Real-World Diagnosis and Treatment of Diabetic Kidney Disease.

Introduction: People with type 2 diabetes mellitus (T2DM) and diabetic kidney disease (DKD) have increased morbidity and mortality risk. Angiotensin-converting enzyme inhibitors (ACEi) or angiotensin II receptor blockers (ARB) are recommended to slow kidney function decline in DKD. This representative, real-world data analysis of patients with T2DM was performed to detect onset of DKD and determine methods and timing of DKD diagnosis and time to initiation of ACEi/ARB therapy.

Chronic Kidney Disease Testing Among Primary Care Patients With Type 2 Diabetes Across 24 U.S. Health Care Organizations.

Objective: Clinical guidelines for people with diabetes recommend chronic kidney disease (CKD) testing at least annually using estimated glomerular filtration rate (eGFR) and urinary albumin-to-creatinine ratio (uACR). We aimed to understand CKD testing among people with type 2 diabetes in the U.S.

Development of risk models for major adverse chronic renal outcomes among patients with type 2 diabetes mellitus using insurance claims: a retrospective observational study.

To develop and validate models allowing the prediction of major adverse chronic renal outcomes (MACRO) in patients with type 2 diabetes mellitus (T2DM) using insurance claims data. The Optum Integrated Real World Evidence Electronic Health Records and Claims de-identified database (10/01/2006-09/30/2016) was used to identify T2DM patients ≥50 years old. Risk factors were assessed over a 12-month baseline period, and MACRO were subsequently assessed until the end of data availability, continuous enrollment, or death.

Factors Associated with Diabetes-Related Clinical Inertia in a Managed Care Population and Its Effect on Hemoglobin A1c Goal Attainment: A Claims-Based Analysis.

Background: Despite evidence showing the benefits of treatment intensification following an elevated hemoglobin A1c (A1c), clinical inertia, or failure to establish and/or escalate treatment to achieve treatment goals, is a concern among patients diagnosed with type 2 diabetes (T2DM). Clinical inertia may contribute to increased health care utilization and costs due to poor clinical outcomes in MCOs.

Objectives: To (a) identify factors associated with clinical inertia in T2DM and (b) determine differences in A1c goal attainment between patients who experience clinical inertia versus treatment intensification in a commercially insured population.

Development of predictive risk models for major adverse cardiovascular events among patients with type 2 diabetes mellitus using health insurance claims data.

Background: There exist several predictive risk models for cardiovascular disease (CVD), including some developed specifically for patients with type 2 diabetes mellitus (T2DM). However, the models developed for a diabetic population are based on information derived from medical records or laboratory results, which are not typically available to entities like payers or quality of care organizations. The objective of this study is to develop and validate models predicting the risk of cardiovascular events in patients with T2DM based on medical insurance claims data.

Changing Patients' Treatment Preferences and Values with a Decision Aid for Type 2 Diabetes Mellitus: Results from the Treatment Arm of a Randomized Controlled Trial.

Introduction: Failure to intensify treatment for type 2 diabetes mellitus (T2DM) when indicated, or clinical inertia, is a major obstacle to achieving optimal glucose control. This study investigates the impact of a values-focused patient decision aid (PDA) for T2DM antihyperglycemic agent intensification on patient values related to domains important in decision-making and preferred treatments.

Methods: Patients with poorly controlled T2DM who were taking a metformin-containing regimen were recruited through physicians to access a PDA presenting evidence-based information on T2DM and antihyperglycemic agent class options.

Real-world evaluation of Hba1c, blood pressure, and weight loss among patients with type 2 diabetes mellitus treated with canagliflozin: an analysis of electronic medical records from a network of hospitals in Florida.

Objective: Clinical trials and real-world studies reported that canagliflozin (CANA) improved HbA1c, blood pressure (BP), and weight in patients with type 2 diabetes mellitus (T2DM). This study examines if previous results hold regionally and within specific patient sub-groups.

Methods: Adults with T2DM and ≥12 months of clinical activity before the first CANA prescription (index) were identified in electronic medical records (January 1, 2012-February 15, 2017) from a network of hospitals in Florida.

Real-world Clinical Outcomes Among Patients With Type 2 Diabetes Receiving Canagliflozin at a Specialty Diabetes Clinic: Subgroup Analysis by Baseline HbA and Age.

Purpose: Canagliflozin, a sodium glucose co-transporter 2 inhibitor developed for the treatment of type 2 diabetes mellitus (T2DM), has demonstrated effectiveness in patients with T2DM receiving care at a specialty diabetes clinic. We report the outcomes in these patients in subgroups classified by baseline hemoglobin A (HbA) and age.

Methods: This subgroup analysis was based on a review of data from the electronic health records of adults with T2DM who were prescribed canagliflozin at a specialty diabetes clinic and who returned for ≥1 follow-up office visit.

Real-world Canagliflozin Utilization: Glycemic Control Among Patients With Type 2 Diabetes Mellitus-A Multi-Database Synthesis.

Purpose: Randomized controlled trials have found that treatment of type 2 diabetes mellitus with canagliflozin, a sodium glucose co-transporter 2 inhibitor, is associated with significant reductions in glycosylated hemoglobin (HbA1c) levels. However, very few studies have evaluated the effectiveness of sodium glucose co-transporter 2 inhibitors in a real-world context. This data synthesis aims to examine the demographic characteristics and glycemic control among patients treated with canagliflozin in clinical practice, using results obtained from 2 US-specific retrospective administrative claims databases.

Glycemic Control Outcomes After Canagliflozin Initiation: Observations in a Medicare and Commercial Managed Care Population in Clinical Practice.

Purpose: Although the efficacy of canagliflozin has been well established in clinical trials, research regarding its use and impact on outcomes in clinical practice has been limited by the availability of data on observations up to and beyond 6 months after the initial use of canagliflozin. The purpose of this study was to evaluate changes in glycemic control after the initiation of canagliflozin use in a managed care population.

Methods: A retrospective cohort analysis in adults with type 2 diabetes mellitus was conducted using medical and pharmacy claims data and laboratory results from the Humana Research Database.

A post-hoc analysis of the comparative efficacy of canagliflozin and glimepiride in the attainment of type 2 diabetes-related quality measures.

Background: The randomized, double-blind CANTATA-SU (CANagliflozin Treatment And Trial Analysis Sulfonyl Urea) clinical trial compared the use of canagliflozin (100 mg or 300 mg) and maximally tolerated glimepiride (6-8 mg) over 104 weeks as add-on therapy for patients with type 2 diabetes mellitus (T2DM) inadequately controlled with metformin. Compared with glimepiride, canagliflozin use was associated with durable reductions in glycated hemoglobin (A1C), blood pressure (BP), and body weight. The aim of this post-hoc analysis of the CANTATA-SU trial was to assess the comparative efficacy of canagliflozin and glimepiride in the attainment of recently updated diabetes-related quality measures (QMs) for up to 104 weeks of treatment.

Effect of a patient decision aid (PDA) for type 2 diabetes on knowledge, decisional self-efficacy, and decisional conflict.

Background: Patients with type 2 diabetes (T2DM) often have poor glycemic control on first-line pharmacologic therapy and require treatment intensification. Intensification decisions can be difficult because of many available options and their many benefits and risks. The American Diabetes Association recommends patient-centered, evidence-based tools supporting shared decision-making between patients and clinicians.

Improving access to shared decision-making for Hispanics/Latinos with inadequately controlled type 2 diabetes mellitus.

Purpose: To describe the cultural and linguistic adaptation and Spanish translation of an English-language patient decision aid (PDA) for use in supporting shared decision-making in Hispanics/Latinos with type 2 diabetes mellitus (T2DM), a group at a high risk for complications.

Patients And Methods: A steering committee of endocrinologists, a primary care physician, a certified diabetes educator, and a dietician, each with extensive experience in providing care to Hispanics/Latinos was convened to assess a PDA developed for English-speaking patients with T2DM. English content was reviewed for cultural sensitivity and appropriateness for a Hispanic/Latino population.

Development of a patient decision aid for type 2 diabetes mellitus for patients not achieving glycemic control on metformin alone.

Purpose: To describe the process used to develop an evidence-based patient decision aid (PDA) that facilitates shared decision-making for treatment intensification in inadequately controlled type 2 diabetes mellitus (T2DM) consistent with International Patient Decision Aids Standards.

Methods: A PDA was developed by a multidisciplinary steering committee of clinicians, patient advocate, nurse, certified diabetes educators, and decision scientist, using a systematic development process. The process included defining the PDA scope and purpose, outlining the framework, content creation, and designing for integration into clinical practice.

Diabetes-Related Composite Quality End Point Attainment: Canagliflozin Versus Sitagliptin Based on a Pooled Analysis of 2 Clinical Trials.

Purpose: This post hoc analysis evaluated attainment of diabetes-related composite quality measures (CQMs) with canagliflozin 100 mg, canagliflozin 300 mg, and sitagliptin 100 mg in patients with type 2 diabetes mellitus (T2DM). We used pooled data from two 52-week Phase III clinical trials evaluating the efficacy of canagliflozin 100 mg, canagliflozin 300 mg, and sitagliptin 100 mg.

Methods: CQMs assessed included the combined attainment of glycosylated hemoglobin (HbA1c), blood pressure (BP), and LDL-C.

Diabetes-related quality measure attainment: canagliflozin versus sitagliptin based on a pooled analysis of 2 clinical trials.

Objective: To evaluate attainment of diabetes-related quality measures with canagliflozin 100 mg, canagliflozin 300 mg, and sitagliptin 100 mg in patients with type 2 diabetes mellitus.

Study Design: This post hoc analysis used pooled data from two 52-week, randomized, double-blind, phase 3 clinical trials that evaluated the comparative efficacy of canagliflozin and sitagliptin. One trial evaluated patients on metformin at baseline with add-on canagliflozin 100 mg, canagliflozin 300 mg, or sitagliptin 100 mg; the other trial evaluated patients on metformin and a sulfonylurea at baseline with add-on canagliflozin 300 mg or sitagliptin 100 mg.

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.

Economic simulation of canagliflozin and sitagliptin treatment outcomes in patients with type 2 diabetes mellitus with inadequate glycemic control.

Objectives: This study examines the association between changes in diabetes-related quality measures (QMs) (HbA1c, systolic and diastolic blood pressure [BP], low-density lipoprotein cholesterol [LDL-C], and body weight) and healthcare costs in Type 2 diabetes mellitus (T2DM) patients. It also performs an economic simulation that evaluates the cost implications of the changes in QMs and of the incidence rates (IRs) of adverse events (AEs) associated with canagliflozin (CANA) and sitagliptin (SITA) treatments in a real-world setting.

Methods: Health-insurance claims and electronic medical records from the Reliant Medical Group database (2007-2011) were used to identify adult patients with T2DM receiving metformin and sulfonylurea who did not achieve adequate glycemic control.

Chronic kidney disease in US adults with type 2 diabetes: an updated national estimate of prevalence based on Kidney Disease: Improving Global Outcomes (KDIGO) staging.

Background: Kidney Disease Improving Global Outcomes (KDIGO) 2013 updated the classification and risk stratification of chronic kidney disease (CKD) to include both the level of renal function and urinary albumin excretion (UAE). The update subclassifies the previous category of moderate renal impairment. There is currently limited information on the prevalence of CKD based on this new classification in United States (US) adults with type 2 diabetes mellitus (T2DM).

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.

Quality measure attainment in patients with type 2 diabetes mellitus.

Objectives: This study examined the demographics, comorbidities, clinical characteristics, and treatments of people with type 2 diabetes mellitus (T2DM) treated with metformin and sulfonylurea as well as an elderly subgroup. Achievement of predefined quality measure goals (glycated hemoglobin [A1C], blood pressure [BP], low-density lipoprotein cholesterol [LDL-C], body mass index [BMI]) and their association with diabetes-related healthcare costs were assessed.

Study Design: The study applied a retrospective longitudinal cohort design.

Attainment of diabetes-related quality measures with canagliflozin versus sitagliptin.

Objective: To evaluate attainment of diabetes-related quality measures with canagliflozin, a sodium glucose cotransporter 2 inhibitor, versus sitagliptin in patients with type 2 diabetes mellitus (T2DM).

Study Design: This post hoc analysis included data from a 52-week, randomized, double-blind, phase 3 study comparing canagliflozin 300 mg and sitagliptin 100 mg in patients with T2DM on metformin plus sulfonylurea.

Methods: Individual and composite diabetes-related quality measures based on glycated hemoglobin (A1C), blood pressure (BP), low-density lipoprotein cholesterol (LDL-C) level, body mass index (BMI), and body weight were assessed in the overall population and a subgroup with a baseline BMI of at least 25 kg/m².

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.

Cost of schizophrenia in the Medicare program.

Medicare beneficiaries diagnosed with non-schizoaffective schizophrenia (MBS) in a 5% national Medicare fee-for-service sample from 2003-2007 were followed for 1-6 years. Medicare population and cost estimates also were made from 2001-2009. Service utilization and Medicare (and beneficiary share) payments for all services except prescription drugs were analyzed.

Propensity score matched assessment of treatment patterns and cost of erythropoiesis stimulating agent treatment in patients with cancer receiving myelosuppressive chemotherapy.

Objective: To examine epoetin alfa (EPO) and darbepoetin alfa (DARB) treatment patterns and erythropoiesis stimulating agent (ESA) costs in patients with cancer receiving chemotherapy (CRC), and to compare the results observed in the pre-matched total study population (TSP) with a propensity score matched population (PSMP).

Methods: A medical claims analysis was conducted from 1 January 2004 through 31 July 2009 using the HealthCore Integrated Research Database. Patients were at least 18 years old, newly initiated on EPO or DARB, received ≥ 2 ESA doses, and had ≥ 1 claim for cancer and chemotherapy proximate to ESA treatment.