Microsoft Word search phase 3 Title Page Amendment

Burden of Diabetes, Disparities, Clinical Presentation, Patterns of Care, Quality 
of Care 
4.2.2.1.
 
Burden of Diabetes in Youth 
In the year 2001, approximately 3.5 million children less than 20 years of age were 
under surveillance at six SEARCH research centers.  We estimated that 1.8 per 1,000 
youth or at least 154,000 children/youth in the U.S. had diabetes in 2001 
(20)
.  Since 
2002, approximately 5.5 million children less than 20 years of age (about 6% of the 
under 20 years U.S. population), have been under surveillance each year by SEARCH 
research centers to estimate diabetes incidence by type, age, sex, and race-ethnicity.  
The overall incidence of diabetes in 2002 and 2003 was estimated to be 24.3 per 
100,000 per year.  Case ascertainment completeness was 93% across all 4 
geographically based sites.  SEARCH estimated that annually 15,000 youth are 
diagnosed with T1D, and 3,700 youth are diagnosed with T2D 
(5)
.  Additionally, 
SEARCH data indicate that diabetes prevalence and incidence vary across major 
racial/ethnic groups.  The CDC used these data to estimate the number of existing and 
new cases of diabetes in youth that would occur in the US each year 
(
http://www.cdc.gov/diabetes/pubs/pdf/ndfs_2007.pdf
).  
4.2.2.2.
 
Health Disparities 
In March 2009, a Supplement to Diabetes Care was published, entitled, “The Many 
Faces of Diabetes in American Youth: Type 1 and Type 2 Diabetes in Five Race and 
Ethnic Populations”.  This series of SEARCH publications presented a 
comprehensive description of the prevalence and incidence of T1D and T2D, as well 

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Section 4A - Study Objectives/Background and Significance (Phase 3 - 11/2010) 
Section 4A - Page 5 
 Registry 
Study
 
 
as the clinical, behavioral, and socio-demographic characteristics, for each of the five 
race and ethnic groups included in SEARCH 
(21 - 26)
. 
4.2.2.3.
 
Clinical Presentation and Patterns of Care 
Over 50% of youth are hospitalized at onset with diabetes.  One in four children 
newly diagnosed with diabetes suffer from diabetic ketoacidosis (DKA).  Young and 
poor children are more likely to be affected 
(19)
.  
A high percentage of U.S. youth with diabetes do not achieve the recommended 
target levels of glycemic control.  17% of T1D patients (n=3947) and 27% with T2D 
(n=552) had HbA
1c
 levels that reflected poor glycemic control (HbA
1c
 > 9.5%).  
African American, American Indian, Hispanic, and Asian/Pacific Islander youth with 
either T1D or T2D were significantly more likely to have higher HbA
1c
 levels 
compared with non-Hispanic white patients 
(27)
. 
The prevalence of multiple cardiovascular disease (CVD) risk factors was high in 
children and adolescents with diabetes, especially in adolescents with T2D 
(28)
.   
About half of the SEARCH participants had a low-density lipoprotein-C (LDL-C) 
concentration above the optimal level of 100 mg/dL.  In older youth (≥ 10 yrs of age), 
the prevalence of abnormal lipids was higher in type 2 (33%) than in type 1 (19%).  
Only 1% of youth were on pharmacologic therapy for dyslipidemia 
(29)
.  Moreover, 
poorer glycemic control was associated with a worse lipid profile, regardless of 
diabetes type 
(30, 31)
. 
Youth with T2D had a high prevalence (22.2%) of elevated albuminuria in youth with 
T2D, well over twice the percentage for youth with T1D (9.2%).  This suggests the 
possibility of a relatively more rapid progression to diabetes-related vascular 
complications in this population 
(18)
. 
Nutritional intake in adolescents with diabetes was poor and did not follow current 
recommendations.  Recommendations for total dietary fat intake were met by only 10 
percent of youth with diabetes and recommendations for saturated fat intake by only 7 
percent 
(32)
.  In youth with T1D, a higher adherence to DASH diet was inversely 
related to hypertension, independent of demographic, clinical, and behavioral 
characteristics 
(33)
. 
4.2.2.4.
 
Quality of Life (QOL) 
Age, gender, family dynamics and coping skills have been associated with the QOL 
among children and youth with diabetes, while the association between QOL and 
health outcomes such as glycemic control is not well established.  

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Section 4A - Study Objectives/Background and Significance (Phase 3 - 11/2010) 
Section 4A - Page 6 
 Registry 
Study
 
 
About 9% of adolescents with diabetes had moderate or severely depressed mood, 
with more girls than boys being affected.  Depressed mood was associated with 
poorer glycemic control and a higher number of emergency room visits 
(34)
.  
Youth with T1D receiving Medicaid or another government funded insurance 
programs had lower health related quality of life (HRQL) than those with private 
insurance.  HRQL was also higher in youth using an insulin pump as compared to 
those injecting insulin, in those with a HbA
1c
 < 9%, and in those with no co- morbid 
conditions, fewer emergency department visits or hospitalizations 
(35)
. 
4.2.3.