Public Workshop - Innovations in Technology for the Treatment of Diabetes: Clinical Development of the Artificial Pancreas (an A
Posted Oct 11 2010 9:00pm
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.
This meeting will be 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 will be videotaped and webcasted.
Welcome and Introductory Remarks
Defining the Artificial Pancreas and the limitations using existing technology
Clinical Expectations for the Low Glucose Suspend Device Systems
Clinical Expectations for Artificial Pancreas Device Systems
What safety information is needed from in clinic studies prior to adding out patient studies?
If you wish to attend this Workshop, you must register by close of business on November 3, 2010.
There is no fee to register for the Workshop and registration will be on a first-come, first-served basis. Early registration is recommended because seating is limited.
If you wish to make an oral presentation during any of the open comment sessions at the meeting (see section II of this document), you must indicate this at the time of registration. FDA requests that presentations focus on the areas defined in section III of this document. You should also identify which discussion topic you wish to address in your presentation and you must submit a brief statement that describes your experience and/or expertise relevant to your proposed presentation. In order to keep each open session focused on the discussion topic at hand, each oral presentation should address only one discussion topic. FDA will do its best to accommodate requests to speak.
If you need special accommodations due to a disability, please contact Susan Monahan at 301-796-5661, at email@example.com at least 7 days in advance of the meeting.
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