Evaluation of Out-of-Pocket Costs and Treatment Intensification With an SGLT2 Inhibitor or GLP-1 RA in Patients With Type 2 Diabetes and Cardiovascular Disease.

Importance: The latest guidelines continue to recommend sodium-glucose cotransporter 2 (SGLT2) inhibitors and glucagon-like peptide-1 receptor agonists (GLP-1 RAs) for patients with type 2 diabetes (T2D) and established cardiovascular disease (CVD). Despite this, overall use of these 2 drug classes has been suboptimal. Objective: To assess the association of high out-of-pocket (OOP) costs and the initiation of an SGLT2 inhibitor or GLP-1 RA among adults with T2D and established CVD who are treated with metformin-treated. Design, Setting, and Participants: This retrospective cohort study used 2017 to 2021 data from the Optum deidentified Clinformatics Data Mart Database. Each individual in the cohort was categorized into quartiles of OOP costs for a 1-month supply of SGLT2 inhibitor and GLP-1 RA based on their health plan assignment. Data were analyzed from April 2021 to October 2022. Exposures: OOP cost for SGLT2 inhibitors and GLP-1 RA. Main Outcomes and Measures: The primary outcome was treatment intensification, defined as a new dispensing (ie, initiation) of either an SGLT2 inhibitor or GLP-1 RA, among patients with T2D previously treated with metformin monotherapy. For each drug class separately, Cox proportional hazards models were used to adjust for demographic, clinical, plan, clinician, and laboratory characteristics to estimate the hazard ratios of treatment intensification comparing the highest vs the lowest quartile of OOP costs. Results: Our cohort included 80 807 adult patients (mean [SD] age, 72 [9.5] years, 45 129 [55.8%] male; 71 128 [88%] were insured with Medicare Advantage) with T2D and established CVD on metformin monotherapy. Patients were followed for a median (IQR) of 1080 days (528 to 1337). The mean (SD) of OOP costs in the highest vs lowest quartile was $118 [32] vs $25 [12] for GLP-1 RA, and $91 [25] vs $23 [9] for SGLT2 inhibitors. Compared with patients in plans with the lowest quartile (Q1) of OOP costs, patients in plans with the highest quartile (Q4) of costs were less likely to initiate a GLP-1 RA (adjusted HR, 0.87 [95% CI, 0.78 to 0.97]) or an SGLT2 inhibitor (adjusted HR, 0.80 [95% CI, 0.73 to 0.88]). The median (IQR) number of days to initiating a GLP-1 RA was 481 (207-820) days in Q1 and 556 (237-917) days in Q4 of OOP costs and 520 (193-876) days in Q1 vs 685 (309-1017) days in Q4 for SGLT2 inhibitors. Conclusions and Relevance: In this cohort study of more than 80 000 older adults with T2D and established CVD covered by Medicare Advantage and commercial plans, those in the highest quartile of OOP cost were 13% and 20% less likely to initiate a GLP-1 RA or SGLT2 inhibitor, respectively, when compared with those in the lowest quartile of OOP costs.

Links of positive affect and stress to HbA1c: a prospective longitudinal study.

While affect is linked to a number of diabetes outcomes, the specific role of positive affect (PA) in HbA1c remains unclear. The present study examined whether PA prospectively predicted lower HbA1c among adults with type 2 diabetes and whether this relation was moderated by stress. Participants were 123 adults (44.7% female; 60.2% White, 39.8% Black) recently diagnosed with type 2 diabetes. Perceived stress, diabetes-specific distress, and PA were assessed at baseline; HbA1c was assessed at baseline (T1), six months (T2), and five years (T3). PA was cross-sectionally associated with lower HbA1c at T1 and prospectively predicted lower HbA1c at T3. PA interacted with both measures of T1 stress to predict T1 HbA1c, and PA interacted with T3 perceived stress to predict T3 HbA1c. Interactions were consistent with stress buffering. Sensitivity analyses attentuated findings, but robust evidence remained for PA as a protective factor for blood glucose five years later and for a stress-buffering effect of PA on diabetes-specific distress. Findings suggest PA may be a clinically useful indicator among adults with type 2 diabetes and may be particularly important for those experiencing the greatest stress from their disease.

Real-world weight-loss effectiveness of glucagon-like peptide-1 agonists among patients with type 2 diabetes: A retrospective cohort study.

OBJECTIVE: Weight loss achieved with standard doses of glucagon-like peptide-1 (GLP-1) agonists among real-world patients with type 2 diabetes has not been determined. This study sought to describe the percent change in body weight 72 weeks after starting a GLP-1 agonist. METHODS: A retrospective cohort study of nonpregnant adults who were first dispensed a GLP-1 agonist between 2011 and 2018 was conducted using electronic health record data from patients receiving care at a large health system. Linear mixed models were used, with a person-level random intercept controlling for baseline variables associated with missing weight data to estimate percent body weight change during follow-up. RESULTS: The cohort included 2405 patients (mean [SD] age 48 [10] years, 53% female), with a mean BMI of 37 (8) kg/m2 and a mean baseline weight of 238 (54) lb. Mean percent weight loss significantly increased from 1.1% (95% CI: 0.6%-1.6%) 8 weeks after GLP-1-agonist dispensing to 2.2% (95% CI: 1.7%-2.6%) 72 weeks after GLP-1-agonist dispensing (p value for quadratic trend < 0.001). One-third of patients lost ≥5% body weight at 72 weeks. CONCLUSIONS: In this real-world study of more than 2400 patients with overweight or obesity and type 2 diabetes, starting a GLP-1 agonist at standard glycemic control doses was associated with modest weight loss through 72 weeks.

A Systematic Review Supporting the Endocrine Society Clinical Practice Guideline for the Management of Hyperglycemia in Adults Hospitalized for Noncritical Illness or Undergoing Elective Surgical Procedures.

CONTEXT: Individuals with diabetes or newly recognized hyperglycemia account for over 30% of noncritically ill hospitalized patients. Management of hyperglycemia in these patients is challenging. OBJECTIVE: To support development of the Endocrine Society Clinical Practice Guideline for management of hyperglycemia in adults hospitalized for noncritical illness or undergoing elective surgical procedures. METHODS: We searched several databases for studies addressing 10 questions provided by a guideline panel from the Endocrine Society. Meta-analysis was conducted when feasible. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology was used to assess certainty of evidence. RESULTS: We included 94 studies reporting on 135 553 patients. Compared with capillary blood glucose, continuous glucose monitoring increased the number of patients identified with hypoglycemia and decreased mean daily blood glucose (BG) (very low certainty). Data on continuation of insulin pump therapy in hospitalized adults were sparse. In hospitalized patients receiving glucocorticoids, combination neutral protamine hagedorn (NPH) and basal-bolus insulin was associated with lower mean BG compared to basal-bolus insulin alone (very low certainty). Data on NPH insulin vs basal-bolus insulin in hospitalized adults receiving enteral nutrition were inconclusive. Inpatient diabetes education was associated with lower HbA1c at 3 and 6 months after discharge (moderate certainty) and reduced hospital readmissions (very low certainty). Preoperative HbA1c level < 7% was associated with shorter length of stay, lower postoperative BG and a lower number of neurological complications and infections, but a higher number of reoperations (very low certainty). Treatment with glucagon-like peptide-1 agonists or dipeptidyl peptidase-4 inhibitors in hospitalized patients with type 2 diabetes and mild hyperglycemia was associated with lower frequency of hypoglycemic events than insulin therapy (low certainty). Caloric oral fluids before surgery in adults with diabetes undergoing surgical procedures did not affect outcomes (very low certainty). Counting carbohydrates for prandial insulin dosing did not affect outcomes (very low certainty). Compared with scheduled insulin (basal-bolus or basal insulin + correctional insulin), correctional insulin was associated with higher mean daily BG and fewer hypoglycemic events (low certainty). CONCLUSION: The certainty of evidence supporting many hyperglycemia management decisions is low, emphasizing importance of shared decision-making and consideration of other decisional factors.

Management of Hyperglycemia in Hospitalized Adult Patients in Non-Critical Care Settings: An Endocrine Society Clinical Practice Guideline.

BACKGROUND: Adult patients with diabetes or newly recognized hyperglycemia account for over 30% of noncritically ill hospitalized patients. These patients are at increased risk for adverse clinical outcomes in the absence of defined approaches to glycemic management. OBJECTIVE: To review and update the 2012 Management of Hyperglycemia in Hospitalized Patients in Non-Critical Care Settings: An Endocrine Society Clinical Practice Guideline and to address emerging areas specific to the target population of noncritically ill hospitalized patients with diabetes or newly recognized or stress-induced hyperglycemia. METHODS: A multidisciplinary panel of clinician experts, together with a patient representative and experts in systematic reviews and guideline development, identified and prioritized 10 clinical questions related to inpatient management of patients with diabetes and/or hyperglycemia. The systematic reviews queried electronic databases for studies relevant to the selected questions. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology was used to assess the certainty of evidence and make recommendations. RESULTS: The panel agreed on 10 frequently encountered areas specific to glycemic management in the hospital for which 15 recommendations were made. The guideline includes conditional recommendations for hospital use of emerging diabetes technologies including continuous glucose monitoring and insulin pump therapy; insulin regimens for prandial insulin dosing, glucocorticoid, and enteral nutrition-associated hyperglycemia; and use of noninsulin therapies. Recommendations were also made for issues relating to preoperative glycemic measures, appropriate use of correctional insulin, and diabetes self-management education in the hospital. A conditional recommendation was made against preoperative use of caloric beverages in patients with diabetes. CONCLUSION: The recommendations are based on the consideration of important outcomes, practicality, feasibility, and patient values and preferences. These recommendations can be used to inform system improvement and clinical practice for this frequently encountered inpatient population.

Enhancing the Trustworthiness of the Endocrine Society's Clinical Practice Guidelines.

In an effort to enhance the trustworthiness of its clinical practice guidelines, the Endocrine Society has recently adopted new policies and more rigorous methodologies for its guideline program. In this Clinical Practice Guideline Communication, we describe these recent enhancements-many of which reflect greater adherence to the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach to guideline development-in addition to the rationale for such changes. Improvements to the Society's guideline development practices include, but are not limited to, enhanced inclusion of nonendocrinologist experts, including patient representatives, on guideline development panels; implementation of a more rigorous conflict/duality of interest policy; a requirement that all formal recommendations must be demonstrably underpinned by systematic evidence review; the explicit use of GRADE Evidence-to-Decision frameworks; greater use and explanation of standardized guideline language; and a more intentional approach to guideline updating. Lastly, we describe some of the experiential differences our guideline readers are most likely to notice.

Sex differences in glycemic measures, complications, discharge disposition, and postdischarge emergency room visits and readmission among non-critically ill, hospitalized patients with diabetes.

INTRODUCTION: The purpose of this prospective observational cohort study was to examine sex differences in glycemic measures, diabetes-related complications, and rates of postdischarge emergency room (ER) visits and hospital readmissions in non-critically ill, hospitalized patients with diabetes. RESEARCH DESIGN AND METHODS: Demographic data including age, body mass index, race, blood pressure, reason for admission, diabetes medications at admission and discharge, diabetes-related complications, laboratory data (hematocrit, creatinine, hemoglobin A1c, point-of-care blood glucose measures), length of stay (LOS), and discharge disposition were collected. Patients were followed for 90 days following hospital discharge to obtain information regarding ER visits and readmissions. RESULTS: 120 men and 100 women consented to participate in this study. There were no sex differences in patient demographics, diabetes duration or complications, or LOS. No differences were observed in the percentage of men and women with an ER visit or hospital readmission within 30 (39% vs 33%, p=0.40) or 90 (60% vs 49%, p=0.12) days of hospital discharge. More men than women experienced hypoglycemia prior to discharge (18% vs 8%, p=0.026). More women were discharged to skilled nursing facilities (p=0.007). CONCLUSIONS: This study demonstrates that men and women hospitalized with an underlying diagnosis of diabetes have similar preadmission glycemic measures, diabetes duration, and prevalence of diabetes complications. More men experienced hypoglycemia prior to discharge. Women were less likely to be discharged to home. Approximately 50% of men and women had ER visits or readmissions within 90 days of hospital discharge. TRIAL REGISTRATION NUMBER: NCT03279627.

Association of formulary restrictions and initiation of an SGLT2i or GLP1-RA among Medicare beneficiaries with type 2 diabetes.

BACKGROUND: Use of SGLT2 inhibitors (SGLT2i) and GLP-1 receptor agonists (GLP1-RA) among older adults with type 2 diabetes (T2D) has been limited. OBJECTIVE: To examine factors associated with initiation of an SGLT2i or GLP-1RA among Medicare beneficiaries with T2D in the early years after their market approval, with a particular focus on formulary restrictions (e.g. prior authorization, step therapy requirements, higher co-pays). METHODS: A retrospective cohort study using data from a 5% random sample of Medicare beneficiaries with T2D followed from 1/1/2015-12/31/16. Formulary restrictiveness was defined as: (1) the number of target drugs (i.e. SGLT2is or GLP1-RAs) included in tiers 1-3 of a beneficiary's formulary (greater number of drugs in tiers 1-3 being less restrictive) and (2) the number of drugs without prior authorization or step therapy (requirement to try less expensive drugs prior to "stepping up" to more expensive therapies). We used multivariable logistic regression models to estimate the association between measures of formulary restrictiveness and initiation of a target drug, controlling for patient demographics, diabetes duration, clinical comorbidities, and provider specialty. RESULTS: Among 112,985 beneficiaries with T2D, 5,619 (5%) initiated an SGLT2i or GLP1-RA. After adjusting for baseline characteristics, patients enrolled in formularies with ≥ 2 target drugs available in tiers 1-3 had 17% higher odds of initiating an SGLT2i or GLP1-RA (aOR 1.17, 95% CI 1.05-1.31) compared to patients enrolled in formularies with 0 drugs available in tiers 1-3. There was no significant association between the number of drugs without prior authorization or step therapy requirements and initiation of a target drug (aOR 0.96, 95% CI, 0.85-1.09). Age 75 years or older (vs < 65, aOR 0.23, 95% CI 0.21-0.26) and black race (vs white, aOR 0.65, 95% CI 0.59-0.71) were associated with lower odds of initiating a target drug. CONCLUSIONS: Having a greater number of target drugs available on less expensive formulary tiers is associated with increased odds of initiating an SGLT2i or GLP-1RA among Medicare beneficiaries with T2D.

Effect of Treatment of OSA With CPAP on Glycemic Control in Adults With Type 2 Diabetes: The Diabetes Sleep Treatment Trial (DSTT).

OBJECTIVE: The effect of obstructive sleep apnea (OSA) treatment with continuous positive airway pressure (CPAP) on glycemic measures in patients with type 2 diabetes (T2D) remains unclear. We aimed to determine whether CPAP treatment of OSA improves glycemic measures in patients with T2D. METHODS: This randomized controlled trial (N = 98) examined changes in glycemic measures following 12 weeks of active (n = 49) or sham (n = 49) CPAP and consideried participants' adherence to CPAP therapy (percentage of days with ≥4 hours use and average hours/day of use). RESULTS: Baseline treatment groups were similar. Regarding the efficacy of active vs sham-CPAP over time, at 6 weeks, both groups had similar reductions in fructosamine (mean difference [MD], 95% confidence interval [CI]: CPAP -13.10 [-25.49 to -0.7] vs. sham -7.26 [-20.2 to 5.69]; P = .519) but different in HbA1c (CPAP -0.24 [-0.48 to -0.003] vs sham 0.15 [-0.10 to 0.4]; P = .027). At 12 weeks, reductions in HbA1c values were similar by group (CPAP -0.26 [-0.53 to 0.002] vs sham -0.24 [-0.53 to 0.04]; P = .924). HbA1c reductions were associated with a greater percentage of cumulative days of CPAP usage ≥4 hours per day (b [SE] = 0.006 [0.002]; P = .013) and cumulative hours of CPAP use (b [SE] = 0.08 [0.08]; P = .012). CPAP use of ≥7 hours was associated with a significant reduction in HbA1c (b [SE] 0.54 [0.16]; P = .0012). CONCLUSION: CPAP treatment of OSA did not result in sustained improved glycemic control compared to sham in the intent-to-treat analysis. CPAP adherence was associated with greater improvements in glycemic control.

Incidence and Predictors of Primary Nonadherence to Sodium Glucose Co-transporter 2 Inhibitors and Glucagon-Like Peptide 1 Agonists in a Large Integrated Healthcare System.

BACKGROUND: Newer glucose-lowering drugs, including sodium glucose co-transporter 2 inhibitors (SGLT2i) and GLP-1 agonists, have a key role in the pharmacologic management of type 2 diabetes. No studies have measured primary nonadherence for these two drug classes, defined as when a medication is prescribed for a patient but ultimately not dispensed to them. OBJECTIVE: To describe the incidence and predictors of primary nonadherence to SGLT2i (canagliflozin, empagliflozin) or GLP-1 agonists (dulaglutide, liraglutide, semaglutide) using a dataset that links electronic prescribing with health insurance claims. DESIGN AND PARTICIPANTS: A retrospective cohort design using data of adult patients from a large health system who had at least one prescription order for a SGLT2i or GLP-1 agonist between 2012 and 2019. We used mixed-effects multivariable logistic regression to determine associations between sociodemographic, clinical, and provider variables and primary nonadherence. MAIN MEASURES: Primary medication nonadherence, defined as no dispensed claim within 30 days of an electronic prescription order for any drug within each medication class. KEY RESULTS: The cohort included 5146 patients newly prescribed a SGLT2i or GLP-1 agonist. The overall incidence of 30-day primary medication nonadherence was 31.8% (1637/5146). This incidence rate was 29.8% (n = 726) and 33.6% (n = 911) among those initiating a GLP-1 agonist and SGLT2i, respectively. Age ≥ 65 (aOR 1.37 (95% CI 1.09 to 1.72)), Black race vs White (aOR 1.29 (95% CI 1.02 to 1.62)), diabetic nephropathy (aOR 1.31 (95% CI 1.02 to 1.68)), and hyperlipidemia (aOR 1.18 (95% CI 1.01 to 1.39)) were associated with a higher odds of primary nonadherence. Female sex (aOR 0.86 (95% CI 0.75 to 0.99)), peripheral artery disease (aOR 0.73 (95% CI 0.56 to 0.94)), and having the index prescription ordered by an endocrinologist vs a primary care provider (aOR 0.76 (95% CI 0.61 to 0.95)) were associated with lower odds of primary nonadherence. CONCLUSIONS: One third of patients prescribed SGLT2i or GLP-1 agonists in this sample did not fill their prescription within 30 days. Black race, male sex, older age, having greater baseline comorbidities, and having a primary care provider vs endocrinologist prescribe the index drug were associated with higher odds of primary nonadherence. Interventions targeting medication adherence for these newer drugs must consider primary nonadherence as a barrier to optimal clinical care.

Metabolic outcomes in adults with type 2 diabetes and sleep disorders.

PURPOSE: Insomnia is frequently co-morbid with obstructive sleep apnea (OSA); the effect of insomnia or co-morbid insomnia and OSA (OSA + I) on associated metabolic outcomes in adults with type 2 diabetes (T2D) remains unclear. This study in adults with T2D compared metabolic outcomes among persons with OSA, insomnia, or OSA + I. METHODS: This study analyzed baseline data from the Diabetes Sleep Treatment Trial of persons recruited for symptoms of OSA or poor sleep quality. Home sleep studies determined OSA presence and severity. Insomnia was evaluated using the Insomnia Severity Index. Height and weight to calculate body mass index (BMI) and blood for laboratory values were obtained. Multivariate general linear models were used to examine the impact of the type of sleep disorder and sociodemographic, lifestyle, and sleep risk factors on metabolic outcomes. RESULTS: Participants (N = 253) were middle-aged (56.3 ± 10.5 years), white (60.5%), obese (mean BMI of 35.3 ± 7.1 kg/m2), and male (51.4%) with poor glucose control (mean HbA1c of 8.0 ± 1.8%). Most participants had OSA + I (42.7%) or insomnia only (41.0%). HbA1c and BMI differed among the sleep disorder groups. In addition, in the adjusted models, having insomnia only, compared to OSA only, was associated on average with higher HbA1c levels (b = 1.08 ± 0.40, p < 0.007) and lower BMI (b = - 7.03 ± 1.43, p < 0.001). CONCLUSIONS: Findings suggest that insomnia frequently co-exists with OSA, is independently associated with metabolic outcomes in adults with T2D, and should be considered in investigations of the effects of OSA in persons with T2D. TRIAL REGISTRATION: Diabetes-Obstructive Sleep Apnea Treatment Trial (NCT01901055), https: Clinicaltrials.gov/ct2/show/NCT01901055; Registration date: July 17, 2013.

Paraneoplastic Hypoglycemia Leading to Insulin Independence in a Patient With Type 1 Diabetes.

OBJECTIVE: Non-islet cell tumor hypoglycemia (NICTH) is an uncommon paraneoplastic syndrome associated with mesenchymal neoplasms such as gastrointestinal stromal tumors (GISTs). We report the case of a patient with type 1 diabetes (T1D) and recurrent GIST who not only required discontinuation of insulin therapy but also required continuous parenteral glucose infusions to prevent hypoglycemia. METHODS: A 59-year-old woman with a 24-year history of T1D and recurrent GIST presented with frequent episodes of symptomatic hypoglycemia despite continuous reductions in her insulin therapy. Laboratory workup revealed undetectable insulin and C-peptide, low insulin-like growth factor (IGF) 1, normal IGF-2, and an elevated IGF-2:IGF-1 ratio. Medical management with prednisone alone and, later, in combination with octreotide did not reduce hypoglycemic episodes. Eventually, during hospitalization for severe hypoglycemia, she was treated and discharged with continuous intravenous dextrose infusion. She ultimately required around-the-clock glucose infusions, which helped her maintain what she believed was an acceptable quality of life during her remaining weeks. DISCUSSION: NICTH is characterized by excessive tumor production of IGF-2 or pro-IGF-2, leading to unrestricted glucose uptake in peripheral tissues and hypoglycemia. A diagnosis of NICTH can be made on the basis of low IGF-1 levels in the plasma with normal or elevated IGF-2. Tumor resection is the most definitive treatment for NICTH. CONCLUSION: This patient with T1D presented with resistant hypoglycemia due to recurrence of an enlarging GIST. She required discontinuation of all insulin therapy and continuous dextrose infusions to maintain euglycemia.

A Closer Look at Racial Differences in Diabetes Outcomes Among a Community Sample: Diabetes Distress, Self-care, and HbA1c.

OBJECTIVE: Approximately 34 million people in the U.S. have diabetes. With this illness come substantial changes to psychological and physical health. However, type 2 diabetes disproportionately affects non-Hispanic Black compared with non-Hispanic White populations. The purpose of this study was to examine racial differences in psychological, behavioral, and physical health over time among individuals recently diagnosed with type 2 diabetes. RESEARCH DESIGN AND METHODS: Data were collected from a community sample of 193 adults recently diagnosed with type 2 diabetes (44% female; 45% Black). Measures of distress, self-care behaviors, and HbA1c were taken at an initial interview (time 1) and 6 months later (time 2). Individuals wore an Actical accelerometer to assess physical activity and participated in three 24-h dietary recall interviews to assess dietary intake within 2 weeks of the initial interview. RESULTS: From time 1 to time 2, Black women showed the highest increase in depressive symptoms. There was a greater increase in regimen and physician distress among White compared with Black participants. White men and Black women reported a decline in medication adherence over time. There were no racial differences in changes in physical activity across 6 months. However, Black individuals had higher overall calorie consumption with greater protein, saturated fat, and cholesterol intake than White individuals. There were no race or sex differences in changes in glycemic stability. CONCLUSIONS: Initial adjustment to a diagnosis of type 2 diabetes differentially influences Black and White men and women in terms of depressive symptoms, diabetes distress, and self-care.

Hypoglycemia symptoms are reduced in hospitalized patients with diabetes.

AIMS: Hospitalized patients with diabetes are have an impaired ability to detect hypoglycemia events. The purpose of this study was to compare hypoglycemia symptom scores (HSS) in hospitalized patients with diabetes after a documented blood glucose (BG) <70mg/dl with recalled HSS with outpatient hypoglycemia events. METHODS: Non-critically ill hospitalized patients with diabetes grouped as symptomatic (n=23) or asymptomatic (n=32) at time of index hypoglycemia completed a standardized HSS-Questionnaires (HSS-Q) related to the inpatient event and to recall of symptoms with outpatient hypoglycemia. RESULTS: After controlling for BG at time of index hypoglycemia (49.8±11.4 vs. 57.4±6.8mg/dl, p=0.02), symptomatic patients reported higher HSS than asymptomatic patients with the inpatient event (11.6±7.3 vs. 1.5±3.4, p<0.001) and in the outpatient setting (13.9±8.6 vs. 10.1±10.6, p<0.01). Recurrent hypoglycemia was more frequent in asymptomatic patients (13% vs. 44%, p=0.015) during the hospitalization. CONCLUSIONS: Compared to symptomatic patients, asymptomatic patients had lower inpatient and outpatient HSS and more frequent recurrent hypoglycemia events. These results suggest modification of glycemic management strategies in high risk patients to reduce risk for hypoglycemia events.

Changes in mood and health-related quality of life in Look AHEAD 6 years after termination of the lifestyle intervention.

OBJECTIVE: The Action for Health in Diabetes (Look AHEAD) study previously reported that intensive lifestyle intervention (ILI) reduced incident depressive symptoms and improved health-related quality of life (HRQOL) over nearly 10 years of intervention compared with a control group (the diabetes support and education group [DSE]) in participants with type 2 diabetes and overweight or obesity. The present study compared incident depressive symptoms and changes in HRQOL in these groups for an additional 6 years following termination of the ILI in September 2012. METHODS: A total of 1,945 ILI participants and 1,900 DSE participants completed at least one of four planned postintervention assessments at which weight, mood (via the Patient Health Questionnaire-9), antidepressant medication use, and HRQOL (via the Medical Outcomes Scale, Short Form-36) were measured. RESULTS: ILI participants and DSE participants lost 3.1 (0.3) and 3.8 (0.3) kg [represented as mean (SE); p = 0.10], respectively, during the 6-year postintervention follow-up. No significant differences were observed between groups during this time in incident mild or greater symptoms of depression, antidepressant medication use, or in changes on the physical component summary or mental component summary scores of the Short Form-36. In both groups, mental component summary scores were higher than physical component summary scores. CONCLUSIONS: Prior participation in the ILI, compared with the DSE group, did not appear to improve subsequent mood or HRQOL during 6 years of postintervention follow-up.

Observed couple interactions among White and Black persons with type 2 diabetes.

The majority of observed couple communication research has focused on physically healthy couples and those who are White, educated, and affluent. In the present study, we observed persons with Type 2 diabetes and their romantic partners discuss how to improve diabetes management; afterward, we measured positive affect, negative affect, and discussion evaluations. We also measured mood and self-care behavior over the next 2 weeks. Couples (n = 207) were recruited from the community and varied in education, income, and race. Half of patients were White (53%), and half were Black (47%). Results showed that observed patient warmth was related to a more positive evaluation of the discussion, more postdiscussion positive affect, less postdiscussion negative affect, and better 2-week daily happy mood; observed patient negativity was related to less postdiscussion progress, a more negative evaluation of the discussion, less postdiscussion positive affect, and poorer 2-week dietary adherence; and observed patient distress was related to a more negative discussion evaluation, more postdiscussion negative affect, and worse mood over the next 2 weeks. Two of the findings were moderated by race, in the direction of links being stronger for Black than White patients. Partner warmth was rarely related to outcomes, but partner negativity was related to patients' poorer discussion evaluation, patient's lower happy mood and higher angry mood over the next 2 weeks, and patient's poorer 2-week dietary adherence. Future research on couple interactions should attend to important contextual variables such as race, ethnicity, income, and social status. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

Patient Understanding of Discharge Instructions for Home Diabetes Self-Management and Risk for Hospital Readmission and Emergency Department Visits.

OBJECTIVE: The primary objective of this study was to examine the patient comprehension of diabetes self-management instructions provided at hospital discharge as an associated risk of readmission. METHODS: Noncritically ill patients with diabetes completed patient comprehension questionnaires (PCQ) within 48 hours of discharge. PCQ scores were compared among patients with and without readmission or emergency department (ED) visits at 30 and 90 days. Glycemic measures 48 hours preceding discharge were investigated. Diabetes Early Readmission Risk Indicators (DERRIs) were calculated for each patient. RESULTS: Of 128 patients who completed the PCQ, scores were similar among those with 30-day (n = 31) and 90-day (n = 54) readmission compared with no readmission (n = 72) (79.9 ± 14.4 vs 80.4 ± 15.6 vs 82.3 ± 16.4, respectively) or ED visits. Clarification of discharge information was provided for 47 patients. PCQ scores of 100% were achieved in 14% of those with and 86% without readmission at 30 days (P = .108). Of predischarge glycemic measures, glycemic variability was negatively associated with PCQ scores (P = .035). DERRIs were significantly higher among patients readmitted at 90 days but not 30 days. CONCLUSION: These results demonstrate similar PCQ scores between patients with and those without readmission or ED visits despite the need for corrective information in many patients. Measures of glycemic variability were associated with PCQ scores but not readmission risk. This study validates DERRI as a predictor for readmission at 90 days.

Inpatient Hyperglycemia and Transitions of Care: A Systematic Review.

OBJECTIVE: The transition of diabetes care from home to hospital, within the hospital, and upon discharge is fraught with gaps that can adversely affect patient safety and length of stay. We aimed to highlight the variability in care during these transitions and point out areas where research is needed. METHODS: A PubMed search was performed with a combination of search terms that pertained to diabetes, hyperglycemia, hospitalization, locations in the hospital, discharge to home or a nursing facility, and diabetes medications. Studies with at least 50 patients that were written in the English language were included. RESULTS: With the exception of transitioning from intravenous insulin infusion to subcutaneous insulin and perhaps admission to the regular floors, few studies pointedly focused on transitions of care, leading us to extrapolate recommendations based on data from disparate areas of care in the hospital. There is evidence at every stage of care, starting from the entry into the hospital and ending with discharge home or to a facility, that patients benefit from having protocols in place guiding overall care. CONCLUSION: Pockets of care exist in hospitals where methods of effective diabetes management have been studied and implemented. However, there is no sustained continuum of care. Protocols and care teams that follow patients from one physical location to the other may result in improved clinical outcomes during and following a hospital stay.

Within-Trial Cost-Effectiveness of a Structured Lifestyle Intervention in Adults With Overweight/Obesity and Type 2 Diabetes: Results From the Action for Health in Diabetes (Look AHEAD) Study.

OBJECTIVE: To assess the cost-effectiveness (CE) of an intensive lifestyle intervention (ILI) compared with standard diabetes support and education (DSE) in adults with overweight/obesity and type 2 diabetes, as implemented in the Action for Health in Diabetes study. RESEARCH DESIGN AND METHODS: Data were from 4,827 participants during their first 9 years of study participation from 2001 to 2012. Information on Health Utilities Index Mark 2 (HUI-2) and HUI-3, Short-Form 6D (SF-6D), and Feeling Thermometer (FT), cost of delivering the interventions, and health expenditures was collected during the study. CE was measured by incremental CE ratios (ICERs) in costs per quality-adjusted life year (QALY). Future costs and QALYs were discounted at 3% annually. Costs were in 2012 U.S. dollars. RESULTS: Over the 9 years studied, the mean cumulative intervention costs and mean cumulative health care expenditures were $11,275 and $64,453 per person for ILI and $887 and $68,174 for DSE. Thus, ILI cost $6,666 more per person than DSE. Additional QALYs gained by ILI were not statistically significant measured by the HUIs and were 0.07 and 0.15, respectively, measured by SF-6D and FT. The ICERs ranged from no health benefit with a higher cost based on HUIs to $96,458/QALY and $43,169/QALY, respectively, based on SF-6D and FT. CONCLUSIONS: Whether ILI was cost-effective over the 9-year period is unclear because different health utility measures led to different conclusions.