Understanding preferences for type 2 diabetes mellitus self-management support through a patient-centered approach: a 2-phase mixed-methods study.

BACKGROUND: Patients with type 2 diabetes mellitus (T2DM) who participate in diabetes management programs have been shown to have better glycemic control and slower disease progression, although program participation remains low. In the USA, increasing participation in diabetes management support programs may also directly impact provider reimbursement, as payments are increasingly based on patient-centered measures. However, little is known about factors that may enhance patient participation. This study aimed at further understanding what is important in diabetes management support from the patients' perspective and at assessing the utilization of various types of diabetes-management programs. METHODS: A two-phase mixed-methods study was conducted of adult US members of PatientsLikeMe®, an online research network of patients. Phase 1 comprised qualitative interviews with 10 individuals to inform the online survey's contents, aided by literature review. During phase 2, this online survey was completed by 294 participants who reported on their diabetes goals and preferences for T2DM self-management support programs. RESULTS: The majority of the respondents were not participating in any program (65 %), but most had goals of improving diet (77 %), weight loss (71 %), and achieving stable blood glucose levels (71 %). Among those currently participating in programs, clinic, hospital-based, or other health-care professional programs were the most commonly used (51 %). The most preferred type of support was diet/weight-loss support (62 %), while doctors or nurses (61 %) and dietitians (55 %) were the most preferred sources of diabetes support. CONCLUSIONS: The low participation in diabetes self-management programs revealed in this study underscores the need for strategies to improve patient engagement. The results revealed support types and formats that patients with T2DM prefer and need. These findings may help improve patient engagement by guiding the future design of more effective diabetes management support programs.

Depression among people with type 2 diabetes mellitus, US National Health and Nutrition Examination Survey (NHANES), 2005-2012.

BACKGROUND: Depression in people with diabetes can result in increased risk for diabetes-related complications. The prevalence of depression has been estimated to be 17.6 % in people with type 2 diabetes mellitus (T2DM), based on studies published between 1980 and 2005. There is a lack of more recent estimates of depression prevalence among the US general T2DM population. METHODS: The present study used the US National Health and Nutrition Examination Survey (NHANES) 2005-2012 data to provide an updated, population-based estimate for the prevalence of depression in people with T2DM. NHANES is a cross-sectional survey of a nationally representative sample of the civilian, non-institutionalized US population. Starting from 2005, the Patient Health Questionnaire (PHQ-9) was included to measure signs and symptoms of depression. We defined PHQ-9 total scores ≥ 10 as clinically relevant depression (CRD), and ≥ 15 as clinically significant depression (CSD). Self-reported current antidepressant use was also combined to estimate overall burden of depression. Predictors of CRD and CSD were investigated using survey logistic regression models. RESULTS: A total of 2182 participants with T2DM were identified. The overall prevalence of CRD and CSD among people with T2DM is 10.6 % (95 % confidence interval (CI) 8.9-12.2 %), and 4.2 % (95 % CI 3.4-5.1 %), respectively. The combined burden of depressive symptoms and antidepressants may be as high as 25.4 % (95 % CI 23.0-27.9 %). Significant predictors of CRD include age (younger than 65), sex (women), income (lower than 130 % of poverty level), education (below college), smoking (current or former smoker), body mass index (≥30 kg/m(2)), sleep problems, hospitalization in the past year, and total cholesterol (≥200 mg/dl). Significant predictors of CSD also include physical activity (below guideline) and cardiovascular diseases. CONCLUSIONS: The prevalence of CRD and CSD among people with T2DM in the US may be lower than in earlier studies, however, the burden of depression remains high. Further research with longitudinal follow-up for depression in people with T2DM is needed to understand real world effectiveness of depression management.

Expert consensus on a protocol for conducting bibliometric analysis of scientific articles on global migration health (GMH).

BACKGROUND: Migration and health are key priorities in global health and essential for protecting and promoting the health of migrants. To better understand the existing evidence on migration health, it is critical to map the research publication activity and evidence on the health of migrants and mobile populations. This paper presents a search strategy protocol for a bibliometric analysis of scientific articles on global migration health (GMH), leveraging the expertise of a global network of researchers and academics. The protocol aims to facilitate the mapping of research and evidence on the health of international migrants and their families, including studies on human mobility across international borders. METHODS: A systematic search strategy using Scopus will be developed to map scientific articles on GMH. The search strategy will build upon a previous bibliometric study and will have two main search components: (1) 'international migrant population', covering specific movements across international borders, and (2) 'health'. The final search strategy will be implemented to determine the final set of articles to be screened for the bibliometric analysis. Title and abstract screening will exclude irrelevant articles and classify the relevant articles according to predefined themes and subthemes. A combination of the following approaches will be used in screening: applying full automation (ie, DistillerSR's machine learning tool) and/or semiautomation (ie, EndNote, MS Excel) tools, and manual screening. The relevant articles will be analysed using MS Excel, Biblioshiny and VOSviewer, which creates a visual mapping of the research publication activity around GMH. This protocol is developed in collaboration with academic researchers and policymakers from the Global South, and a network of migration health and research experts, with guidance from a bibliometrics expert. ETHICS AND DISSEMINATION: The protocol will use publicly available data and will not directly involve human participants; an ethics review will not be required. The findings from the bibliometric analysis (and other research that can potentially arise from the protocol) will be disseminated through academic publications, conferences and collaboration with relevant stakeholders to inform policies and interventions aimed at improving the health of international migrants and their families.

Novel Type 2 Diabetes Medication Access and Effect of Patient Cost Sharing.

BACKGROUND: Although drug formulary restrictions may reduce use of prescription medication and pharmacy costs, the effect of patient cost sharing on medication adherence and health care utilization and cost is unclear. OBJECTIVE: To evaluate the relationship between patient cost sharing for novel type 2 diabetes mellitus (T2DM) medications and medication adherence, persistence, and health care utilization and cost. METHODS: This retrospective study used medical and pharmacy claims linked to pharmacy benefit plan design data. Patients with T2DM were identified via ICD-9-CM codes (medical claims), outpatient prescription fills (pharmacy claims), and pharmacy benefit design information. Patients with T2DM treated with novel T2DM medications (DPP4 or GLP-1) were enrolled in plans with fixed or coinsurance medication copayment structures and followed for 12-48 months. Endpoints included medication persistence and adherence and total all-cause health care cost. Multivariable regression analysis estimated the effect of benefit design parameters, adjusting for baseline patient characteristics. RESULTS: The integrated database included 36,475 patients with T2DM. The majority (83.1%) had fixed copayment plans, and 3-tier plans were common (93.1%). Higher third-tier copayment was associated with poorer medication adherence and persistence but not total health care cost during follow-up. A $10 higher third-tier copayment was associated with 11% greater risk of novel T2DM medication discontinuation and 3% lower adherence. A comparison of patients with fixed versus coinsurance plans found that fixed plans were associated with higher adjusted persistence and total all-cause health care costs. CONCLUSIONS: Higher medication copayment amounts were associated with lower patient medication adherence and persistence in T2DM but not total health care costs, as health plan costs decreased while patient out-of-pocket costs increased. We observed higher total all-cause health care costs among T2DM patients with a fixed copay (vs. coinsurance) pharmacy benefit. Additional research incorporating plan design information is needed to further examine this finding. DISCLOSURES: This study was funded by Janssen Scientific Affairs, which was involved in study design, interpretation of data, editing manuscript content, and had final approval of the manuscript before submission. Lopez and Bookhart are employed by Janssen Scientific Affairs. At the time of this study, Henk was employed by Optum HEOR, which was contracted by Janssen to conduct this study. Portions of this study were presented at the 21st Annual International Meeting, ISPOR; May 21-25, 2016; in Washington, DC.

Impact of type 2 diabetes medication cost sharing on patient outcomes and health plan costs.

OBJECTIVES: To study the association between cost sharing for diabetes medications, adherence, hospitalization rates, and healthcare costs, with relationship to patient risk. STUDY DESIGN: A retrospective claims analysis of data from 35 large, private, self-insured employers (2004 to 2012). METHODS: We examined outcomes for 92,410 patients aged 18 to 64 years with a type 2 diabetes (T2D) diagnosis who filled at least 1 T2D prescription. First, we examined the relationship between adherence, measured as the proportion of days covered, and cost sharing, measured as the out-of-pocket cost to purchase a pre-specified bundle of T2D prescriptions. We then examined the association between adherence and hospital days. Simulations showed the effect of increased cost sharing on adherence and inpatient utilization. RESULTS: A $10 increase in out-of-pocket cost was associated with a 1.9% reduction in adherence (P < .01). In turn, a 10% reduction in adherence was associated with a 15% increase in per-patient hospital days (0.17 days; P < .01). For the average plan, switching from low to high cost sharing reduced per-patient medication costs by $242 and increased per-patient hospitalization costs by $342, for a net increase of $100 in plan costs. Increases in per-patient costs were greater for high-risk patients, such as those with heart failure ($1328). CONCLUSIONS: Increased cost sharing for T2D medication was associated with reductions in pharmacy costs, but higher total costs for patients with T2D. This problem is particularly acute for patients with 1 or more cardiovascular comorbidities. The results suggest that increased diabetes cost sharing may hamper efforts to lower the total cost of diabetes care.

Changes in Body Weight Among People With Type 2 Diabetes Mellitus in the United States, NHANES 2005-2012.

PURPOSE: To understand weight loss strategies, weight changes, goals, and behaviors in people with type 2 diabetes mellitus (T2DM) and whether these differ by ethnicity. METHODS: T2DM was identified by self-reported diagnosis using the NHANES 2005-2012 data, which also included measured and self-reported current body weight and height, self-reported weight the prior year, and self-reported aspired weight. Nineteen weight loss strategies were evaluated for association with ≥5% weight loss or weight gain versus <5% weight change. RESULTS: Among people with T2DM, 88.0% were overweight/obese (body mass index [BMI] ≥25 kg/m(2)) in the prior year and 86.1% the current year. About 60% of the overweight/obese took weight loss actions, mostly using diet-related methods with average weight lost <5%. Two most "effective" methods reported (smoking, taking laxatives/vomiting) are also potentially most harmful. Similar BMI distributions but different goals and behaviors about weight and weight loss were observed across ethnicity. Only physical activity meeting the recommended level and changing eating habits were consistently associated with favorable and statistically significant weight change. CONCLUSIONS: Weight management in T2DM is an ongoing challenge, regardless of ethnicity/race. Among overweight/obese T2DM subjects, recommended level of physical activity and changing eating habits were associated with statistically significant favorable weight change.

Demographic Disparities Among Medicare Beneficiaries with Type 2 Diabetes Mellitus in 2011: Diabetes Prevalence, Comorbidities, and Hypoglycemia Events.

This study describes demographic characteristics, comorbidities, and hypoglycemia events in patients with type 2 diabetes mellitus (T2DM) identified using 2011 Medicare 5% Standard Analytical Files. Among 1,913,477 Medicare beneficiaries, 367,602 (19.2%) had T2DM. T2DM prevalence increased with age and was higher in blacks (26.4%) and Hispanics (25.5%) than in whites (18.0%); and in Medicare/Medicaid dual-eligible versus non-dual-eligible patients (28.0% vs 17.2%, respectively). Compared with whites, diagnosed hypertension and diabetic retinopathy were more common in blacks and Hispanics, and lipid metabolism disorders and atrial fibrillation were less common. Hypoglycemia requiring health care services was more common in blacks (4.7%) and Hispanics (3.6%) compared with whites (2.9%). T2DM, related comorbidities, and hypoglycemia are burdensome to the Medicare population. Differences in these endpoints were observed based on race/ethnicity, age, and dual-eligible status, highlighting the importance of demographic factors when determining T2DM management strategies.

Evaluating Drug Cost per Response with SGLT2 Inhibitors in Patients with Type 2 Diabetes Mellitus.

BACKGROUND: The sodium-glucose cotransporter 2 (SGLT2) inhibitors, which include canagliflozin, dapagliflozin, and empagliflozin, represent a new class of antihyperglycemic agents. Few studies have assessed their cost per response, with "cost per response" being the total cost of a select drug, divided by the resulting change in glycated hemoglobin (HbA1c) levels. OBJECTIVE: To examine the drug cost of SGLT2 inhibitors per a reduction in placebo-adjusted 1% HbA1c in patients with type 2 diabetes mellitus who received treatment during 26 weeks with canagliflozin, dapagliflozin, or empagliflozin. METHODS: The drug cost per response for each of the 3 agents individually was assessed based on data from a subset of clinical trials discussed in the prescribing information for each drug that were all placebo-controlled studies evaluating each drug as monotherapy, dual therapy (combined with metformin), and triple therapy (combined with metformin and a sulfonylurea) in patients with uncontrolled, type 2 diabetes mellitus. The US 2015 wholesale acquisition cost for each drug was used to calculate each drug's treatment costs over 26 weeks. The average cost per response for each drug was defined as the prescription drug cost of each SGLT2 inhibitor, divided by the average, placebo-adjusted HbA1c reduction at 26 weeks. RESULTS: The drug cost per unit dose was the same for canagliflozin (100 mg or 300 mg), dapagliflozin (5 mg or 10 mg), and empagliflozin (10 mg or 25 mg), at $11.43. The drug cost per placebo-adjusted 1% HbA1c reduction varied by agent and by dose, as a result of the differences in the treatment responses for each of the 3 drugs. The costs per response for canagliflozin 100 mg as monotherapy, dual therapy, and triple therapy regimens ranged from $2286 to $3355, and for canagliflozin 300 mg, from $1793 to $2702. The costs per response for dapagliflozin 5 mg as monotherapy and dual therapy (triple therapy was not available at the time of the study) ranged from $4161 to $5201; the cost for dapagliflozin 10 mg ranged from $2972 to $4161. The costs per response for empagliflozin 10 mg ranged from $2972 to $3467 across the monotherapy, dual therapy, and triple therapy regimens; the cost for empagliflozin 25 mg ranged from $2311 to $3467. CONCLUSION: Simple analyses, such as the drug cost per placebo-adjusted 1% reduction in HbA1c, may be useful when considering the addition of antihyperglycemic agents to the health plan's formulary.

Characterization of type 2 diabetes mellitus burden by age and ethnic groups based on a nationwide survey.

BACKGROUND: Type 2 diabetes mellitus (T2DM) is the most common form of diabetes. Risk factors for its development include older age, obesity, family history of diabetes, history of gestational diabetes, impaired glucose metabolism, physical inactivity, and race/ethnicity. OBJECTIVE: The purpose of this study was to characterize T2DM burden, from a patient perspective, with respect to age and race/ethnicity. METHODS: Adults aged ≥18 years with T2DM from a large, Internet-based, nationwide survey were retrospectively analyzed. Demographic and clinical characteristics (glycemic control, body mass index [BMI], comorbidities, and diabetes-related complications), hypoglycemic episodes, and medication adherence were used to assess diabetes burden. Degree of burden was compared across age (18-64, 65-74, and ≥75 years) and racial/ethnic (white, African American, Hispanic, Asian, and American Indian) groups. RESULTS: An apparent association was found between glycemic control and medication adherence. Hispanics had the lowest percentage of participants with a hemoglobin A1c (HbA1c) level <7.0% (24.4%) and the highest percentage of those not knowing their HbA1c levels (55.4%) but also had the poorest medication adherence among racial/ethnic groups. Conversely, American Indians and whites had the best glycemic control, HbA1c knowledge, and medication adherence. The 18- to 64-year age group had the poorest glycemic control (28.8%), the most with unknown HbA1c levels (46.3%), and the poorest medication adherence of the age groups. Mean BMIs were high (>30 mg/kg(2)) for all racial/ethnic groups other than the Asian group (28.9 mg/kg(2)). Approximately 71% of Asians were obese or overweight compared with ≥90% in the other racial/ethnic groups. Mean BMIs decreased with increasing age group (34.5, 32.6, and 29.8 kg/m(2) for the age groups of 18-64, 65-74, and ≥75 years, respectively). Regarding diabetes-related comorbidities, the Asian group had the lowest percentages of those with hypertension (39.1%) and hypercholesterolemia (46.6%). The Asian group had the lowest mean Charlson Comorbidity Index (CCI) score (score of 1.4); the American Indian group had the highest CCI score (score of 1.8). Of the age groups, the 65- to 74-year group had the highest percentages of those with hypertension (69.0%) and hypercholesterolemia (67.4%). The mean CCI scores in the 65- to 74-year and ≥75-year age groups (scores of 1.8 for both) were significantly higher than in the 18- to 64-year age group. The Asian group had the lowest percentage of participants reporting hypoglycemia (37.3%). The 18- to 64-year age group had the highest percentage of participants reporting hypoglycemia (52.7%). Limitations of this study include selection bias (Internet-based survey), recall bias, missing values, and descriptive analyses without adjustment for multiplicity. CONCLUSION: There are many factors that contribute to diabetes burden and the complexity of diabetes management. The results of this study provide insight from a patient perspective regarding how these factors vary across age and race/ethnicity to aid in the individualization of diabetes treatment.

Impact of hypoglycemia on patients with type 2 diabetes mellitus and their quality of life, work productivity, and medication adherence.

BACKGROUND: The purpose of this study was to determine the characteristics of adults with type 2 diabetes mellitus (T2DM) that correlate with greater risk of hypoglycemia and determine the impact of hypoglycemia on health-related quality of life, work productivity, and medication adherence from a patient perspective. METHODS: Data from a large web-based survey were retrospectively analyzed. Adults with a diagnosis of T2DM taking antihyperglycemic agents were included in the analysis. Participants with knowledge of their hypoglycemic history were divided into three groups: those experiencing recent hypoglycemia (previous 3 months), those experiencing nonrecent hypoglycemia, and those never experiencing hypoglycemia. RESULTS: Of the participants with T2DM taking antihyperglycemic agents who were knowledgeable of their hypoglycemia history, 55.7% had ever experienced hypoglycemia. Of those, 52.7% had recent hypoglycemia. Compared with those who never experienced hypoglycemia, those who experienced hypoglycemia tended to: be younger; be more aware of their glycated hemoglobin (HbA1c) levels; have higher HbA1c levels; have a higher body mass index; have higher Charlson Comorbidity Index scores; be on insulin, sulfonylureas, and/or glucagon-like peptide-1 agonists; and be less adherent to their antihyperglycemic agents. Hypoglycemia interfered with social activities, caused more missed work (absenteeism), more impairment while at work (presenteeism), and decreased overall work productivity compared with patients who had never experienced hypoglycemia. Overall health-related quality of life, as determined by the Short Form-36 health questionnaire, was negatively impacted by hypoglycemia. Both Physical and Mental Summary scores were significantly lower for the recent hypoglycemia and nonrecent hypoglycemia groups compared with the never hypoglycemia group. CONCLUSION: Hypoglycemia can negatively impact many aspects of life. Greater awareness of those who are at risk for developing hypoglycemia can lead to the development of measures (eg, patient and physician education) to prevent future hypoglycemia episodes.

Cost efficiency of canagliflozin versus sitagliptin for type 2 diabetes mellitus.

OBJECTIVES: To compare 1-year clinical outcomes and cost efficiency of treating adults with type 2 diabetes mellitus (T2DM) with canagliflozin (300 mg/day) or sitagliptin (100 mg/day), both added on a background of metformin and sulfonylurea. STUDY DESIGN: An economic model integrated data from an active-controlled, randomized trial, claims database analyses, and published literature. METHODS: The model adopted a US managed care payer perspective and included the clinical and economic impact of achieving specific clinical quality goals. The model was run separately for 2 single clinical quality metrics, glycated hemoglobin (A1C) < 7% (used as base case) or < 8%, and 4 composite metrics (A1C < 7% or < 8% combined with body mass index < 30 kg/m2 and blood pressure < 140/90 mm Hg or low-density lipoprotein cholesterol < 100 mg/dL). Cost savings of achieving versus not achieving metrics were derived from a claims database analysis. Drug and adverse event costs were included. RESULTS: In the base case, compared with sitagliptin 100 mg, treatment with canagliflozin 300 mg resulted in $215 in annual cost savings and 12.3 absolute percentage points more patients achieving goal. Similar findings were found across all other quality metrics (difference in proportion achieving goal ranging from 6.7% to 19.0% and annual savings ranging from $1 to $669). Canagliflozin remained cost saving versus sitagliptin in sensitivity analyses. CONCLUSIONS: Canagliflozin 300 mg may represent a cost-efficient T2DM treatment option versus sitagliptin 100 mg for patients on metformin plus sulfonylurea due to lower overall costs and better achievement of A1C and quality composite goals.

Health plan retention and pharmacy costs of newly diagnosed patients with chronic kidney disease in a managed care population.

BACKGROUND: Chronic kidney disease is prevalent in the United States, and diabetes and hypertension cause up to two thirds of all new cases. Many health plans believe that these patients do not retain their health plans for a long duration, therefore plans do not focus on prevention for this disease. OBJECTIVE: To determine health plan retention rates and direct healthcare costs of adults with newly diagnosed chronic kidney disease with diabetes or hypertension. METHODS: A total of 31,917 patients with chronic kidney disease were included in this study between January 1995 and December 2006, using a managed care database. Patients were divided into 3 subgroups for cost comparison-patients with chronic kidney disease only (n = 8836), those with chronic kidney disease with diabetes (n = 11,252), and patients with chronic kidney disease with hypertension (n = 20,836). Follow-up of patients from index period of initial kidney disease diagnosis was 5 years. Average enrollment duration was 38 months; 60% of all patients remained enrolled at 3 years postdiagnosis. RESULTS: On average, patients with chronic kidney disease and diabetes and those with chronic kidney disease and hypertension remained enrolled slightly longer than chronic kidney disease-only patients (39 months, 40 months, and 36 months, respectively). The largest number of claims was for inpatient medical, followed by pharmacy and laboratory. Mean annual direct healthcare costs were higher for patients with chronic kidney disease and diabetes ($20,165) and those with chronic kidney disease and hypertension ($17,612) compared with patients with chronic kidney disease only ($9390). CONCLUSION: The study findings indicate that most patients who are newly diagnosed with chronic kidney disease retain their health plan affiliation for a considerable period, including those with diabetes or hypertension. Increased direct healthcare costs were associated with the presence of comorbidities in patients with chronic kidney disease.

Performance characteristics of the Euroimmun enzyme-linked immunosorbent assay kits for Brucella IgG and IgM.

Brucella IgG and IgM ELISA kits manufactured by Euroimmun (Lubeck, Germany) were evaluated in a reference laboratory setting. Intraassay coefficient of variation (CV) values were < or =10% for positive sera and < or =12% for negative sera; interassay CVs were < or =12% for positive sera and < or =20% for negative sera. The tube agglutination test (TAT) was performed on 51 sera exhibiting various ELISA reactivity profiles. All 18 sera negative for both IgG and IgM by ELISA were TAT negative (titer <1:80), whereas 31 (94%) of 33 sera positive for IgG and/or IgM were TAT positive; the 2 discordant sera were IgG positive IgM negative by ELISA. None of 41 sera from healthy laboratory employees were ELISA IgG positive, whereas 1 (2%) of 41 was ELISA IgM positive. Similarly, 0 of 149 potentially cross-reactive sera (containing rheumatoid factor or antibodies to selected Gram-negative bacteria) was ELISA IgG positive, whereas 4 (3%) of 149 were ELISA IgM positive. These findings demonstrate the acceptable performance of the Euroimmun ELISAs for Brucella antibodies.