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Supplement: Diabetes Translation and Public Health: 25 Years of CDC Research and Programs |

The Evolving Diabetes Burden in the United States FREE

Michael M. Engelgau, MD, MS; Linda S. Geiss, MS; Jinan B. Saaddine, MD, MPH; James P. Boyle, PhD; Stephanie M. Benjamin, PhD; Edward W. Gregg, PhD; Edward F. Tierney, MPH; Nilka Rios-Burrows, MPH; Ali H. Mokdad, PhD; Earl S. Ford, MD; Giuseppina Imperatore, MD, PhD; and K. M. Venkat Narayan, MD, MPH
[+] Article and Author Information

From the National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention, Atlanta, Georgia.


Potential Financial Conflicts of Interest: None disclosed.

Requests for Single Reprints: Michael M. Engelgau, MD, MS, Centers for Disease Control and Prevention, Mailstop K-10, 4770 Buford Highway NE, Atlanta, GA 30341; e-mail, mxe1@cdc.gov.

Current Author Addresses: Drs. Engelgau, Saaddine, Boyle, Benjamin, Gregg, Mokdad, Ford, Imperatore, and Narayan; Ms. Geiss and Rios-Burrows; and Mr. Tierney: Centers for Disease Control and Prevention, Mailstop K-10, 4770 Buford Highway NE, Atlanta, GA 30341.


Ann Intern Med. 2004;140(11):945-950. doi:10.7326/0003-4819-140-11-200406010-00035
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Diabetes was first described in ancient times with the cardinal symptoms of polyuria, polydipsia, and polyphagia (1). The use of uniform diagnostic criteria provided a means to reliably track the disease and unveiled a worldwide epidemic that emerged during the second half of the 20th century and is now extending into the 21st century (24). This report examines the evolution of the diabetes epidemic in the United States and the burden imposed by its complications.

There are 3 major types of diabetes (5). Type 1 diabetes usually involves children and was previously called insulin-dependent diabetes mellitus or juvenile-onset diabetes. It develops when the body's immune system destroys pancreatic β cells, which make insulin. Type 1 diabetes accounts for 5% to 10% of all diagnosed cases of diabetes in the United States. Type 2 diabetes, previously called noninsulin-dependent diabetes mellitus or adult-onset diabetes, usually begins as insulin resistance, in which target tissues do not use insulin properly. It accounts for approximately 90% to 95% of all diagnosed cases of diabetes. Gestational diabetes is glucose intolerance diagnosed during pregnancy with return to a normal metabolic state after delivery. Other, lesser types of diabetes result from specific genetic conditions (such as maturity-onset diabetes of youth), surgery, drugs, malnutrition, infections, and other illnesses; these account for 1% to 5% of all diagnosed cases of diabetes (5).

Uniform diagnostic criteria for diabetes were first recommended by the American Diabetes Association and the World Health Organization in 1979 and 1980 and were updated in the late 1990s (56). Currently, when typical symptoms of diabetes are present (for example, polyuria, polydipsia, or unexplained weight loss), a casual (that is, at any time without regard to the last meal) plasma glucose level of 11.1 mmol/L (200 mg/dL) or greater confirms the diagnosis. In addition, the diagnosis can be made with a fasting plasma glucose level of 7.0 mmol/L (126 mg/dL) or greater or an oral glucose tolerance test with a 2-hour value of 11.0 mmol/L (200 mg/dL) or greater. A positive diagnostic test result should be followed by a repeated test on a different day to confirm the clinical diagnosis. In contrast, for epidemiologic studies, a single fasting plasma glucose or 2-hour oral glucose tolerance test measurement is used to estimate the prevalence of diabetes in a population.

Currently, 3 periodic national surveys track diabetes prevalence in the United States. The National Health Interview Survey and National Health and Nutrition Examination Survey (NHANES) use national population-based samples and query persons in face-to-face interviews about whether they have been told by their health care provider that they have diabetes. A third survey, the Behavioral Risk Factors Surveillance System, asks a similar question of state-based population samples during telephone interviews of residents. Unlike the other 2 surveys, NHANES includes a laboratory-based examination that measures glucose levels and identifies persons with undiagnosed diabetes. All 3 surveys provide national estimates of the prevalence of diagnosed diabetes. Only the Behavioral Risk Factors Surveillance System provides state-based estimates, and only NHANES provides estimates of undiagnosed diabetes.

Prevalence

In 2002, an estimated 6.3% of the U.S. population (about 18.2 million persons) had diabetes (7). Diabetes affects various sociodemographic groups unequally. According to data from the National Health Interview Survey, persons 65 years of age or older make up almost 40% of all persons with diagnosed diabetes, and the prevalence in this age group is more than 10 times that in persons younger than 45 years of age (8). Minority race and ethnic groups, including black persons, Hispanic persons, and Native Americans, are disproportionately affected; the prevalence of diagnosed diabetes is generally 2 to 4 times higher in these groups than in the majority population (Figure 1) (78).

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Figure 1.
Prevalence of diagnosed diabetes in people 20 years of age and older by age and race or ethnicity, United States, 2002.

Data obtained from the 1999 to 2001 National Health Interview Survey estimates projected to 2002 and the 2002 outpatient database of the Indian Health Service.

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The longest running of the surveys, the National Health Interview Survey, found a 4- to 8-fold increase over the last half-century in the number of persons who received a diagnosis of diabetes (1.6 million in 1958 and 12.1 million in 2000) and the prevalence of diagnosed diabetes in the United States (0.9% in 1958 and 4.4% in 2000) (Figure 2) (89). Increases occurred across all demographic categories, including sex, race or ethnicity, and age (8). Between 1990 and 2001, data from the Behavioral Risk Factors Surveillance System indicate that the largest relative increases in diagnosed diabetes occurred in persons 30 to 39 and 40 to 49 years of age (95% and 83%, respectively); increases in other age groups were 40% in persons 18 to 29 years of age, 49% in persons 50 to 59 years of age, 42% in persons 60 to 69 years of age, and 33% in persons 70 years of age or older (1011). Although the magnitude of the increase varied, the prevalence of diagnosed diabetes among adults increased in every state in the United States (Figure 3). Trends are also disturbing in children and adolescents, in whom type 2 diabetes is increasingly being recognized, but as yet less commonly than type 1 diabetes (12). Studies of estimates of the incidence of type 1 diabetes in the United States, which are limited by sparse data, do not find a consistent pattern—some show an increase, some show a decrease, and some remain unchanged (13).

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Figure 2.
Prevalence of diagnosed diabetes and the number of people with diagnosed diabetes in the United States, 1958 to 2000.

Data obtained from the National Health Interview Survey.

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Figure 3.
Prevalence of diagnosed diabetes (including gestational diabetes) by state in the United States, 1990 to 2001.

Data obtained from the Behavioral Risk Factors Surveillance System survey.

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The NHANES found that diabetes is undiagnosed in approximately one third of all persons with diabetes and that this fraction has changed little over time (14). Many factors may have affected these uptrends in the prevalence of diabetes, including changes in diagnostic criteria, improved or enhanced detection, decreasing mortality, changes in demographic characteristics of the population (for example, aging), and growth in minority populations in whom the prevalence and incidence of diabetes are increasing.

Morbidity
Cardiovascular Disease

Data on cardiovascular disease among the diabetic population are scant. However, in 2000, 37.2% of diabetic persons age 35 years and older reported receiving a diagnosis of a cardiovascular disease (8). Prevalence of ischemic heart disease among persons with diabetes was about 14 times the rate among those without diabetes in persons 18 to 44 years of age (2.7% vs. 0.2 %), 3 times as high in persons 45 to 64 years of age (14.3% vs. 4.7%), and almost twice as high in those 65 years of age or older (20% vs. 12%) (15). Other studies have shown that the absolute rates of cardiovascular disease in persons with diabetes are higher in men than in women (as in the general population), but the relative risk (comparing those with and without diabetes) is higher in women than in men (relative risk, 2 to 4 for women and 1.5 to 2.5 for men) (1617).

Eye, Kidney, and Lower-Extremity Disease

Visual impairment and blindness are major disabling complications of diabetes. Diabetic retinopathy, the leading cause of blindness (visual acuity ≤ 20/200) in persons age 20 to 64 years, accounts for 12% of all new cases of blindness and leads to 12 000 to 24 000 new cases each year in the United States (18). Considerable visual impairment (best corrected [for example, with glasses] visual acuity in either eye < 20/40) among persons with diabetes is much more common than blindness and is associated with reduced functional status. A national population-based survey based on self-reports found that 25% of all persons with diabetes had considerable visual impairment, approximately double the proportion among persons without diabetes (19). Impairment among persons with diabetes can have several causes. Some are specific to diabetes, such as macular edema and diabetic retinopathy, and others are not specific to diabetes but occur more commonly in diabetic than in nondiabetic persons. Examples of conditions not specific to diabetes are cataracts (32% vs. 20% in persons 65 to 74 years of age) and glaucoma (6.0% vs. 2.3% in persons 65 to 74 years of age) (2023).

In the United States in 2000, diabetic nephropathy accounted for more than 40% of new cases of end-stage renal disease (that is, kidney failure that requires dialysis or transplantation) (8). Persons with diabetes are the fastest-growing group of recipients of dialysis and transplantation (8). Several factors may account for the increase in incidence, including greater recognition of the etiologic role of diabetes, more use of treatments for end-stage renal disease, a true increase in the incidence of diabetes-related end-stage renal disease, or a combination of these factors.

Lower-extremity disease, which includes peripheral neuropathy and peripheral arterial disease or both, results in elevated rates of lower-extremity amputations among persons with diabetes. An estimated 15% of persons with diabetes will have a diabetic foot ulcer during their lifetime (24); of these, 6% to 43% will ultimately undergo a lower-extremity amputation (25). Among persons with diabetes who have had an amputation, as many as 85% may have had a preceding foot ulcer (25). Currently, more than half of all nontraumatic lower-extremity amputations in the United States occur among people with diagnosed diabetes (8).

An analysis of the 1999 to 2000 NHANES found that an estimated 8.1% of the diabetic population age 40 years or older have peripheral arterial disease (defined as an ankle to brachial artery blood pressure ratio < 0.90) versus 4.0% in those without diabetes (26). People with diabetes also had 2 to 3 times the prevalence of peripheral neuropathy symptoms (29.9% vs. 10.2%), insensate feet (on the basis of monofilament testing, 26.4% vs. 14.0%), or either peripheral neuropathy or insensate feet (45.3% vs. 20.7%). In summary, 47.4% of people with diabetes had at least one lower-extremity condition (peripheral arterial disease, peripheral neuropathy, insensate feet, ulcer, or lower-extremity amputation) (26).

Acute Metabolic Complications

Diabetic ketoacidosis is an acute metabolic complication that may require hospitalization and even result in death. The number of hospitalizations in the United States for which diabetic ketoacidosis was listed as the first diagnosis increased from 61 800 in 1980 and 99 913 hospitalizations in 2001 (8). Deaths due to diabetic ketoacidosis are rare and have declined between 1980 and 2000 by 28% (32 to 23 per 100 000 diabetic population) (8). Population-based data on the occurrence of hypoglycemia are scant, but 2 major clinical trials that carefully assessed its significance found that intensive glycemic control increases the risk for hypoglycemia. The United Kingdom Prospective Diabetes Study examined intensive glycemic control among persons with type 2 diabetes and found that the rate of major hypoglycemia (that is, at a minimum requiring attention from persons other than the patient) was significantly more common in those treated intensively with insulin than in those receiving conventional care (1.8% versus 0.7%; P < 0.001). The Diabetes Control and Complications Trial studied intensive glycemic control among persons with type 1 diabetes and found that the rate of severe hypoglycemia (coma, seizure, or needing help from other persons) in the intensive treatment group was 3 times that of persons in the conventional group (62 vs. 19 episodes per 100 patient-years; P < 0.001) (2728).

Disability

Persons with diabetes suffer disproportionately from physical and cognitive disability. The National Health Interview Survey indicates that persons with diabetes have about twice the prevalence of physical disability as persons without diabetes (66% vs. 29%; P < 0.001) (29). In a prospective study, newly developed functional disability was also nearly twice as common in persons with diabetes than in their counterparts without diabetes (yearly incidence, 9.8% vs. 4.8%), and, after adjustment for potential confounders, diabetes remained associated with a 42% risk for any incident disability (30). Among elderly persons, diabetes-related cognitive impairment or dementia has been documented. Several prospective studies that used repeated neuropsychological tests and diagnostic protocols found an approximate doubling of the overall risk for dementia in persons with diabetes compared with those without diabetes (31).

Mortality

National data estimate that among Americans age 25 years and older who die, approximately 17% have diabetes (32). Age-adjusted mortality among adults with diabetes is about twice that of people who do not have diabetes (32). A large meta-analysis that included 10 prospective studies found a relative risk of 1.9 for men and 2.6 for women when their counterparts without diabetes were the referent (33). Among middle-aged people with diabetes, life expectancy is reduced by 5 to 10 years (32), and, for the entire population with diabetes, an estimated 13 years is lost by both men and women (34). The increased risk for death associated with diabetes is greater for younger people (ratio of 3.6:1 for people age 25 to 44 years and 1.5:1 for those age 65 to 74 years) (34).

In 2000, under the new 10th version of the International Classification of Diseases, diabetes was the sixth leading cause of death in the United States (35). This ranking is based on the 69 301 death certificates on which it was listed as the underlying cause (7). Diabetes was listed as a contributing cause of death on an additional 143 761 death certificates. However, only about 35% to 40% of decedents with diabetes have it listed anywhere on the death certificate, and only about 10% to 15% have it listed as the underlying cause of death (36). Thus, data from death certificates substantially underestimate the impact of diabetes.

Cardiovascular disease is the reported cause of up to 65% of all deaths in persons with diabetes in the United States (32). In addition, a recent U.S. study involving cohorts from 1971 to 1984 and 1982 to 1993 found that the population with diabetes did not experience the reductions in heart disease mortality experienced by those without the disease (37). Comparing rates for the 2 periods, the authors found that both men and women without diabetes had statistically significant declines in age-adjusted heart disease mortality (36% and 27%, respectively), whereas men and women with diabetes did not have statistically significant changes (13% decline and 23% increase, respectively). In a more recent population-based study in Rochester, Minnesota, the mortality rate for persons with diabetes declined between 1970 and 1994 by 13.8%, which is smaller than the corresponding decline among those without diabetes (21.4%) (38).

Among persons with diabetes, the major risk factors for microvascular complications (eye disease, kidney disease, and peripheral neuropathy) are long-term poor glycemic control, as measured by hemoglobin A1c levels, and hypertension (39).

Risk factors for cardiovascular disease among persons with diabetes are similar to those in persons without diabetes; however, the magnitude may be greater. The Multiple Risk Factor Intervention Trial (MRFIT) followed a large cohort (approximately 350 000 persons that included 5000 persons with diabetes) for 12 years and found that systolic hypertension, elevated cholesterol level, and cigarette smoking independently predicted cardiovascular mortality and that the presence of any one risk factor affected important clinical outcomes more in persons with diabetes than in those without diabetes (40).

The risk for cardiovascular disease associated with hyperglycemia or other underlying factors is less clear, but it may be related to insulin resistance or the metabolic syndrome. Among persons with diabetes, large prospective studies have found high blood glucose concentrations to be associated with a greater incidence of cardiovascular disease (41). In a Finnish cohort of 1373 persons without diabetes and 1059 with the disease who were followed for 7 years, the incidence of either fatal or nonfatal acute myocardial infarction largely depended on diabetes status. Among persons with diabetes, the incidence was 45% in those with a history of heart disease and 20.2% in those with no such history; for those without diabetes, the incidence was only 18.8% for persons with a history of heart disease and 3.5% for those with no such history (42). However, in another study of a United Kingdom cohort of 3477 persons with diabetes and no history of myocardial infarction and 7414 without diabetes but a history of myocardial infarction, the risk for cardiovascular events (either fatal or nonfatal) was higher in the group without diabetes (adjusted risk ratio, approximately 3) (43). A third study, which combined 22 prospective studies with follow-up for up to 11 years, found J-shaped cardiovascular disease mortality rates for the fasting glucose concentration, with mortality highest at low and high fasting glucose values (44). By contrast, the 2-hour glucose concentrations had a graded and increasing hazard ratio across the entire range of values (44).

Projections of diabetes into the 21st century are of concern. One in 3 people born in the United States in 2000 are projected to develop diabetes at some point in their lifetime (45). On the basis of age-, sex-, and race-specific rates for diagnosed diabetes from the 1984 to 2000 National Health Interview Survey and census projections, a 225% increase is projected between 2000 and 2050, a rise from 12 to 39 million diagnosed persons of all ages and an increase in prevalence from 4.4% to 9.7% (120% increase) (46). Persons 75 years of age or older are expected to have the largest increase in terms of numbers of persons affected (460%), followed by increases of 241% among those 65 to 74 years of age, 159% among those 45 to 64 years of age, 125% among those 20 to 44 years of age, and 97% among those 0 to 19 years of age. Among racial and ethnic groups, the prevalence is expected to increase by 149% among Hispanic persons, 118% among black persons, and 104% among white persons. These increases are due to expected demographic changes in the population (26%), population growth (20%), and, mostly, changes in prevalence (54%). However, increasing prevalence among younger age groups and the emergence of type 2 diabetes in children may worsen these projections.

The diabetes epidemic has already taken an extraordinary toll on the U.S. population, but the price it exacts in the future will be far greater if the current trends continue. Urgent efforts are needed to stem this tide. Because the possibility of delaying or preventing the complications of diabetes and diabetes itself is a reality (2728, 47), efforts must be directed at realizing these possibilities.

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Figures

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Figure 1.
Prevalence of diagnosed diabetes in people 20 years of age and older by age and race or ethnicity, United States, 2002.

Data obtained from the 1999 to 2001 National Health Interview Survey estimates projected to 2002 and the 2002 outpatient database of the Indian Health Service.

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Figure 2.
Prevalence of diagnosed diabetes and the number of people with diagnosed diabetes in the United States, 1958 to 2000.

Data obtained from the National Health Interview Survey.

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Figure 3.
Prevalence of diagnosed diabetes (including gestational diabetes) by state in the United States, 1990 to 2001.

Data obtained from the Behavioral Risk Factors Surveillance System survey.

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Tables

References

Hazlett BE.  Historical perspective: the discovery of insulin. Davidson JK Clinical Diabetes Mellitus: A Problem-Oriented Approach. New York: Thieme; 2000; 3-11.
 
World Health Organization Expert Committee on Diabetes Mellitus.  Second Report on Diabetes Mellitus. Geneva: World Health Organization; 1980:8-14. WHO Technical Report Series 646.
 
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Mokdad AH, Bowman BA, Ford ES, Vinicor F, Marks JS, Koplan JP.  The continuing epidemics of obesity and diabetes in the United States. JAMA. 2001; 286:1195-200. PubMed
CrossRef
 
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Alberti KG, Zimmet PZ.  Definition, diagnosis and classification of diabetes mellitus and its complications. Part 1: diagnosis and classification of diabetes mellitus provisional report of a WHO consultation. Diabet Med. 1998; 15:539-53. PubMed
 
Centers for Disease Control and Prevention. National Diabetes Fact Sheet: General Information and National Estimates on Diabetes in the United States, 2003. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention; 2003. Accessed athttp://www.cdc.gov/diabetes/pubs/factsheet.htmon 30 November 2003.
 
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Kenny SJ, Aubert RE, Geiss LS.  Prevalence and incidence of non-insulin-dependent diabetes. Harris MI, Cowie CC, Stern MP, Boyko EJ, Reiber GE, Bennett PH Diabetes in America. 2nd ed. Bethesda, MD: National Institutes of Health; 1995; 47-68.
 
Mokdad AH, Ford ES, Bowman BA, Nelson DE, Engelgau MM, Vinicor F, et al..  Diabetes trends in the U.S.: 1990-1998. Diabetes Care. 2000; 23:1278-83. PubMed
 
Mokdad AH, Ford ES, Bowman BA, Dietz WH, Vinicor F, Bales VS, et al..  Prevalence of obesity, diabetes, and obesity-related health risk factors, 2001. JAMA. 2003; 289:76-9. PubMed
 
Fagot-Campagna A, Pettitt DJ, Engelgau MM, Burrows NR, Geiss LS, Valdez R, et al..  Type 2 diabetes among North American children and adolescents: an epidemiologic review and a public health perspective. J Pediatr. 2000; 136:664-72. PubMed
 
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Harris MI, Flegal KM, Cowie CC, Eberhardt MS, Goldstein DE, Little RR, et al..  Prevalence of diabetes, impaired fasting glucose, and impaired glucose tolerance in U.S. adults. The Third National Health and Nutrition Examination Survey, 1988-1994. Diabetes Care. 1998; 21:518-24. PubMed
 
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Barzilay JI, Spiekerman CF, Kuller LH, Burke GL, Bittner V, Gottdiener JS, et al..  Prevalence of clinical and isolated subclinical cardiovascular disease in older adults with glucose disorders: the Cardiovascular Health Study. Diabetes Care. 2001; 24:1233-9. PubMed
 
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Saaddine JB, Narayan KM, Engelgau MM, Aubert RE, Klein R, Beckles GL.  Prevalence of self-rated visual impairment among adults with diabetes. Am J Public Health. 1999; 89:1200-5. PubMed
 
Klein R, Klein BE, Moss SE.  Visual impairment in diabetes. Ophthalmology. 1984; 91:1-9. PubMed
 
Ederer F, Hiller R, Taylor HR.  Senile lens changes and diabetes in two population studies. Am J Ophthalmol. 1981; 91:381-95. PubMed
 
Klein BE, Klein R, Wang Q, Moss SE.  Older-onset diabetes and lens opacities. The Beaver Dam Eye Study. Ophthalmic Epidemiol. 1995; 2:49-55. PubMed
 
Klein BE, Klein R, Jensen SC.  Open-angle glaucoma and older-onset diabetes. The Beaver Dam Eye Study. Ophthalmology. 1994; 101:1173-7. PubMed
 
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Apelqvist J, Castenfors J, Larsson J, Stenstrom A, Agardh CD.  Wound classification is more important than site of ulceration in the outcome of diabetic foot ulcers. Diabet Med. 1989; 6:526-30. PubMed
 
Gregg EW, Sorlie P, Paulose-Ram R, Gu Q, Eberhardt M, Wolz M, et al..  Prevalence of lower extremity disease in the U.S. population [Abstract]. Diabetes. 2003; 52:suppl 1A62.
 
.  Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). UK Prospective Diabetes Study (UKPDS) Group. Lancet. 1998; 352:837-53. PubMed
 
.  The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. The Diabetes Control and Complications Trial Research Group. N Engl J Med. 1993; 329:977-86. PubMed
 
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Klein R.  Hyperglycemia and microvascular and macrovascular disease in diabetes. Diabetes Care. 1995; 18:258-68. PubMed
 
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Haffner SM, Lehto S, Ronnemaa T, Pyorala K, Laakso M.  Mortality from coronary heart disease in subjects with type 2 diabetes and in nondiabetic subjects with and without prior myocardial infarction. N Engl J Med. 1998; 339:229-34. PubMed
 
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Letters

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Translating "tight control"?
Posted on June 18, 2004
Thomas E. Finucane
Johns Hopkins Bayview Medical Center
Conflict of Interest: None Declared

In the Annals Supplement "Diabetes Translation and Public Health" (Supplement to June 1, 2004 issue), several of the articles assume or state that careful monitoring and tight control of blood glucose are important in managing type II diabetes mellitus.

In the February, 2003, Annals, the United States Preventive Services Task Force presented a table with results from all published randomized controlled trials of "tight control" of type II diabetes(1). If the Metformin arm of the UKPDS, and a multi-intervention STENO2 trial (of 160 patients followed for three years) are excluded, the table can be summarized very briefly. Thousands of patients have been randomized and studied in several trials lasting years. No trial has ever found any benefit from tight control on the endpoints of severe visual impairment, renal failure, amputation, myocardial infarction or all-cause mortality.

This mismatch between evidence and recommendation is based on several factors. One is the failure to distinguish clearly between type I and type II diabetes. Murphy and colleagues, for example, note the findings of the DCCT and claim as a "major program implication(s)"¦.that the findings needed to be translated to all persons with diabetes"¦".(2)

A second is to report the association between higher blood glucose or hemoglobin A1C and worse outcome in patients who were either untreated or were treated without randomization, and then to imply better "control" improves outcome. Engelgau et al report that "the major risk factors"¦.are long term poor glycemic control as measured by both hemoglobin A1C levels and hypertension". The reference for this remark contains no data that tighter "control" due to a more aggressive treatment strategy will lead to better outcomes.(3)

"Diabetes translation" is extremely important. Strong evidence shows that certain interventions can prevent harm from this serious disease. So far, "tight control" is not one of these interventions. Translators should be careful that they have understood the original text correctly and translated it without prejudice.

1. Harris R, Donahue K, Rathore SS, Frame P, Woolf SH, Lohr KN. Screening adults for type 2 diabetes: a review of the evidence for the U.S. Preventive Services Task Force. Ann Intern Med. 2003;138(3):215-29. 2. Murphy D, Chapel T, Clark C. Moving diabetes care from science to practice: the evolution of the National Diabetes Prevention and Control Program. Ann Intern Med. 2004;140(11):978-84. 3. Engelgau MM, Geiss LS, Saaddine JB, et al. The evolving diabetes burden in the United States. Ann Intern Med. 2004;140(11):945-50.

Conflict of Interest:

None declared

In Response
Posted on August 9, 2004
Michael M Engelgau
Centers for Disease Control and Prevention
Conflict of Interest: None Declared

We thank Dr. Finucane for his interest in diabetes translation and his recognition of its importance. He questioned the effectiveness of interventions to improve glycemic control and whether such interventions are ready for translation.

We agree with Dr Finucane that no clinical trial has shown that improved glycemic control prevents single endstage microvascular complications such as blindness and kidney disease.1 However, such endstage events are rare and researchers would need to conduct decades of follow-up in order to detect enough cases for meaningful analyses. More often, clinical trials have either examined conditions antecedent to endstage complications (e.g., retinopathy rather than blindness) or combined antecedent and endstage complications into an aggregate measure. For example, results of the Diabetes Control and Complications Trial (DCCT) among persons with type 1 diabetes showed that compared with patients in conventional therapy, those in intensive therapy has 76% less risk of developing new retinopathy and 54% less risk of established retinopathy.2 In the United Kingdom Prospective Diabetes Study (UKPDS) of conventional and intensive glycemic control among persons with newly diagnosed type 2 diabetes 3 researchers developed aggregate outcomes that included several diabetes-related endpoints. "Any diabetes-related end point" included sudden death, death from hyperglycemia or hypoglycaemia, fatal and nonfatal myocardial infraction, angina, heart failure, stroke, renal failure, amputation, vitreous hemorrhage, retinal photocoagulation, blindness in one eye, or cataract extraction. They used this aggregate outcome to compare the results of conventional treatment with results of intensive treatment and found that intensive treatment significantly reduced "any diabetes-related endpoint" (40.9 versus 46.0 events/1000 patient years; p=0.03

The outcome of interventions are dependent on the duration of a patients diabetes, on the duration of the study's follow-up, and on the quality of care provided outside the clinical trial of glycemic control per se. Observational studies may help sort these issues out. For example, the Wisconsin Epidemiologic Study of Diabetic Retinopathy (WESDR), had a large enough study sample to give us some insight into the risk for end stage disease associated with a given glycemic exposure. 4

For translation, we are interested in multiple endpoints in aggregate, and not necessarily single outcomes, as these aggregate outcomes can greatly affect the quality of life in persons. As such, the evidence for reducing microvascular complications is sound, but we need more direct evidence for the effectiveness to long term endstage complications.

Michael M. Engelgau MD Linda S. Geiss MS Dara Murphy MPH KM Venkat Narayan MD Frank Vinicor MD

Division of Diabetes Translation National Center for Chronic Disease Prevention and Health Promotion Centers for Disease Control and Prevention Atlanta, GA

References 1. Harris R, Donahue K, Rathore SS, Frame P, Woolf SH, Lohr KN. Screening adults for type 2 diabetes: A review of the evidence for the U.S. Preventive Services Task Force. Ann Intern Med 2003;138:215-29.

2. The Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med 1993:329:977-86.

3. U.K. Prospective Diabetes Study Group. Intensive blood-glucose control with sulphonnylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet1998:352:837-53.

4. Klein R. Hyperglycemia and microvascular and macrovascular disease in diabetes. Diabetes Care 1995;18:258-68.

Conflict of Interest:

None declared

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