Differential Effects of Type 2 Diabetes Treatment Regimens on Diabetes Distress and Depressive Symptoms in the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE).

OBJECTIVE: We evaluated whether adding basal insulin to metformin in adults with early type 2 diabetes mellitus (T2DM) would increase emotional distress relative to other treatments. RESEARCH DESIGN AND METHODS: The Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE) of adults with T2DM of <10 years' duration, HbA1c 6.8-8.5%, and taking metformin monotherapy randomly assigned participants to add insulin glargine U-100, sulfonylurea glimepiride, the glucagon-like peptide-1 receptor agonist liraglutide, or the dipeptidyl peptidase 4 inhibitor sitagliptin. The Emotional Distress Substudy enrolled 1,739 GRADE participants (mean [SD] age 58.0 [10.2] years, 32% female, 56% non-Hispanic White, 18% non-Hispanic Black, 17% Hispanic) and assessed diabetes distress and depressive symptoms every 6 months. Analyses examined differences at 1 year and over the 3-year follow-up. RESULTS: Across treatments, diabetes distress (-0.24, P < 0.0001) and depressive symptoms (-0.67, P < 0.0001) decreased over 1 year. Diabetes distress was lower at 1 year for the glargine group than for the other groups combined (-0.10, P = 0.002). Diabetes distress was also lower for liraglutide than for glimepiride or sitagliptin (-0.10, P = 0.008). Over the 3-year follow-up, there were no significant group differences in total diabetes distress; interpersonal diabetes distress remained lower for those assigned to liraglutide. No significant differences were observed for depressive symptoms. CONCLUSIONS: Contrary to expectations, this randomized trial found no evidence for a deleterious effect of basal insulin on emotional distress. Glargine lowered diabetes distress modestly at 1 year rather than increasing it. Liraglutide also reduced diabetes distress at 1 year. Results can inform treatment decisions for adults with early T2DM.

Emotional Distress Predicts Reduced Type 2 Diabetes Treatment Adherence in the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE).

OBJECTIVE: We examined longitudinal associations between emotional distress (specifically, depressive symptoms and diabetes distress) and medication adherence in Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE), a large randomized controlled trial comparing four glucose-lowering medications added to metformin in adults with relatively recent-onset type 2 diabetes mellitus (T2DM). RESEARCH DESIGN AND METHODS: The Emotional Distress Substudy assessed medication adherence, depressive symptoms, and diabetes distress in 1,739 GRADE participants via self-completed questionnaires administered biannually up to 3 years. We examined baseline depressive symptoms and diabetes distress as predictors of medication adherence over 36 months. Bidirectional visit-to-visit relationships were also examined. Treatment satisfaction, beliefs about medication, diabetes care self-efficacy, and perceived control over diabetes were evaluated as mediators of longitudinal associations. RESULTS: At baseline, mean ± SD age of participants (56% of whom were White, 17% Hispanic/Latino, 18% Black, and 66% male) was 58.0 ± 10.2 years, diabetes duration 4.2 ± 2.8 years, HbA1c 7.5% ± 0.5%, and medication adherence 89.9% ± 11.1%. Higher baseline depressive symptoms and diabetes distress were independently associated with lower adherence over 36 months (P < 0.001). Higher depressive symptoms and diabetes distress at one visit predicted lower adherence at the subsequent 6-month visit (P < 0.0001) but not vice versa. Treatment assignment did not moderate relationships. Patient-reported concerns about diabetes medications mediated the largest percentage (11.9%-15.5%) of the longitudinal link between emotional distress and adherence. CONCLUSIONS: Depressive symptoms and diabetes distress both predict lower adherence to glucose-lowering medications over time among adults with T2DM. Addressing emotional distress and concerns about anticipated negative effects of taking these treatments may be important to support diabetes treatment adherence.

Does Emotional Distress Predict Worse Glycemic Control Over Time? Results From the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE).

OBJECTIVE: To evaluate whether baseline levels of depressive symptoms and diabetes-specific distress are associated with glycemic control in Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE), a large randomized controlled trial comparing the metabolic effects of four common glucose-lowering medications when combined with metformin in individuals with type 2 diabetes mellitus (T2DM). RESEARCH DESIGN AND METHODS: The primary and secondary outcomes were defined as an HbA1c value ≥7%, subsequently confirmed, and an HbA1c value >7.5%, subsequently confirmed, respectively. Separate Cox proportional hazards models assessed the association between baseline levels of each exposure of interest (depressive symptoms measured with the eight-item Patient Health Questionnaire and diabetes distress measured with the Diabetes Distress Scale) and the subsequent risk of metabolic outcomes. RESULTS: This substudy included 1,739 participants (56% of whom were non-Hispanic White, 18% non-Hispanic Black, 17% Hispanic, and 68% male; mean [SD] age 58.0 [10.2] years, diabetes duration 4.2 [2.8] years, and HbA1c 7.5% [0.48%]). A total of 1,157 participants reached the primary outcome, with time to event of 2.1 years on average, while 738 participants reached the secondary outcome at 3 years on average. With adjustment for sex, race/ethnicity, treatment group, baseline age, duration of T2DM, BMI, and HbA1c, there were no significant associations between the depressive symptoms or diabetes distress and the subsequent risk of the primary or secondary outcomes. CONCLUSIONS: The current findings suggest that, at least for individuals with diabetes of relatively short duration, baseline levels of emotional distress are not associated with glycemic control over time.

Patient-level factors associated with hemoglobin A1C testing in Alabama Medicaid beneficiaries with diabetes.

AIM: We evaluated patient-level factors associated with receipt of hemoglobin A1c (HbA1c) testing among Alabama Medicaid beneficiaries with type 2 diabetes. METHODS: We conducted a retrospective analysis of person-year observations from Medicaid claims data from 2011 to 2020. Adults aged 19-64 years with type 2 diabetes and continuous enrollment in Medicaid for study year and year prior were included. Primary outcomes were ≥ 1 and ≥ 2 HbA1c test(s) per year. We conducted multivariable Poisson regression stratified by Medicaid eligibility reason (disability, poverty) examining the association of study year, demographics, clinical factors, and healthcare utilization with HbA1c testing. RESULTS: We analyzed 288,379 observations, 51% with disability-based, 49% poverty-based eligibility. Overall, 57% observations had ≥ 1 HbA1c, 35% had ≥ 2 HbA1c tests. More observations with disability-based than poverty-based eligibility had ≥ 1 (76% vs. 38%) and ≥ 2 HbA1c tests (49% vs. 20%). Patient-level factors were associated with a higher likelihood of having ≥ 1 HbA1c: Black race and older age (disability-based eligibility); year after 2011, female sex, and younger age (poverty-based eligibility); and rurality, insulin use, endocrinology care, diabetes complications, and ambulatory care visits (both groups). CONCLUSIONS: Just over one-third of adult Alabama Medicaid beneficiaries with diabetes had ≥ 2 HbA1c tests per year; testing frequency differed by Medicaid eligibility.

Trends and Predictors of Glycemic Control Among Adults With Type 2 Diabetes Covered by Alabama Medicaid, 2011-2019.

INTRODUCTION: Despite advances in diabetes management, only one-quarter of people with diabetes in the US achieve optimal targets for glycated hemoglobin A1c (HbA1c), blood pressure, and cholesterol. We sought to evaluate temporal trends and predictors of achieving glycemic control among adults with type 2 diabetes covered by Alabama Medicaid from 2011 through 2019. METHODS: We completed a retrospective analysis of Medicaid claims and laboratory data, using person-years as the unit of analysis. Inclusion criteria were being aged 19 to 64 years, having a diabetes diagnosis, being continuously enrolled in Medicaid for a calendar year and preceding 12 months, and having at least 1 HbA1c result during the study year. Primary outcomes were HbA1c thresholds of <7% and <8%. Primary exposure was study year. We conducted separate multivariable-adjusted logistic regressions to evaluate relationships between study year and HbA1c thresholds. RESULTS: We included 43,997 person-year observations. Mean (SD) age was 51.0 (9.9) years; 69.4% were women; 48.1% were Black, 42.9% White, and 0.4% Hispanic. Overall, 49.1% had an HbA1c level of <7% and 64.6% <8%. Later study years and poverty-based eligibility were associated with lower probability of reaching target HbA1c levels of <7% or <8%. Sex, race, ethnicity, and geography were not associated with likelihood of reaching HbA1c <7% or <8% in any model. CONCLUSION: Later study years were associated with lower likelihood of meeting target HbA1c levels compared with 2011, after adjusting for covariates. With approximately 35% not meeting an HbA1c target of <8%, more work is needed to improve outcomes of low-income adults with type 2 diabetes.

Measuring continuity of care for diabetes: which visits to include?

OBJECTIVES: Continuity of care measures are widely used to evaluate the quality of health care delivery, but which visits are included vary across studies. Our objective was to determine how the provider specialties included affect continuity values, year-to-year stability, and association with emergency department (ED) visits. STUDY DESIGN: Retrospective study of Alabama Medicaid administrative data. METHODS: We included beneficiaries with diabetes who had at least 3 outpatient visits in each of 2018 and 2019 (N = 9578). We defined 3 provider groupings: all providers, diabetes-broad (primary care, cardiology, neurology, endocrinology, ophthalmology, nephrology, and psychiatry), and diabetes-narrow (primary care and endocrinology). Continuity of care was calculated using the Continuity of Care Index (COCI) for each provider grouping. We compared correlation between measures and from year to year using Spearman correlations, and we used multivariable logistic regression to determine association with ED visits. RESULTS: The mean COCI was 0.54 using visits with all providers, 0.64 with diabetes-broad providers, and 0.83 with diabetes-narrow providers. COCI with diabetes-narrow providers was moderately correlated with the broader sets of providers (Spearman ρ, 0.52-0.65). Comparing each participant's COCI in 2018 with that in 2019, the mean intraperson difference was similar (0.16-0.22), and correlation was moderate (Spearman ρ, 0.41-0.47) for each measure. COCI had similar weak association with ED visits using each provider grouping (odds ratio, 0.99; 95% CI, 0.98-0.99 for each 0.1-unit difference in COCI). CONCLUSIONS: Continuity values differed substantially depending on which provider specialties were included. The importance of this variation is uncertain, as continuity was weakly associated with ED visits using each of the measures.

Emotional distress and cardiovascular disease risk among participants enrolled in the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness (GRADE) study.

AIMS: People with type 2 diabetes (T2DM) have an increased risk of cardiovascular disease (CVD). We examined depressive symptoms (DS) and diabetes distress (DD) in relation to the estimated 10-year risk of CVD in adults with T2DM enrolled in the GRADE Emotional Distress Substudy. METHODS: Linear regression models examined the associations of baseline DS and DD with estimated 10-year risk of CVD using the Atherosclerotic Cardiovascular Disease (ASCVD) risk score, adjusting for age, sex, race/ethnicity, education, income, diabetes duration, diabetes-related complications, and HbA1c. RESULTS: A total of 1,605 GRADE participants were included: 54% Non-Latino (NL) White, 18% Latino, 19% NL-Black, 66% male, mean age 57.5 (SD = 10.25) years, diabetes duration 4.2 (SD = 2.8) years, and HbA1c 7.5% (SD = 0.5%). After incorporating covariates, only DS, especially cognitive-affective symptoms, were associated with ASCVD risk (estimate = 0.15 [95% CI: 0.04, 0.025], p = 0.006). Higher DS remained significantly associated with higher ASCVD risk when adding DD to covariates (estimate = 0.19 [95% CI: 0.07, 0.30], p = 0.002). DD was not associated with ASCVD risk when accounting for covariates. CONCLUSIONS: Depressive symptoms, particularly cognitive-affective symptoms, are associated with increased 10-year predicted ASCVD risk among adults with early T2DM. Diabetes distress is not significantly associated with the predicted ASCVD risk when accounting for covariates.

Disparities in Postdischarge Ambulatory Care Follow-Up Among Medicaid Beneficiaries With Diabetes, Hospitalized for Heart Failure.

Background Ambulatory follow-up for all patients with heart failure (HF) is recommended within 7 to 14 days after hospital discharge to improve HF outcomes. We examined postdischarge ambulatory follow-up of patients with comorbid diabetes and HF from a low-income population in primary and specialty care. Methods and Results Adults with diabetes and first hospitalizations for HF, covered by Alabama Medicaid in 2010 to 2019, were included and the claims analyzed for ambulatory care use (any, primary care, cardiology, or endocrinology) within 60 days after discharge using restricted mean survival time regression and negative binomial regression. Among 9859 Medicaid-covered adults with diabetes and first hospitalization for HF (mean age, 53.7 years; SD, 9.2 years; 47.3% Black; 41.8% non-Hispanic White; 10.9% Hispanic/Other [Other included non-White Hispanic, American Indian, Pacific Islander and Asian adults]; 65.4% women, 34.6% men), 26.7% had an ambulatory visit within 0 to 7 days, 15.2% within 8 to 14 days, 31.3% within 15 to 60 days, and 26.8% had no visit; 71% saw a primary care physician and 12% a cardiology physician. Black and Hispanic/Other adults were less likely to have any postdischarge ambulatory visit (P<0.0001) or the visit was delayed (by 1.8 days, P=0.0006 and by 2.8 days, P=0.0016, respectively) and were less likely to see a primary care physician than non-Hispanic White adults (adjusted incidence rate ratio, 0.96 [95% CI, 0.91-1.00] and 0.91 [95% CI, 0.89-0.98]; respectively). Conclusions More than half of Medicaid-covered adults with diabetes and HF in Alabama did not receive guideline-concordant postdischarge care. Black and Hispanic/Other adults were less likely to receive recommended postdischarge care for comorbid diabetes and HF.

Diabetes distress and self-reported health in a sample of Alabama Medicaid-covered adults before and during the COVID-19 pandemic.

Temporary closures of outpatient health facilities and transitions to virtual care during the COVID-19 pandemic interrupted the care of millions of patients with diabetes contributing to worsening psychosocial factors and enhanced difficulty in managing type 2 diabetes mellitus. We explored associations between COVID time period and self-reported diabetes distress on self-reported health among a sample of Alabama Medicaid-covered adults with diabetes pre-COVID (2017-2019) and during-COVID (2020-2021). Method: In this cross-sectional study, we surveyed a population-based sample of adults with type 2 diabetes covered by the Alabama Medicaid Agency. Participants were dichotomized into pre-COVID (March 2017 to October 2019) vs during-COVID (October 2020 to May 2021) groups. Participants with missing data were removed from analyses. We assessed diabetes related stress by the Diabetes Distress Scale. We measured self-reported health using a single item with a 5-point Likert scale. We ran logistic regressions modeling COVID time period on self-reported poor health controlling for demographics, severity of diabetes, and diabetes distress. Results: In this sample of 1822 individuals, median age was 54, 74.5% were female and 59.4% were Black. Compared to pre-COVID participants, participants surveyed during COVID were younger, more likely to be Black (64.1% VS 58.2%, p=0.01) and female (81.8% VS 72.5%, p<0.001). This group also had fewer individuals from rural areas (29.2% VS 38.4%, p<0.001), and shorter diabetes duration (7 years VS 9 years, p<0.001). During COVID individuals reported modestly lower levels of diabetes distress (1.2 VS 1.4, p<0.001) when compared to the pre-COVID group. After adjusting for demographic differences, diabetes severity, and diabetes distress, participants responding during COVID had increased odds of reporting poor health (Odds ratio [OR] 1.41, 95% Confidence Interval [CI] 1.11-1.80). Discussion: We found respondents were more likely to report poorer health during COVID compared to pre-COVID. These results suggest that increased outreach may be needed to address diabetes management for vulnerable groups, many of whom were already at high risk for poor outcomes prior to the pandemic.

The Mediating Role of Self-Efficacy in the Association Between Diabetes Education and Support and Self-Care Management.

RESULTS: A total of 1,318 participants were included in the study (mean age = 52.9 years, SD = 9.6; 72.5% female, 56.4% Black, 3.1% Hispanic). Diabetes education was associated with increases in self-care activity scores related to general diet, physical activity, glucose self-monitoring, and foot care; care coordination was associated with glucose self-monitoring. In addition, mediation analysis models confirmed that improvements in self-efficacy led to improved self-care activities scores, mediating the association of diabetes education and self-care activities. CONCLUSIONS: Diabetes education and self-efficacy were associated with better self-care. Receiving diabetes education led to a higher likelihood of engaging in self-care activities, driven in part by increases in self-efficacy. Future interventions that aim to improve diabetes self-management behaviors can benefit from targeting self-efficacy constructs and from the integration of diabetes education in the care coordination structure.

Primary care visits and ambulatory care sensitive diabetes hospitalizations among adult Alabama Medicaid beneficiaries.

PURPOSE: To describe patterns of care use for Alabama Medicaid adult beneficiaries with diabetes and the association between primary care utilization and ambulatory care sensitive (ACS) diabetes hospitalizations. METHODS: This retrospective cohort study analyzes Alabama Medicaid claims data from January 2010 to April 2018 for 52,549 covered adults ages 19-64 with diabetes. Individuals were characterized by demographics, comorbidities, and health care use including primary, specialty, mental health and hospital care. Characteristics of those with and without any ACS diabetes hospitalization are reported. A set of 118,758 observations was created, pairing information on primary care use in one year with ACS hospitalizations in the following year. Logistic regression analysis was used to assess the impact of primary care use on the occurrence of an ACS hospitalization. RESULTS: One third of the cohort had at least one ACS diabetes hospitalization over their observed periods; hospital users tended to have multiple ACS hospitalizations. Hospital users had more comorbidities and pharmaceutical and other types of care use than those with no ACS hospitalizations. Controlling for other types of care use, comorbidities and demographics, having a primary care visit in one year was significantly associated with a reduced likelihood of ACS hospitalization in the following year (odds ratio comparing 1-2 visits versus none 0.79, 95% confidence interval 0.73-0.85). CONCLUSIONS: Program and population health interventions that increase access to primary care can have a beneficial effect of reducing excess inpatient hospital use for Medicaid covered adults with diabetes.

Social support and diabetes distress among adults with type 2 diabetes covered by Alabama Medicaid.

AIMS: Diabetes distress affects approximately 36% of adults with diabetes and is associated with worse diabetes self-management and poor glycaemic control. We characterized participants' diabetes distress and studied the relationship between social support and diabetes distress. METHODS: In this cross-sectional study, we surveyed a population-based sample of adults with type 2 diabetes covered by Alabama Medicaid. We used the Diabetes Distress Scale assessing emotional burden, physician-related, regimen-related and interpersonal distress. We assessed participants' level of diabetes-specific social support and satisfaction with this support, categorized as low or moderate-high. We performed multivariable logistic regression of diabetes distress by level of and satisfaction with social support, adjusting for demographics, disease severity, self-efficacy and depressive symptoms. RESULTS: In all, 1147 individuals participated; 73% were women, 41% White, 58% Black and 3% Hispanic. Low level of or satisfaction with social support was reported by 11% of participants; 7% of participants had severe diabetes distress. Participants with low satisfaction with social support were statistically significantly more likely to have severe diabetes distress than those with moderate-high satisfaction, adjusted odds ratio 2.43 (95% CI 1.30, 4.54). CONCLUSIONS: Interventions addressing diabetes distress in adults with type 2 diabetes may benefit from a focus on improving diabetes-specific social support.

Mobile-Enhanced Peer Support for African Americans with Type 2 Diabetes: a Randomized Controlled Trial.

BACKGROUND: Peer support has been shown to improve diabetes self-management and control, but no standard exists to link peer support interventions to clinical care. OBJECTIVE: To compare a community-based diabetes self-management education (DSME) plus mobile health (mHealth)-enhanced peer support intervention to community-based diabetes self-management education (DSME) alone for African American adults with poorly controlled type 2 diabetes. DESIGN: A randomized controlled trial. PARTICIPANTS: African American adults, age > 19 years, receiving care within a safety-net healthcare system in Jefferson County, Alabama, with a diagnosis of type 2 diabetes and a hemoglobin A1c (A1C) ≥ 7.5%. INTERVENTIONS: Participants in the intervention group received community-based diabetes self-management education (DSME) plus 6 months of mHealth-enhanced peer support, including 12 weekly phone calls, then 3 monthly calls from community health workers, who used a novel web application to communicate with participants' healthcare teams. In the control group, participants received community-based DSME alone. MAIN MEASURES: The primary outcome was A1C; secondary outcomes included diabetes distress, depressive symptoms, self-efficacy or confidence in their ability to manage diabetes, and social support. We used mixed models repeated measures analyses to assess for between-arm differences and baseline to follow-up changes. KEY RESULTS: Of 120 participants randomized, 97 completed the study. Participants in intervention and control groups experienced clinically meaningful reduction in A1C, 10.1 (SD 1.7) to 9.6 (SD 1.9) and 9.8 (SD 1.7) to 9.1 (SD 1.9) respectively, p = 0.004. Participants in the intervention group experienced a significantly larger reduction in diabetes distress compared to the control, 2.7 (SD 1.2) to 2.1 (1.0) versus 2.6 (SD 1.1) to 2.3 (SD 1.0) p = 0.041. CONCLUSIONS: Community-based DSME with and without peer support led to improved glycemic control. Peer support linked to clinical care led to a larger reduction in diabetes distress, which has important implications for the overall wellbeing of adults with type 2 diabetes.

The Rural VA Multi-Center Medication Reconciliation Quality Improvement Study (R-VA-MARQUIS).

PURPOSE: High-quality medication reconciliation reduces medication discrepancies, but smaller hospitals serving rural patients may have difficulty implementing this because of limited resources. We sought to adapt and implement an evidence-based toolkit of best practices for medication reconciliation in smaller hospitals, evaluate the effect on unintentional medication discrepancies, and assess facilitators and barriers to implementation. METHODS: We conducted a 2-year mentored-implementation quality improvement feasibility study in 3 Veterans Affairs (VA) hospitals serving rural patients. The primary outcome was unintentional medication discrepancies per medication per patient, determined by comparing the "gold standard" preadmission medication history to the documented preadmission medication list and admission and discharge orders. RESULTS: In total, 797 patients were included; their average age was 68.7 years, 94.4% were male, and they were prescribed an average of 9.6 medications. Sites 2 and 3 implemented toolkit interventions, including clarifying roles among clinical personnel, educating providers on taking a best possible medication history, and hiring pharmacy professionals to obtain a best possible medication history and perform discharge medication reconciliation. Site 1 did not implement an intervention. Discrepancies improved in intervention patients compared with controls at Site 3 (adjusted incidence rate ratio [IRR], 0.55; 95% confidence interval [CI], 0.45-0.67) but increased in intervention patients compared with controls at Site 2 (adjusted IRR, 1.22; 95% CI, 1.08-1.36). CONCLUSIONS: An evidence-based toolkit for medication reconciliation adapted to the VA setting was adopted in 2 of 3 small, rural, resource-limited hospitals, resulting in both reduced and increased unintentional medication discrepancies. We highlight facilitators and barriers to implementing evidence-based medication reconciliation in smaller hospitals.

An environmental scan of medication history technician programs within the Veterans Health Administration.

PURPOSE: Results of a study to identify medication history technician (MHT) programs within the Veterans Health Administration (VHA) and to evaluate the personnel, structure, and scope of such programs are reported. METHODS: Specially trained pharmacy technicians can take accurate patient medication histories and contribute to the medication reconciliation process. An environmental scan of MHT programs within VHA was conducted via an email query of pharmacy personnel. Semistructured interviews of personnel at each responding site (an MHT, a pharmacist, or both) were conducted. RESULTS: Ten VHA sites had existing MHT programs; the earliest was initiated in 2010. Sites employed from 1 to 4 MHTs, who most commonly worked in the inpatient setting (7 sites). At most sites (9), MHTs obtained a "best possible medication history" through systematic collection of medication information using 2 reliable sources, such as patients, caregivers, and medical records. Survey respondents at all sites reported benefits of MHT programs, including dedicated time to obtain medication histories, allowing for more effective use of pharmacists' time. Six sites were eager to increase the reach of their programs. MHT training, oversight, and quality assurance varied across the sites. The survey results indicated that there are opportunities nationally-within and outside VHA-to develop standardized training, competency assessments, and quality assurance measures for MHT programs. CONCLUSION: Ten VHA sites with MHT programs were identified. MHTs most commonly worked in inpatient settings as part of admission medication reconciliation processes.

Factors associated with antidepressant use among low-income racially and ethnically diverse patients with type 2 diabetes.

OBJECTIVE: Depression is common in patients with type 2 diabetes and associated with poor diabetes-related outcomes. We evaluated the factors associated with antidepressant use in a low-income, racially and ethnically diverse sample of patients with type 2 diabetes. RESEARCH DESIGN AND METHODS: We performed a cross-sectional study of baseline data from participants in a cluster randomized trial evaluating a health literacy intervention for diabetes care in safety net clinics. Depressive symptoms were measured by the Center for Epidemiological Studies Depression Scale (CES-D); antidepressant use was abstracted from medication lists. Multivariable mixed effects logistic regression was used to evaluate the relationship between antidepressant use and race/ethnicity adjusting for depressive symptoms, age, gender, income, and health literacy. RESULTS: Of 403 participants, 58% were non-Hispanic White, 18% were non-Hispanic Black, and 24% were Hispanic. Median age was 51 years old; 60% were female, 52% of participants had a positive screen for depression, and 18% were on antidepressants. Black and Hispanic participants were significantly less likely to be on an antidepressant compared with white participants, adjusted odds ratios 0.31(95% CI: 0.12 to 0.80) and 0.26 (95% CI: 0.10 to 0.74), respectively. CONCLUSIONS: In this vulnerable population with type 2 diabetes, we found a high prevalence of depressive symptoms, and a small proportion of participants were on an antidepressant. Black and Hispanic participants were significantly less likely to be treated with an antidepressant. Our findings suggest depression may be inadequately treated in low-income, uninsured patients with type 2 diabetes, especially racial and ethnic minorities.

Accuracy of a composite event definition for hypoglycemia.

PURPOSE: To evaluate the accuracy of a composite definition for the identification of hypoglycemia events that used both administrative claims and laboratory data in a cohort of patients. METHODS: We reviewed medical records in a sample of presumed hypoglycemia events among patients who received care at the Veterans Health Administration Tennessee Valley Healthcare System in 2001 to 2012. A hypoglycemia event was defined as a hospitalization or emergency department visit judged by the treating clinician to be due to hypoglycemia, or an outpatient laboratory or point-of-care blood glucose measurement <60 mg/dL. Based on medical record review, each event was classified as true positive (severe, documented symptomatic, documented asymptomatic) or false positive (probable symptomatic, not hypoglycemia). The positive predictive values (PPV) of the individual event types (hospitalization, emergency department, and outpatient) were estimated. RESULTS: Of 2250 events identified through the composite definition, 321 events (15 hospitalizations, 103 emergency department visits, and 203 outpatient events) were reviewed. The PPVs were 80% for hospitalization events, 48% for emergency department events, and 96% for outpatient events. The emergency department definition included a nonspecific diagnosis code for diabetic complications which captured many false positive events. Excluding this code from the definition improved the PPV for emergency department events to 70% and missed one true event. CONCLUSIONS: Our composite definition for hypoglycemia performed moderately well in a cohort of Veterans. Further evaluation of the emergency department events may be needed.

Evaluation of Frailty as an Unmeasured Confounder in Observational Studies of Antidiabetic Medications.

BACKGROUND: It is unknown whether observational studies evaluating the association between antidiabetic medications and mortality adequately account for frailty. Our objectives were to evaluate if frailty was a potential confounder in the relationship between antidiabetic medication regimen and mortality and how well administrative and clinical electronic health record (EHR) data account for frailty. METHODS: We conducted a retrospective cohort study in a single Veterans Health Administration (VHA) healthcare system of 500 hospitalizations-the majority due to heart failure-of Veterans who received regular VHA care and initiated type 2 diabetes treatment from 2001 to 2008. We measured frailty using a modified frailty index (FI, >0.21 frail). We obtained antidiabetic medication regimen and time-to-death from administrative sources. We compared FI among patients on different antidiabetic regimens. Stepwise Cox proportional hazards regression estimated time-to-death by demographic, administrative, clinical EHR, and FI data. RESULTS: Median FI was 0.22 (interquartile range 0.18, 0.27). Frailty differed across antidiabetic regimens (p < .001). An FI increase of 0.05 was associated with an increased risk of death (hazard ratio 1.45, 95% confidence interval 1.32, 1.60). Cox proportional hazards model for time-to-death including demographic, administrative, and clinical EHR data had a c-statistic of 0.70; adding FI showed marginal improvement (c-statistic 0.72). CONCLUSIONS: Frailty was associated with antidiabetic regimen and death, and may confound that relationship. Demographic, administrative, and clinical EHR data, commonly used to balance differences among exposure groups, performed moderately well in assessing risk of death, with minimal gain from adding frailty. Study design and analytic techniques can help minimize potential confounding by frailty in observational studies.

Validation of an algorithm to identify heart failure hospitalisations in patients with diabetes within the veterans health administration.

OBJECTIVES: We aimed to validate an algorithm using both primary discharge diagnosis (International Classification of Diseases Ninth Revision (ICD-9)) and diagnosis-related group (DRG) codes to identify hospitalisations due to decompensated heart failure (HF) in a population of patients with diabetes within the Veterans Health Administration (VHA) system. DESIGN: Validation study. SETTING: Veterans Health Administration-Tennessee Valley Healthcare System PARTICIPANTS: We identified and reviewed a stratified, random sample of hospitalisations between 2001 and 2012 within a single VHA healthcare system of adults who received regular VHA care and were initiated on an antidiabetic medication between 2001 and 2008. We sampled 500 hospitalisations; 400 hospitalisations that fulfilled algorithm criteria, 100 that did not. Of these, 497 had adequate information for inclusion. The mean patient age was 66.1 years (SD 11.4). Majority of patients were male (98.8%); 75% were white and 20% were black. PRIMARY AND SECONDARY OUTCOME MEASURES: To determine if a hospitalisation was due to HF, we performed chart abstraction using Framingham criteria as the referent standard. We calculated the positive predictive value (PPV), negative predictive value (NPV), sensitivity and specificity for the overall algorithm and each component (primary diagnosis code (ICD-9), DRG code or both). RESULTS: The algorithm had a PPV of 89.7% (95% CI 86.8 to 92.7), NPV of 93.9% (89.1 to 98.6), sensitivity of 45.1% (25.1 to 65.1) and specificity of 99.4% (99.2 to 99.6). The PPV was highest for hospitalisations that fulfilled both the ICD-9 and DRG algorithm criteria (92.1% (89.1 to 95.1)) and lowest for hospitalisations that fulfilled only DRG algorithm criteria (62.5% (28.4 to 96.6)). CONCLUSIONS: Our algorithm, which included primary discharge diagnosis and DRG codes, demonstrated excellent PPV for identification of hospitalisations due to decompensated HF among patients with diabetes in the VHA system.

Comparative Safety of Sulfonylurea and Metformin Monotherapy on the Risk of Heart Failure: A Cohort Study.

BACKGROUND: Medications that impact insulin sensitivity or cause weight gain may increase heart failure risk. Our aim was to compare heart failure and cardiovascular death outcomes among patients initiating sulfonylureas for diabetes mellitus treatment versus metformin. METHODS AND RESULTS: National Veterans Health Administration databases were linked to Medicare, Medicaid, and National Death Index data. Veterans aged ≥18 years who initiated metformin or sulfonylureas between 2001 and 2011 and whose creatinine was <1.4 (females) or 1.5 mg/dL (males) were included. Each metformin patient was propensity score-matched to a sulfonylurea initiator. The outcome was hospitalization for acute decompensated heart failure as the primary reason for admission or a cardiovascular death. There were 126 867 and 79 192 new users of metformin and sulfonylurea, respectively. Propensity score matching yielded 65 986 per group. Median age was 66 years, and 97% of patients were male; hemoglobin A1c 6.9% (6.3, 7.7); body mass index 30.7 kg/m2 (27.4, 34.6); and 6% had heart failure history. There were 1236 events (1184 heart failure hospitalizations and 52 cardiovascular deaths) among sulfonylurea initiators and 1078 events (1043 heart failure hospitalizations and 35 cardiovascular deaths) among metformin initiators. There were 12.4 versus 8.9 events per 1000 person-years of use (adjusted hazard ratio 1.32, 95%CI 1.21, 1.43). The rate difference was 4 heart failure hospitalizations or cardiovascular deaths per 1000 users of sulfonylureas versus metformin annually. CONCLUSIONS: Predominantly male patients initiating treatment for diabetes mellitus with sulfonylurea had a higher risk of heart failure and cardiovascular death compared to similar patients initiating metformin.