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.

This meeting will be 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 will be webcast.

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.

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?

Registration to Attend the Workshop

If you wish to attend this Workshop, you must register by close of business on June 15, 2012.

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 you must indicate this at the time of registration. FDA requests that presentations focus on the areas defined in the Federal Register Notice. 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 require special accommodations due to a disability, or need additional information regarding registration, please contact Susan Monahan, Office of Communications, Education, and Radiation Programs, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 66, Silver Spring, MD 20993, 301-796-5661, FAX: 301-847-8142,

Attendance In-Person


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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