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U.S. Department of Health and Human Services

Medical Devices

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Public Meeting - Clinical Study Design and Performance of Hospital Glucose Sensors, June 25, 2012

The Food and Drug Administration (FDA) is announcing a public Meeting entitled "Clinical Study Design and Performance of Hospital Glucose Sensors." The purpose of the meeting is to discuss clinical study design considerations and performance metrics for innovative glucose sensors intended to be used in hospital point of care settings.

Date, Time and Location

This meeting was held June 25, 2012, beginning at 8:00 a.m. – 5:00 p.m. at the following location:

FDA White Oak Campus
0903 New Hampshire Ave.
Building 31 Conference Center (Great Room, Room 1503)
Silver Spring, MD 20993

The meeting was webcast.

Background

FDA is seeking input from the clinical community, academia, Government, industry, clinical laboratories, and other stakeholders regarding clinical validation studies and performance criteria for innovativehospital glucose sensors. These types of devices are intended to be used at the patient bedside, and are different from currently available glucose sensors in that they are generally indwelling or inserted. Furthermore, they are often designed to collect continuous or near-continuous glucose concentrations for each patient.

These devices have the potential to benefit patient care but to date they are not widely available. This is due, in part, to the challenges in designing and studying these complex devices. One challenge is the study design itself; determining the types of patients to include and what data are needed to adequately validate performance is often difficult given the varied hospital environment and patient populations. Once the study is complete, determining whether or not the results are sufficiently accurate and reliable for the proposed intended use(s) is equally challenging.

The purpose of this public meeting is to share information about the challenges in validating these kinds of hospital glucose sensors and solicit public input and discussion. The feedback may increase communication and collaboration within the stakeholder community, and, ultimately, help overcome some of the current challenges associated with designing clinical studies and generating clinical performance data for these devices.

The public meeting will include 2 sessions of the following topics: (1) The clinical studies and data needed to adequately validate the performance of these devices in the intended use population and (2) discussion of metrics that may be used to evaluate results to demonstrate a safe and effective device. Each session will include presentations from physicians, Government, and other experts in the field. Presentations will be followed by panel discussions of session topics and questions from the audience.

Topics for Discussion at the Public Meeting

The following questions represent the kinds of topics that will be discussed at the meeting. The final questions to be discussed at each session will be available the day of the meeting.

1. Who is the likely intended use population for these devices and how will they be used in patient management? For example, will they be used for general hospital, surgical, critically ill, pediatric patients, etc.? What are the study considerations for evaluating the devices in these different populations?

2. How does the intended use of the device affect the design of the clinical studies and the evaluation and adequacy of device performance? For example, are the accuracy needs for a device used to monitor trends over time different from the accuracy needs of one where the individual glucose results are used to replace discrete glucose measurements? Is greater accuracy needed when the device is used in certain populations? What metrics can be used to evaluate whether or not results from these devices are sufficiently accurate and reliable for the proposed intended use(s)?

3. What conditions, medications or therapies have the potential to cause interference and require evaluation? What kinds of studies/models are appropriate to evaluate interference?

4. Differences in glucose concentrations may be observed when testing arterial and venous blood samples from the same patient. How can the potential differences in blood glucose concentrations be addressed when conducting the clinical studies?

Agenda

TimeEvent
7:00 - 8:00 am Registration
8:00 - - 8:05 am Welcome:
Vicki Moyer,
Scientific Reviewer, Division of Chemistry and Toxicology Devices, Center for Devices and Radiological Health, Silver Spring, Maryland
8:05 - 8:10 am Opening Remarks:
Alberto Gutierrez, Ph.D,
Director Office of In Vitro Diagnostic Device Evaluation and Safety, Center for Devices and Radiological Health, Silver Spring, Maryland
8:10 - 8:20 am Overview of FDA considerations for hospital glucose sensors
Vicki Moyer,

Scientific Reviewer, Division of Chemistry and Toxicology Devices, Center for Devices and Radiological Health, Silver Spring, Maryland
8:20 - 8:25 am Topic 1: Clinical Study Design
Moderator: Arleen Pinkos, M.T. (ASCP),
Scientific Reviewer,Division of Chemistry and Toxicology Devices, Center for Devices and Radiological Health, Silver Spring, Maryland
8:25 - 9:05 am Presentation:
Clinical Study Design and Performance of Hospital Glucose Sensors

Jeff I Joseph, D.O.
Director of Research, Department of Anesthesiology, Jefferson Medical College of Thomas Jefferson University, Director, Jefferson Artificial Pancreas Center, Anesthesiology Program for Translational Research
9:05 - 9:35 am Presentation:
Hospital - based CGM: Should we validate by patient or by condition?
Michael AgusM.D.
Director, Medicine Critical Care Program
Medical Director, Intermediate Care Program
Medical Director, Medicine Intensive Care Unit, Boston Children’s Hospital
9:35 - 9:50 am Break
9:50 - 11:15 am Topic 1: Clinical Study Design
Panel Discussion and Q&A
Panelists:
Jeff Joseph, D.O.
Michael Agus, M.D.
Brian Hipszer, Ph.D.Assistant Research Professor, Department of Anesthesiology, Artificial Pancreas Center at Thomas Jefferson University
Mikhail Kosiborod, MD, FACC, FAHAAssociate Professor of Medicine, St. Luke’s Mid America Heart Institute and University of Missouri - Kansas City
Courtney Lias, Ph.D Director, Division of Chemistry and Toxicology Devices, Center for Devices and Radiological Health, Silver Spring, Maryland
11:15 am - 12:30 pm Lunch on your own
12:30 pm - 12:35 pm Welcome back/Announcements:
Vicki Moyer,
Scientific Reviewer, Division of Chemistry and Toxicology Devices, Center for Devices and Radiological Health, Silver Spring, Maryland
12:35 - 1:40 pm Public comment session
Moderator: Arleen Pinkos, M.T. (ASCP),
Scientific Reviewer, Division of Chemistry and Toxicology Devices, Center for Devices and Radiological Health, Silver Spring, Maryland
1:45 - 1:50 pm Topic 2: Performance expectations for hospital glucose sensors
Moderator: David Klonoff,M.D., F.A.C.P.

Clinical Professor of Medicine, U.C. San Francisco, Editor - in - Chief, Journal of Diabetes Science and Technology, Medical Director, Diabetes Research Institute
Mills - Peninsula Health Services
1:50 - 2:10 pm Presentation
FDA Perspectives on Accuracy and Performance of Hospital Glucose Sensors
Denise Johnson - Lyles,
Ph.D.,
Scientific Reviewer, Division of Chemistry and Toxicology Devices, Center for Devices and Radiological Health, Silver Spring, Maryland
2:10 - 2:30 pm Presentation
Clinical perspective on performance and accuracy

Howard Wolpert, M.D
Senior Physician, Section of Adult Diabetes, Joslin Diabetes Center/Harvard Medical School, Director of the Insulin Pump and Continuous Glucose Monitoring Programs, Joslin in Boston, Massachusetts
2:30 - 2:50 pm Presentation
Methods of evaluating accuracy
Marc Breton, Ph.D.,

Associate Professor, Center for Diabetes Technology Research
University of Virginia Health System
2:50 - 3:05 pm Break
3:05 - 4:05 pm Topic 2 Panel Discussion:
Performance expectations for hospital glucose sensors
Panelists:
Denise Johnson - Lyles, Ph.D
Howard Wolpert, M.D
Marc Breton, Ph.D.
Jeff Joseph, D.O.
Ulrike Holzinger, MD Associate Professor of Medicine,Division of Gastroenterology and Hepatology Intensive Care Unit, Medical University of Vienna, Vienna, Austria.
Christine Kessler MN,CNS, ANP, BC - ADM Nurse practitioner and advanced diabetes specialist, Diabetes Institute at Walter Reed National Military Medical Center at Bethesda Maryland and the Endocrinology Dept at Fort Belvoir Community Hospital in Virginia.
James Krinsley MD, FCCM, Director of Critical Care at Stamford Hospital and Clinical Professor of Medicine at the Columbia University College of Physicians and Surgeons.
4:05 pm FDA Closing remarks:
Courtney Lias, Ph.D.,
Director, Division of Chemistry and Toxicology Devices, Center for Devices and Radiological Health, Silver Spring, Maryland
 

Public Hearing Presentations

 

 

Transcript

Webcast

An online webcast archive of this event is available:

Contact Us

For questions regarding workshop content please contact:

Vicki Moyer
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Ave., Bldg. 66, Rm. 5626
Silver Spring, MD 20993
301-796-6148, FAX: 301-847-8513
email: vicki.moyer@fda.hhs.gov