DSc, FRCPath

   King’s College London

   London, United Kingdom

16:35 Quell & Quell Apps

   Frank McGillin  Shai Gozani, MD, PhD

   Neurometrix, Inc., Waltham, Massachusetts  Neurometrix, Inc., Waltham, Massachusetts

16:50 Meeting Summary

17:00  Adjourn Meeting