Why Are Diabetes Medications So Expensive and What Can Be Done to Control Their Cost?

PURPOSE OF REVIEW: The purposes of this study were to describe how medication prices are established, to explain why antihyperglycemic medications have become so expensive, to show trends in expenditures for antihyperglycemic medications, and to highlight strategies to control expenditures in the USA. RECENT FINDINGS: In the U.S., pharmaceutical manufacturers set the prices for new products. Between 2002 and 2012, expenditures for antihyperglycemic medications increased from $10 billion to $22 billion. This increase was primarily driven by expenditures for insulin which increased sixfold. The increase in insulin expenditures may be attributed to several factors: the shift from inexpensive beef and pork insulins to more expensive genetically engineered human insulins and insulin analogs, dramatic price increases for the available insulins, physician prescribing practices, policies that limit payers' abilities to negotiate prices, and nontransparent negotiation of rebates and discounts. The costs of antihyperglycemic medications, especially insulin, have become a barrier to diabetes treatment. While clinical interventions to shift physician prescribing practices towards lower cost drugs may provide some relief, we will ultimately need policy interventions such as more stringent requirements for patent exclusivity, greater transparency in medication pricing, greater opportunities for price negotiation, and outcomes-based pricing models to control the costs of antihyperglycemic medications.

The impact of weight loss on health-related quality-of-life: implications for cost-effectiveness analyses.

PURPOSE: To assess the impact of weight loss on health-related quality-of-life (HRQL), to describe the factors associated with improvements in HRQL after weight loss, and to assess the relationship between obesity as assessed by body mass index (BMI) and HRQL before and after weight loss. METHODS: We studied 188 obese patients with BMI ≥ 32 kg/m(2) with one or more comorbidities or ≥35 kg/m(2). All patients had baseline and follow-up assessments of BMI and HRQL using the EuroQol (EQ-5D) and its visual analog scale (VAS) before and after 6 months of medical weight loss that employed very low-calorie diets, physical activity, and intensive behavioral counseling. RESULTS: At baseline, age was 50 ± 8 years (mean ± SD), BMI was 40. 0 ± 5.0 kg/m(2), EQ-5D-derived health utility score was 0.85 ± 0.13, and VAS-reported quality-of-life was 0.67 ± 0.18. At 6-month follow-up, BMI decreased by 7.0 ± 3.2 kg/m(2), EQ-5D increased by 0.06 [interquartile range (IQR) 0.06-0.17], and VAS increased by 0.14 (IQR 0.04-0.23). In multivariate analyses, improvement in EQ-5D and VAS were associated with lower baseline BMI, greater reduction in BMI at follow-up, fewer baseline comorbidities, and lower baseline HRQL. For any given BMI category, EQ-5D and VAS tended to be higher at follow-up than at baseline. CONCLUSION: Measured improvements in HRQL between baseline and follow-up were greater than predicted by the reduction in BMI at follow-up. If investigators use cross-sectional data to estimate changes in HRQL as a function of BMI, they will underestimate the improvement in HRQL associated with weight loss and underestimate the cost-utility of interventions for obesity treatment.

Uptake, retention, and outcomes of the National Diabetes Prevention Program by enrollee characteristics and program type.

AIMS: To describe National Diabetes Prevention Program (NDPP) uptake, retention, and outcomes by enrollee characteristics and program type. METHODS: We studied 776 adult University of Michigan employees, dependents, and retirees with prediabetes and overweight or obesity who enrolled in one of four CDC-recognized NDPPs at no out-of-pocket cost. Programs included 1) an in-person classroom-based program led by certified diabetes educators in an endocrinology outpatient clinic; 2) an in-person classroom-based program led by trained peer instructors in community settings; 3) an in-person fitness-focused program led by trained lifestyle coaches; and 4) an online digital program led by personal health coaches with virtual group meetings. Data from the insurer and surveys were analyzed. RESULTS: Older individuals with hypertension and cardiovascular disease were more likely to enroll in classroom-based programs. Program time, location, and perceived focus on diet or physical activity influenced program selection. Retention, weight loss, and physical activity were greater among enrollees in in-person classroom-based programs. Changes in blood pressure, lipid levels, self-rated health, and health-related quality-of-life did not differ by program, nor did Type 2 diabetes mellitus incidence. CONCLUSIONS: Individuals with prediabetes who enrolled in a NDPP achieved health benefits regardless of the type of program they chose.

Retention and outcomes of National Diabetes Prevention Program enrollees and non-enrollees with prediabetes: The University of Michigan experience.

AIMS: To evaluate retention and outcomes of insured adults with prediabetes who enrolled or did not enroll in National Diabetes Prevention Programs (NDPPs). METHODS: Between 2015 and 2019, 776 University of Michigan employees, dependents, and retirees with prediabetes and overweight or obesity enrolled in one-year NDPPs. RESULTS: Enrollees attended a median of 18 sessions. Median retention was 38 weeks. Retention was associated with older age, greater initial weight loss, and physical activity. At both 1- and 2-years, body mass index, triglycerides, and HbA1c were significantly improved among enrollees. After adjusting for age group, sex, and race, the odds of developing diabetes based on HbA1c ≥6.5 % was 40 % lower at 1-year and 20 % lower at 2-years, and the odds of self-reported diabetes was 57 % lower at 1-year and 46 % lower at 2-years in enrollees compared to non-enrollees. Enrollees who disenrolled before completing the core curriculum had higher odds and enrollees who completed the NDPP had lower odds of developing diabetes that non-enrollees. CONCLUSIONS: In this population with prediabetes, NDPP retention was generally good, risk factors were improved, and diabetes was delayed or prevented for up to two years.

The effect of parental diabetes prevention program participation on weight loss in dependent children: a prospective cohort study.

INTRODUCTION: Obesity has reached epidemic proportions in children and adolescents in the United States. Children's behaviors are strongly influenced by parental behaviors, and weight loss in parents is positively associated with weight changes in their overweight/obese children. Research is limited on how parents' National Diabetes Prevention Program (DPP) participation affects the health outcomes of their dependent children. Analyzing the impact of parental DPP participation on weight loss in their dependent children may provide valuable insight into an important secondary benefit of DPP participation. METHODS: In this study, we identified 128 adults with prediabetes who were offered the opportunity to participate in a DPP (n = 54 DPP participants and n = 74 DPP non-participants) and who had at least one child 3 to 17 years of age living with them. Age and BMI percentile for dependent children were collected from insurance claims data for 203 children (n = 90 children of DPP participants and n = 113 children of DPP non-participants). Parental practices related to diet and physical activity were assessed by surveys. RESULTS: There were no significant changes in BMI percentiles of overweight or obese children (i.e. BMI percentile ≥ 50%) of DPP participants vs DPP non-participants with prediabetes over one-year. Parents who enrolled and did not enroll in the DPP did not report differences in their parenting practices related to diet and physical activity. DISCUSSION: These results are not consistent with the literature that suggests parent-based interventions may influence their children's weight trajectories. Limitations include small sample size, short time span of intervention, and limited availability of additional health/biographic data on dependent children. Future studies should collect primary outcome data on children, investigate whether there is a minimum duration of parental involvement and level of parental adherence, and assess the effect of parent-child dynamics on child weight trajectories.

Study protocol: Behavioral economics and self-determination theory to change diabetes risk (BEST Change).

BACKGROUND: The Diabetes Prevention Program (DPP) and metformin can prevent or delay the onset of type 2 diabetes mellitus (T2DM) among patients with prediabetes. Yet, even when these evidence-based strategies are accessible and affordable, uptake is low. Thus, there is a critical need for effective, scalable, and sustainable approaches to increase uptake and engagement in these interventions. METHODS: In this randomized controlled trial, we will test whether financial incentives and automated messaging to promote autonomous motivation for preventing T2DM can increase DPP participation, metformin use, or both among adults with prediabetes. Participants (n = 380) will be randomized to one of four study arms. Control Arm participants will receive usual care and educational text messages about preventing T2DM. Incentives Arm participants will receive the Control Arm intervention plus financial incentives for DPP participation or metformin use. Tailored Messages Arm participants will receive the Control Arm intervention plus tailored messages promoting autonomous motivation for preventing T2DM. Combined Arm participants will receive the Incentives Arm and Tailored Messages Arm interventions plus messages to increase the personal salience of financial incentives. The primary outcome is change in hemoglobin A1c from baseline to 12 months. Secondary outcomes are change in body weight, DPP participation, and metformin use. DISCUSSION: If effective, these scalable and sustainable approaches to increase patient motivation to prevent T2DM can be deployed by health systems, health plans, and employers to help individuals with prediabetes lower their risk for developing T2DM.

Factors affecting timing of surgery following neoadjuvant chemoradiation for esophageal cancer.

Background: Neoadjuvant chemoradiation with esophagectomy is standard management for locally advanced esophageal cancer. Studies have shown that surgical timing following chemoradiation is important for minimizing postoperative complications, however in practice timing is often variable and delayed. Although postoperative impact of surgical timing has been studied, less is known about factors associated with delays. Materials and methods: A retrospective review was performed for 96 patients with esophageal cancer who underwent chemoradiation then esophagectomy between 2018 and 2020 at a single institution. Univariable and stepwise multivariable analyses were used to assess association between social (demographics, insurance) and clinical variables (pre-operative weight, comorbidities, prior cardiothoracic surgery, smoking history, disease staging) with time to surgery (≤8 weeks "on-time" vs. >8 weeks "delayed"). Results: Fifty-one patients underwent esophagectomy within 8 weeks of chemoradiation; 45 had a delayed operation. Univariate analysis showed the following characteristics were significantly different between on-time and delayed groups: weight loss within 3 months of surgery (3.9 ± 5.1 kg vs. 1.5 ± 3.6 kg; P = 0.009), prior cardiovascular disease (29% vs. 49%; P = 0.05), prior cardiothoracic surgery (4% vs. 22%; P = 0.01), history of ever smoked (69% vs. 87%; P = 0.04), absent nodal metastasis on pathology (57% vs. 82%; P = 0.008). Multivariate analysis demonstrated that prior cardiothoracic surgery (OR 8.924, 95%CI 1.67-47.60; P = 0.01) and absent nodal metastasis (OR 4.186, 95%CI 1.50-11.72; P = 0.006) were associated with delayed surgery. Conclusions: Delayed esophagectomy following chemoradiotherapy is associated with prior cardiothoracic surgery and absent nodal metastasis. Further investigations should focus on understanding how these factors contribute to delays to guide treatment planning and mitigate sources of outcome disparities.

Evaluation of risk equations for prediction of short-term coronary heart disease events in patients with long-standing type 2 diabetes: the Translating Research into Action for Diabetes (TRIAD) study.

BACKGROUND: To evaluate the U.K. Prospective Diabetes Study (UKPDS) and Framingham risk equations for predicting short-term risk of coronary heart disease (CHD) events among adults with long-standing type 2 diabetes, including those with and without preexisting CHD. METHODS: Prospective cohort of U.S. managed care enrollees aged ≥ 18 years and mean diabetes duration of more than 10 years, participating in the Translating Research into Action for Diabetes (TRIAD) study, was followed for the first occurrence of CHD events from 2000 to 2003. The UKPDS and Framingham risk equations were evaluated for discriminating power and calibration. RESULTS: A total of 8303 TRIAD participants, were identified to evaluate the UKPDS (n = 5914, 120 events), Framingham-initial (n = 5914, 218 events) and Framingham-secondary (n = 2389, 374 events) risk equations, according to their prior CHD history. All of these equations exhibited low discriminating power with Harrell's c-index <0.65. All except the Framingham-initial equation for women and the Framingham-secondary equation for men had low levels of calibration. After adjsusting for the average values of predictors and event rates in the TRIAD population, the calibration of these equations greatly improved. CONCLUSIONS: The UKPDS and Framingham risk equations may be inappropriate for predicting the short-term risk of CHD events in patients with long-standing type 2 diabetes, partly due to changes in medications used by patients with diabetes and other improvements in clinical care since the Frmaingham and UKPDS studies were conducted. Refinement of these equations to reflect contemporary CHD profiles, diagnostics and therapies are needed to provide reliable risk estimates to inform effective treatment.

Domains from the health belief model predict enrollment in the National Diabetes Prevention Program among insured adults with prediabetes.

AIMS: To examine enrollment in the National Diabetes Prevention Program (DPP) by insured adults with prediabetes according to domains of the Health Belief Model (HBM). METHODS: Between 2015 and 2019, University of Michigan employees, retirees, and dependents with prediabetes were offered the National DPP at no out-of-pocket cost. Individuals with prediabetes were identified and mailed letters encouraging them to enroll. We surveyed those who enrolled and a random sample of those who did not using the HBM as a framework to examine factors associated with enrollment. Analyses were performed using multivariable logistic regression models. RESULTS: Of 64,131 employees, retirees, and dependents, 8131 were identified with prediabetes and 776 (9.5%) enrolled in the National DPP. Of those surveyed, 532 of 776 National DPP enrollees and 945 of 2673 non-enrollees responded to the survey (adjusted response rates 74% and 43%, respectively). Among survey respondents, factors associated with National DPP enrollment included older age, female sex, higher BMI, prediabetes awareness, greater perceived benefits of health-protective action, and one or more cues to action. CONCLUSIONS: Optimizing National DPP enrollment among adults with prediabetes will require identifying individuals with prediabetes, increasing personal awareness of the diagnosis, increasing perceived benefits of enrollment, and providing strong cues to action.

Health Beliefs Associated With Metformin Use Among Insured Adults With Prediabetes.

OBJECTIVE: To use the framework of the Health Belief Model (HBM) to explore factors associated with metformin use among adults with prediabetes. RESEARCH DESIGN AND METHODS: We analyzed survey data from 200 metformin users and 1,277 nonmetformin users with prediabetes identified from a large, insured workforce. All subjects were offered the National Diabetes Prevention Program (DPP) at no out-of-pocket cost. We constructed bivariate and multivariate models to investigate how perceived threat, perceived benefits, self-efficacy, and cues to action impacted metformin use and how demographic, clinical, sociopsychological, and structural variables impacted the associations. RESULTS: Adults with prediabetes who used metformin were younger and more likely to be women and to have worse self-rated health and higher BMIs than those with prediabetes who did not use metformin. Those who used metformin were also more likely to be aware of their prediabetes and to have a personal history of gestational diabetes mellitus or a family history of diabetes. After consideration of perceived threat, perceived benefits, self-efficacy, and cues to action, the only independent predictors of metformin use were younger age, female sex, higher BMI, and cues to action, most specifically, a doctor offering metformin therapy. CONCLUSIONS: Demographic and clinical factors and cues to action impact the likelihood of metformin use for diabetes prevention. Perceived threat, perceived benefits, and self-efficacy were not independently associated with metformin use. These results highlight the importance of patient-centered primary care and shared decision-making in diabetes prevention. Clinicians should proactively offer metformin to patients with prediabetes to facilitate effective diabetes prevention.

Primary language, income and the intensification of anti-glycemic medications in managed care: the (TRIAD) study.

BACKGROUND: Patients who speak Spanish and/or have low socioeconomic status are at greater risk of suboptimal glycemic control. Inadequate intensification of anti-glycemic medications may partially explain this disparity. OBJECTIVE: To examine the associations between primary language, income, and medication intensification. DESIGN: Cohort study with 18-month follow-up. PARTICIPANTS: One thousand nine hundred and thirty-nine patients with Type 2 diabetes who were not using insulin enrolled in the Translating Research into Action for Diabetes Study (TRIAD), a study of diabetes care in managed care. MEASUREMENTS: Using administrative pharmacy data, we compared the odds of medication intensification for patients with baseline A1c ≥ 8%, by primary language and annual income. Covariates included age, sex, race/ethnicity, education, Charlson score, diabetes duration, baseline A1c, type of diabetes treatment, and health plan. RESULTS: Overall, 42.4% of patients were taking intensified regimens at the time of follow-up. We found no difference in the odds of intensification for English speakers versus Spanish speakers. However, compared to patients with incomes <$15,000, patients with incomes of $15,000-$39,999 (OR 1.43, 1.07-1.92), $40,000-$74,999 (OR 1.62, 1.16-2.26) or >$75,000 (OR 2.22, 1.53-3.24) had increased odds of intensification. This latter pattern did not differ statistically by race. CONCLUSIONS: Low-income patients were less likely to receive medication intensification compared to higher-income patients, but primary language (Spanish vs. English) was not associated with differences in intensification in a managed care setting. Future studies are needed to explain the reduced rate of intensification among low income patients in managed care.

The Effectiveness of a Proactive, Three-Level Strategy to Identify People With Prediabetes in a Large Workforce With Employer-Sponsored Health Insurance.

OBJECTIVE: Rates of diagnosis of prediabetes and uptake of the National Diabetes Prevention Program (NDPP) are low. We evaluated a proactive three-level strategy to identify individuals with prediabetes in a population with employer-sponsored health insurance. RESEARCH DESIGN AND METHODS: We studied 64,131 insured employees, dependents, and retirees ≥18 years of age without diagnosed diabetes, 19,397 (30%) of whom were estimated to have prediabetes. Individuals with prediabetes were identified by 1) searching claims diagnoses and previously performed HbA1c test results, 2) risk stratifying people 40-64 years of age without diabetes, prediabetes, or documented normal HbA1c to identify individuals at higher risk and encourage them to be tested, and 3) using a media campaign to encourage employees not otherwise targeted to self-screen and, if at higher risk, to be tested. RESULTS: Using claims and laboratory data, 11% of the population was identified as having prediabetes. Of those 40-64 years of age, 25% were identified as being at higher risk, and 27% of them were tested or diagnosed within 1 year. Of employees exposed to the media campaign, 14% were tested or diagnosed within 1 year. Individuals with prediabetes were older, heavier, and more likely to have hypertension and dyslipidemia. Testing and diagnosis were associated with receiving medical care and provider outreach. A total of 8,129 individuals, or 42% of those with prediabetes, were identified. CONCLUSIONS: Analysis of existing health insurance data facilitated the identification of individuals with prediabetes. Better identification of people with prediabetes is a first step in increasing uptake of the NDPP.

Use of metformin following a population-level intervention to encourage people with pre-diabetes to enroll in the National Diabetes Prevention Program.

INTRODUCTION: The National Diabetes Prevention Program (NDPP) and metformin are interventions to slow progression from pre-diabetes to type 2 diabetes. When coverage for the NDPP was offered by a public research university's health insurance plan, proactive strategies were used to combat historically low enrollment. Although not specifically targeted by these strategies, metformin use was higher than expected, leading to this evaluation. RESEARCH DESIGN AND METHODS: We used insurance enrollment, claims, pharmacy, and laboratory data for 64 131 adult employees, dependents, and retirees to identify individuals with pre-diabetes and invite them to enroll in the NDPP at no out-of-pocket cost. The characteristics of individuals with pre-diabetes who used metformin before and after their invitation were compared with NDPP enrollees. RESULTS: 8131 individuals with pre-diabetes were identified. Of these, 776 (9.5%) enrolled in a NDPP and 802 (9.9%) used metformin. Metformin users were younger, had higher body mass index, were more likely to have comorbidities, and had higher baseline hemoglobin A1c levels than non-users. Timing of metformin use varied with 107 (13%) discontinuing, 426 (53%) continuing, and 269 (34%) initiating metformin use after their NDPP invitation. Of NDPP enrollees, 13 (2%) discontinued, 56 (7%) continued, and 34 (4%) initiated metformin use when they enrolled. CONCLUSIONS: Despite no active encouragement, use of metformin was similar to the rate of enrollment in the NDPP. Metformin use was higher for individuals with higher likelihood of responding. With the proven cost-effectiveness of metformin, targeted strategies to increase metformin use in individuals with pre-diabetes who are likely to respond, but not willing to enroll in a lifestyle intervention, are needed.

Thiazolidinediones, cardiovascular disease and cardiovascular mortality: translating research into action for diabetes (TRIAD).

BACKGROUND: Studies have associated thiazolidinedione (TZD) treatment with cardiovascular disease (CVD) and questioned whether the two available TZDs, rosiglitazone and pioglitazone, have different CVD risks. We compared CVD incidence, cardiovascular (CV), and all-cause mortality in type 2 diabetic patients treated with rosiglitazone or pioglitazone as their only TZD. METHODS: We analyzed survey, medical record, administrative, and National Death Index (NDI) data from 1999 through 2003 from Translating Research Into Action for Diabetes (TRIAD), a prospective observational study of diabetes care in managed care. Medications, CV procedures, and CVD were determined from health plan (HP) administrative data, and mortality was from NDI. Adjusted hazard rates (AHR) were derived from Cox proportional hazard models adjusted for age, sex, race/ethnicity, income, history of diabetic nephropathy, history of CVD, insulin use, and HP. RESULTS: Across TRIAD's 10 HPs, 1,815 patients (24%) filled prescriptions for a TZD, 773 (10%) for only rosiglitazone, 711 (10%) for only pioglitazone, and 331 (4%) for multiple TZDs. In the seven HPs using both TZDs, 1,159 patients (33%) filled a prescription for a TZD, 564 (16%) for only rosiglitazone, 334 (10%) for only pioglitazone, and 261 (7%) for multiple TZDs. For all CV events, CV, and all-cause mortality, we found no significant difference between rosiglitazone and pioglitazone. CONCLUSIONS: In this relatively small, prospective, observational study, we found no statistically significant differences in CV outcomes for rosiglitazone- compared to pioglitazone-treated patients. There does not appear to be a pattern of clinically meaningful differences in CV outcomes for rosiglitazone- versus pioglitazone-treated patients.

Severe obesity and the impact of medical weight loss on estimated glomerular filtration rate.

OBJECTIVE: To assess the impact of obesity, glucose tolerance, and weight loss on renal function, we measured serum creatinine and cystatin C and estimated glomerular filtration rate (GFR) indexed to 1.73m2 body surface area (BSA) and GFR indexed to actual BSA in subjects with normal and abnormal glucose tolerance before and up to 2 years after medical weight loss. METHODS: We studied 146 subjects at baseline and 3-to-6 months after 18% reduction in weight; 43 were also studied at 2-years. GFR was estimated using the MDRD, CKD-EPICr, CKD-EPICysCr, and the CKD-EPICys equations. RESULTS: eGFR was consistently lower when creatinine-based rather than cystatin C-based estimating equations were used. eGFR was lower when creatinine-based or cystatin C-based equations were indexed to 1.73m2 BSA than when they were indexed to actual BSA. eGFR indexed to actual BSA was more likely to demonstrate hyperfiltration (eGFR ≥135 ml/min) than eGFR indexed to 1.73m2 BSA and decreased into the normal range with weight loss. eGFR was highest in subjects with impaired fasting glucose but there was little difference in the patterns of change in eGFR across groups by glucose tolerance status. CONCLUSIONS: With severe obesity, high fat-free mass and BSA result in low estimates of eGFR indexed to 1.73m2 BSA, especially when creatinine-based estimating equations are used. GFR indexed to actual BSA is approximately 50% higher. When eGFR is indexed to actual BSA, many subjects display evidence of renal hyperfiltration which improves with weight loss. In subjects with severe obesity undergoing medical weight loss, estimating equations that use cystatin C and are indexed to actual BSA may provide a more accurate assessment of renal function.

Imputing HbA1c from capillary blood glucose levels in patients with type 2 diabetes in Sri Lanka: a cross-sectional study.

OBJECTIVE: To develop a population-specific methodology for estimating glycaemic control that optimises resource allocation for patients with diabetes in rural Sri Lanka. DESIGN: Cross-sectional study. SETTING: Trincomalee, Sri Lanka. PARTICIPANTS: Patients with non-insulin-treated type 2 diabetes (n=220) from three hospitals in Trincomalee, Sri Lanka. OUTCOME MEASURE: Cross-validation was used to build and validate linear regression models to identify predictors of haemoglobin A1c (HbA1c). Validation of models that regress HbA1c on known determinants of glycaemic control was thus the major outcome. These models were then used to devise an algorithm for categorising the patients based on estimated levels of glycaemic control. RESULTS: Time since last oral intake other than water and capillary blood glucose were the statistically significant predictors of HbA1c and thus included in the final models. In order to minimise type II error (misclassifying a high-risk individual as low-risk or moderate-risk), an algorithm for interpreting estimated glycaemic control was created. With this algorithm, 97.2% of the diabetic patients with HbA1c ≥9.0% were correctly identified. CONCLUSIONS: Our calibrated algorithm represents a highly sensitive approach for detecting patients with high-risk diabetes while optimising the allocation of HbA1c testing. Implementation of these methods will optimise the usage of resources devoted to the management of diabetes in Trincomalee, Sri Lanka. Further external validation with diverse patient populations is required before applying our algorithm more widely.

Changes in Screening Practices for Prediabetes and Diabetes Since the Recommendation for Hemoglobin A1c Testing.

OBJECTIVE: Screening involves the presumptive identification of asymptomatic individuals at increased risk for unrecognized disease. We examined changes in screening practices for prediabetes and diabetes since January 2010, when HbA1c was first recommended as an option for screening and diagnosis. RESEARCH DESIGN AND METHODS: We studied members without diabetes of an HMO ≥45 years of age continuously enrolled for ≥3 years and assigned to primary care clinicians affiliated with a large academic health system. We defined screening as the first oral glucose tolerance test, HbA1c, or glucose test performed between 2010 and 2014. RESULTS: Of 12,772 eligible patients, 9,941 (78%) were screened at least once over 3 years. HbA1c was the initial screening test 14% of the time and glucose 86% of the time. Of those screened with HbA1c, 63% had abnormal results defined as HbA1c ≥5.7% (≥39 mmol/mol). Of those tested with glucose, 30% had abnormal results defined as glucose ≥100 mg/dL, and 5% had abnormal results defined as glucose ≥126 mg/dL. Patients with abnormal HbA1c levels and those with glucose levels ≥126 mg/dL were equally likely to be scheduled for follow-up appointments (41% vs. 39%), but those with abnormal HbA1c levels were more likely to be diagnosed with prediabetes or diabetes (36% vs. 26%). CONCLUSIONS: As we observed in 2004, rates of screening are high. HbA1c is still used less frequently than glucose for screening but is more likely to result in a clinical diagnosis. Evidence to support guidelines to define the role of random glucose screening, including definition of appropriate cut points and follow-up, is needed.

Stress urinary incontinence in women with a history of gestational diabetes mellitus.

OBJECTIVE: Stress urinary incontinence may serve as a barrier to lifestyle modification among women at high risk for diabetes, but the prevalence of stress urinary incontinence among women with histories of gestational diabetes mellitus (hGDM) is unknown. The purpose of this study was to examine the prevalence of stress incontinence among women with hGDM and to examine its association with their current physical activity. METHODS: We surveyed women with hGDM within the past 5 years who were currently enrolled in a managed care plan (n = 228). In a cross-sectional analysis, self-reported weekly or more frequent stress incontinence was the primary independent variable and measures of physical activity and body mass index (BMI) were the outcomes of interest. We constructed multivariable models that adjusted for participant characteristics associated with the measure of incontinence or outcomes in bivariate analyses. RESULTS: Of the 228 women with hGDM, 49% reported weekly or more frequent incontinence during pregnancy, and 28% reported that incontinence affected their activities during pregnancy. Fifty percent reported weekly or more frequent incontinence after delivery, with 27% reporting interference of incontinence with activity. Less than a third of women reported optimal physical activity, and 42% were obese. After adjustment for characteristics associated with measures of activity and incontinence, there was minimal association between levels of activity and stress urinary incontinence; similarly, there was no association between BMI and measures of stress incontinence. CONCLUSIONS: Stress urinary incontinence is common among women with hGDM but does not appear to be associated with physical activity levels or BMI.

Self-efficacy, social support, and associations with physical activity and body mass index among women with histories of gestational diabetes mellitus.

PURPOSE: To examine the associations between 2 potential facilitators of healthy behaviors (self-efficacy and social support), and both physical activity and body mass index (BMI) among women with histories of gestational diabetes mellitus (GDM). METHODS: Two hundred and twenty-eight women with histories of GDM who were enrolled in a managed care plan were surveyed. A cross-sectional analysis was used to assess the association between women's social support from family and friends for physical activity and self-efficacy for physical activity with women's physical activity levels. The association between women's social support from family and friends for healthy diet and self-efficacy for not overeating and their dietary habits also were examined. Finally, the association between all of these psychosocial constructs and body mass index (BMI) were assessed before and after adjustment for covariates. RESULTS: Participants reported low to moderate social support and self-efficacy scores, suboptimal performance of physical activity, suboptimal dietary scores, and high BMIs. Self-efficacy and social support from family and friends for physical activity were associated with physical activity. Social support from family and friends for a healthy diet was associated with better dietary scores, and the association between self-efficacy for not overeating and healthy diet bordered on significance. No significant associations existed between psychosocial constructs and BMI. CONCLUSIONS: Psychosocial constructs such as social support and self-efficacy are associated with physical activity and dietary habits. However, associations with BMI are weak. Further exploration of constructs associated with BMI may be needed to design effective weight-loss interventions in this population.

Changes in Health Insurance Coverage Under the Affordable Care Act: A National Sample of U.S. Adults With Diabetes, 2009 and 2016.

OBJECTIVE: To assess national changes in health insurance coverage and related costs before and after implementation of the Affordable Care Act (ACA) among U.S. adults with diabetes. RESEARCH DESIGN AND METHODS: Data were cross-sectional from the 2009 and 2016 National Health Interview Surveys (NHIS). Participants were adults age ≥18 years with a previous diagnosis of diabetes who self-reported on their health insurance coverage, demographic information, diabetes-related factors, and amount spent on medical expenses and insurance premiums (N = 6,220). RESULTS: Among adults with diabetes age 18-64 years, health insurance coverage increased from 84.7% in 2009 to 90.1% in 2016 (P < 0.001). Coverage remained near universal for those age ≥65 years (99.5%). For adults age 18-64 years, coverage increased for almost all subgroups and significantly for men; non-Hispanic whites, non-Hispanic blacks, and Hispanics; those who were married; those with less than or more than a high school education, family income <$35,000, or diabetes duration <5 or >15 years; and those taking oral agents (P < 0.05 for all). Among adults age 18-64 years, Medicaid coverage significantly increased between 2009 and 2016 (19.4% vs. 24.3%, P = 0.006), and for those with private insurance, 7.8% acquired their plan through HealthCare.gov. For adults age ≥65 years, private insurance decreased and Medicare Part D increased (P < 0.007 for both). Among those age 18-64 years with an income <$35,000, the proportion of income spent on family medical costs decreased (6.3% vs. 4.8% for 2009 vs. 2016, respectively; P = 0.004). CONCLUSIONS: Health insurance coverage among adults with diabetes age 18-64 years increased significantly after implementation of the ACA, and medical costs to families decreased among those with lower incomes.