Fifth Artificial Pancreas Workshop

Event Details

Meeting Objectives

• Towards Fully Automated and Personalized Diabetes Management Systems. What is needed?
• Challenges and Opportunities for higher Accessibility, Adoption, and Improvement in Quality of Life of People with Diabetes

Purpose

The purpose of this workshop is to discuss in a multi-disciplinary forum, the current and potential future challenges for the development, testing, accessibility and adoption of fully automated diabetes management technologies and their components. Topics to be discussed include:

1. Lessons learned from Clinical Trials. Clinical testing modalities for real world translatability.
2. Discussion of current state of interoperability and perspectives for the future.
3. Adaptation of systems throughout the life span and to special populations.
4. Potential benefits of multihormone closed loop systems and the use of adjuvant therapies.
5. Artificial intelligence/ ML and integration strategies for personalized systems.
6. Technical challenges and potential solutions in glucose sensing and more physiological and durable insulin/pancreatic hormones delivery.
7. Human psychosocial factors, quality of life, ethical considerations and health disparities in the adoption and access to these technologies.
8. Prospective areas of research emphasis to accelerate the availability of wearable, affordable, accessible, and more user-friendly systems for individuals with diabetes”

This event has been organized in collaboration with the Diabetes Technology Society, the Helmsley Charitable Trust, the JDRF, and the U.S. Food and Drug Administration.

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

Andrew Bremer, M.D., Ph.D.
Chief, Pediatric Growth and Nutrition Branch
Division of Extramural Research
National Institute of Child Health and Human Development
National Institutes of Health

Miranda Broadney, M.D.
Director, Type 1 Diabetes Therapeutics program.
Division of Diabetes, Endocrinology, and Metabolic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
National Institutes of Health

Deniz Dalton, M.S.
Program Officer for the T1D Program
The Leona M. and Harry B. Helmsley Charitable Trust

Thomas Eggerman, M.D., Ph.D.
Program Director for Artificial Pancreas Clinical Trials
Division of Diabetes, Endocrinology, and Metabolic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
National Institutes of Health

Jessica Flynn, Ph.D.
Division of Chemistry and Toxicology, Diabetes Diagnostic Devices Branch
Center for Devices and Radiological Health
U.S. Food and Drug Administration

Jaime Giraldo, Ph.D.
Associate Director of Research
JDRF

David C. Klonoff, M.D.
President, Diabetes Technology Society
Medical Director, Diabetes Research Institute
Mills-Peninsula Health Services

Marjana Marinac, Pharm.D.
Senior Director, Regulatory Affairs
JDRF

Jonathan Rosen, Ph.D.
Director of Research
JDRF

Sean Sullivan, Ph.D.
Senior Program Officer, Type 1 Diabetes
The Leona M. and Harry B. Helmsley Charitable Trust

Registration Deadline

April 27, 2023

Agenda

Monday, May 1, 2023

Goals of the Day

• Discuss Current Challenges of Automated Insulin Delivery (AID) Systems and Future Progress
• Define Research Opportunities to Improve Performance, Access, and Adoption of AID Systems in a Diverse Population for Better Health Outcomes and Quality of Life

8:00 a.m. - 8:20 a.m.

Welcome and Introductory Remarks

• Griffin P. Rodgers, M.D., M.A.C.P., Director, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH)
• Dr. Sanjoy Dutta, JDRF International
• Dr. Sean Sullivan, The Leona M. and Harry B. Helmsley Charitable Trust
• Dr. David Klonoff, M.D., Diabetes Technology Society/Mills Peninsula Medical Center

8:20 a.m. - 9:50 a.m.

Session I: Lessons Learned From Recent Advanced Clinical Trials and Real-World Data

Moderators:
Dr. Jessica Castle, Physician, Oregon Health & Science University
Dr. Viral Shah, Associate Professor, University of Colorado-Denver

• What is needed to improve real-world testing and adaptation of systems?
• Are the results generalizable and applicable to a diverse population?
• How can we improve representation of minority groups in clinical trials?

Lessons Learned Through the Development of Advanced AID Systems
Dr. Sue Brown, Professor of Medicine, University of Virginia

Generalizability of Trial Results to Diverse Populations: Lessons from the Bionic Pancreas Pivotal Trial
Dr. Steven Russell, Massachusetts General Hospital/BetaBionics

Real World Testing of Open-Source AID Systems
Mr. John Lum, Jaeb Center for Health Research

Using CamAPS FX Across All Age Groups: RCTs and Real-World Settings
Dr. Roman Hovorka, University of Cambridge

Control-IQ Outcomes from Age 2 to 72
Dr. Roy Beck, Jaeb Center for Health Research

Disparities in the Access to Advanced Technologies
Dr. Nelly Mauras, Nemours Children’s Health

Lessons Learned from the Real-World Data of Automatic Insulin Delivery Systems
Dr. Ohad Cohen, Sheva Medical Center/Medtronic

Improving Access to Hybrid Close System: Insights from T1D Exchange Clinic Network
Dr. Osagie Ebekozien, T1D Exchange

9:40 a.m. - 10:10 a.m.

30-minute Discussion with Speakers, Moderators/Other Participants

10:10 a.m. - 10:20 a.m.

Break

10:20 a.m. - 11:20 a.m.

Session II: Interoperability, Data Management, Integration of Systems and Cybersecurity; Challenges and Regulatory Considerations

Moderators:
Dr. Jessica Flynn, U.S. Food and Drug Administration (FDA)
Dr. Juan Espinoza, Northwestern University, Lurie Children’s Hospital

Streamlining Regulatory Processes to Facilitate Innovations for Automated Insulin Dosing Systems
Dr. Jessica Flynn, FDA

Bridging the Gap Between DIY/Open-Source Systems and Regulated Systems
Mr. Howard Look, Tidepool

Composing Secure AID Systems from Interoperable Components: Challenges and Opportunities
Mr. Lane Desborough, Nudge BG, Inc.

The IEEE 2621 Cybersecurity Standard for Connected Diabetes Devices
Dr. David Klonoff, Diabetes Technology Society/Mills Peninsula Medical Center

Data Considerations to Enable Advanced Analytics and Applications
Dr. Juan Espinoza, Northwestern University, Lurie’s Children’s Hospital

Device Integration into the EHR: Challenges and Opportunities
Dr. Amy Criego, International Diabetes Center

11:20 a.m. - 11:50 a.m.

30-minute Discussion with Speakers, Moderators/Other Participants

11:50 a.m. - 12:00 p.m.

Break

12:00 p.m. - 1:20 p.m.

Session III: Adaptation of Systems Throughout the Life Span and Special Populations: Are Specific Algorithms Needed?

Moderators:
Dr. Andrew Bremer, Eunice Kennedy Shriver National Institute of Child Health and Human Development
Dr. Ega Cengiz, University of California, San Francisco

Findings from an RCT of Automated Insulin Delivery in Young Children with Type 1 Diabetes
Dr. Paul Wadwa, Barbara Davis Center Medical School, University of Colorado

At-Home Use of a Pregnancy-Specific Hybrid Closed-Loop System for Pregnancies Complicated by Type 1 Diabetes: A Multicenter U.S. Clinical Study
Dr. Carol Levy, Icahn School of Medicine

AP Research in T1DM with Severe Gastroparesis
Dr. Ananda Basu, University of Virginia

Automated Insulin Delivery Across the Lifespan: A Comparative Analysis of a Large Real-World Database
Dr. Boris Kovatchev, University of Virginia

Can One Algorithm Fit All Ages of People with Type 1 Diabetes?
Dr. Robert Vigersky, Medtronic Diabetes

The Role of Automated Diabetes Management Systems in Patients with Diabetes and Kidney Disease
Dr. Connie Rhee, University of California, Irvine

Artificial Pancreas Technology in the Management of Cystic Fibrosis Related Diabetes
Dr. Melissa Putman, Massachusetts General Hospital/Harvard University

Closed-Loop in Type 2 Diabetes
Dr. Charlotte Boughton, University of Cambridge

1:20 p.m. - 1:50 p.m.

30-minute Discussion with Speakers, Moderators and Other Participants

1:50 p.m. - 3:40 p.m.

Lunch and Poster Session

3:40 p.m. - 4:50 p.m.

Session IV: Development of Adaptive Algorithms for Insulin Only and for Multihormonal Systems or Combination With Adjuvant Therapies and Drugs: Clinical Expected Outcomes and Public Health Impact

Moderators:
Dr. Eyal Dassau, Harvard University/Eli Lilly and Company
Dr. Claudio Cobelli, University of Padova

Design and Early Clinical Validation of an Insulin Only Automated Insulin Delivery Capable of Full Closed Loop
Dr. Mark Breton, University of Virginia

Autonomous Adaptation of the Single -and Dual -Hormone iLet Bionic Pancreas in Type 1 Diabetes
Dr. Edward Damiano, Boston University/BetaBionics

Insulin -and -Pramlintide Fully Closed-Loop System
Dr. Ahmad Haidar, McGill University

Enabling Full Closed Control Using a Multi-Stage Model Predictive Control Approach
Dr. Patricio Colmegna, University of Virginia

Utilizing AI, Metabolic Modeling, and Multiple Hormones to Enable Automated Responses to Meals and Exercise in Closed-Loop Systems
Dr. Peter Jacobs, Oregon Health and Science University

Islet Preservation in Children with New Onset T1D: Results from the CLVer Trial
Dr. Greg Forlenza, The Barbara Davis Center/University of Colorado

4:50 p.m. - 5:30 p.m.

30-Minute Discussion with Speakers, Moderators and Other Participants

5:30 p.m.

Adjournment

Tuesday, May 2, 2023

Goals of the Day

• Discuss What Is Needed to Move Toward Fully Automated and Personalized AID Systems
• Emerging biomedical and technological advances: Perspectives for the future
• More physiological alternatives for insulin delivery
• Psychosocial and environmental factors determining disparities in the use and accessibility to these technologies: Potential research and interventions.

8:00 a.m. - 8:05 a.m.

Welcome and Summary of the First Day, Perspectives for the Second Day
Dr. David Klonoff, Diabetes Technology Society/Mills Peninsula Medical Center

8:05 a.m. - 8:25 a.m.

Special Lecture
Dr. Michael Rickels, University of Pennsylvania

Session V: Novel Artificial Intelligence Strategies to Develop Smarter, More Automated, Personalized Diabetes Management Systems

• Behavioral profiles: Adapting to meals, exercise, stress, sleep patterns, contextual
  
  Moderators:
  Dr. Boris Kovatchev, University of Virginia
  Dr. Ahmad Haidar, McGill University

Making Fully Automated Insulin Delivery a Reality – Strategies from the Engineer’s Toolbox
Dr. Jose Garcia Tirado, Insel Hospital

Enabling Fully Automated Insulin Delivery in Type 1 Diabetes Using AI: From Task-Specific Predictive Models to AI-Based Digital Twins
Dr. Clara Mosquera, Oregon Health and Science University

Transforming Diabetes Treatment with Artificial Intelligence: Fully Automated Multivariable Artificial Pancreas to Mitigate the Effects of Meals, Exercise, and Stress
Dr. Mudassir Rashid, Illinois Institute of Technology

Meal Composition and Postprandial Glucose Excursion in Closed-Loop Systems
Dr. Laya Ekhlaspour, University of California, San Francisco

Physical Activity and Current Closed-Loop Control in Type 1 Diabetes
Dr. Michael Riddell, York University

9:15 a.m. – 9:45 a.m.

30-minute Discussion with Speakers, Moderators, and Other Participants

9:45 a.m. – 10:55 a.m.

Session VI: Novel Sensing Strategies, Hormone Formulations and Delivery to Optimize CL Systems

Moderators:
Dr. Barry Ginsberg, Diabetes Technology Society
Dr. Jennifer Sherr, Yale University School of Medicine

Innovative Multi-Sensing Techniques Using Long-Term Implantable CGM
Dr. Mukal Jain, Senseonics

Beyond the Glucose-Centric Diabetes Management: The Path to Multiple Sensing
Dr. Alfonso Galderisi, Yale University

How Continuous Ketone Monitoring Can Augment an Automated Insulin Delivery System
Dr. Ketan Dhatariya, Norfolk and Norwich University Hospitals

Design and Validation of a Mechanism-Based Glucose-Responsive Insulin
Dr. Michael Weiss, Indiana University

Ultrafast Insulin and Insulin-Pramlintide Formulations to Improve Closed-Loop Control
Dr. Eric Appel, Stanford University

Why Are Insulin Pharmacokinetics So Variable…The Clinical Need for Consistent Insulin Absorption
Dr. Jeffrey Joseph, Jefferson University

The Impact of Long-Term Insulin Pump Use on the Skin: Results of the DERMIS Study
Dr. Irl Hirsch, University of Washington Medicine Diabetes Institute

10:55 a.m. – 11:25 a.m.

30-minute Discussion with Speakers, Moderators, and Other Participants

11:25 a.m. – 11:40 a.m.

Break

11:40 a.m. – 12:28 p.m.

Session VII: Special Topic: Clinical and Real-World Viability of IP-IP Systems. “Fully Automated Closed-Loop Insulin Delivery Using the IP Route”?

Moderators:
Dr. Anna Casu, Advent Health, Orlando
Dr. Peter Lord, Physiologic Devices

Experience of Closed-Loop Insulin Delivery Using the Peritoneal Route and Perspectives
Dr. Eric Renard, University of Montpellier

The Magic of Intraperitoneal Insulin Delivery
Dr. Rayhan Lal, Stanford University

Technical Challenges of Intraperitoneal Sensing and Delivery
Dr. Chris Hanson, Perikenetics

The European Project FORGETDIABETES: A Fully-Implantable, Fully-Automated Pancreas with IP Insulin Delivery and IP Glucose Sensing
Dr. Claudio Cobelli, University of Padova

12:28 p.m. – 1:00 p.m.

32-minute Discussion with Speakers, Moderators, and Other Participants

1:00 p.m. – 2:30 p.m.

Lunch and Poster Session

2:30 p.m. – 3:40 p.m.

Session VIII: Round Table Panel: Closed-Loop Performance: What to Expect and What Are the Best Metrics to Assess It

Moderators:
Dr. Roy Beck, Jaeb Center for Health Research
Dr. Stuart Weinzimer, Yale University

Round Panel:
Dr. Roy Beck, Jaeb Center for Health Research
Dr. Richard Bergenstal, International Diabetes Center
Dr. David Klonoff, Diabetes Technology Society/Mills Peninsula Medical Center
Dr. Boris Kovatchev, University of Virginia
Dr. Anne Peters, Keck School of Medicine
Dr. Moshe Phillip, Schneider Medical Center
Dr. David Rodbard, Biomedical Informatics
Dr. Robert Vigersky, Medtronic Diabetes

3:40 p.m. – 4:10 p.m.

Session IX: Round Table Discussion: What is Needed for More Adaptable, Accessible, and Usable Future Generation of Systems? How To Promote Equitable Innovation?

Moderators:
Dr. Lori Laffel, Joslin Diabetes Center
Dr. David Kerr, Diabetes Technology Society

Discussants:
Dr. Simon Heller, University of Sheffield
Dr. Desmond Schatz, University of Florida

Patients’ Expectations and Experience When Using AID Systems
Dr. Kellee Miller, T1D Exchange

Implementing Care and Research with Technologies in Under-Resourced Settings
Dr. Anne Peters, Keck School of Medicine

Ethical Issues Associated with The Artificial Pancreas
Dr. Remi Rabasa-Lhoret, McGill University

4:10 p.m. – 5:50 p.m.

General Discussion

Discussion Topics

• Biopsychosocial Drivers and Barriers
• Disparities in Accessibility and Adoption
• Stakeholder Engagement
• Patients’ Perspectives
• Industry Perspective
• Regulatory Considerations
• Payers’ Perspectives

Relevant Discussion Participants

• PwD and Advocates
  Mr. Kyle Banks, PwD, Kyler Cares
  Dr. Anna Casu, PwD, Advent Health
  Dr. Alexis Carmer
  Ms. Kelly Close, PwD, Close Concerns
  Mr. Lane Desborough, Nudge BG, Inc.
  Dr. Carol Haft, National Institute of Diabetes and Digestive and Kidney
  Diseases, National Institutes of Health
  Ms. Julie Heverly, Diatribe
  Mr. Jeff Hitchcock, Children with Diabetes
  Dr. Rayhan Lal, PwD, Stanford University
  Dr. Joanne Milo, The Savvy Diabetic
  Dr. Jennifer Sherr, PwD, Yale University
  Mr. John Sjolund, Luna Health
  Dr. Yao Qin, PwD, University of California, Santa Barbara
  
• Psychosocial/Behavioral
  Dr. Katharine Barnard-Kelly, Barnard Health
  Dr. Maureen Monaghan Center, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health
  Dr. Linda Gonder-Frederick, University of Virginia
  Dr. Korey Hood, PwD, Stanford University
  Dr. Jill Weisberg Benchell, Ann & Robert H. Lurie Children’s Hospital of Chicago
  Dr. Lisa Sharp, University of Illinois Chicago
• Care in Underserved Areas/Approach to Disparities
  Dr. Keisha Bird, Nemours
  Dr. Juan Espinoza, Ann & Robert H. Lurie Children’s Hospital of Chicago
  Dr. Nelly Mauras, Nemours
  Dr. Anne Peters, Keck School of Medicine
  Dr. Devin Steenkamp, Boston Medical Center, Boston University
  Dr. Howard Wolpert, Boston Medical Center, Boston University
• Industry
  Dr. Nauhinal Virdi and Mr. Tim Dunn, Abbot
  Dr. Jan Jezek, Arecor
  Dr. Farshad Teharini, AquilX, Inc.
  Dr. Ed Damiano, Mr. Douglas Ferguson, and Dr. Steven Russell, BetaBionics
  Bigfoot
  Mr. Den Kamen and Mr. Paul Smolenski, Deka
  Dr. Stayce Beck and Dr. Daniel Chernavvsky, Dexcom
  Mr. Luis Blanco and Mr. John Wilcox, Diatech
  Mr. Erik Huneker, Diabeloop
  Dr. Eyal Dassau, Dr. David Duke, Ms. Jennal Johnson, and Dr. Michele
  Katz, Eli Lilly and Company
  Dr. Leon DeJournett, Ideal
  Dr. Muhammad Mujeeb, Integrated Medical Sensors, Inc.
  Mr. Robin Koops, Inreda
  Dr. Trang Ly and Mr. Todd Vienneau, Insulet
  Dr. Robert Vigersky and Dr. Ohad Cohen, Medtronic
  Mr. Christopher Hanson, Perikinetics
  Mr. Peter Lord, Physiologic
  Dr. Christoph Fischer, Roche Diabetes Care
  Dr. Mukul Jain and Mr. Hari Sree, Senseonics
  Dr. Forrest Payne, SFC Fluidics
  Mr. Bryan Maslizh and Dr. Jennifer Schneider, SurfBio
  Dr. Laurel Messer and Dr. Jordan Pinsker, Tandem
  Mr. Howard Look and Ms. Kelly Watson, Tidepool
• Regulatory
  Dr. Hans de Vries, EMA
  Dr. Joshua Balsam and Dr. Jessica Flynn, U.S. Food and Drug Administration
• Payers/Centers for Medicare & Medicaid Services
  CMS – Medical Officer
  Dr. Cynthia Miller, Precision Value
• Funding Agencies, Foundations, Associations
  Dr. Marlon Pragnell, American Diabetes Association
  Dr. David Kerr and Dr. David Klonoff, Diabetes Technology Society
  Ms. Deniz Dalton and Dr. Sean Sullivan, Helmsley Trust
  Dr. Sanjoy Dutta, Dr. Jaime Giraldo, Ms. Campbell Hutton, Dr. Marjana Marinac, and Dr. Jonathan Rosen, JDRF
  Dr. Guillermo Arreaza-Rubin, Dr. Andrew Bremer, Dr. Henry Burch, Dr. Maureen Monaghan Center, Dr. Thomas Eggerman, Dr. Carol Haft, Dr. Barbara Linder, Dr. Pamela Thornton, and Dr. Xujing Wang, National Institutes of Health
  Dr. Osagie Ebekozien, Dr. Kellee Miller, Dr. Caitlin Kelly, and Mr. David Walton, T1D Exchange
• All Investigators and Other Stakeholders Participating in the Meeting

5:50 p.m.

Adjournment