Judith E. Fradkin

Prevalence of Diabetes and High Risk for Diabetes Using A1C Criteria in the U.S. Population in 1988–2006

OBJECTIVE We examined prevalences of previously diagnosed diabetes and undiagnosed diabetes and high risk for diabetes using recently suggested A1C criteria in the U.S. during 2003–2006. We compared these prevalences to those in earlier surveys and those using glucose criteria. RESEARCH DESIGN AND METHODS In 2003–2006, the National Health and Nutrition Examination Survey included a probability sample of 14,611 individuals aged ≥12 years. Participants were classified on glycemic status by interview for diagnosed diabetes and by A1C, fasting, and 2-h glucose challenge values measured in subsamples. RESULTS Using A1C criteria, the crude prevalence of total diabetes in adults aged ≥20 years was 9.6% (20.4 million), of which 19.0% was undiagnosed (7.8% diagnosed, 1.8% undiagnosed using A1C ≥6.5%). Another 3.5% of adults (7.4 million) were at high risk for diabetes (A1C 6.0 to <6.5%). Prevalences were disproportionately high in the elderly. Age-/sex-standardized prevalence was more than two times higher in non-Hispanic blacks and Mexican Americans versus non-Hispanic whites for diagnosed, undiagnosed, and total diabetes (P < 0.003); standardized prevalence at high risk for diabetes was more than two times higher in non-Hispanic blacks versus non-Hispanic whites and Mexican Americans (P < 0.00001). Since 1988–1994, diagnosed diabetes generally increased, while the percent of diabetes that was undiagnosed and the percent at high risk of diabetes generally decreased. Using A1C criteria, prevalences of undiagnosed diabetes and high risk of diabetes were one-third that and one-tenth that, respectively, using glucose criteria. CONCLUSIONS Although A1C detects much lower prevalences than glucose criteria, hyperglycemic conditions remain high in the U.S., and elderly and minority groups are disproportionately affected.

The prevention or delay of type 2 diabetes: American Diabetes Association and National Institute of Diabetes, Digestive and Kidney Diseases

D iabetes is one of the most costly and burdensome chronic diseases of our time and is a condition that is increasing in epidemic proportions in the U.S. and throughout the world (1). The complications resulting from the disease are a significant cause of morbidity and mortality and are associated with the damage or failure of various organs such as the eyes, kidneys, and nerves. Individuals with type 2 diabetes are also at a significantly higher risk for coronary heart disease, peripheral vascular disease, and stroke, and they have a greater likelihood of having hypertension, dyslipidemia, and obesity (2–6). There is also growing evidence that at glucose levels above normal but below the diabetes threshold diagnostic now referred to as pre-diabetes, there is a substantially increased risk of cardiovascular disease (CVD) and death (5,7–10). In these individuals, CVD risk factors are also more prevalent (5–7,9,11–14), which further increases the risk but is not sufficient to totally explain it. In contrast to the clear benefit of glucose lowering to prevent or retard the progression of microvascular complications associated with diabetes (15– 18,21), it is less clear whether the high rate of CVD in people with impaired glucose homeostasis, i.e., those with impaired fasting glucose (IFG), impaired glucose tolerance (IGT), or diabetes, is caused by elevated blood glucose levels or will respond to treatments that lower blood glucose. Epidemiological studies have shown a clear relationship (19,20), whereas intervention trials in people with diabetes suggest, but have not demonstrated, a clear benefit of glycemic control (15,16,21,22). Additionally, there are no studies that have investigated a benefit of glucose lowering on macrovascular disease in subjects with only pre-diabetes (IFG or IGT) but not diabetes. Although the treatment of diabetes has become increasingly sophisticated, with over a dozen pharmacological agents available to lower blood glucose, a multitude of ancillary supplies and equipment available, and a clear recognition by health care professionals and patients that diabetes is a serious disease, the normalization of blood glucose for any appreciable period of time is seldom achieved (23). In addition, in well-controlled socalled “intensively” treated patients, serious complications still occur (15–18,21), and the economic and personal burden of diabetes remains. Furthermore, microvascular disease is already present in many individuals with undiagnosed or newly diagnosed type 2 diabetes (11,24– 28). Given these facts, it is not surprising that studies have been initiated in the last decade to determine the feasibility and benefit of various strategies to prevent or delay the onset of type 2 diabetes. Two early reports (29,30) suggested that changes in lifestyle can prevent diabetes, but weaknesses in study design limited their general relevance. Recently, however, four well-designed randomized controlled trials have been reported (31–35). In the Finnish study (31), 522 middleaged (mean age 55 years) obese (mean BMI 31 kg/m) subjects with IGT were randomized to receive either brief diet and exercise counseling (control group) or intensive individualized instruction on weight reduction, food intake, and guidance on increasing physical activity (intervention group). After an average follow-up of 3.2 years, there was a 58% relative reduction in the incidence of diabetes in the intervention group compared with the control subjects. A strong correlation was also seen between the ability to stop the progression to diabetes and the degree to which subjects were able to achieve one or more of the following: lose weight (goal of 5.0% weight reduction), reduce fat intake (goal of 30% of calories), reduce saturated fat intake (goal of 10% of calories), increase fiber intake (goal of 15 g/1,000 kcal), and exercise (goal of 150 min/week). No untoward effects of the lifestyle interventions were observed. In the Diabetes Prevention Program (DPP) (32–34), the 3,234 enrolled subjects were slightly younger (mean age 51 years) and more obese (mean BMI 34 kg/m) but had nearly identical glucose intolerance compared with subjects in the Finnish study. About 45% of the participants were from minority groups (e.g, AfricanAmerican, Hispanic), and 20% were 60 years of age. Subjects were randomized to one of three intervention groups, which included the intensive nutrition and exercise counseling (“lifestyle”) group or either of two masked medication treatment groups: the biguanide metformin group or the placebo group. The latter interventions were combined with standard diet and exercise recommendations. After an average follow-up of 2.8 years (range 1.8–4.6 years), a 58% relative reduction in the progression to diabetes was observed in the lifestyle group (absolute incidence 4.8%), and a 31% relative reduction in the progression of diabetes was observed in the metformin group (absolute incidence 7.8%) compared with control subjects (absolute incidence 11.0%). ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ●

The Prevalence of Meeting A1C, Blood Pressure, and LDL Goals Among People With Diabetes, 1988–2010

OBJECTIVE To determine the prevalence of people with diabetes who meet hemoglobin A1c (A1C), blood pressure (BP), and LDL cholesterol (ABC) recommendations and their current statin use, factors associated with goal achievement, and changes in the proportion achieving goals between 1988 and 2010. RESEARCH DESIGN AND METHODS Data were cross-sectional from the National Health and Nutrition Examination Surveys (NHANES) from 1988–1994, 1999–2002, 2003–2006, and 2007–2010. Participants were 4,926 adults aged ≥20 years who self-reported a previous diagnosis of diabetes and completed the household interview and physical examination (n = 1,558 for valid LDL levels). Main outcome measures were A1C, BP, and LDL cholesterol, in accordance with the American Diabetes Association recommendations, and current use of statins. RESULTS In 2007–2010, 52.5% of people with diabetes achieved A1C <7.0% (<53 mmol/mol), 51.1% achieved BP <130/80 mmHg, 56.2% achieved LDL <100 mg/dL, and 18.8% achieved all three ABCs. These levels of control were significant improvements from 1988 to 1994 (all P < 0.05). Statin use significantly increased between 1988–1994 (4.2%) and 2007–2010 (51.4%, P < 0.01). Compared with non-Hispanic whites, Mexican Americans were less likely to meet A1C and LDL goals (P < 0.03), and non-Hispanic blacks were less likely to meet BP and LDL goals (P < 0.02). Compared with non-Hispanic blacks, Mexican Americans were less likely to meet A1C goals (P < 0.01). Younger individuals were less likely to meet A1C and LDL goals. CONCLUSIONS Despite significant improvement during the past decade, achieving the ABC goals remains suboptimal among adults with diabetes, particularly in some minority groups. Substantial opportunity exists to further improve diabetes control and, thus, to reduce diabetes-related morbidity and mortality.

Update on prevention of cardiovascular disease in adults with type 2 diabetes mellitus in light of recent evidence: A scientific statement from the American Heart Association and the American Diabetes Association

Cardiovascular disease risk factor control as primary prevention in patients with type 2 diabetes mellitus has changed substantially in the past few years. The purpose of this scientific statement is to review the current literature and key clinical trials pertaining to blood pressure and blood glucose control, cholesterol management, aspirin therapy, and lifestyle modification. We present a synthesis of the recent literature, new guidelines, and clinical targets, including screening for kidney and subclinical cardiovascular disease for the contemporary management of patients with type 2 diabetes mellitus.

Update on Prevention of Cardiovascular Disease in Adults With Type 2 Diabetes Mellitus in Light of Recent Evidence: A Scientific Statement From the American Heart Association and the American Diabetes Association

Cardiovascular disease risk factor control as primary prevention in patients with type 2 diabetes mellitus has changed substantially in the past few years. The purpose of this scientific statement is to review the current literature and key clinical trials pertaining to blood pressure and blood glucose control, cholesterol management, aspirin therapy, and lifestyle modification. We present a synthesis of the recent literature, new guidelines, and clinical targets, including screening for kidney and subclinical cardiovascular disease for the contemporary management of patients with type 2 diabetes mellitus.

Diabetes Performance Measures: Current Status and Future Directions

Just as treatment guidelines for diabetes care were at the forefront of medical guideline development (1), diabetes has been a prominent focus of performance measurement and quality improvement initiatives for well over a decade. However, the constraints of pre-electronic health records (EHRs) data systems have consistently limited the clinical scope and sophistication of current diabetes quality measures. The U.S. health care system is nearing a tipping point in the use of more sophisticated EHR-based information systems, and widespread use of these systems will usher in a new era for diabetes quality measurement. New information system capabilities will enable improvements to existing measures and enable development of much more sophisticated measures that can accommodate personalization of clinical goals, patient preferences, and patient-reported data, thus moving both guidelines and measures toward personalization based on sophisticated assessment of the risks and benefits of certain clinical actions for a given patient at a given clinical encounter. To facilitate discussion of the future of performance measurement in diabetes in this era of rapid transition to EHRs, the American Diabetes Association (ADA) convened a consensus development conference in December 2010. Participating experts identified and discussed the following questions: 1. 1. What is the evidence that measuring quality, benchmarking, and providing feedback or incentives improve diabetes care? 2. 2. What are the limitations, burdens, and consequences (intended or unintended) of diabetes quality measures as currently structured? 3. 3. What should be the role of shared decision making, patient preferences, and patient-reported data in quality measures? 4. 4. What is the future of quality measurement in diabetes? 5. 5. How can quality monitoring be integrated into population surveillance efforts? This report summarizes the consensus meeting, and represents the expert opinion of its authors and not the official position of the ADA or any other participating organization. ### 1. What is the evidence that measuring quality, benchmarking, and providing feedback or incentives improve diabetes care? The first national effort to develop a …

Depressive symptoms and the risk of type 2 diabetes mellitus in a US sample

There is some evidence to suggest that individuals with depression are at an almost twofold increased risk of developing type 2 diabetes mellitus, but results are far from conclusive. Therefore, to determine if depressive symptoms increased the risk of type 2 diabetes, we conducted longitudinal analyses using data from the NHANES I Epidemiologic Follow‐up Survey (NHEFS).

Associations Between Trends in Race/Ethnicity, Aging, and Body Mass Index With Diabetes Prevalence in the United States: A Series of Cross-sectional Studies

Context The prevalence of diabetes has increased in the United States during the past several decades. The extent to which demographic changes and rising obesity rates have contributed to this increase is unknown. Contribution Data collected from nationally representative samples of men and women between 1976 and 2010 showed a greater increase in diabetes prevalence in men than in women. After adjustment for race/ethnicity, age, and body mass index, diabetes prevalence still increased in men but not women. Caution This study could not adjust for physical activity. Implication Body mass index is a substantial contributor to the observed increase in diabetes prevalence. The Editors The increasing prevalence of diabetes over the past few decades (13) has made it one of the most common and costly chronic disorders in the United States. The nationwide prevalence of diagnosed diabetes more than doubled between 1976 to 1980 and 1999 to 2004 (3), and the prevalence of diagnosed and undiagnosed diabetes combined increased by 33% between 1988 to 1994 and 2005 to 2010 (1). The increase in diabetes prevalence has coincided with an increase in certain risk factors for diabetes. The most important modifiable risk factors for diabetes are obesity and overweight. The prevalence of adult obesity, defined as a body mass index (BMI) of 30 kg/m2 or more, in national surveys was 22.3% from 1988 to 1994, 30.5% from 2000 to 2002, and 35.9% from 2009 to 2010, whereas the prevalence of overweight, defined as a BMI of 25.0 to 29.9 kg/m2, was 32.6%, 34.0%, and 33.3% during these respective periods (46). Racial and ethnic groups at increased risk for diabetes (3) make up a growing proportion of the population. Non-Hispanic black and Hispanic persons represented 11.7% and 6.4% of the U.S. population, respectively, in 1980, and their numbers grew to 12.6% and 16.3%, respectively, in 2010 (7, 8). Risk for diabetes increases with age (9). Furthermore, the U.S. population is aging; in recent years, the median age has increased from 30.0 years in 1980 to 37.2 years in 2010 (10). How much of the increased prevalence of diabetes is explained by an increase in these known risk factors and how much is due to other factors is unclear. We sought to determine the extent to which this increase is explained by changing distributions of race/ethnicity, age, and obesity prevalence in U.S. adults. To do so, we analyzed data from several National Health and Nutrition Examination Surveys (NHANES). Each survey was designed to be representative of the U.S. population. The surveys have been conducted in waves from 1976 to 1980 (NHANES II) and 1988 to 1994 (NHANES III), as well as the continuous NHANES from 1999 to 2010. We limited the study sample to adults aged 20 to 74 years for consistency across surveys. Methods Data Collection The NHANES is a series of stratified, multistage probability surveys designed to be representative of the U.S. noninstitutionalized civilian population (1113). Data were collected in an in-home interview and a subsequent visit to a mobile examination center. The response rate was 91% for the interview and 73% for the examination in NHANES II; respective response rates were 86% and 78% in NHANES III, 82% and 76% in 1999 to 2000, 84% and 80% in 2001 to 2002, 79% and 76% in 2003 to 2004, 80% and 77% in 2005 to 2006, 78% and 75% in 2007 to 2008, and 79% and 77% in 2009 to 2010. Each NHANES survey consisted of participants who were randomly selected to participate in a morning examination for which they were asked to fast or an afternoon or evening examination. We used data from the morning sessions, which were capable of independently producing national estimates. We excluded pregnant women from the analysis because pregnancy affects glucose and BMI measurements. Respective years and sample sizes from the NHANES series were 1976 to 1980 with 4343 participants, 1988 to 1994 with 7023 participants, 1999 to 2002 with 3848 participants, 2003 to 2006 with 3688 participants, and 2007 to 2010 with 5030 participants. For NHANES III and NHANES 19992010, all participants gave written informed consent and the research ethics boards of the National Center for Health Statistics approved all protocols. The National Center for Health Statistics did an internal human subjects review in NHANES II, which did not consist of institutional review board approval using current standards. A standardized questionnaire was used to collect demographic information, including age, race/ethnicity, and sex during an in-home interview, except race/ethnicity may have been determined on the basis of interviewer observation in NHANES II. Participants were also asked if they had ever been diagnosed with diabetes by a doctor (NHANES II and III) or a doctor or other health professional (NHANES 19992010). During the visit to the mobile examination center, height and weight were measured and BMI was calculated. A trained phlebotomist obtained a blood sample according to a standardized protocol, and fasting glucose was measured in plasma by a hexokinase method. Fasting glucose was measured by using an Abbott ABA-100 analyzer in NHANES II, and the interassay coefficient of variation was not reported. Respective equipment and coefficients of variation in the NHANES series were the Roche Cobas Mira chemistry system with 1.6% to 3.7% in NHANES III, Roche Cobas Mira chemistry system with 1.3% to 3.0% in NHANES 19992002, Roche Cobas Mira chemistry system or Roche/Hitachi 911 glucose analyzer with 1.3% to 2.3% in NHANES 20032006, and Roche Modular P chemistry analyzer with 0.8% to 2.6% in NHANES 20072010. Although NHANES III and NHANES 19992004 used the same equipment and methods to measure fasting glucose, NHANES 20052010 used different equipment and was therefore calibrated to the earlier data; calibration of NHANES II data was not possible (14, 15). Diabetes was defined as a self-reported previous diagnosis of diabetes or a fasting plasma glucose level of 7.0 mmol/L (126 mg/dL) or more. Although fasting plasma glucose level was consistently measured in all of the NHANES surveys, 2-hour plasma glucose and hemoglobin A1c levels were not. Statistical Analysis We calculated means or percentages of participant characteristics by survey year and diabetes status. We then used multivariable logistic regression models with diabetes as the outcome and terms for survey year, age, race/ethnicity, and BMI to find the adjusted prevalence of diabetes by survey period, for which we computed predicted margins (16). We fit an unadjusted logistic regression model with only a term for time (midpoint of survey yearthe results are denoted as unadjusted estimates); models including covariates of age, race/ethnicity, or BMI; and a model with all 3 variables. We compared these models to determine the extent to which covariates explained the trend in diabetes over time. All tests for trend were computed by including the midpoint year for each survey period as a continuous variable in regression models. We initially included sex and a sex-by-time interaction term in all models and found the interaction to be significant. Therefore, we conducted all analyses separately by sex. Appropriate sample weights were used to account for unequal probabilities of selection and nonresponse and thus provided estimates representative of the U.S. noninstitutionalized civilian population. Data were analyzed using SUDAAN (RTI International) and accounted for the NHANES-stratified, clustered sample design. Role of the Funding Source The Centers for Disease Control and Prevention (CDC) and the National Institutes of Diabetes and Digestive and Kidney Diseases funded NHANES and oversaw its conduct and reporting with regard to diabetes-related data. As employees or contractors of the Centers for Disease Control and Prevention or National Institutes of Diabetes and Digestive and Kidney Diseases, the authors had a direct role in the design and interpretation of the secondary analysis and the decision to submit the manuscript for publication. Results Participant characteristics by diabetes status are presented for men (Table 1) and women (Table 2). The no diabetes group includes persons with both normal fasting glucose levels (<5.6 mmol/L [<100 mg/dL]) and impaired fasting glucose levels (5.6 to 6.9 mmol/L [100 to 125 mg/dL]). Our study population was limited to persons aged 20 to 74 years; within this age range, a significant increase in mean age over time was seen only in women without diabetes. The percentage of non-Hispanic white men and women without diabetes significantly decreased over time, but the decrease was not significant in those with diabetes. Both the percentage of Mexican Americans and mean BMI significantly increased over time in all subgroups. Mean fasting plasma glucose levels significantly increased over time in men and women without diabetes but not in those with diabetes. Mean fasting plasma glucose levels were generally higher in men than in women among people with and without diabetes. Table 1. Baseline Characteristics of Men, by Diabetes Status and Survey Period, 19762010 Table 2. Baseline Characteristics of Women, by Diabetes Status and Survey Period, 19762010 The crude prevalence of diabetes increased between 1976 to 1980 and 2007 to 2010 for both men and women (both P for trends < 0.001) (Figure 1) (Supplement 1). After adjustment for age, race/ethnicity, and BMI, the prevalence of diabetes in men increased from 6.2% in 1976 to 1980 to 9.6% in 2007 to 2010 (P for trend < 0.001) (Figure 2). After identical adjustment, the prevalence of diabetes in women was 7.6% in 1976 to 1980 and 7.5% in 2007 to 2010 (P for trend = 0.69) (Figure 2). Figure 1. Crude and unadjusted prevalence of diabetes in men and women, 19762010. Points refer to crude prevalence, and lines refer to unadjusted prevalence (logistic regressionbased). Figure 2. Crude and adjusted prevalence of diabetes in men and women, 19762010. Adjustmen

Promoting health after gestational diabetes: a National Diabetes Education Program call to action.

The National Diabetes Education Program joins the American College of Obstetricians and Gynecologists (the College) to promote opportunities for obstetrician-gynecologists (ob-gyns) and other primary care providers to better meet the long-term health needs of women with prior gestational diabetes mellitus (GDM) and their children. Up to one third of GDM women may have diabetes or prediabetes postpartum, yet only about half of these women are tested postpartum, and about a quarter are tested 6-12 weeks postpartum. Women with GDM face a lifelong increased risk for subsequent diabetes, primarily type 2 diabetes mellitus. Timely testing for prediabetes may provide an opportunity for ob-gyns to prevent or delay the onset of type 2 diabetes mellitus through diet, physical activity, weight management, and pharmacologic intervention. The College and the American Diabetes Association recommend testing women with a history of GDM at 6-12 weeks postpartum. If the postpartum test is normal, retest every 3 years and at the first prenatal visit in a subsequent pregnancy. If prediabetes is diagnosed, test annually. Because children of GDM pregnancies face an increased risk for obesity and type 2 diabetes mellitus, families need support to develop healthy eating and physical activity behaviors. Current criteria indicate that GDM occurs in 2% to 10% of all pregnancies. If new GDM diagnostic criteria are used, the frequency of GDM may increase to about 18% of pregnancies annually. The projected increase in the number of women with GDM and the potential subsequent associated risks underscore the need for proactive long-term primary care treatment of the mother and her children.

Diabetes Knowledge and Its Relationship With Achieving Treatment Recommendations in a National Sample of People With Type 2 Diabetes

OBJECTIVE We examined the prevalence of knowledge of A1C, blood pressure, and LDL cholesterol (ABC) levels and goals among people with diabetes, its variation by patient characteristics, and whether knowledge was associated with achieving levels of ABC control recommended for the general diabetic population. RESEARCH DESIGN AND METHODS Data came from 1,233 adults who self-reported diabetes in the 2005–2008 National Health and Nutrition Examination Survey. Participants reported their last ABC level and goals specified by their physician (not validated by medical record data). Analysis included descriptive statistics and logistic regression. RESULTS Among participants tested in the past year, 48% stated their last A1C level. Overall, 63% stated their last blood pressure level and 22% stated their last LDL cholesterol level. Knowledge of ABC levels was greatest in non-Hispanic whites, lowest in Mexican Americans, and higher with more education and income (all P ≤ 0.02). Demographic associations were similar for those reporting physician-specified ABC goals at the American Diabetes Association–recommended levels (A1C <7%, blood pressure <130/80 mmHg, and LDL cholesterol <100 mg/dL). Nineteen percent of participants stated that their provider did not specify an A1C goal compared with 47% and 41% for blood pressure and LDL cholesterol goals, respectively. For people who self-reported A1C <7.0%, 83% had an actual A1C <7.0%. Otherwise, participant knowledge was not significantly associated with risk factor control, except for in those who knew their last LDL cholesterol level (P = 0.046 for A1C <7.0%). Results from logistic regression corroborated these findings. CONCLUSIONS Ample opportunity exists to improve ABC knowledge. Diabetes education should include behavior change components in addition to information on ABC clinical measures.