Microsoft Word search phase 3 Title Page Amendment

4.
 
Study Objectives & Background and Significance 
4.1.
 
SEARCH REGISTRY STUDY OBJECTIVES 
4.1.1.
 
Goals 
SEARCH for Diabetes in Youth originally began in 2000 as a multi-center, 
epidemiological study, conducted in six geographically dispersed Study Centers that 
encompassed the racial and ethnic diversity of the U.S.  The study was designed to 
estimate the prevalence and incidence of diabetes among youth age < 20 years, according 
to diabetes type, age, sex, and race/ethnicity, and to characterize selected acute and 
chronic complications of diabetes and their risk factors, as well as the quality of life and 
quality of health care.  Major strengths of SEARCH include 1) race/ethnic diversity 
within the large cohort of youth with type 1 diabetes (T1D); and 2) size and diversity of 
the cohort of youth with type 2 diabetes (T2D).  In addition, SEARCH has substantially 
contributed to the understanding of the etiologic and clinical dimensions of childhood 
diabetes that relate to classification of diabetes.  Critical questions remain regarding 
ongoing trends in incidence of childhood diabetes, as well as the rationale and 
sustainability of public health surveillance systems for diabetes in youth.  SEARCH is 
exceptionally strongly positioned to address these questions through its well-established 
infrastructure and surveillance system, and its highly experienced, collaborative and 
multi-disciplinary investigative team. 
The SEARCH for Diabetes in Youth Registry Study in SEARCH Phase 3 will continue to 
ascertain newly diagnosed incident diabetes cases in youth age < 20 years across five 
geographically dispersed Study Centers (Ohio, Colorado, Washington, South Carolina, 
and California) in order to accomplish the Specific Aims shown below. 
Aim 1:  To continue to ascertain newly diagnosed (2010 - 2014) incident diabetes cases 
in youth age < 20 years in order to assess temporal trends in diabetes incidence 
and temporal trends in presentation of diabetes for the period 2002-2014, by age, 
sex, race/ethnicity, and diabetes type. 
Research Question 1.1:  What is the temporal trend of Type 1 Diabetes (T1D) 
incidence in US youth and how does this differ by race/ethnicity, age, and gender? 
Research Question 1.2:  What is the temporal trend of Type 2 Diabetes (T2D) 
incidence in US youth and how does this differ by race/ethnicity, age, and gender? 
Research Question 1.3:  Are there temporal changes in the clinical characteristics at 
onset of diabetes in youth and how do these differ by a) clinical diabetes type (T1D 
versus T2D); b) race/ethnicity (non-Hispanic white versus minority); and c) sex 
(males versus females)? 

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Section 4A - Study Objectives/Background and Significance (Phase 3 - 11/2010) 
Section 4A - Page 2 
 Registry 
Study
 
 
Specific characteristics to be examined are: age at onset of diabetes, markers of 
disease severity (diabetic ketoacidosis, residual insulin secretion, HbA
1c
), 
immunogenetic markers (diabetes autoantibodies, HLA risk genotypes), markers of 
insulin sensitivity (insulin sensitivity score, waist circumference, body mass index), 
cardio-vascular risk factors (lipid profile, blood pressure, microalbuminuria). 
Aim 2:  To provide consultation and support to inform the development of low-cost 
sustainable public health surveillance systems of childhood diabetes in the U.S., 
with a focus on challenges in ascertainment of cases with T2D and cases among 
older youth (ages 15 years or older) with any form of non-gestational diabetes.  
Research Question 2.1:  Within the SEARCH surveillance system, what factors 
contribute to time from diagnosis to case ascertainment?  Can an extended period of 
time to case ascertainment be accounted for by the time to receipt of specialty care or 
hospitalization?  Are there temporal changes in time to case ascertainment?  
Research Question 2.2:  Within and across health care systems, using the same case 
ascertainment algorithm, are patterns of care different for youth with T2D or older 
youth with any type of diabetes, around the time of clinical diagnosis, and thereafter?  
Are there temporal changes in observed differences, both within and across systems?