Designing Efficient Clinical Trials for Glucose Sensors Focus of Upcoming FDA Meeting

The US Food and Drug Administration (FDA) is planning an upcoming meeting to discuss the challenges of designing and implementing clinical trial designs for glucose sensors, as well as ways to improve industry efficiency when conducting such trials.

"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," wrote FDA in a Federal Register statement.

The devices, primarily used in hospital settings to obtain continuous or near-continuous information on a patient's glucose concentrations, are not widely available, explained FDA.

FDA implied it hopes to expand the use of the devices by laying out a clear path through the research and development process, and plans to address several topics at an upcoming meeting to spur development of glucose sensors.

Among the general questions FDA intends to address and possibly answer at the meeting:

• How much clinical data and how many studies are needed to adequately validate the performance of a glucose device
• What metrics will be used to evaluate results to demonstrate the safety and effectiveness of a glucose device
• Who is the likely intended use population for the devices
• How will the devices be used in patient management
• How does the intended use of the device affect the design of the clinical studies and the evaluation and adequacy of device performance
• What conditions, medications or therapies have the potential to cause interference and require evaluation
• What kinds of studies or models are appropriate to evaluate interference
• How can the potential differences in blood glucose concentrations be addressed when conducting the clinical studies

The meeting will be held on 25 June 2012 at FDA's White Oak Campus in Silver Spring, Maryland.

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