throbber
National Diabetes Statistics Report, 2017
`Estimates of Diabetes and Its Burden in the United States
`
`Background
`The National Diabetes Statistics Report is a periodic publication of the Centers
`for Disease Control and Prevention (CDC) that provides updated statistics
`about diabetes in the United States for a scientific audience. It includes
`information on prevalence and incidence of diabetes, prediabetes, risk
`factors for complications, acute and long-term complications, deaths, and
`costs. These data can help focus efforts to prevent and control diabetes
`across the United States. This report was previously known as the National
`Diabetes Fact Sheet.
`Methods
`The estimates in this document (unless otherwise noted) were derived from
`various data systems of CDC, the Indian Health Service (IHS), the Agency
`for Healthcare Research and Quality (AHRQ), the U.S. Census Bureau, and
`published studies. The estimated percentages and the total number of
`people with diabetes and prediabetes were derived from the National
`Health and Nutrition Examination Survey (NHANES), National Health
`Interview Survey (NHIS), IHS National Data Warehouse (NDW), Behavioral
`Risk Factor Surveillance System (BRFSS), United States Diabetes Surveillance
`System (USDSS), and U.S. resident population estimates.
`
`Numbers and rates for acute and long-term complications of diabetes were
`derived from the National Inpatient Sample (NIS) and National Emergency
`Department Sample (NEDS), as well as NHIS. Diagnosed diabetes was
`determined by self-report among survey respondents and by diagnostic
`codes for American Indians and Alaska Natives who accessed IHS, tribal, or
`Urban Indian health facilities that submitted data to the IHS NDW.
`
`Both fasting glucose and hemoglobin A1C (A1C) levels were used to derive
`estimates for undiagnosed diabetes and prediabetes. An alpha level of 0.05
`was used when assessing statistical differences between groups.
`
`Most estimates of diabetes in this report do not differentiate between
`type 1 and type 2 diabetes. However, because type 2 diabetes accounts for
`90% to 95% of all diabetes cases, the data presented are likely to be more
`characteristic of type 2 diabetes. More detailed information about data
`sources and methods is available in the Appendix.
`
`I
`
`•
`
`Fast Facts on
`Diabetes
`30.3 million people
`have diabetes
`(9.4% of the U.S. population)
`
`a
`
`Diagnosed
`23.1 million people
`
`Undiagnosed
` 7.2 million
`(23.8% of people with
`diabetes are undiagnosed)
`
`CS279910-A
`
`National Center for Chronic Disease Prevention and Health Promotion
`Division of Diabetes Translation
`
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`2 | National Diabetes Statistics Report, 2017
`
`Results
`Prevalence of Both Diagnosed and Undiagnosed Diabetes
`• An estimated 30.3 million people of all ages—or 9.4% of the U.S. population—had diabetes in 2015 (Methods).
`
`• This total included 30.2 million adults aged 18 years or older (12.2% of all U.S. adults), of which 7.2 million (23.8%)
`were not aware of or did not report having diabetes (Table 1) (Methods).
`
`• The percentage of adults with diabetes increased with age, reaching a high of 25.2% among those aged 65 years
`or older (Table 1).
`
`• Compared to non-Hispanic whites, the age-adjusted prevalence of diagnosed and undiagnosed diabetes was
`higher among Asians, non-Hispanic blacks, and Hispanics during 2011–2014 (see Table 1a in the Appendix for
`more details).
`
`Table 1. Estimated number and percentage of diagnosed and undiagnosed diabetes among adults aged ≥18
`years, United States, 2015
`
`Characteristic
`
`Total
`Age in years
`18–44
`
`45–64
`
`≥65
`Sex
`Women
`
`Men
`
`Total
`Age in years
`18–44
`
`45–64
`
`≥65
`Sex
`Women
`
`Men
`
`Diagnosed diabetes
`No. in millions
`(95% CI)a
`23.0 (21.1–25.1)
`
`Undiagnosed diabetes
`No. in millions
`(95% CI)a
`7.2 (6.0–8.6)
`
`3.0 (2.6–3.6)
`
`10.7 (9.3–12.2)
`
`9.9 (9.0–11.0)
`
`11.7 (10.5–13.1)
`
`11.3 (10.2–12.4)
`Percentage
`(95% CI)b
`9.3 (8.5–10.1)
`
`2.6 (2.2–3.1)
`
`12.7 (11.1–14.5)
`
`20.8 (18.8–23.0)
`
`9.2 (8.2–10.3)
`
`9.4 (8.5–10.3)
`
`1.6 (1.1–2.3)
`
`3.6 (2.8–4.6)
`
`2.1 (1.4–3.0)
`
`3.1 (2.4–4.1)
`
`4.0 (3.0–5.5)
`Percentage
`(95% CI)b
`2.9 (2.4–3.5)
`
`1.3 (0.9–2.0)
`
`4.3 (3.3–5.5)
`
`4.4 (3.1–6.3)
`
`2.5 (1.9–3.2)
`
`3.4 (2.5–4.6)
`
`Total diabetes
`No. in millions
`(95% CI)a
`30.2 (27.9–32.7)
`
`4.6 (3.8–5.5)
`
`14.3 (12.7–16.1)
`
`12.0 (10.7–13.4)
`
`14.9 (13.5–16.4)
`
`15.3 (13.8–17.0)
`Percentage
`(95% CI)b
`12.2 (11.3–13.2)
`
`4.0 (3.3–4.8)
`
`17.0 (15.1–19.1)
`
`25.2 (22.5–28.1)
`
`11.7 (10.6–12.9)
`
`12.7 (11.5–14.1)
`
`CI = confidence interval.
`a Numbers for subgroups may not add up to the total because of rounding.
`b Data are crude, not age-adjusted.
`Data source: 2011–2014 National Health and Nutrition Examination Survey and 2015 U.S. Census Bureau data.
`
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`National Diabetes Statistics Report, 2017 | 3
`
`;
`
`0.1
`
`Prevalence of Diagnosed Diabetes
`Among people of all ages, 2015 data indicated the
`following:
`• An estimated 23.1 million people—or 7.2% of the
`U.S. population—had diagnosed diabetes (Methods)
`(see Table 1b in the Appendix for more details).
`
`• This total included:
` » 132,000 children and adolescents younger than age
`18 years (0.18% of the total U.S. population younger than
`age 18 years).
` » 193,000 children and adolescents younger than age
`20 years (0.24% of the total U.S. population younger
`than age 20 years).
`
`• About 5% of people with diabetes are estimated to have
`type 1 diabetes (Methods).
`
`•
`
`Among U.S. adults aged 18 years or older, age-adjusted
`data for 2013–2015 indicated the following:
`• American Indians/Alaska Natives had the highest prevalence
`of diagnosed diabetes for both men (14.9%) and women
`(15.3%) (Figure 1) (Methods). Prevalence varied by region, from
`6.0% among Alaska Natives to 22.2% among American Indians
`in certain areas of the Southwest.
`
`• Overall, prevalence was higher among American Indians/Alaska Natives (15.1%), non-Hispanic blacks (12.7%), and
`people of Hispanic ethnicity (12.1%) than among non-Hispanic whites (7.4%) and Asians (8.0%) (see Table 1c in
`the Appendix for more details).
`
`• Among people of Hispanic ethnicity, Mexicans had the highest prevalence (13.8%), followed by Puerto Ricans
`(12.0%), Cubans (9.0%), and Central/South Americans (8.5%) (see Table 1c in the Appendix for more details).
`
`• Among Asians, Asian Indians had the highest prevalence (11.2%), followed by Filipinos (8.9%), and Chinese (4.3%).
`Other Asian groups had a prevalence of 8.5% (see Table 1c in the Appendix for more details).
`
`• Prevalence varied significantly by education level, which is an indicator of socioeconomic status. Specifically,
`12.6% of adults with less than a high school education had diagnosed diabetes versus 9.5% of those with a high
`school education and 7.2% of those with more than a high school education (see Table 1c in the Appendix for
`more details).
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`4 | National Diabetes Statistics Report, 2017
`
`Figure 1. Estimated age-adjusted prevalence of diagnosed diabetes by race/ethnicity and sex among adults
`aged ≥18 years, United States, 2013–2015
`
`14.9%
`
`15.3%
`
`I
`12.2%
`
`13.2%
`
`12.6%
`
`I
`11.7%
`
`I
`I
`
`9.0%
`
`7.3%
`
`AI/AN = American Indian/
`Alaska Native.
`
`Note: Error bars represent
`upper and lower bounds of
`the 95% confidence interval.
`
`Data source: 2013–2015
`National Health Interview
`Survey, except American
`Indian/Alaska Native data,
`which are from the 2015
`Indian Health Service
`National Data Warehouse.
`
`8.1%
`
`6.8%
`
`Men
`
`Women
`
`15
`
`10
`
`5
`
`0
`
`Percentage
`
`AI/AN
`
`Asian
`
`Black, non-Hispanic
`Race/Ethnicity
`
`Hispanic
`
`White, non-Hispanic
`
`Figure 2 shows model-based county-level estimates of the age-adjusted prevalence of diagnosed diabetes among
`U.S. adults aged 20 years or older in 2013 (Methods). Specifically, this figure shows that:
`
`• The median age-adjusted county-level prevalence of diagnosed diabetes was 9.4%, with a range of 3.8% to 20.8%.
`
`• Counties in the southern and Appalachian regions of the United States tended to have the highest prevalence of
`diagnosed diabetes.
`
`Figure 2. Age-adjusted, county-level prevalence of diagnosed diabetes among adults aged ≥20 years,
`United States, 2013
`
`2013 Diagnosed Diabetes Prevalence
`
`■
`
`a
`
`a
`■
`
`i
`
`I■
`11111 or •
`
`To.
`
`'511>
`
`Percentage in quintiles
`
` 0-7.83
`
` 7.84-8.80
`8.81-9.96
` 9.97-11.65
`211.66
`
`
`
`Puerto Rico
`
`Data source: United States Diabetes Surveillance System. https://www.cdc.gov/diabetes/atlas/countydata/atlas.html
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`National Diabetes Statistics Report, 2017 | 5
`
`Incidence of Diagnosed Diabetes
`Incidence Among Adults
`•
`In 2015, an estimated 1.5 million new cases of
`diabetes (6.7 per 1,000 persons) were diagnosed
`among U.S. adults aged 18 years or older (Table 2)
`(Methods).
`
`• More than half of these new cases were among
`adults aged 45 to 64 years, and the numbers were
`about equal for men and women (Table 2).
`
`• Non-Hispanic blacks (9.0 per 1,000 persons) and
`people of Hispanic origin (8.4 per 1,000 persons)
`had a higher age-adjusted incidence compared
`to non-Hispanic whites (5.7 per 1,000 persons)
`during 2013–2015 (see Table 2a in the Appendix for
`more details).
`
`• Age-adjusted incidence was about 2 times higher
`for people with less than a high school education
`(10.4 per 1,000 persons) compared to those with
`more than a high school education (5.3 per 1,000
`persons) during 2013–2015 (see Table 2a in the
`Appendix for more details).
`
`4
`
`t
`
`Table 2. Estimated incidence of diabetes among adults aged ≥18 years, United States, 2015
`
`Characteristic
`Total
`Age in years
`18–44
`
`45–64
`
`≥65
`Sex
`Women
`
`Men
`
`No. in thousands (95% CI)a
`1,530 (1,402–1,658)
`
`Rate per 1,000 (95% CI)b
`6.7 (6.2–7.3)
`
`355 (289–420)
`
`809 (714–905)
`
`366 (310–422)
`
`787 (694–880)
`
`743 (645–840)
`
`3.1 (2.6–3.8)
`
`10.9 (9.6–12.2)
`
`9.4 (8.0–10.9)
`
`6.8 (6.0–7.6)
`
`6.7 (5.9–7.7)
`
`CI = confidence interval.
`a Numbers for subgroups may not add up to the total because of rounding.
`b Rates are crude, not age-adjusted.
`Data source: 2013–2015 National Health Interview Survey, 2011–2014 National Health and Nutrition Examination Survey, and 2015 U.S. Census
`Bureau data.
`
`Figure 3 shows model-based county-level estimates of the age-adjusted incidence of diagnosed diabetes among
`U.S. adults aged 20 years or older in 2013 (Methods). Specifically, this figure shows that:
`
`• The median age-adjusted county-level incidence of diagnosed diabetes was 8.2 per 1,000 persons, with a
`range of 3.1 to 21.9 per 1,000 persons.
`
`• Similar to the geographic pattern of the prevalence of diagnosed diabetes, counties in the southern and
`Appalachian regions of the United States tended to have the highest incidence.
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`6 | National Diabetes Statistics Report, 2017
`
`Figure 3. Age-adjusted, county-level incidence of diagnosed diabetes among adults aged ≥20 years,
`United States, 2013
`
`2013 Diagnosed Diabetes Incidence
`
`a
`
`Rate per 1,000 in quintiles
`
`b
`
`Note: Data unavailable for U.S. territories.
`Data source: United States Diabetes Surveillance System. https://www.cdc.gov/diabetes/atlas/countydata/atlas.html
`
`
`
`0-6.60
`6.61-7.75
` 7.76-8.78
`8.79-10.41
`210.42
`
`rsr
`11g
`1110
`
`Incidence Among Children and Adolescents
`Data from the SEARCH for Diabetes in Youth Study1
`indicated that:
`
`• During 2011–2012, the estimated annual number
`of newly diagnosed cases in the United States
`included:
`
` » 17,900 children and adolescents younger than
`age 20 years with type 1 diabetes.
`
` » 5,300 children and adolescents age 10 to 19
`years with type 2 diabetes.
`
`• Among children and adolescents younger than age
`20 years, non-Hispanic whites had the highest rate of
`new cases of type 1 diabetes compared to members
`of other U.S. racial and ethnic groups (Figure 4).
`
`• Among children and adolescents aged 10 to 19
`years, U.S. minority populations had higher rates
`of new cases of type 2 diabetes compared to
`non-Hispanic whites (Figure 4).
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`Figure 4. Incidence of type 1 and type 2 diabetes by race/ethnicity, 2011–2012
`
`Type 1 diabetes (age 0 to 19 years)
`
`Type 2 diabetes (age 10 to 19 years)
`
`National Diabetes Statistics Report, 2017 | 7
`
`50
`
`40
`
`30
`
`20
`
`10
`
`0
`
`Rate per 100,000
`
`Total
`
`NHW
`
`NHB
`
`H
`
`API
`
`AI
`
`Total
`
`NHB
`
`H
`
`NHW
`
`50
`
`40
`
`30
`
`20
`
`10
`
`0
`
`Rate per 100,000
`
`II I.
`
`API
`
`AI
`
`NHW = non-Hispanic whites, NHB = non-Hispanic blacks, H = Hispanics, API = Asians/Pacific Islands, AI = American Indians.
`
`Note: American Indian (AI) youth who participated in the SEARCH study are not representative of all AI youth in the United States. Thus, these rates cannot be
`generalized to all AI youth nationwide.
`
`Data source: SEARCH for Diabetes in Youth Study.
`
`Prevalence of Prediabetes
`• An estimated 33.9% of U.S. adults aged 18 years or older (84.1 million people) had prediabetes in 2015, based
`on their fasting glucose or A1C level. Nearly half (48.3%) of adults aged 65 years or older had prediabetes
`(Table 3) (Methods).
`
`• Among adults with prediabetes, 11.6% reported being told by a health professional that they had this condition
`(Table 3).
`
`• Age-adjusted data for 2011–2014 indicated that more men (36.6%) than women (29.3%) had prediabetes.
`Prevalence of prediabetes was similar among racial and ethnic groups (see Table 3a in the Appendix for
`more details).
`
`Table 3. Estimated number, percentage, and awareness of prediabetes among adults aged ≥18 years,
`United States, 2015
`
`Characteristic
`
`Total
`Age in years
`18–44
`
`45–64
`
`≥65
`Sex
`Women
`
`Men
`
`No. in millions
`(95% CI)a
`
`84.1 (78.0–90.4)
`
`27.4 (24.5–30.6)
`
`34.3 (31.5–37.2)
`
`23.1 (21.1–25.1)
`
`39.5 (36.0–43.3)
`
`44.5 (40.5–48.7)
`
`Percentage
`(95% CI)b
`
`33.9 (31.5–36.5)
`
`23.7 (21.1–26.4)
`
`40.9 (37.5–44.3)
`
`48.3 (44.2–52.5)
`
`31.1 (28.3–34.0)
`
`36.9 (33.6–40.4)
`
`Percentage aware of
`prediabetes
`(95% CI)a,c
`11.6 (9.9–13.6)
`
`8.2 (5.8–11.5)
`
`12.9 (10.2–16.1)
`
`14.1 (10.5–18.6)
`
`14.1 (11.3–17.6)
`
`9.4 (6.6–13.3)
`
`CI = confidence interval.
`a Numbers for subgroups may not add up to the total because of rounding.
`b Data are crude, not age-adjusted.
`c Among those with prediabetes.
`Data source: 2011–2014 National Health and Nutrition Examination Survey and 2015 U.S. Census Bureau data.
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`8 | National Diabetes Statistics Report, 2017
`
`Risk Factors for Complications
`Risk factor data for 2011–2014 for U.S. adults aged 18 years
`or older with diagnosed diabetes indicated the following
`(Methods):
`
`Smoking
`• 15.9% (95% confidence interval [CI], 13.9%–18.1%) of adults
`were current smokers, and 34.5% (95% CI, 31.7%–37.3%)
`had quit smoking but had a history of smoking at least 100
`cigarettes in their lifetime.
`
`Overweight and Obesity
`• 87.5% (95% CI, 84.8%–89.7%) of adults were overweight or
`obese, defined as a body mass index (BMI) of 25 kg/m2 or
`higher. Specifically:
`
` » 26.1% (95% CI, 23.2%–29.3%) of adults were overweight
`(BMI of 25.0 to less than 30.0 kg/m2).
`
` » 43.5% (95% CI, 39.6%–47.6%) of adults had obesity (BMI
`of 30.0 to less than 40.0 kg/m2).
`
` » 17.8% (95% CI, 14.8%–21.3%) of adults had severe obesity
`(BMI of 40.0 kg/m2 or higher).
`
`Physical Inactivity
`• 40.8% (95% CI, 36.8%–45.0%) of adults were physically inactive, defined as getting less than 10 minutes a week of
`moderate or vigorous activity in each of the physical activity categories of work, leisure time, and transportation.
`
`High Blood Pressure
`• 73.6% (95% CI, 69.9%–77.1%) of adults had systolic blood pressure of 140 mm Hg or higher or diastolic blood
`pressure of 90 mm Hg or higher, or they were on prescription medication for high blood pressure.
`
`High Cholesterol (Hyperlipidemia)
`• 58.2% (95% CI, 49.7%–66.3%) of adults aged 21 years or older with no self-reported cardiovascular disease but who
`were eligible for statin therapy were on a lipid-lowering medication (see Table 4a in the Appendix for more details).
`
`• 66.9% (95% CI, 58.5%–74.4%) of adults aged 21 years or older with self-reported cardiovascular disease who were
`thus eligible for statin therapy were on a lipid-lowering medication.
`
`High Blood Glucose (Hyperglycemia)
`• 15.6% (95% CI, 13.2%–18.3%) of adults had an A1C value higher than 9%.
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`National Diabetes Statistics Report, 2017 | 9
`
`Coexisting Conditions and Complications
`Hospitalizations
`In 2014, a total of 7.2 million hospital discharges
`were reported with diabetes as any listed diagnosis
`among U.S. adults aged 18 years or older (Table 4)
`(Methods). These discharges included the following:
`
`• 1.5 million for major cardiovascular diseases
`(70.4 per 1,000 persons with diabetes), including:
`
` » 400,000 for ischemic heart disease (18.3 per
`1,000 persons with diabetes).
`
` » 251,000 for stroke (11.5 per 1,000 persons
`with diabetes).
`
`• 108,000 for a lower-extremity amputation
`(5.0 per 1,000 persons with diabetes).
`
`• 168,000 for diabetic ketoacidosis (7.7 per 1,000 persons with diabetes).
`
`Table 4. Number and rate of hospitalizations among adults aged ≥18 years with diagnosed diabetes for selected
`causes, United States, 2014
`
`Cause of hospitalization
`
`No. in thousands
`
`Diabetes as any listed diagnosis
`
`Major cardiovascular disease
`
`Ischemic heart disease
`
`Stroke
`
`Lower-extremity amputation
`
`Diabetic ketoacidosis
`
`CI = confidence interval.
`Data source: United States Diabetes Surveillance System.
`
`7,155
`
`1,539
`
`400
`
`251
`
`108
`
`168
`
`Crude rate per 1,000 persons with
`diabetes (95% CI)
`327.2 (311.3–343.1)
`
`70.4 (66.8–73.9)
`
`18.3 (17.3–19.3)
`
`11.5 (10.9–12.1)
`
`5.0 (4.7–5.2)
`
`7.7 (7.3–8.1)
`
`Emergency Department Visits
`In 2014, a total of 14.2 million emergency department visits were reported with diabetes as any listed diagnosis
`among adults aged 18 years or older (Table 5), including:
`
`• 245,000 for hypoglycemia (11.2 per 1,000 persons with diabetes).
`
`• 207,000 for hyperglycemic crisis (9.5 per 1,000 persons with diabetes).
`
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`
`Mylan Ex. 1044
`Mylan v. Sanofi - IPR2018-01676
`
`

`

`National Diabetes Statistics Report, 2017 | 11
`
`Acknowledgments
`The following organizations provided content and helped compile data for this report:
`
`• Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health
`Promotion, Division of Diabetes Translation
`
`• Indian Health Service, Division of Diabetes Treatment and Prevention
`
`• National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases
`
`The following organizations collaborated on the content of this report:
`
`• American Diabetes Association
`
`• JDRF
`
`References
`1. Mayer-Davis EJ, Lawrence JM, Dabelea D, et al. Incidence trends of type 1 and type 2 diabetes among youths, 2002–2012.
`N Engl J Med. 2017;376:1419–1429.
`
`2. Murphy D, McCulloch CE, Lin F, et al. Trends in prevalence of chronic kidney disease in the United States. Ann Intern Med.
`2016;165:473–481.
`
`3. Centers for Disease Control and Prevention. Chronic Kidney Disease (CKD) Surveillance Project website.
`https://nccd.cdc.gov/CKD/default.aspx. Accessed June 16, 2017.
`
`4. United States Renal Data System. 2016 USRDS Annual Data Report: Epidemiology of Kidney Disease in the United States.
`Bethesda, MD: National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health; 2016.
`
`5. Centers for Disease Control and Prevention. About Underlying Cause of Death 1999–2015. CDC WONDER Database.
`http://wonder.cdc.gov/ucd-icd10.html. Updated December 2016. Accessed April 4, 2017.
`
`6. American Diabetes Association. Economic costs of diabetes in the U.S. in 2012. Diabetes Care. 2013;36(4):1033–1046.
`
`Suggested Citation
`Centers for Disease Control and Prevention. National Diabetes Statistics Report, 2017. Atlanta, GA: Centers for
`Disease Control and Prevention, U.S. Dept of Health and Human Services; 2017.
`
`Mylan Ex. 1044
`Mylan v. Sanofi - IPR2018-01676
`
`

`

`12 | National Diabetes Statistics Report, 2017
`
`Appendix
`Detailed Tables
`This section provides additional data for Tables 1–3, Figure 1, and the High Cholesterol (Hyperlipidemia) section
`under Risk Factors for Complications of the National Diabetes Statistics Report, 2017.
`
`Table 1a. Age-adjusted prevalence of diagnosed and undiagnosed diabetes among adults aged ≥18 years,
`United States, 2011–2014
`
`Characteristic
`
`Total
`Sex
`Women
`
`Men
`Race/Ethnicity
`Asian, non-Hispanic
`
`Black, non-Hispanic
`
`Hispanic
`
`White, non-Hispanic
`Education
`Less than high school
`
`High school
`
`More than high school
`
`Diagnosed diabetes
`Percentage (95% CI)
`8.7 (8.1–9.4)
`
`Undiagnosed diabetes
`Percentage (95% CI)
`2.7 (2.3–3.3)
`
`Total
`Percentage (95% CI)
`11.5 (10.7–12.4)
`
`8.5 (7.5–9.5)
`
`9.1 (8.4–9.9)
`
`10.3 (8.6–12.4)
`
`13.4 (12.2–14.6)
`
`11.9 (10.3–13.7)
`
`7.3 (6.6–8.1)
`
`11.4 (9.9–13.1)
`
`10.3 (8.8–12.0)
`
`7.4 (6.6–8.4)
`
`2.3 (1.8–3.1)
`
`3.2 (2.4–4.3)
`
`5.7 (4.0–8.2)
`
`4.4 (3.0–6.2)
`
`4.5 (3.2–6.2)
`
`2.0 (1.5–2.6)
`
`4.1 (3.0–5.6)
`
`3.2 (2.4–4.2)
`
`2.2 (1.6–3.0)
`
`10.8 (9.8–11.9)
`
`12.3 (11.3–13.4)
`
`16.0 (13.6–18.9)
`
`17.7 (15.8–19.9)
`
`16.4 (14.1–18.9)
`
`9.3 (8.4–10.2)
`
`15.5 (13.5–17.7)
`
`13.5 (11.9–15.2)
`
`9.6 (8.6–10.7)
`
`CI = confidence interval.
`Data source: 2011–2014 National Health and Nutrition Examination Survey.
`
`Table 1b. Estimated prevalence of diagnosed diabetes among the total population and among children and
`adolescents, United States, 2015
`
`Characteristic
`Total
`Age in years
`<18
`
`<20
`
`No. (95% CI)
`23,131,000 (22,555,000–23,706,000)
`
`Percentage (95% CI)
`7.20 (7.02–7.38)
`
`132,000 (92,000–172,000)
`
`193,000 (140,000–246,000)
`
`0.18 (0.13–0.24)
`
`0.24 (0.18–0.31)
`
`CI = confidence interval.
`Note: Data rounded to nearest thousand and not age-adjusted.
`Data source: 2013–2015 National Health Interview Survey and 2015 U.S. Census Bureau data.
`
`Mylan Ex. 1044
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`

`National Diabetes Statistics Report, 2017 | 13
`
`Table 1c. Age-adjusted prevalence of diagnosed diabetes by race/ethnicity, education level, and sex among
`adults aged ≥18 years, United States, 2013–2015
`
`Characteristic
`
`Race/Ethnicity
`American Indian/Alaska Native
`
`Asian, non-Hispanic, overall
`
`Asian Indian
`
`Chinese
`
`Filipino
`
`Other Asian
`
`Black, non-Hispanic
`
`Hispanic, overall
`
`Central/South American
`
`Cuban
`
`Mexican
`
`Puerto Rican
`
`White, non-Hispanic
`Education
`Less than high school
`
`High school
`
`More than high school
`
`Total Percentage
`(95% CI)
`
`Men Percentage
`(95% CI)
`
`Women Percentage
`(95% CI)
`
`15.1 (15.0–15.2)
`
`8.0 (7.3–8.9)
`
`11.2 (9.1–13.7)
`
`4.3 (3.2–5.9)
`
`8.9 (7.4–10.8)
`
`8.5 (7.1–10.0)
`
`12.7 (12.1–13.4)
`
`12.1 (11.4–12.7)
`
`8.5 (7.3–10.0)
`
`9.0 (7.1–11.4)
`
`13.8 (13.0–14.8)
`
`12.0 (10.5–13.7)
`
`7.4 (7.2–7.6)
`
`12.6 (11.9–13.2)
`
`9.5 (9.1–10.0)
`
`7.2 (7.0–7.5)
`
`14.9 (14.8–15.0)
`
`9.0 (7.6–10.5)
`
`12.2 (9.1–16.2)
`
`6.2 (4.1–9.1)
`
`9.1 (6.8–11.9)
`
`8.9 (6.9–11.4)
`
`12.2 (11.3–13.1)
`
`12.6 (11.6–13.5)
`
`8.5 (6.6–10.8)
`
`11.6 (8.0–16.5)
`
`14.2 (12.9–15.7)
`
`12.2 (10.0–14.9)
`
`8.1 (7.8–8.5)
`
`12.2 (11.3–13.1)
`
`10.1 (9.5–10.8)
`
`7.9 (7.5–8.3)
`
`15.3 (15.2–15.3)
`
`7.3 (6.4 –8.3)
`
`10.0 (7.4–13.3)
`
`2.8 (1.8–4.4)
`
`8.9 (7.1–11.2)
`
`8.2 (6.5–10.2)
`
`13.2 (12.4–14.0)
`
`11.7 (10.9–12.5)
`
`8.8 (7.2–10.7)
`
`5.9 (3.7–9.3)
`
`13.5 (12.5–14.7)
`
`11.8 (9.8–14.1)
`
`6.8 (6.5–7.1)
`
`13.0 (12.2–13.9)
`
`9.2 (8.6–9.8)
`
`6.6 (6.3–6.9)
`
`CI = confidence interval.
`Data source: 2013–2015 National Health Interview Survey, except American Indian/Alaska Native data, which were from the 2015 Indian Health
`Service National Data Warehouse.
`
`Table 2a. Age-adjusted incidence of diagnosed diabetes among adults aged ≥18 years, United States, 2013–2015
`
`Characteristic
`Race/Ethnicity
`Asian, non-Hispanic
`
`Black, non-Hispanic
`
`Hispanic
`
`White, non-Hispanic
`Education
`Less than high school
`
`High school
`
`More than high school
`
`CI = confidence interval.
`Data source: 2013–2015 National Health Interview Survey and 2015 U.S. Census Bureau data.
`
`Rate per 1,000 (95% CI)
`
`6.0 (4.2–8.6)
`
` 9.0 (7.4–10.9)
`
`8.4 (7.2–9.8)
`
`5.7 (5.0–6.4)
`
`10.4 (8.8–12.4)
`
`7.8 (6.6–9.2)
`
`5.3 (4.7–5.9)
`
`Mylan Ex. 1044
`Mylan v. Sanofi - IPR2018-01676
`
`

`

`14 | National Diabetes Statistics Report, 2017
`
`Table 3a. Age-adjusted prevalence of prediabetes among adults aged ≥18 years, United States, 2011–2014
`
`Characteristic
`
`Total
`Sex
`Women
`
`Men
`Race/Ethnicity
`Asian, non-Hispanic
`
`Black, non-Hispanic
`
`Hispanic
`
`White, non-Hispanic
`Education
`Less than high school
`
`High school
`
`More than high school
`
`Percentage with prediabetes
`(95% CI)
`33.0 (30.6–35.5)
`
`Percentage reporting awareness
`of prediabetes (95% CI)
`10.6 (9.0–12.6)
`
`29.3 (26.8–31.8)
`
`36.6 (33.2–40.0)
`
`35.7 (33.0–38.5)
`
`36.3 (33.3–39.4)
`
`31.7 (28.4–35.2)
`
`31.5 (28.3–34.9)
`
`37.6 (33.2–42.3)
`
`37.0 (33.8–40.3)
`
`30.4 (27.6-33.4)
`
`13.3 (10.0–17.4)
`
`8.9 (6.2–12.4)
`
`9.0 (5.9–13.6)
`
`10.5 (7.9–13.9)
`
`7.5 (4.4–12.5)
`
`11.3 (8.9–14.1)
`
`9.3 (6.7–12.9)
`
`12.4 (8.0–18.8)
`
`10.4 (8.2–13.0)
`
`CI = confidence interval.
`Note: Percentage reporting awareness is a subset of adults with prediabetes.
`Data source: 2011–2014 National Health and Nutrition Examination Survey.
`
`Table 4a. Rates of eligibility for statin therapy and treatment with lipid-lowering medication by cardiovascular
`disease prevention stage among adults aged ≥21 years with diagnosed diabetes, United States, 2011–2014
`
`Cardiovascular disease
`prevention stage
`
`Percentage (95% CI) of adults who
`were eligible for statin therapy
`
`Among eligible adults, percentage
`(95% CI) on lipid-lowering therapy
`
`Primarya
`
`Secondaryb
`
`75.2 (68.7–80.8)
`
`23.3 (18.9–28.3)
`
`58.2 (49.7–66.3)
`
`66.9 (58.5–74.4)
`
`CI = confidence interval.
`a Defined as adults aged 40–75 years with no self-reported cardiovascular disease or adults aged 21–39 years with no self-reported cardiovascular
`disease and a low-density lipoprotein cholesterol level ≥190 mg/dL, according to 2013 guidelines from the American College of Cardiology and
`American Heart Association.
`b Defined as adults with self-reported cardiovascular disease, according to 2013 guidelines from the American College of Cardiology and American
`Heart Association.
`Data source: 2011–2014 National Health and Nutrition Examination Survey.
`
`Mylan Ex. 1044
`Mylan v. Sanofi - IPR2018-01676
`
`

`

`National Diabetes Statistics Report, 2017 | 15
`
`Data Sources and Methods
`This section provides additional details about data sources and methods used in the National Diabetes Statistics
`Report, 2017.
`
`Prevalence of Both Diagnosed and Undiagnosed Diabetes Among People of
`All Ages, United States, 2015
`Data Sources
`• 2011–2014 National Health and Nutrition Examination Survey (NHANES), National Center for Health Statistics,
`Centers for Disease Control and Prevention.
`
`• 2013–2015 National Health Interview Survey (NHIS), National Center for Health Statistics, Centers for Disease
`Control and Prevention.
`
`• Annual Estimates of the Resident Population by Single Year of Age and Sex for the United States: April 1, 2010 to
`July 1, 2015, Population Division, U.S. Census Bureau.
`
`Methods
`The total number of people with diabetes is the sum of the number of those aged 18 years or older with diagnosed
`or undiagnosed diabetes and the number of those younger than age 18 years with diagnosed diabetes. Estimates
`of undiagnosed diabetes for children and adolescents younger than age 18 years are not available. The 2011–2014
`NHANES was used to calculate the percentage of adults aged 18 years or older with diagnosed and undiagnosed
`diabetes (see next section for detail). The 2013–2015 NHIS was used to calculate the percentage of children
`and adolescents younger than 18 years with diagnosed diabetes. These percentages were then applied to the
`corresponding July 1, 2015 U.S. resident population estimates from the U.S. Census Bureau to derive the total
`number of people with diabetes.
`
`Applying 2011–2014 NHANES estimates to the 2015 U.S. resident population estimates has limitations. This
`methodology assumes that the prevalence of diabetes in 2015 was the same as it was in earlier periods
`(2011–2014) and that the prevalence of diabetes in the resident population was identical to those in the civilian,
`noninstitutionalized population (from NHANES). Deviations from these assumptions may result in overestimated or
`underestimated numbers and rates.
`
`Prevalence of Both Diagnosed and Undiagnosed Diabetes Among Adults
`Aged 18 Years or Older, United States, 2015
`Data Sources
`• 2011–2014 National Health and Nutrition Examination Survey (NHANES), National Center for Health Statistics,
`Centers for Disease Control and Prevention.
`
`• Annual Estimates of the Resident Population by Single Year of Age and Sex for the United States: April 1, 2010 to
`July 1, 2015, Population Division, U.S. Census Bureau.
`
`Methods
`The percentage of adults aged 18 years or older with diabetes (diagnosed or undiagnosed) was obtained using
`2011–2014 NHANES data. People who self-reported being told by a doctor or health professional that they had
`diabetes (other than during pregnancy) were classified as having diagnosed diabetes. Those not reporting a history
`of diagnosed diabetes but who had ei

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