This proposal describes the development, implementation and maintenance of a data coordinating center (CoC) for the second phase of the SEARCH for Diabetes in Youth Study. The SEARCH study CoC is being proposed by a team of investigators from the Wake Forest University School of Medicine (WFUSM) in response to an RFA from the Centers for Disease Control and Prevention entitled, "Incidence, Natural History, and Quality of Life of Diabetes in Youth" (RFA-DP-05-069). WFUSM is well positioned to serve in this capacity, having served as the CoC for the first phase of the SEARCH study since 2001. This study was a six-center study examining the prevalence, incidence, and clinical presentation of diabetes among youth 0 - 19years by diabetes type, ethnicity, gender and age, since 2001. Data from over 10,000 youth, representing prevalent cases in 2001 and incident cases in 2002 - 2005 atthe six SEARCH centers (South Carolina, Cincinnati, Seattle, Southern California, Colorado, Hawaii), is currently being stored and analyzed by the WFUSM SEARCH CoC. The WFUSM will provide statistical and operational support to address the following study aims proposed by the original SEARCH clinic sites for the second phase of SEARCH: (1) to prospectively ascertain newly diagnosed (2006-2008) incident diabetes cases in children/youth <20 years of age and collect data that permits estimation of temporal trends in diabetes incidence by age-group, gender, race/ethnicity anddiabetes type for the period 2002 - 2008;(2)to conduct longitudinal follow-up of incident cases already recruited to SEARCH in 2003 - 2005 in order to document the evolution of newly diagnosed diabetes according to clinical and biochemical factors and characterize the evolution of key risk factors for diabetes complications, according to diabetes type and race/ethnicity;(3) to assess the impact of quality of diabetes care in youth on short- and long-term outcomes including quality of life by completing analytic work initiated in SEARCH as described in the Quality of Care Roadmap and expanding the scope of quality of care assessment initiated in SEARCH in order to explore the interrelationships of patient characteristics, important domains of health care with outcomes, including glycemic control, satisfaction with care, receipt of recommended services, complications, and quality of life;and (4) to develop and validate simple and low- cost case definitions and classifications of diabetes types in youth that can be used for public health surveillance. Additionally, the WFUSM CoC will develop a plan to secure a central laboratory for the SEARCH study for storage and analysis of blood and urine sample and storage of DNA for ancillary studies. This phase of the SEARCH study will build on the knowledge gained in the first phase of the study, and will provide valuable clinical and public health information to address the growing problem of childhood diabetes.

U01DP000250

2005-09-30

2011-09-29