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U.S. Department of Health and Human Services

Medical Devices

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Public Workshop - Innovations in Technology for the Treatment of Diabetes: Clinical Development of the Artificial Pancreas (an Autonomous System), November 10, 2010

The Food and Drug Administration (FDA) in collaboration with the National Institutes of Health (NIH) are announcing a public workshop to facilitate medical device innovation in the development of the Artificial Pancreas (or Autonomous System) for the treatment of Diabetes Mellitus. An Artificial Pancreas is a medical device that links a glucose monitor to an insulin infusion pump where the pump automatically takes action (using a control algorithm) based upon the glucose monitor reading. As control algorithms can vary significantly, there are a variety of Artificial Pancreas Systems currently under development. These systems span a wide range of device design from Low Glucose Suspend device systems to the more complex Bihormonal Control-to-Target systems. Current research in this area use existing medical device technology, which have inherent limitations regarding performance and may pose additional obstacles that need addressed during the clinical evaluation of these investigational systems. FDA and NIH seeks feedback on ways to overcome obstacles towards the development of an artificial pancreas and what might be considered reasonable clinical expectations for systems considering the available existing technology.

The purpose of the workshop is to discuss the current state of device systems for autonomous systems for the treatment of Diabetes Mellitus, the challenges in developing this expert device system using existing technology, a discussion of the clinical expectations for these systems and a discussion of development plans for the transition of this device system toward an outpatient setting.

Date, Time and Location

This meeting was held November 10, 2010, from 7:55am to 5:30pm at the following location:

Hilton Washington DC North/Gaithersburg
620 Perry Parkway
Gaithersburg, MD 20877

The meeting was videotaped and webcasted.

Agenda

Time Session Title Speaker(s)
8:00amWelcome and Introductory RemarksJeff Shuren, M.D., J.D.
Director, Center for Devices and Radiological Health (CDRH)

Roderic Pettigrew, Ph.D., M.D., Director, National Institute of Biomedical Imaging and Bioengineering (NIBIB)

Gregory Germino, M.D., Deputy Director, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

8:30amDevice Limitations Using Existing Technology for the Artificial Pancreas
 
  • Defining the Artificial Pancreas (an Autonomous System for the Treatment of Diabetes Mellitus)
Charles Zimliki, Ph.D., CDRH/Office of Device Evaluation (ODE)
 
  • Continuous Glucose Monitors
Arleen Pinkos, M.T. (ASCP), CDRH/Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
 
  • Insulin Pumps
Alan Stevens, CDRH/ODE
 
  • Pharmacokinetics When Using Insulin and Other Drugs in the Artificial Pancreas
Sally Choe, Ph.D., Center for Drug Evaluation and Research (CDER)
 
  • Comprehensive Safety Analysis Applied to Medical Systems
John Knight, Ph.D., University of Virginia
10:10amClinical Expectations for the Low Glucose Suspend Device Systems
 
  • Low Glucose Suspend (LGS) Device Systems: Goals and Considerations
Patricia Beaston, M.D., Ph.D., CDRH/ODE
 
  • Round-Table Discussion

Moderator: Jeffery Joseph, D.O. (Thomas Jefferson Univeristy)

Table Members:

  • David Klonoff, M.D., Mills-Peninsula Health Services
  • David Klonoff, M.D., Mills-Peninsula Health Services
  • William Tamborlane, M.D., Yale University
  • Bruce Buckingham, M.D., Stanford University
  • Fran Kaufman, M.D., Medtronic
  • lan Irony, M.D., CDER
     
1:30pmClinical Expectations for Artificial Pancreas Device Systems
 
  • Artificial Pancreas Device Systems: Goals and Considerations
Pat Bernhardt, M.T. (ASCP)
 
  • Round-Table Discussion
Moderator: David Klonoff, M.D., Mills-Peninsula Health Services

Table Members:

  • David Nathan, M.D., Harvard University
  • Robert Vigersky, M.D., Walter Reed Health Care System
  • Richard Bergenstal, M.D., International Diabetes Center
  • Henry Anhalt, D.O., Animas
  • John Mastrototaro, Ph.D., Medtronic
  • Ilan Irony, M.D., CDER
  • Patricia Beaston, M.D., Ph.D., CDRH/ODE
     
4:00pmWhat safety information is needed from in clinic studies prior to adding out patient studies?
 
  • Round-Table Discussion

Moderator: Robert Vigersky, M.D., Walter Reed Health Care System

Presenters:

  • Edward Damiano, Ph.D., Boston University
  • Roman Hovorka, Ph.D., University of Cambridge

Table Members:

  • Steven Russell, M.D., Ph.D., Mass General Hospital Diabetes Center
  • William Tamborlane, M.D., Yale University
     
5:10pmFunding Opportunities for Development of the Artificial PancreasGuillermo Arreaza-Rubin, M.D., NIDDK
5:30pmClosing RemarksCharles Zimliki, Ph.D., CDRH/ODE

Webcast

Contacts for Additional Information

For information regarding logistics, registration and special accommodations, contact:

  • Susan Monahan
    Office of Communication, Education, and Radiation Programs
    Center for Devices and Radiological Health
    Food and Drug Administration
    10903 New Hampshire Avenue, Bldg. 66
    Silver Spring, MD 20993
    phone: 301-796-5661
    email: Susan.Monahan@fda.hhs.gov
  • Victoria Wagman
    Office of Center Director
    Center for Devices and Radiological Health
    Food and Drug Administration
    10903 New Hampshire Avenue, Bldg. 66
    Silver Spring, MD 20993
    phone: 301-796-6581
    email: Victoria.Wagman@fda.hhs.gov

For information regarding the program, contact:

  • Charles Zimliki, Ph.D.
    Chair, Critical Path & InterAgency Artificial Pancreas Working Groups
    Division of Anesthesiology, General Hospital, Infection Control & Dental Devices
    Office of Device Evaluation
    Center for Devices and Radiological Health
    Food and Drug Administration
    phone: 301-796-6297
    email: Charles.Zimliki@fda.hhs.gov

 

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