U.S. Department of Health and Human Services

Workshop on Innovation Towards an Artificial Pancreas

4/9/2013 7:00 AM
4/10/2013 7:00 AM
Yes
No
For questions concerning program content, contact:
Guillermo Arreaza-Rubin M.D.
National Institute of Diabetes and Digestive and Kidney Diseases
National Institutes of Health
Two Democracy Plaza, Room 6101
6707 Democracy Boulevard, MSC 5460
Bethesda, MD  20892-5460
Phone: (301) 594-4724
Fax: (301) 480-3503
Email:   arreazag@mail.nih.gov
 
For questions concerning meeting logistics, contact:
John Hare, M.S., CMP, CGMP
The Scientific Consulting Group, Inc. 
656 Quince Orchard Road, Suite 210 
Gaithersburg, MD  20878 
Phone: (301) 670-4990  
Fax: (301) 670-3815  
Email:  jhare@scgcorp.com
Bethesda
 

Event Details

Meeting Objective

Current evidence demonstrates that when glycemic control is not optimized, diabetes imposes additional burdensome care requirements, health care costs, and high risk of disabling complications. It is expected that close to physiological glucose-metabolic control provided by an artificial pancreas will reduce the incidence of acute and chronic complications and significantly improve the quality of life of the individuals affected. As a consequence, further morbidity and mortality also may be prevented. The purpose of this workshop is to have a multidisciplinary discussion of advances and prospective areas of research that would accelerate the development and delivery of a wearable, automated artificial pancreas for individuals with diabetes. It will be focused on the following topics:

  • State of the art: designs, results and challenges from the latest closed loop studies;
  • Learning algorithms with more inputs and fault detection;
  • Improved sensors;
  • New hormones and delivery for improved kinetics;
  • Innovative approaches in closing the loop;
  • Elements for a new generation of devices/technologies.

Organizing Committee:

FDA Arleen Pinkos, M.T.
JDRF Marlon Pragnell, Ph.D.
NIH Guillermo Arreaza, M.D.

Meeting Chairs:

Rich Bergenstal, M.D., Park Nicollet Health Services
Claudio Cobelli, Ph.D., Padova University, Italy
Barry Ginsberg, M.D., Ph.D., Diabetes Technology Consultants
David Klonoff, M.D., Mills Peninsula Health Services
Robert Vigersky, M.D., Walter Reed National Military Medical Center
Kenneth Ward, M.D., Legacy Research Institute
Mike Weiss, M.D., Case Western Reserve University and Thermalin, Inc.
Natalie Wisniewski, Ph.D., Medical Device Consultancy
Todd Zion, Ph.D., Akston Biosciences Corporation
Howard Zisser, M.D., Sansum Diabetes Research Institute

Agenda

Tuesday, April 9, 2013

​ ​
8:00 a.m. Welcome and Introductory Remarks
8:00 a.m. Griffin Rodgers, M.D., Director, National Institute of Diabetes, Digestive, and Kidney Diseases (NIDDK), National Institutes of Health (NIH)
8:05 a.m. Alberto Gutierrez, Ph.D., Director, Office of In Vitro Diagnostic Device Evaluation and Safety, U.S. Food and Drug Administration (FDA)
8:10 a.m. Aaron Kowalski, Ph.D., Vice President, Treat Therapies, JDRF
8:15 a.m.

State of the Art: Designs, Results, and Challenges From the Latest Clinical Studies

Chairs: Robert Vigersky, M.D., Walter Reed National Military Medical Center Rich Bergenstal, M.D., Park Nicollet Health Services

8:15 a.m. Introduction and Overview of Session
8:20 a.m. Predictive Pump Shut-off Approaches
Bruce Buckingham, M.D., Stanford University
8:40 a.m. The Diabetes Assistant Mobile Artificial Pancreas Platform
Boris Kovatchev, Ph.D., University of Virginia
9:00 a.m. Time to Go Home
Roman Hovorka, Ph.D., University of Cambridge, United Kingdom
9:20 a.m. Preliminary Results of a Bihormonal Bionic Pancreas in an Outpatient Setting: The Beacon Hill Study
Edward Damiano Ph.D., Boston University
9:40 a.m. AP@home: Lessons Learned From Clinical Studies on the Way to Daily Life Usage
Lutz Heinemann, Ph.D., Profil Institut für Stoffwechselforschung, Germany
10:00 a.m. Coffee Break and Posters
10:30 a.m. The DREAM Way to Control Overnight Glucose Using the MD-Logic Artificial Pancreas System
Moshe Phillip, M.D., Schneider Children's Medical Center of Israel
10:50 a.m. Multivariable Adaptive Closed-loop Control of an Artificial Pancreas Without Meal and Activity Announcement
Ali Cinar, Ph.D., Illinois Institute of Technology
11:10 a.m. Human Factors That May Influence Clinical Efficacy of Closed-loop Technologies
Linda Gonder-Frederick, Ph.D., University of Virginia Health System
11:30 a.m. FDA Challenges and the Artificial Pancreas
Arleen Pinkos, FDA
11:40 a.m.

Roundtable Discussion

12:30 p.m. Lunch and Posters
1:20 p.m.

New Developments in Modeling, Algorithms, and Technology

Chairs: David Klonoff, M.D., Mills Peninsula Health Services, Claudio Cobelli, Ph.D., Padova University, Italy

1:20 p.m. Introduction/Overview of Session
1:25 p.m. The Type 1 Diabetic Simulator: New Developments for the Artificial Pancreas
Claudio Cobelli, Ph.D., Padova University, Italy
1:40 p.m. Personalized Model-based Algorithms for Controlling the Artificial Pancreas
Frank Doyle, Ph.D., University of California, Santa Barbara
1:55 p.m. Carbohydrate Physiology, Accelerometry Input, and Meal Detection to Personalize a Closed-loop Control System
Ananda Basu, M.D., and Yogish Kudva, M.D., Mayo Clinic
2:15 p.m. Algorithms to Detect Glucose Sensor and Infusion Pump Anomalies
Wayne Bequette, Ph.D., Rensselaer Polytechnic Institute
2:30 p.m. Operating System and Remote Monitoring of the Diabetes Assistant Mobile Artificial Pancreas
Patrick Keith-Hynes, Ph.D., University of Virginia Center for Diabetes Technology
2:45 p.m. m-Health
David Klonoff, M.D., Mills Peninsula Health Services
3:00 p.m. Roundtable Discussion
3:45 p.m. Coffee Break and Posters
4:00 p.m.

Improving Insulin and Non-insulin Hormone Replacement

Chairs: Howard Zisser, M.D., Sansum Diabetes Research Institute, Mike Weiss, M.D., Case Western Reserve University and Thermalin, Inc.

4:00 p.m. Introductions and Overview of Topic
4:05 p.m. Developing Ultra-rapid Insulin Analogs for Closed-loop Applications
Michael Weiss, M.D., Case Western Reserve University and Thermalin, Inc.
4:20 p.m. Ultra-rapid Insulin Use in Closed-loop Artificial Pancreas: Preliminary Clinical Results
Howard Zisser, M.D., Sansum Diabetes Research Institute
4:35 p.m. Microneedle Intradermal Delivery Enables Rapid Insulin Uptake and Effect
Ron Pettis, Ph.D., BD Technologies
4:50 p.m. Next Generation Insulin Delivery CSII Catheters: Optimized Insulin Delivery Using a Continuous Subcutaneous Insulin Infusion (CSII) Catheter
Jeffrey Joseph, D.O., Thomas Jefferson University Hospital
5:05 p.m. Site Delivery Warming to Improve Rapid Acting Insulin Pharmacokinetics and Pharmacodynamics
Eda Cengiz, M.D., Yale University
5:20 p.m. Novel Glucagon Formulations
Steve Prestrelski, Ph.D., Xeris Pharmaceutics
5:35 p.m. Use of Adjunctive Pramlintide to Improve Mealtime Glycemic Excursions During Closed-loop Glucose Control
Stuart Weinzimer, M.D., Yale University
5:50 p.m. Roundtable Discussion
6:30 p.m. Adjourn, First day—Posters
8:00 a.m.

Future Devices and Other Innovative Approaches to Optimize a Closed-loop System

Chairs: Kenneth Ward, M.D., Legacy Research Institute, Barry Ginsberg, M.D., Ph.D., Diabetes Technology Consultants

8:00 a.m. Introductions and Overview of Topic
8:05 a.m. Medtronic's Current and Next Generation Sensing and Delivery Devices
Rajiv Shah, Ph.D., Medtronic
8:20 a.m. Current and Future Dexcom CGM Systems for Artificial Pancreas Applications
Tom Peyser, Ph.D., Dexcom
8:35 a.m. BD's Novel Sensors and Insulin Delivery
Kerstin Rebrin, M.D., Ph.D., BD Medical
8:50 a.m. Pathway to Commercializing Closed-loop Systems
John Mastrototaro, Ph.D., Medtronic
9:05 a.m. Intelligent Catheters That Combine Hormone Delivery With Amperometric Glucose Sensing
Kenneth Ward, M.D., Legacy Research Institute
9:20 a.m. Coffee Break and Posters
9:45 a.m. Afferent Limb Solution: Real-time Blood Glucose via a Noninvasive Sensor
Robert Peura, Ph.D., Grove Instruments
10:00 a.m. Miniaturized Implantable Sensors
Fotios Papadimitrakopoulos, Ph.D., University of Connecticut
10:15 a.m. Long-term, Fully Implanted, Self-contained Subcutaneous Glucose Sensor: Results from Clinical Evaluation and Applicability for Closed-loop Systems
Joe Lucisano, Ph.D., GlySens, Inc.
10:30 a.m. Non-glucose Oxidase-based Sensing Technologies
Natalie Wisniewski, Ph.D., Medical Device Consultancy
10:45 a.m. Feasibility of the Peritoneal Cavity as a Site for Glucose Sensing
Dan Burnett, M.D., Theranova, LLC
11:00 a.m. Contribution of Insulin Sensing to Optimize a CLS
Tania Konry, Ph.D., Massachusetts General Hospital/Harvard Medical School
11:15 a.m. Modeling the Relative Impacts of Protein Biofouling and Cellular Metabolic Effects on Glucose Sensor Performance
William M. Reichert, Ph.D., Duke University
11:35 a.m. Roundtable Discussion
12:50 p.m. Lunch and Posters
1:30 p.m.

Elements for a New Generation of Devices/Technologies

Moderators: Todd Zion, Ph.D., Akston Biosciences Corporation, Natalie Wisniewski, Ph.D., Medical Device Consultancy

1:30 p.m. Introduction and Overview of Topic
1:35 p.m. Closed-loop Insulin Delivery in Diabetic Pigs Using a Smart Biomaterial Device
Margaret Joan Taylor, Ph.D., De Montfort University, United Kingdom
1:50 p.m. Engineering a Cell-based Glucose Monitor
Eric Schreiter, Ph.D., Janelia Farm Research Campus, Howard Hughes Medical Institute
2:05 p.m. Microchip-based Sensing and Delivery
Robert Farra, M.S., MicroCHIPS, Inc.
2:20 p.m. Advancement of the Artificial Pancreas Through the Development of Data and Communication Standards
Joseph Cafazzo, Ph.D., Toronto General Hospital and the University of Toronto
2:35 p.m. Bioartificial Pancreas: Challenges and Opportunities
Cheryl Stabler, Ph.D., University of Miami
2:50 p.m. Hybrid Flexible Electronics
Eric Forsythe, U.S. Army Research Laboratory (Invited)
3:05 p.m. Break
3:15 p.m. Roundtable Discussion: Perspectives for the Future
4:15 p.m. Adjournment

Directions/Travel

Air Travel

Travel arrangements are your own responsibility, but you should know that three airports (listed below) serve the Washington, DC, metropolitan area. Please make your own air or rail reservations.
 
If you decide to extend your stay to take advantage of lower fares, DC-area attractions are only a short distance away from the host hotel.
 
Hotel and travel information are listed below.

Accommodations

A block of sleeping rooms has been reserved at the following hotel:
 
Hyatt Regency Bethesda Hotel
One Bethesda Metro Center
7400 Wisconsin Avenue
Bethesda, MD 20814
Telephone: (301) 657-1234 or (800) 233-1234
Fax: (301) 657-6453
(More hotel information can be obtained from this website.)
 
A limited number of sleeping rooms for conference participants has been reserved at the Hyatt Regency Bethesda Hotel. The rate is the prevailing government rate of $224 per night for single occupancy, plus tax (13%). To reserve a hotel room at the group rate, call reservations at (888) 421-1442 and identify yourself as a member of the Innovation Towards an Artificial Pancreas Meeting, or book online at https://resweb.passkey.com/go/SCGG . THE ROOM BLOCK WILL BE IN EFFECT AT THE GOVERNMENT RATE ONLY UNTIL FRIDAY, MARCH 8, 2013, OR UNTIL FULL, WHICHEVER COMES FIRST. ANY ROOM RESERVATIONS RECEIVED AFTER THIS DATE WILL BE ACCEPTED ON A SPACE- AND RATE-AVAILABILITY BASIS. Reservations should be made for arrival on April 8, 2013, with departure on April 10, 2013. If you require alternate dates, please send an email to John Hare of The Scientific Consulting Group, Inc. (SCG) at jhare@scgcorp.com . Any alternate date requests will need to be approved through the NIDDK.
 
Please be certain that the hotel provides you with a confirmation number for your reservation. After March 8, 2013, the official room block will be released, and the hotel may charge significantly higher rates and may be sold out. When making a reservation, please provide your room and bedding preferences. The hotel will assign specific room types at check-in, based on availability. Please be advised that requests are not guaranteed. Check-in time is 3:00 p.m., and checkout time is 12:00 p.m. If you need to cancel your reservation, please do so by 3:00 p.m. on the day prior to arrival, or you will be charged a no-show fee for 1 night on your credit card.

Taxi Service to Hotel

From Baltimore/Washington International Thurgood Marshall Airport (BWI):
Approximate hotel distance and direction: 35 miles southwest
Estimated Taxi Fare: $65–$75
 
From Washington Dulles International Airport (IAD):
Approximate hotel distance and direction: 25 miles northeast
Estimated Taxi Fare: $55–$65
 
From Ronald Reagan Washington National Airport (DCA):
Approximate hotel distance and direction: 21 miles northeast
Estimated Taxi Fare: $45–$55
 
Barwood Taxi frequents the NIH campus and can be reached at (301) 984-1900 or (800) 831-2323. All three airports have taxis available and waiting.

Metro to the Hotel/NIH

The Metro system is clean and reliable. It operates from 5:00 a.m. to 12:00 midnight on Mondays through Thursdays; 5:00 a.m. to 3:00 a.m. on Fridays; 7:00 a.m. to 3:00 a.m. on Saturdays; and 7:00 a.m. to 12:00 midnight on Sundays. Each passenger must purchase a farecard to travel in the system. Instructions for purchasing farecards are posted on the vending machines in each station. Each Metro car features a complete, color-coded map of the system. Station attendants on duty at each station can provide additional information on request. From Ronald Reagan Washington National Airport, a cost-effective way to travel to the meeting is by using the Metrorail system. A map of the system is available at: http://www.wmata.com/rail/maps/map.cfm .
 
From the Ronald Reagan Washington National Airport station, take the Yellow Line toward Mt. Vernon Square or Fort Totten. At the Gallery Place/Chinatown stop, transfer to the Red Line toward Shady Grove or Grosvenor-Strathmore. For arrival at the hotel, exit at the Bethesda Station. For arrival at the NIH campus, exit at the Medical Center Station, one stop beyond Bethesda.
 
The NIH visitors entrance is directly adjacent to the Medical Center Station. Once through security, it is a short walk to Building 38A (Lister Hill Auditorium), or you may take the campus shuttle.

SuperShuttle

SuperShuttle offers service to most hotels from Ronald Reagan Washington National Airport, Washington Dulles International Airport, and Baltimore/Washington International Thurgood Marshall Airport. The shuttle leaves on an as-needed basis between the hours of 5:30 a.m. and 11:00 p.m. During other times, arrangements for a shuttle can be made by calling (800) 258-3826 from the airport, or visit their website at http://supershuttle.com .

NIH Visitor Information

Building 38A is on Center Drive on the NIH Campus. For a map, general information, and directions to and around the NIH Campus, visit http://www.ors.od.nih.gov/maps/Pages/NIH-Visitor-Map.aspx .

NIH Security

The NIH, like all Federal Government facilities, has instituted security measures to ensure the safety of NIH employees, patients, and visitors. The national threat advisory level, determined by the Department of Homeland Security ( http://www.whitehouse.gov/homeland /), currently is yellow (elevated).

Perimeter Security

All visitor vehicles, including taxicabs, hotel and airport shuttles, delivery trucks, and vans, will be inspected before being allowed on campus. Visitors will be asked to show one (1) form of identification (a government-issued photo ID: driver’s license, passport, green card, etc.) and to state the purpose of their visit. Be sure to allow at least 15–20 minutes for this vehicle inspection procedure.

Building Security

Due to the checking of IDs at the perimeter, employees and visitors will not be required to show their ID again to gain access to the majority of buildings on the NIH Campus during the normal business day.
 
Employees and visitors should continue to wear their identification prominently at all times while on campus.
 
Guards will remain at certain buildings to address specific program requirements, such as sensitive research and safety concerns. At building entrances where guards are posted:
  • Employees must show a U.S. Department of Health and Human Services-issued photo ID (for example, your NIH-issued ID badge).
  • Visitors may be required to log in, wear a visitor's pass, and be escorted by an employee through the building.
  • Visitors may be required to pass through a metal detector and have bags, backpacks, or purses inspected or X-rayed as they enter buildings.
  • Security staff will confiscate any suspicious or potentially dangerous materials. U.S. code prohibits bringing any dangerous weapons onto federal property, including anything with a blade longer than 2½ inches. Meeting participants may want to leave extra bags or personal materials at their hotel to minimize the time needed for inspection.

Weekday Pedestrian Campus Access

All visitors must enter through the NIH Gateway Center at the Metro or the West Gateway Center (see the Visitor Map at http://www.ors.od.nih.gov/maps/Pages/NIH-Visitor-Map.aspx ).
  • Gateway Center
    Wisconsin Avenue at Gateway Drive (near the Metro)
    Open 24 hours, 7 days per week
  • West Gateway Center
    Near Old Georgetown Road and South Drive
    Open 6:00 a.m.–12:00 p.m., Monday-Friday

Driving Directions to NIH

From Points North and East:
Take I-95 South to I-495 West (Capital Beltway) toward Silver Spring. Follow I-495 West for 9 miles to Exit 34 (Bethesda/Wisconsin Avenue). Follow signs for Route 355 South, and stay in the right lane. Travel approximately 1 mile, and turn right on NIH Gateway Drive, just past the light at South Drive. Pass through NIH security, and follow the signs to Building 38A.
 
From Points North and West:
Take I-270 South to I-495 East (Capital Beltway) toward Washington, DC. Stay in one of the three left lanes. Follow signs for Route 355 South, a left-lane exit, onto Wisconsin Avenue. Travel approximately 1 mile, and turn right on NIH Gateway Drive, just past the light at South Drive. Pass through NIH security, and follow the signs to Building 38A.
 
From Points South:
Take I-95 North to I-495 (Capital Beltway) toward Tyson's Corner/Rockville. Follow I-495 for 20 miles. Take Exit 34 (Bethesda/Wisconsin Avenue). Travel approximately 1 mile, and turn right on NIH Gateway Drive, just past the light at South Drive. Pass through NIH security, and follow the signs to Building 38A.
 
From Baltimore/Washington International Thurgood Marshall Airport (BWI):
Take the Route 195 connector to I-95 South. Take I-95 South to I-495 West (Capital Beltway) toward Silver Spring. Follow I-495 West for 9 miles to Exit 34 (Bethesda/Wisconsin Avenue). Follow signs for Route 355 South, and stay in the right lane. Travel approximately 1 mile, and turn right on NIH Gateway Drive, just past the light at South Drive. Pass through NIH security, and follow the signs to Building 38A.
 
From Washington Dulles International Airport (IAD):
Take the Dulles Access Road for approximately 13 miles to Exit 18. Move to the right on the Dulles Toll Road (Route 267) and take Exit 18. Stay left on the ramp for Bethesda/Baltimore, and proceed toward Bethesda (I-495). Continue approximately 9 miles on I-495. Stay on I-495 at the I-495/I-270 split (bear right). Take Exit 34 (Wisconsin Avenue South/Route 355) toward Bethesda. Travel approximately 1 mile, and turn right on NIH Gateway Drive, just past the light at South Drive. Pass through NIH security, and follow the signs to Building 38A.
 
From Ronald Reagan Washington National Airport (DCA):
Take the George Washington Parkway North for 12 miles to I-495 (Capital Beltway) toward Maryland. Take Exit 34 (Bethesda/Wisconsin Avenue). Travel approximately 1 mile, and turn right on NIH Gateway Drive, just past the light at South Drive. Pass through NIH security, and follow the signs to Building 38A.

Parking

Parking on the NIH campus is limited and is $12 per day in the visitor lots. A large parking garage is located at Gateway Center, just outside security. It is a 5-minute walk from there to Building 38A.

Minutes

​Minutes are currently unavailable.

Attendees

​​Attendees are currently unavailable.​

Abstracts

​​Abstracts are currently unavailable.

Location

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  • Lister Hill Auditorium
  • Building 38A, NIH Campus
  • MD 20892
Webinar

Contacts

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For questions concerning program content, contact:
Guillermo Arreaza-Rubin M.D.
National Institute of Diabetes and Digestive and Kidney Diseases
National Institutes of Health
Two Democracy Plaza, Room 6101
6707 Democracy Boulevard, MSC 5460
Bethesda, MD  20892-5460
Phone: (301) 594-4724
Fax: (301) 480-3503
Email:   arreazag@mail.nih.gov
 
For questions concerning meeting logistics, contact:
John Hare, M.S., CMP, CGMP
The Scientific Consulting Group, Inc. 
656 Quince Orchard Road, Suite 210 
Gaithersburg, MD  20878 
Phone: (301) 670-4990  
Fax: (301) 670-3815  
Email:  jhare@scgcorp.com