sample size requirements for studies of treatment effects on beta-cell function in newly diagnosed type 1 diabetes样本量要求治疗对β细胞功能影响的研究在新诊断出患1型糖尿病.pdfVIP

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sample size requirements for studies of treatment effects on beta-cell function in newly diagnosed type 1 diabetes样本量要求治疗对β细胞功能影响的研究在新诊断出患1型糖尿病.pdf

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sample size requirements for studies of treatment effects on beta-cell function in newly diagnosed type 1 diabetes样本量要求治疗对β细胞功能影响的研究在新诊断出患1型糖尿病

Sample Size Requirements for Studies of Treatment Effects on Beta-Cell Function in Newly Diagnosed Type 1 Diabetes 1 1 2 3 4{ John M. Lachin *, Paula L. McGee , Carla J. Greenbaum , Jerry Palmer , Mark D. Pescovitz , Peter 5 6 Gottlieb , Jay Skyler , Type 1 Diabetes Trial Network 1The Biostatistics Center, The George Washington University, Rockville, Maryland, United States of America, 2 Benaroya Research Institute, Seattle, Washington, United States of America, 3 Department of Medicine, University of Washington, Seattle, Washington, United States of America, 4 Department of Surgery and Microbiology/ Immunology, Indiana University Medical Center, Indianapolis, Indiana, United States of America, 5 Barbara Davis Center for Childhood Diabetes, University of Colorado Health Sciences Center, Denver, Colorado, United States of America, 6 Diabetes Research Institute, University of Miami School of Medicine, Miami, Florida, United States of America Abstract Preservation of b-cell function as measured by stimulated C-peptide has recently been accepted as a therapeutic target for subjects with newly diagnosed type 1 diabetes. In recently completed studies conducted by the Type 1 Diabetes Trial Network (TrialNet), repeated 2-hour Mixed Meal Tolerance Tests (MMTT) were obtained for up to 24 months from 156 subjects with up to 3 months duration of type 1 diabetes at the time of study enrollment. These data provide the information needed to more accurately determine the sample size needed for future studies of the effects of new agents on