2019 Endocrine Society Measures Set for Older Adults With Type 2 Diabetes Who Are at Risk for Hypoglycemia.

CONTEXT: Hypoglycemia in the outpatient setting has a significant financial impact on the health care system and negative impact on a person's quality of life. Primary care physicians must address a multitude of issues in a visit with a person with type 2 diabetes mellitus (T2DM), often leaving little time to ask about hypoglycemia. OBJECTIVE: To develop quality measures that focus on outpatient hypoglycemia episodes for patients 65 and older with T2DM, which facilitate a clinician's ability to identify opportunities to improve the quality of care and reduce hypoglycemic episodes. PARTICIPANTS AND PROCESS: A technical expert panel established by the Endocrine Society in March 2019, which includes endocrinologists, primary care physicians, a diabetes care and education specialist/pharmacist, and a patient, developed 3 outpatient hypoglycemia quality measures. The measure set is intended to improve quality of care for patients with T2DM who are at greatest risk for hypoglycemia. The measures were available for public comment in July 2019. A fourth measure on shared decision-making was removed from the final measure set based on public feedback. CONCLUSION: A lack of outpatient hypoglycemia measures focusing on older adults with T2DM is a barrier to improving care of people with diabetes and reducing hypoglycemic episodes. This paper provides measure specifications for 3 measures that may be used to focus quality improvement efforts on patients at greatest risk for hypoglycemia.

Primary Prevention of ASCVD and T2DM in Patients at Metabolic Risk: An Endocrine Society* Clinical Practice Guideline.

OBJECTIVE: To develop clinical practice guidelines for the primary prevention of atherosclerotic cardiovascular disease (ASCVD) and type 2 diabetes mellitus (T2DM) in individuals at metabolic risk for developing these conditions. CONCLUSIONS: Health care providers should incorporate regular screening and identification of individuals at metabolic risk (at higher risk for ASCVD and T2DM) with measurement of blood pressure, waist circumference, fasting lipid profile, and blood glucose. Individuals identified at metabolic risk should undergo 10-year global risk assessment for ASCVD or coronary heart disease to determine targets of therapy for reduction of apolipoprotein B-containing lipoproteins. Hypertension should be treated to targets outlined in this guideline. Individuals with prediabetes should be tested at least annually for progression to diabetes and referred to intensive diet and physical activity behavioral counseling programs. For the primary prevention of ASCVD and T2DM, the Writing Committee recommends lifestyle management be the first priority. Behavioral programs should include a heart-healthy dietary pattern and sodium restriction, as well as an active lifestyle with daily walking, limited sedentary time, and a structured program of physical activity, if appropriate. Individuals with excess weight should aim for loss of ≥5% of initial body weight in the first year. Behavior changes should be supported by a comprehensive program led by trained interventionists and reinforced by primary care providers. Pharmacological and medical therapy can be used in addition to lifestyle modification when recommended goals are not achieved.

Lack of association of apolipoprotein E (Apo E) polymorphism with the prevalence of metabolic syndrome: the National Heart, Lung and Blood Institute Family Heart Study.

OBJECTIVE: Metabolic syndrome (MetS), characterized by abdominal obesity, atherogenic dyslipidaemia, elevated blood pressure and insulin resistance, is a major public health concern in the United States. The effects of apolipoprotein E (Apo E) polymorphism on MetS are not well established. METHODS: We conducted a cross-sectional study consisting of 1551 participants from the National Heart, Lung and Blood Institute Family Heart Study to assess the relation of Apo E polymorphism with the prevalence of MetS. MetS was defined according to the American Heart Association-National Heart, Lung and Blood Institute-International Diabetes Federation-World Health Organization harmonized criteria. We used generalized estimating equations to estimate adjusted odds ratios (ORs) for prevalent MetS and the Bonferroni correction to account for multiple testing in the secondary analysis. RESULTS: Our study population had a mean age (standard deviation) of 56.5 (11.0) years, and 49.7% had MetS. There was no association between the Apo E genotypes and the MetS. The multivariable adjusted ORs (95% confidence interval) were 1.00 (reference), 1.26 (0.31-5.21), 0.89 (0.62-1.29), 1.13 (0.61-2.10), 1.13 (0.88-1.47) and 1.87 (0.91-3.85) for the Ɛ3/Ɛ3, Ɛ2/Ɛ2, Ɛ2/Ɛ3, Ɛ2/Ɛ4, Ɛ3/Ɛ4 and Ɛ4/Ɛ4 genotypes, respectively. In a secondary analysis, Ɛ2/Ɛ3 genotype was associated with 41% lower prevalence odds of low high-density lipoprotein [multivariable adjusted ORs (95% confidence interval) = 0.59 (0.36-0.95)] compared with Ɛ3/Ɛ3 genotype. CONCLUSIONS: Our findings do not support an association between Apo E polymorphism and MetS in a multicentre population-based study of predominantly White US men and women.

Night-shift work and incident diabetes among African-American women.

AIMS/HYPOTHESIS: The aim of this study was to assess shift work in relation to incident type 2 diabetes in African-American women. METHODS: In the Black Women's Health Study (BWHS), an ongoing prospective cohort study, we followed 28,041 participants for incident diabetes during 2005-2013. They answered questions in 2005 about having worked a night shift. We estimated HR and 95% CIs for incident diabetes using Cox proportional hazards models. The basic multivariable model included age, time period, family history of diabetes, education and neighbourhood socioeconomic status. In further models, we controlled for lifestyle factors and BMI. RESULTS: Over the 8 years of follow-up, there were 1,786 incident diabetes cases. Relative to never having worked the night shift, HRs (95% CI) for diabetes were 1.17 (1.04, 1.31) for 1-2 years of night-shift work, 1.23 (1.06, 1.41) for 3-9 years and 1.42 (1.19, 1.70) for ≥ 10 years (p-trend < 0.0001). The monotonic positive association between night-shift work and type 2 diabetes remained after multivariable adjustment (p-trend = 0.02). The association did not vary by obesity status, but was stronger in women aged <50 years. CONCLUSIONS/INTERPRETATION: Long duration of shift work was associated with an increased risk of type 2 diabetes. The association was only partially explained by lifestyle factors and BMI. A better understanding of the mechanisms by which shift work may affect the risk of diabetes is needed in view of the high prevalence of shift work among workers in the USA.

Birth weight and risk of type 2 diabetes in the black women's health study: does adult BMI play a mediating role?

OBJECTIVE: To assess the association of birth weight with incident type 2 diabetes, and the possible mediating influence of obesity, in a large cohort of U.S. black women. RESEARCH DESIGN AND METHODS: The Black Women's Health Study is an ongoing prospective study. We used Cox proportional hazards models to estimate incidence rate ratios (IRRs) and 95% CI for categories of birth weight (very low birth weight [<1,500 g], low birth weight [1,500-2,499 g], and high birth weight [≥4,000 g]) in reference to normal birth weight (2,500-3,999 g). Models were adjusted for age, questionnaire cycle, family history of diabetes, caloric intake, preterm birth, physical activity, years of education, and neighborhood socioeconomic status with and without inclusion of terms for adult BMI. RESULTS: We followed 21,624 women over 16 years of follow-up. There were 2,388 cases of incident diabetes. Women with very low birth weight had a 40% higher risk of disease (IRR 1.40 [95% CI 1.08-1.82]) than women with normal birth weight; women with low birth weight had a 13% higher risk (IRR 1.13 [95% CI 1.02-1.25]). Adjustment for BMI did not appreciably change the estimates. CONCLUSIONS: Very low birth weight and low birth weight appear to be associated with increased risk of type 2 diabetes in African American women, and the association does not seem to be mediated through BMI. The prevalence of low birth weight is especially high in African American populations, and this may explain in part the higher occurrence of type 2 diabetes.

Depressive symptoms, antidepressant use, and the incidence of diabetes in the Black Women's Health Study.

OBJECTIVE: To assess the relationship of depressive symptoms and use of antidepressants with incident type 2 diabetes in prospective data from a large cohort of U.S. African American women. RESEARCH DESIGN AND METHODS: The Black Women's Health Study (BWHS) is an ongoing prospective cohort study. We followed 35,898 women from 1999 through 2011 who were without a diagnosis of diabetes and who had completed the Center for Epidemiologic Studies Depression Scale (CES-D) in 1999. CES-D scores were categorized as <16, 16-22, 23-32, and ≥33, which reflected increasingly more depressive symptoms. We estimated incidence rate ratios (IRRs) and 95% CIs for incident diabetes using Cox proportional hazards models. The basic multivariable model included age, time period, family history of diabetes, and education. In further models, we controlled for lifestyle factors and BMI. We also assessed the association of antidepressant use with incident diabetes. RESULTS: Over 12 years of follow-up, there were 3,372 incident diabetes cases. Relative to CES-D score <16, IRRs (95% CI) of diabetes for CES-D scores 16-22, 23-32, and ≥33 were 1.23 (1.12-1.35), 1.26 (1.12-1.41), and 1.45 (1.24-1.69), respectively, in the basic multivariate model. Multiple adjustment for lifestyle factors and BMI attenuated the IRRs to 1.11 (1.01-1.22), 1.08 (0.96-1.22), and 1.22 (1.04-1.43). The adjusted IRR for antidepressant use was 1.26 (1.11-1.43). Results were similar among obese women. CONCLUSIONS: Both depressive symptoms and antidepressant use are associated with incident diabetes among African American women. These associations are mediated in part, but not entirely, through lifestyle factors and BMI.

The influence of sex on cardiovascular outcomes associated with diabetes among older black and white adults.

AIMS: It is unknown whether sex differences in the association of diabetes with cardiovascular outcomes vary by race. We examined sex differences in the associations of diabetes with incident congestive heart failure (CHF) and coronary heart disease (CHD) between older black and white adults. METHODS: We analyzed data from the Cardiovascular Health Study (CHS), a prospective cohort study of community-dwelling individuals aged ≥65 from four US counties. We included 4817 participants (476 black women, 279 black men, 2447 white women and 1625 white men). We estimated event rates and multivariate-adjusted hazard ratios for incident CHF, CHD, and all-cause mortality by Cox regression and competing risk analyses. RESULTS: Over a median follow-up of 12.5years, diabetes was more strongly associated with CHF among black women (HR, 2.42 [95% CI, 1.70-3.40]) than black men (1.39 [0.83-2.34]); this finding did not reach statistical significance (P for interaction=0.08). Female sex conferred a higher risk for a composite outcome of CHF and CHD among black participants (2.44 [1.82-3.26]) vs. (1.44 [0.97-2.12]), P for interaction=0.03). There were no significant sex differences in the HRs associated with diabetes for CHF among whites, or for CHD or all-cause mortality among blacks or whites. The three-way interaction between sex, race, and diabetes on risk of cardiovascular outcomes was not significant (P=0.07). CONCLUSIONS: Overall, sex did not modify the cardiovascular risk associated with diabetes among older black or white adults. However, our results suggest that a possible sex interaction among older blacks merits further study.

The association between small vessel infarcts and the activities of amyloid-ß peptide degrading proteases in apolipoprotein E4 allele carriers.

Small vessel (SV) and large vessel (LV) brain infarcts are distinct pathologies. Using a homebound elderly sample, the numbers of either infarct subtypes were similar between those apolipoprotein E4 allele (ApoE4) carriers (n = 80) and noncarriers (n = 243). We found that the higher the number of SV infarcts, but not LV infarcts, a participant had, the higher the activity of substrate V degradation in serum especially among ApoE4 carriers (ß = +0.154, SE = 0.031, P < .0001) after adjusting for the confounders. Since substrate V degradation could be mediated by insulin-degrading enzyme (IDE) or/and angiotensin-converting enzyme (ACE), but no relationship was found between SV infarcts and specific ACE activities, blood IDE may be a useful biomarker to distinguish the brain infarct subtypes. Insulin-degrading enzyme in blood may also imply an important biomarker and a pathological event in Alzheimer disease through SV infarcts in the presence of ApoE4.

Comparison of diabetes control among Haitians, African Americans, and non-Hispanic whites in an urban safety-net hospital.

OBJECTIVE: To compare diabetes care and outcomes among Haitians, African Americans, and non-Hispanic whites. RESEARCH DESIGN AND METHODS: We analyzed data from 715 Haitian, 1,472 African American, and 466 non-Hispanic white adults with diabetes using χ² testing and multiple logistic regression. RESULTS: Haitians had a higher mean A1C than African Americans (8.2 ± 1.9 vs. 7.7 ± 2.0%) and non-Hispanic whites (7.5 ± 1.7%) (both P < 0.0001). There was no difference in completion of process measures. Haitians were more likely than non-Hispanic whites to have elevated LDL cholesterol or blood pressure. Macrovascular complications were fewer among Haitians than African Americans (adjusted odds ratio 0.35 [95% CI 0.23-0.55]), as were microvascular complications (0.56 [0.41-0.76]). Haitians also had fewer macrovascular (0.32 [0.20-0.50]) and microvascular (0.55 [0.39-0.79]) complications than non-Hispanic whites. CONCLUSIONS: Haitians have worse glycemic control than African Americans or non-Hispanic whites. Future research and interventions to improve diabetes care should target Haitians as a distinct racial/ethnic group.

Diabetes disease management in Medicare Advantage reduces hospitalizations and costs.

OBJECTIVE: To evaluate the effectiveness of a telephonic diabetes disease management intervention in a Medicare Advantage population with comorbid diabetes and coronary artery disease (CAD). STUDY DESIGN: Prospective unequal randomization design of 526 members from a Medicare Advantage segment of one region of a large national health plan from May 2005 through April 2007. METHODS: High-risk and high-cost patients with diabetes and CAD who were enrolled in telephonic diabetes disease management were compared with a randomly selected comparison group receiving usual care. Wilcoxon signed-rank tests were used to compare the groups on all-cause hospital admissions, diabetes-related hospital admissions, all-cause and diabetes-related emergency department (ED) visits, and all-cause medical costs. Changes in self-reported clinical outcomes also were measured in the intervention group. RESULTS: Patients receiving telephonic diabetes disease management had significantly decreased all-cause hospital admissions and diabetes-related hospital admissions (P <.05). The intervention group had decreased all-cause and diabetes-related ED visits, although the difference was not statistically significant. The comparison group had increased ED utilization. The intervention group decreased their all-cause total medical costs by $984.87 per member per year (PMPY) compared with a $4547.06 PMPY increase in the comparison group (P <.05). All clinical measures significantly improved (P <.05) in the intervention group. CONCLUSIONS: A disease management program for high-risk patients with diabetes and CAD was effective in reducing hospital inpatient admission and total costs in a Medicare Advantage population.

The economic consequences of diabetes and cardiovascular disease in the United States.

Diabetes-related care and complications constitute a significant proportion of the United States' (US) health care expenditure. Of these complications, cardiovascular disease (CVD) is a major component. Higher morbidity and mortality rates translate to higher costs of care in patients with diabetes compared to those who do not have the disease. Minorities bear a disproportionate burden of diabetes and CVD. We review this disparity and examine potential etiologies for it in Hispanics and African-Americans, the two largest minority groups in the US. We examine strategies in these populations that may improve outcomes in diabetes and CVD, potentially decreasing health care costs.

Primary prevention of cardiovascular disease and type 2 diabetes in patients at metabolic risk: an endocrine society clinical practice guideline.

OBJECTIVE: The objective was to develop clinical practice guidelines for the primary prevention of cardiovascular disease (CVD) and type 2 diabetes mellitus (T2DM) in patients at metabolic risk. CONCLUSIONS: Healthcare providers should incorporate into their practice concrete measures to reduce the risk of developing CVD and T2DM. These include the regular screening and identification of patients at metabolic risk (at higher risk for both CVD and T2DM) with measurement of blood pressure, waist circumference, fasting lipid profile, and fasting glucose. All patients identified as having metabolic risk should undergo 10-yr global risk assessment for either CVD or coronary heart disease. This scoring will determine the targets of therapy for reduction of apolipoprotein B-containing lipoproteins. Careful attention should be given to the treatment of elevated blood pressure to the targets outlined in this guideline. The prothrombotic state associated with metabolic risk should be treated with lifestyle modification measures and in appropriate individuals with low-dose aspirin prophylaxis. Patients with prediabetes (impaired glucose tolerance or impaired fasting glucose) should be screened at 1- to 2-yr intervals for the development of diabetes with either measurement of fasting plasma glucose or a 2-h oral glucose tolerance test. For the prevention of CVD and T2DM, we recommend that priority be given to lifestyle management. This includes antiatherogenic dietary modification, a program of increased physical activity, and weight reduction. Efforts to promote lifestyle modification should be considered an important component of the medical management of patients to reduce the risk of both CVD and T2DM.

Use of a disease severity index for evaluation of healthcare costs and management of comorbidities of patients with diabetes mellitus.

OBJECTIVES: To evaluate a stratification system for patients with diabetes mellitus according to severity of illness and care requirements and to correlate severity of illness with total medical and pharmaceutical costs of care. STUDY DESIGN, PATIENTS, AND METHODS: A cohort of 697 patients with diabetes mellitus was followed in a diabetes clinic under a managed care plan. Patients were stratified according to severity of illness in 6 clinical areas: glycemic control, cardiovascular disease, peripheral vascular disease/peripheral neuropathy, eye disease, renal disease, and autonomic neuropathy. Stratification was based on clinical elements in patients' medical records related to diabetes mellitus care and its comorbidities. Total medical and pharmaceutical costs were identified for 508 patients who participated in the managed care program for at least 8 months. RESULTS: Patients in high- and very high-risk categories for cardiovascular disease, peripheral vascular disease/peripheral neuropathy, eye disease, and renal disease had markedly increased medical and pharmaceutical costs compared with those in low-risk categories. Pharmaceutical costs for patients in the glycemic control clinical area show a trend toward lower costs at higher risk. Pregnancy and depression were also associated with markedly increased healthcare costs. Patients who were in multiple high- and very high-risk categories had dramatically increased medical costs, as much as 10-fold those of patients who were in none of these categories. CONCLUSIONS: A diabetes mellitus-specific risk stratification system related to required care intensity can be used to identify patients with high medical costs and can enable care providers to select patients for case management and triage into specific care programs.