Context Control of blood glucose levels, blood pressure, and cholesterol levels
is proven to reduce the risk of vascular disease among individuals with diabetes
mellitus; however, the current state of control of these risk factors among
individuals in the United States is uncertain.
Objectives To examine 1999-2000 national data on control of risk factors for vascular
disease among adults with previously diagnosed diabetes and to assess trends
during the past decade.
Design, Setting, and Participants Review of data from the Third National Health and Nutrition Examination
Survey (NHANES III, conducted 1988-1994) and NHANES 1999-2000, cross-sectional
surveys of a nationally representative sample of the noninstitutionalized
civilian US population. Participants were adults aged 20 years and older with
previously diagnosed diabetes who participated in both the interview and examination
in either NHANES III (n = 1265) or NHANES 1999-2000 (n = 441).
Main Outcome Measures Levels of glycosylated hemoglobin (HbA1c), blood pressure,
and total serum cholesterol in reference to target goals.
Results Compared with NHANES III, participants with previously diagnosed diabetes
in NHANES 1999-2000 were similar by age and sex, were less likely to be non-Hispanic
white, were diagnosed at an earlier age, had a higher body mass index, and
were more likely to use insulin in combination with oral agents. In NHANES
1999-2000, only 37.0% of participants achieved the target goal of HbA1c level less than 7.0% and 37.2% of participants were above the recommended
"take action" HbA1c level of greater than 8.0%; these percentages
did not change significantly from NHANES III (P =
.11 and P = .87, respectively). Only 35.8% of participants
achieved the target of systolic blood pressure (SBP) less than 130 mm Hg and
diastolic blood pressure (DBP) less than 80 mm Hg, and 40.4% had hypertensive
blood pressure levels (SBP ≥140 or DBP ≥90 mm Hg). These percentages
did not change significantly from NHANES III (P =
.10 and P = .56, respectively). Over half (51.8%)
of the participants in NHANES 1999-2000 had total cholesterol levels of 200
mg/dL or greater (vs 66.1% in NHANES III; P<.001).
In total, only 7.3% (95% confidence interval, 2.8%-11.9%) of adults with diabetes
in NHANES 1999-2000 attained recommended goals of HbA1c level less
than 7%, blood pressure less than 130/80 mm Hg, and total cholesterol level
less than 200 mg/dL (5.18 mmol/L).
Conclusion Further public health efforts are needed to control risk factors for
vascular disease among individuals with diagnosed diabetes.
Diabetes presents a significant public health burden on the basis of
its increased morbidity, mortality, and economic costs.1,2 Individuals
with diagnosed diabetes are at an increased risk for vascular disease, including
microvascular complications (eg, retinopathy, neuropathy, and nephropathy)
and macrovascular complications (eg, coronary heart disease and stroke), and
lower extremity amputations.3-6 Improved
glycemic control clearly reduces the risk of microvascular disease among individuals
with diagnosed diabetes and is associated with lower risk of atherosclerosis
and macrovascular disease.4,7-12 While
treatment for individuals with diabetes has traditionally focused on control
of glycemia to reduce these vascular complications, there is growing evidence
highlighting the importance of controlling blood pressure and cholesterol
levels.9,13-16 In
addition, while intensive control of glycemia, blood pressure, and cholesterol
levels all improve health outcomes for individuals with diabetes, control
of blood pressure has been reported to be the most cost-effective intervention.17
Current American Diabetes Association (ADA) standards of medical care
for individuals with diagnosed diabetes aim to reduce vascular complications
through control of glycemia, blood pressure, and blood lipid levels, as well
as through smoking cessation.18 The ADA goal
for control of glycemia is glycosylated hemoglobin (HbA1c) level
less than 7%; additional treatment is suggested for individuals with HbA1c levels greater than 8%. The goal for control of blood pressure is
systolic blood pressure less than 130 mm Hg and diastolic blood pressure less
than 80 mm Hg.18 The Joint National Committee
on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure
(JNC) also now recommends this level of blood pressure control although the
recommended diastolic target was 85 mm Hg until 2003.19 The
ADA goal for lipid management is aimed at lowering levels of low-density lipoprotein
cholesterol to less than 100 mg/dL (2.59 mmol/L), increasing levels of high-density
lipoprotein cholesterol to greater than 45 mg/dL (1.16 mmol/L) for men and
55 mg/dL (1.42 mmol/L) for women, and lowering levels of triglycerides to
less than 150 mg/dL (1.7 mmol/L).18 In addition,
the National Cholesterol Education Program Adult Treatment Panel III (NCEP-ATP-III)
sets a goal for total cholesterol levels of less than 200 mg/dL (5.18 mmol/L).20
Previous analysis of nationally representative surveys found that individuals
with diabetes had poor control of risk factors for vascular disease.21-23 However, these results
were based on national surveys conducted in the early 1990s and may not accurately
reflect the current state of control of risk factors for vascular disease
among individuals with diabetes in the United States.
We examined the trends in control of risk factors for vascular disease
among adults with diagnosed diabetes in the United States over nearly a decade
using data from 2 national health surveys: the Third National Health and Nutrition
Examination Survey (NHANES III) conducted from 1988-1994 and the NHANES 1999-2000.
Specifically, we compared HbA1c levels, blood pressure, and total
cholesterol levels among adults with previously diagnosed diabetes between
these surveys to assess whether control of risk factors for vascular disease
has changed.
The survey instruments, physical examination, and laboratory measurements
of NHANES III and NHANES 1999-2000 have been described in detail.24-28 Both
surveys comprised nationally representative samples of the noninstitutionalized
civilian US population, obtained by a complex, stratified, multistage probability
cluster sample design. Both surveys oversampled non-Hispanic blacks, Mexican
Americans, and individuals aged 60 years and older; NHANES 1999-2000 also
oversampled low-income individuals. Participants were interviewed in their
homes to ascertain sociodemographic, medical, and family history data. A standardized
set of physical examinations and laboratory measurements was performed in
a mobile examination center. Blood pressure was measured using a mercury sphygmomanometer.
In NHANES III, the average of the second and third values was used; in NHANES
1999-2000, 3 to 4 blood pressure measurements were averaged after excluding
the first. In both surveys, HbA1c measurements were standardized
to the Diabetes Control and Complications Trial (DCCT) method and levels of
total serum cholesterol were measured enzymatically. The overall response
rate for completion of the interview and physical examination was 78% in NHANES
III and 75% in NHANES 1999-2000.
We included adults aged 20 years and older who completed the interview
and examination and who answered "yes" when asked whether a physician (or
a health care professional, in NHANES 1999-2000) ever told them they had diabetes
(n = 1265 in NHANES III and n = 441 in NHANES 1999-2000). Women who reported
a history of diabetes only during pregnancy were not included. To determine
the percentage with diagnosed diabetes in each survey we included all adults
aged 20 years and older who completed the interview (NHANES III, n = 18 822;
NHANES 1999-2000, n = 4874).
To define categories of desirable and undesirable HbA1c levels
and blood pressure, we used the ADA standards of medical care for persons
with diabetes.18 For desirable and undesirable
levels of total cholesterol, we used guidelines from the ADA18 and
the NCEP-ATP-III.20 We did not evaluate levels
of low-density lipoprotein cholesterol or triglycerides, since few participants
with diagnosed diabetes in NHANES 1999-2000 (n = 99 and n = 111, respectively)
had valid measurements.
Microalbuminuria was defined as 30 µg or more of albumin per milligram
of creatinine determined by spot urine collection for participants in each
survey who reported fasting at least 6 hours prior to collection.18 A history of cardiovascular disease was defined as
a history of angina, heart attack, or coronary heart disease. Participants
were considered to be current smokers if they reported smoking at least 100
cigarettes in their lifetime and reported smoking on at least some days within
the past 30 days.
Risk factors for vascular disease were reported for participants in
both surveys overall and by sex. Due to the small number of individuals with
diagnosed diabetes in NHANES 1999-2000, we were unable to stratify by age
or race/ethnicity.
We report the unadjusted and age-standardized prevalence of diagnosed
diabetes in NHANES III and NHANES 1999-2000. We age-standardized the prevalence
of diagnosed diabetes to the 2000 US Census population using 3 age groups
(20-39 years, 40-59 years, and ≥60 years) and corresponding weights (0.40589,
0.36621, 0.22790).
To compare characteristics and risk factors between the surveys, we
age-standardized the NHANES III results by the direct method to the NHANES
1999-2000 diabetes population using 3 age groups (20-39 years, 40-59 years,
≥60 years) and corresponding weights (0.0505, 0.2283, 0.7212). The NHANES
1999-2000 diabetes population was selected as the standard to minimize random
variability.29 Since NHANES III and NHANES
1999-2000 are independent samples, we used 2-sample t tests
for testing differences in means and proportions.30
Analyses were performed using SUDAAN version 8.0 (Research Triangle
Institute, Research Triangle Park, NC) with appropriate sampling weights to
account for the complex survey design and to provide nationally representative
estimates. Although the NHANES surveys oversampled different groups, survey
weighting ensures that the results from the 2 surveys are comparable. Since
the primary sampling units and strata were not provided in the NHANES 1999-2000
public release data set, we used the replicate weights provided with the jackknife
command. Unreliable estimates, ie, those with a relative standard error greater
than 30%, are noted in the tables.31,32
The prevalence of diagnosed diabetes and the characteristics of adults
with diabetes are shown in Table 1.
The unadjusted prevalence of diagnosed diabetes in adults aged 20 years and
older in NHANES 1999-2000 was 5.9% (SE, 0.52). The age-standardized prevalence
of previously diagnosed diabetes did not increase significantly from NHANES
III (5.4%; SE, 0.21) to NHANES 1999-2000 (6.1%; SE, 0.52) (P = .17). Participants with diagnosed diabetes were similar by age
and sex in the 2 surveys. In NHANES 1999-2000, there were significantly fewer
non-Hispanic whites, similar proportions of non-Hispanic blacks and Mexican
Americans, and a significantly larger proportion of participants of other
race/ethnicity groups compared with NHANES III. These changes in race/ethnicity
between the 2 surveys reflect the changes in the US Census between 1990 and
2000. However, the decrease in the proportion of non-Hispanic whites and the
increase in the proportion of persons of other race/ethnicity are more substantial
among individuals with diabetes than in the general population (data not shown).
Mean body mass index (BMI, calculated as weight in kilograms divided
by the square of height in meters) among adults with diagnosed diabetes increased
significantly from 29.9 in NHANES III to 32.3 in NHANES 1999-2000 (P = .002), and the percentage of those with diagnosed diabetes who
were obese (BMI ≥30) increased from 41.6% to 54.6% (P = .008).
Individuals with previously diagnosed diabetes in NHANES 1999-2000 had
been diagnosed at a significantly younger age (46.7 vs 50.7 years; P = .003) and had a significantly longer duration of diabetes (12.5
vs 10.2 years; P = .03) than those in NHANES III.
There was no significant change in the prevalence of microalbuminuria or history
of cardiovascular disease.
Use of insulin alone decreased significantly (27.6% vs 17.0%, P = .002), and insulin use in combination with oral agents
increased significantly (3.5% vs 10.4%, P = .01)
over the 2 surveys. The percentage of adults who reported no pharmacological
treatment for diabetes decreased (24.8% vs 18.7%; P =
.06) and use of blood pressure medications increased (77.0% vs 85.2%; P = .05). Use of blood pressure medications could be underreported
if use of renin-angiotensin system agents were attributed to nephropathy rather
than to hypertension. Among adults with diagnosed high cholesterol, medication
use for high cholesterol was more than 2-fold higher in NHANES 1999-2000 (56.1%)
compared with NHANES III (27.7%) (P<.001). There
was no difference in regular use of aspirin.
The mean HbA1c levels did not change from NHANES III to NHANES
1999-2000 (Table 2). Overall,
only 37.0% of adults in NHANES 1999-2000 had HbA1c levels at the
ADA goal of less than 7.0%. The percentage of participants with HbA1c levels less than 7.0% did not change significantly from NHANES III
(P = .11) and did not differ by sex. Overall, the
percentage of participants with HbA1c levels greater than 8%, the
level suggested by the ADA for focused treatment action, was 37.2% in NHANES
1999-2000 and was unchanged from NHANES III (P =
.87).
The mean systolic blood pressure among adults with diagnosed diabetes
was significantly lower in NHANES 1999-2000, particularly in men, but the
diastolic blood pressure did not change appreciably between the surveys (Table 2). There was a slight increase in
the percentage of participants with blood pressure at the level currently
recommended by the ADA (systolic <130 mm Hg and diastolic <80 mm Hg)
from NHANES III (29.0%) to NHANES 1999-2000 (35.8%) (P =
.10), with a corresponding small decrease in the percentage with high normal
(28.2% vs 23.8%; P = .19) and hypertensive (42.9%
vs 40.4%; P = .56) blood pressures. The proportions
based on the recommended levels by the ADA in 1995 (systolic <130 mm Hg
and diastolic <85 mm Hg) also did not change significantly from the NHANES
III (1988-1994) (32.1%) to NHANES 1999-2000 (36.6%) (P =
.29).
Total Serum Cholesterol Levels
Overall, total serum cholesterol levels decreased significantly from
NHANES III to NHANES 1999-2000 (P<.001) (Table 2). However, in NHANES 1999-2000,
50.0% of men and 53.8% of women still had total serum cholesterol levels of
200 mg/dL (5.18 mmol/L) or greater, below which is the NCEP-ATP-III goal.
Combined Control of Risk Factors
Overall, the percentage of adults with diagnosed diabetes in NHANES
1999-2000 who achieved currently recommended goals of HbA1c level,
blood pressure, and total serum cholesterol level was only 7.3% (95% confidence
interval, 2.8%-11.9%) (Figure 1).
This is similar to the percentage who had these recommended levels in NHANES
III (5.2%; 95% confidence interval, 3.8%-6.6%).
Compelling evidence from well-designed, randomized clinical trials demonstrates
that control of glucose levels, blood pressure, and cholesterol levels can
dramatically delay or prevent the microvascular and macrovascular complications
of diabetes.8,9,11-15 Based
on these data, the ADA,8 the JNC,19 and
the NCEP20 have developed guidelines for control
of blood glucose levels, blood pressure, and cholesterol levels in individuals
with diabetes. Despite these evidence-based guidelines, only a small fraction
(2.8% to 11.9%) of adults with diagnosed diabetes in the United States are
achieving the currently recommended levels of control. Other studies examining
diabetes care in various clinical settings also have found that current medical
practice is not achieving goals for management of glucose levels, blood pressure,
and lipid levels in individuals with diabetes.23,33-36 This
study presents contemporary data from a nationally representative sample of
noninstitutionalized adults in the United States with previously diagnosed
diabetes. Comparison of the current data and representative data from approximately
a decade earlier, obtained through similar standardized procedures, demonstrates
significant improvement in the control of total cholesterol levels, but little
to no change in control of blood glucose levels and blood pressure.
The period between NHANES III (1988-1994) and NHANES 1999-2000 has seen
a substantial accumulation of evidence regarding the benefits of glycemic
control. In 1993, the landmark DCCT study showed that intensive glycemic therapy
of type 1 diabetes reduced the risk of microvascular disease by up to 70%.8 Similar dramatic reductions in risk of microvascular
complications in type 2 diabetes were subsequently found in the United Kingdom
Prospective Diabetes Study (UKPDS).9 Despite
this compelling evidence of benefit, an ADA recommendation of an HbA1c target level of less than 7.0% in January 1995, the creation of the
National Diabetes Education Program (NDEP) in 199737 to
promulgate the importance of glycemic control, and the advent of several new
classes of medications for glycemic control,38 NHANES
1999-2000 found no change in mean HbA1c values or in the fraction
of adults with diabetes with HbA1c levels below the target levels.
Long-term follow-up of the DCCT study population provides impressive new evidence
of the importance of glycemic control. The period of improved glycemic control
in the intensively treated arm of the DCCT continues to yield potent reduction
in risk of microvascular disease well beyond the period of intensive implementation11 and the beneficial effect of glycemic control now
extends to macrovascular disease, indicated by reduced carotid artery wall
thickening.12 These latest observations should
strengthen public health efforts to translate intensive glycemic control into
clinical practice.
Impressive evidence that intensive control of blood pressure in adults
with type 2 diabetes prevents both microvascular and macrovascular diseases
also emerged during and after NHANES III,13,14,39 leading
to recommendations by the JNC-5 in 1993 and the ADA in 1995 that blood pressure
levels for patients with diabetes should be lower (<130/85 mm Hg) than
in other hypertensive groups. The recommended blood pressure level was further
reduced to less than 130/80 mm Hg by the ADA in 200118 and
the JNC-7 in 2003.19 From NHANES III to NHANES
1999-2000, the prevalence of hypertension increased significantly in the general
US population, and its prevalence was associated with risk factors for diabetes
including older age, non-Hispanic black race, and higher BMI.40 When
individuals with diabetes were excluded from analysis, the prevalence of hypertension
was no longer significantly increased. That analysis of individuals with diagnosed
hypertension found that the percentage of those with diabetes and hypertension
controlled to less than 140/90 mm Hg declined nonsignificantly (to 46.9%)
in those with diabetes. We found a small but statistically significant decrease
in mean systolic blood pressure in individuals with diagnosed diabetes and
a small and nonsignificant increase in the fraction of participants with diabetes
with normal blood pressure. The new guidelines for control of blood pressure
issued near the conclusion of NHANES III may have contributed to the small
but statistically significant decrease in mean systolic blood pressure in
individuals with diagnosed diabetes in NHANES 1999-2000, but there has been
minimal, if any, effect in reducing the proportion of those with blood pressure
of 140/90 mm Hg or greater.
Data from NHANES 1999-2000 was collected just after clinical trials
demonstrated that, by lowering lipid levels, individuals with diabetes can
substantially reduce the risk of developing cardiovascular disease.15 Moreover, in 1998, diabetes was identified as a risk
factor for cardiovascular disease equivalent to having preexisting coronary
artery disease.41 The ADA guidelines on management
of lipid disorders issued in 1993 were revisited in 1998 based on these new
data42 and the American Heart Association43 and the NCEP20 also
subsequently issued guidelines for lipid management in diabetes. Thus the
improvement in total cholesterol levels observed in NHANES 1999-2000 occurred
on the cusp of new data showing the benefits of lowering lipid levels, and
further reductions in total cholesterol levels may be anticipated in the future
as a result of dissemination of the new guidelines.
Progress in improving risk factors for vascular disease among individuals
with diagnosed diabetes in the United States over nearly a decade has been
modest. While there has been increased awareness among physicians and individuals
with diabetes of the use of HbA1c levels to monitor glycemic control,23 only 37.0% of adults with diagnosed diabetes in the
United States are achieving the ADA goal of HbA1c levels less than
7.0%. In addition, 37.2% of adults with diagnosed diabetes have HbA1c levels greater than 8.0%, the level of additional treatment action
suggested by the ADA. Although the percentage of adults with diagnosed diabetes
and diagnosed hypertension who use blood pressure medication has increased
in the past decade, only 35.8% of individuals with diagnosed diabetes have
achieved the current ADA blood pressure goal of less than 130/80 mm Hg and
only 36.6% achieved the ADA goal set in 1995 (<130/85 mm Hg); 40.4% have
hypertensive blood pressure levels. Finally, although the percentage of adults
with diagnosed high cholesterol levels has increased and twice as many of
these adults report taking medication for their high cholesterol in NHANES
1999-2000 compared with NHANES III (1988-1994), more than half the individuals
with diagnosed diabetes have total cholesterol levels greater than 200 mg/dL
(5.18 mmol/L). The increased use of medication to control high cholesterol
levels and high blood pressure has not been accompanied by attention to lifestyle
change; fewer adults with diabetes report eating less fat to control cholesterol
than approximately a decade ago, and there has been no change in the use of
weight control or exercise to control lipid levels or blood pressure. Due
to the small sample size, we were unable to stratify the analysis by previously
diagnosed high blood pressure or high cholesterol levels.
Biological and behavioral characteristics of individuals with diagnosed
diabetes are likely to affect control of risk factors for vascular disease.
The earlier age at diagnosis of diabetes in NHANES 1999-2000 may reflect an
earlier onset of disease or may be due to increased screening for undiagnosed
diabetes leading to individuals being diagnosed at an earlier point in the
disease pathway. This earlier age at diagnosis corresponded to a significantly
longer duration of diabetes in 1999-2000. The longer duration might also reflect
increased longevity due to better treatment. The increase in BMI of adults
with diagnosed diabetes in the United States over nearly a decade mirrors
the increase in prevalence of overweight and obesity in the US population
as a whole.44 Both longer duration of diabetes
and increased BMI are likely to correspond to higher levels of glycemia, blood
pressure, and cholesterol; however, these levels did not appear to increase
over the past decade. This may be due in part to the greater use of medications
for control of blood glucose levels, blood pressure, and cholesterol levels
that was observed in NHANES 1999-2000. Thus, although progress toward achieving
guidelines for therapy has been disappointing, maintenance of levels of HbA1c control, in the face of increased BMI and duration of diabetes, may
reflect intensification of therapy. The greater improvement in cholesterol
levels compared with glycemic control may reflect differences in the complexity
of the medical regimens for these conditions, as well as the earlier initiation
and broader dissemination of messages from the NCEP compared with the NDEP.
These factors could influence both prescription of and adherence to therapy.
A major limitation of this study is the small number of participants
with diagnosed diabetes in NHANES 1999-2000, which limits analyses by subgroups,
specifically by age, race/ethnicity, or treatment group. In addition, the
surveys only include noninstitutionalized adults. There were 68 500 residents
with a diagnosis of diabetes in nursing homes in 199545 and
81 700 residents in 1999.46 We have no
information on risk factors for vascular disease among these individuals with
diagnosed diabetes. In addition, the NHANES surveys are cross-sectional in
design. Although we can draw inferences on trends among participants with
diagnosed diabetes, different adults participated in each survey and therefore
we cannot draw conclusions on temporal relationships of observations.
Rapidly increasing rates of type 2 diabetes in the United States have
been attributed to aging of the population, increased prevalence of overweight
and obesity, and decreased physical activity.47,48 We
recently reported49 and show here a slight
trend for an increase in the overall prevalence of previously diagnosed diabetes
among adults aged 20 years and older, although the change was not significantly
different. The lack of a statistically significant increase in the prevalence
of previously diagnosed diabetes in NHANES 1999-2000 could be due to the small
sample size of the survey. The 95% confidence interval for the change in the
prevalence of diagnosed diabetes between the 2 surveys ranges from a decrease
of 0.34 percentage points to an increase of 1.98 percentage points. The estimated
prevalence of diagnosed diabetes in NHANES 1999-2000 is similar in magnitude
to that obtained by the National Health Interview Survey (prevalence of 5.9%
for persons aged ≥18 years in 2000), which interviews a much larger number
of participants resulting in more precise estimates.50
The cost of providing care for diabetes and its complications in the
United States is rapidly increasing and was estimated at $132 billion annually
in 2002.2 The failure to achieve recommended
levels of control of vascular risk factors, coupled with the rise in type
2 diabetes and its occurrence in individuals at earlier ages—which increases
the risk of duration-dependent vascular complications—have ominous implications
for the future burden of morbidity, mortality, and health care costs associated
with diabetes.
The increased awareness of the importance of controlling risk factors
for vascular disease among adults with diabetes has led to national programs
such as the "Control the ABCs" (for which A, B, and C indicate HbA1c, blood pressure, and cholesterol, respectively) campaign by the NDEP37 and the Diabetes Quality Improvement Project.51 While these programs represent important steps toward
improving the quality of diabetes care, further measures are needed to reduce
the large proportion of adults with diagnosed diabetes in the United States
who continue to have high levels of blood glucose, blood pressure, and total
cholesterol. Ongoing monitoring and measurement of the quality of care, empowering
clinicians with medical decision-support tools and patients with information
to improve the quality of care they receive, and building incentives for providing
comprehensive care into the health care delivery system52 are
essential to translating into practice the therapies that have been proven
effective in reducing the risk of vascular disease in individuals with diabetes.
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