JSM 2012 Home

JSM 2012 Online Program

The views expressed here are those of the individual authors and not necessarily those of the JSM sponsors, their officers, or their staff.

Online Program Home

Abstract Details

Activity Number: 281
Type: Topic Contributed
Date/Time: Tuesday, July 31, 2012 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract - #306164
Title: Sample Size Calculation and Data Analysis Given Endpoint Choice in Studies of Continuous Glucose Monitors
Author(s): Chava Zibman*+
Companies: FDA
Address: 10903 New Hampshire Ave, Silver Spring, MD, 20993, United States
Keywords: medical devices ; sample size calculation ; diabetes

In studies of continuous glucose monitors (CGMs) and similar devices, multiple observations per subject are obtained at regular or unevenly spaced intervals. It is therefore the case that the sample size calculations and the analyses performed for these studies must account for the auto-correlation structure of the data. Adjustment for repeated measures, however, poses a challenge to many device manufacturers. This presentation will offer a closer look at the design and analysis of studies of monitoring devices and will provide an overview of how sponsors performing these studies might proceed in accounting for repeated measures. Since CGM accuracy may be expressed in terms of the mean absolute difference, mean absolute relative difference, or a binary variable indicating whether the difference between the measurements made by the test device and the reference standard fall within a specified range, we will address cases involving each of these possible endpoints.

The address information is for the authors that have a + after their name.
Authors who are presenting talks have a * after their name.

Back to the full JSM 2012 program

2012 JSM Online Program Home

For information, contact jsm@amstat.org or phone (888) 231-3473.

If you have questions about the Continuing Education program, please contact the Education Department.