Predictors of insulin pump initiation among people with type 2 diabetes from a US claims database using machine learning.

OBJECTIVE: Insulin pump use is increasing among people with type 2 diabetes (T2D), albeit at a slower rate compared to people with type 1 diabetes (T1D). Factors associated with insulin pump initiation among people with T2D in the real-world are understudied. METHODS: This retrospective, nested case-control study aimed to identify predictors of insulin pump initiation among people with T2D in the United States (US). Adults with T2D who were new to bolus insulin use were identified from the IBM MarketScan Commercial database (2015-2020). Candidate variables of pump initiation were entered into conditional logistic regression (CLR) and penalized CLR models. RESULTS: Of the 32,104 eligible adults with T2D, 726 insulin pump initiators were identified and matched to 2,904 non-pump initiators using incidence density sampling. Consistent predictors of insulin pump initiation across the base case, sensitivity, and post hoc analyses included continuous glucose monitor (CGM) use, visiting an endocrinologist, acute metabolic complications, higher count of HbA1c tests, lower age, and fewer diabetes-related medication classes. CONCLUSIONS: Many of these predictors could represent a clinical indication for treatment intensification, greater patient engagement in diabetes management, or proactive management by healthcare providers. Improved understanding of predictors for pump initiation may lead to more targeted efforts to improve access and acceptance of insulin pumps among persons with T2D.

Characterizing Diabetes Empowerment and Motivation for Changing Health Behaviors Among People with Type 2 Diabetes: A Cross-Sectional Survey.

INTRODUCTION: Effectively engaging people with type 2 diabetes (T2D) earlier in their health journeys is critical to prevent downstream complications. Digitally based diabetes programs are a growing component of care delivery that have the potential to engage individuals outside of traditional clinic-based settings and use personalized data to pair people to tailored diabetes self-management interventions. Knowing an individuals' diabetes empowerment and health-related motivation can help drive appropriate recommendations for personalized interventions. We aimed to characterize diabetes empowerment and motivation towards changing health behaviors among participants in Level2, a T2D specialty care organization in the USA that combines wearable technology with personalized clinical support. METHODS: A cross-sectional online survey was conducted among people enrolled in Level2 (February-March 2021). Distributions of respondent-reported diabetes empowerment and health motivation were analyzed using Motivation and Attitudes Toward Changing Health (MATCH) and Diabetes Empowerment Scale Short Form (DES-SF) scales, respectively. Associations between MATCH and DES-SF scores with Level2 engagement measures and glycemic control were analyzed. RESULTS: The final analysis included 1258 respondents with T2D (mean age 55.7 ± 8.4 years). Respondents had high average MATCH (4.19/5) and DES-SF (4.02/5) scores. The average MATCH subscores for willingness (4.43/5) and worthwhileness (4.39/5) were higher than the average ability subscore (3.73/5). Both MATCH and DES-SF scores showed very weak correlations with Level2 engagement measures and glycemic control (ρ = - 0.18-0.19). CONCLUSIONS: Level2 survey respondents had high average motivation and diabetes empowerment scores. Further research is needed to validate sensitivity of these scales to detect changes in motivation and empowerment over time and to determine whether differences in scores can be used to pair people to personalized interventions.

Predicting Response to Bolus Insulin Therapy in Patients With Type 2 Diabetes.

BACKGROUND: The aim of this study was to develop a predictive model to classify people with type 2 diabetes (T2D) into expected levels of success upon bolus insulin initiation. METHODS: Machine learning methods were applied to a large nationally representative insurance claims database from the United States (dNHI database; data from 2007 to 2017). We trained boosted decision tree ensembles (XGBoost) to assign people into Class 0 (never meeting HbA1c goal), Class 1 (meeting but not maintaining HbA1c goal), or Class 2 (meeting and maintaining HbA1c goal) based on the demographic and clinical data available prior to initiating bolus insulin. The primary objective of the study was to develop a model capable of determining at an individual level, whether people with T2D are likely to achieve and maintain HbA1c goals. HbA1c goal was defined at <8.0% or reduction of baseline HbA1c by >1.0%. RESULTS: Of 15 331 people with T2D (mean age, 53.0 years; SD, 8.7), 7800 (50.9%) people met HbA1c goal but failed to maintain that goal (Class 1), 4510 (29.4%) never attained this goal (Class 0), and 3021 (19.7%) people met and maintained this goal (Class 2). Overall, the model's receiver operating characteristic (ROC) was 0.79 with greater performance on predicting those in Class 2 (ROC = 0.92) than those in Classes 0 and 1 (ROC = 0.71 and 0.62, respectively). The model achieved high area under the precision-recall curves for the individual classes (Class 0, 0.46; Class 1, 0.58; Class 2, 0.71). CONCLUSIONS: Predictive modeling using routine health care data reasonably accurately classified patients initiating bolus insulin who would achieve and maintain HbA1c goals, but less so for differentiation between patients who never met and who did not maintain goals. Prior HbA1c was a major contributing parameter for the predictions.

Patients' Preferences for Connected Insulin Pens: A Discrete Choice Experiment Among Patients with Type 1 and Type 2 Diabetes.

BACKGROUND: This study quantified how people with diabetes value the unique features of connected insulin pens and related mobile apps, and the underlying reasons for preferring connected versus non-connected insulin pens. METHODS: A discrete choice experiment (DCE) was conducted in the USA and UK to elicit preferences of adults (≥ 18 years) with type 1 or 2 diabetes for attributes of insulin pens. Attributes included device type, dosing support, glucose monitoring, additional app features, and data sharing. Relative attribute importance (RAI) scores were calculated to capture the relative importance of an attribute. Predicted choice probabilities were obtained to compare different profiles for connected and non-connected insulin pens. RESULTS: The DCE was completed by 540 participants (58.9% male; 90.7% Caucasian; mean age, 58.3 years; 69.4% type 2 diabetes). Participants most valued the possibility of using a connected insulin pen with dosing support and automated dose logging (RAI = 39.9%), followed by automatic transfer of glucose levels (RAI = 29.0%), additional features of tracking diet and physical activity (RAI = 14.6%), data sharing (RAI = 13.6%), and device type (RAI = 2.9%). All profiles of connected insulin pens were preferred over a non-connected pen (p < 0.001), and pen profiles with advanced features were preferred over those without (p < 0.001). Preferences differed by age but not diabetes type, country of residence, or insulin regimen. CONCLUSION: People with diabetes in the USA and UK prefer connected over non-connected insulin pens due largely to the availability of automated logging of dose and glucose levels.

Adherence and Persistence to Insulin Therapy in People with Diabetes: Impact of Connected Insulin Pen Delivery Ecosystem.

Diabetes is an increasing public health problem, and insulin is the mainstay for treatment of type 1 diabetes. In type 2 diabetes treatment, insulin therapy is used after oral or other injectable agents become inadequate to achieve glycemic control. Despite the advances in insulin therapy, management of diabetes remains challenging. Numerous studies have reported low adherence and persistence to insulin therapy, which acts as a barrier to successful glycemic control and diabetes management. The aim of this targeted review article is to provide an overview of adherence and persistence to insulin therapy in people with diabetes and to discuss the impact of the emergence of a new connected ecosystem of increasingly sophisticated insulin pens, glucose monitoring systems, telemedicine, and mHealth on diabetes management. With the emergence of a connected diabetes ecosystem, we have entered an era of advanced personalized insulin delivery, which will have the potential to enhance diabetes self-management and clinical management. Early systems promise to unlock the potential to address missed or late bolus insulin delivery, which should help to address non-adherence and non-persistence. Over time, improvements in this ecosystem have the potential to combine insulin data with previously missing contextualized patient data, including meal, glucose, and activity data to support personalized clinical decisions and ultimately revolutionize insulin therapy.

Trends in U.S. Insulin Use and Glucose Monitoring for People with Diabetes: 2009-2018.

BACKGROUND: The delivery and administration of insulin has undergone many changes over the years. This research examines U.S. trends in insulin use among people with type 1 diabetes (T1D) or type 2 diabetes (T2D) in the U.S. from 2009 to 2018. METHODS: The IBM® MarketScan® Commercial and Medicare databases were used to identify trends in insulin use over 10 years. The study included people with T1D or T2D who filled a prescription for insulin in any calendar year from 2009 to 2018. The analyses examined insulin regimen and delivery and the use of glucose monitoring systems. Generalized estimating equations were used to test whether trends were statistically significant. RESULTS: Individuals with T1D were most commonly prescribed a basal and bolus insulin regimen or short/rapid insulin only, while for people with T2D the use of basal-only insulin increased significantly over the study period. In both groups there was a significant decline in the use of premix insulin from 2009 to 2018. Insulin pump use increased for individuals with T1D, while disposable pen use increased for people in both cohorts. In both cohorts, there was a statistically significant increase in the use of continuous glucose monitoring, although this increase was more pronounced and occurred earlier among individuals with T1D. CONCLUSIONS: Results indicate significant changes in insulin regimens and delivery and glucose monitoring from 2009 to 2018. These findings suggest that insulin prescribing continues to change in response to the development of new therapeutics, advances in insulin delivery technology, and glucose monitoring systems.

Evaluating the relationship between clinical and demographic characteristics of insulin-using people with diabetes and their health outcomes: a cluster analysis application.

BACKGROUND: The aim of this study was to determine how clusters or subgroups of insulin-treated people with diabetes, based upon healthcare resource utilization, select social demographic and clinical characteristics, and diabetes management parameters, are related to health outcomes including acute care visits and hospital admissions. METHODS: This was a non-experimental, retrospective cluster analysis. We utilized Aetna administrative claims data to identify insulin-using people with diabetes with service dates from 01 January 2015 to 30 June 2018. The study included adults over the age of 18 years who had a diagnosis of type 1 (T1DM) or type 2 diabetes mellitus (T2DM) on insulin therapy and had Aetna medical and pharmacy coverage for at least 18 months (6 months prior and 12 months after their index date, defined as either their first insulin prescription fill date or their earliest date allowing for 6 months' prior coverage). We used K-means clustering methods to identify relevant subgroups of people with diabetes based on 13 primary outcome variables. RESULTS: A total of 100,650 insulin-using people with diabetes were identified in the Aetna administrative claims database and met study criteria, including 11,826 (11.7%) with T1DM and 88,824 (88.3%) with T2DM. Of these 79,053 (78.5%) people were existing insulin users. Seven distinct clusters were identified with different characteristics and potential risks of diabetes complications. Overall, clusters were significantly associated with differences in healthcare utilization (emergency room visits, inpatient admissions, and total inpatient days) after multivariable adjustment. CONCLUSIONS: This analysis of healthcare claims data using clustering methodologies identified meaningful subgroups of patients with diabetes using insulin. The subgroups differed in comorbidity burden, healthcare utilization, and demographic factors which could be used to identify higher risk patients and/or guide the management and treatment of diabetes.

The Association Between Adherence to Insulin Therapy and Health Care Costs for Adults with Type 2 Diabetes: Evidence from a U.S. Retrospective Claims Database.

BACKGROUND: Research has shown that many patients with type 2 diabetes (T2D) are not adherent to their medication regimen. OBJECTIVE: To examine the association between adherence to insulin therapy and all-cause health care costs for patients with T2D. METHODS: This study used the IQVIA PharMetrics Plus Linkable to Ambulatory Electronic Medical Record data from January 1, 2012, through September 30, 2017. Patients were included if they were identified with T2D and initiated therapy on basal insulin (BAS) or basal-bolus (BAS-BOL) combination at any time from January 1, 2013, through October 1, 2016. Patients aged < 18 years, who used an insulin pump, identified as pregnant, or did not have continuous insurance coverage from 1 year before initiation on insulin therapy through 1 year after initiation were excluded. Descriptive statistics compared patient characteristics and costs (in U.S. 2017 dollars) between patients who were adherent or nonadherent to their insulin therapy in the 1-year postperiod, where adherence was defined as having proportion of days covered (PDC) of at least 80%. In addition, generalized linear models were used to compare costs between adherent and nonadherent patients, while controlling for patient characteristics, previous general health and comorbidities, resource utilization, medication use and type of insulin. RESULTS: 13,296 patients were included in the BAS cohort (5,502 adherent; 7,794 nonadherent) and 10,069 in the BAS-BOL cohort (2,006 adherent; 8,063 nonadherent). Adherent patients had significantly lower all-cause total unadjusted costs following initiation on BAS ($29,322 vs. $31,888, P = 0.0134) and BAS-BOL combination ($36,229 vs. $40,147, P = 0.0078). Drug costs comprised 39.5%-45.4% of costs among adherent patients and 23.0%-25.9% of costs among nonadherent patients. Multivariable analyses revealed that adherent patients had significantly lower adjusted all-cause total costs than nonadherent patients in the BAS cohort ($30,127 vs. $37,049, 95% CI for difference -$8,460 to -$5,384) and the BAS-BOL cohort ($36,603 vs. $44,702, 95% CI for difference -$9,129 to -$6,980). CONCLUSIONS: In patients with T2D who initiated BAS or BAS-BOL combination therapy, adherence was associated with significantly lower all-cause total health care costs, despite significantly higher drug costs. These results illustrate the potential economic benefits associated with adherence to insulin therapy. DISCLOSURES": Eli Lilly and Company funded this study and was responsible for study design and execution. Bajpai, Eby, Faries, and Haynes are employees and own stock in Eli Lilly and Company. Lage received compensation from Eli Lilly and Company for her work on this research project.

Economic impact of cardiac implantable electronic device infections: cost analysis at one year in a large U.S. health insurer.

Aims: Cardiac device infections (CDIs) are serious adverse events associated with morbidity and mortality, significant costs and increased healthcare utilization. The objective of the current study was to characterize the CDI rate by device type, risk factors for infection and healthcare costs from a large U.S. health insurer perspective.Materials and Methods: A retrospective analysis of a large U.S. health insurer database identified commercial and Medicare Advantage with Part D (MAPD) members ≥18 years with ≥1 claim for a cardiac implantable electronic device (CIED) procedure between 01 October 2011 and 31 October 2015. CIEDs included pacemakers (IPG), implantable cardioverter defibrillators (ICDs), and cardiac resynchronization therapy - pacemakers without (CRT-P) and with defibrillation (CRT-D). Probabilities of CDI through one-year post implant were estimated using the Kaplan-Meier method. A regression model with stepwise variable selection was used to select risk factors associated with CDIs.Results: A total of 63,406 patients were included with an overall CDI rate of 1.28% (1.0% de novo and 1.74% replacement devices), varying by device type: IPG = 0.91%; ICD = 1.63%; CRT-p = 1.50%; CRT-D = 2.22%. The average adjusted annual medical costs were 2.4 times greater [95% confidence interval (CI) = 2.1-2.7] for those with an infection compared to those without, and the incremental cost difference was estimated to be $57,322 [95% CI $46,572-$70,484]. Observed risk factors of CDIs included prior device infection [Odds ratio (OR) = 11.356; 95% CI = 7.923-16.276], undergoing a CIED replacement procedure (OR = 1.644; 95% CI = 1.361-1.987), implantation of a high-power device (OR = 1.354; 95% CI = 1.115-1.643), and younger age (age < 65) (OR = 1.607; 95% CI = 1.307-1.976).Conclusions: The CDI rate at one year ranged from 0.91%-2.22% depending on device type. Management of CDIs among commercial and MAPD members is associated with high healthcare expenditures.

Treatment patterns, costs, and mortality among Medicare beneficiaries with CIED infection.

BACKGROUND: Cardiac implantable electronic device (CIED) infection is a serious adverse event, but there are limited contemporary real-world data on treatment pathways and associated costs in the Medicare population following diagnosis of CIED infection. Hence, this study evaluates postinfection treatment pathways and associated healthcare expenditures and mortality among Medicare fee-for-service beneficiaries with CIED infection. METHODS: Retrospective cohort analysis of 5,401 beneficiaries who developed a device-related infection in the year following implantation/upgraded CIED (1/1/2010-12/31/2012). Patients were followed-up to 12 months/death following diagnosis of infection and were divided into mutually exclusive groups based on whether they underwent CIED system removal (Group I), or no CIED system intervention (Group II; IIA with or IIB without infection hospitalization). All-cause healthcare resource utilization/expenditures were also measured. RESULTS: In the year following infection, 64.1% of patients underwent device extraction, of who 2,109 (39.0%) had their device replaced (Group IA) and 1,355 (25.1%) had their device extracted without replacement (Group IB); 62.2% of patients were hospitalized and 25.3% of patients died. Mean Medicare payments-per-patient for facility-based services by group were: IA = $62,638 (standard deviation [SD]: $46,830), IB = $50,079 (SD: $45,006), IIA = $77,397 (SD: $79,130), and IIB = $22,856 (SD: $31,167). CONCLUSIONS: Hospitalizations were the largest cost driver; infection-related costs, including cost of extraction/replacement, accounted for >50% of expenditures for patients with surgical/hospital intervention. Management of CIED infection in Medicare beneficiaries is associated with high healthcare expenditures in the year following infection. Additional measures to prevent device infection are needed to improve the outcomes and reduce costs in these patients.

Cost-effectiveness of TYRX absorbable antibacterial envelope for prevention of cardiovascular implantable electronic device infection.

AIMS: Infection is a major complication of cardiovascular implantable electronic device (CIED) therapy that usually requires device extraction and is associated with increased morbidity and mortality. The TYRX Antibacterial Envelope is a polypropylene mesh that stabilizes the CIED and elutes minocycline and rifampin to reduce the risk of post-operative infection. METHODS: A decision tree was developed to assess the cost-effectiveness of TYRX vs standard of care (SOC) following implantation of four CIED device types. The model was parameterized for a UK National Health Service perspective. Probabilities were derived from the literature. Resource use included drug acquisition and administration, hospitalization, adverse events, device extraction, and replacement. Incremental cost-effectiveness ratios (ICERs) were calculated from costs and quality-adjusted life-years (QALYs). RESULTS: Over a 12-month time horizon, TYRX was less costly and more effective than SOC when utilized in patients with an ICD or CRT-D. TYRX was associated with ICERs of £46,548 and £21,768 per QALY gained in patients with an IPG or CRT-P, respectively. TYRX was cost-effective at a £30,000 threshold at baseline probabilities of infection exceeding 1.65% (CRT-D), 1.95% (CRT-P), 1.87% (IPG), and 1.38% (ICD). LIMITATIONS AND CONCLUSIONS: Device-specific infection rates for high-risk patients were not available in the literature and not used in this analysis, potentially under-estimating the impact of TYRX in certain devices. Nevertheless, TYRX is associated with a reduction in post-operative infection risk relative to SOC, resulting in reduced healthcare resource utilization at an initial cost. The ICERs are below the accepted willingness-to-pay thresholds used by UK decision-makers. TYRX, therefore, represents a cost-effective prevention option for CIED patients at high-risk of post-operative infection.

Incidence, Treatment Intensity, and Incremental Annual Expenditures for Patients Experiencing a Cardiac Implantable Electronic Device Infection: Evidence From a Large US Payer Database 1-Year Post Implantation.

BACKGROUND: Because of the increasing use of cardiac implantable electronic devices (CIEDs), it is important to estimate the incidence and annual healthcare expenditures associated with CIED infections. METHODS AND RESULTS: Patients with a record of an initial or replacement (full implant or generator only) CIED implant during the calendar years 2009 to 2012 in MarketScan Commercial Claims and Medicare Supplemental database were identified. CIED infections were classified into 4 categories: (1) infection not managed by inpatient admission nor implant removal, (2) infection managed by inpatient admission but no implant removal, (3) infection managed by an implant removal either in an inpatient or in an outpatient setting, and (4) infection with severe sepsis and managed in an inpatient setting with implant removal. Using separate models for initial and replacement cohorts, annualized incidence of infection and incremental annual expenditures by treatment intensity were estimated. Cumulative incidence of infection at 1 year post implant was 1.18% for initial CIED implants and 2.37% for replacement. Median time to infection was 35 days for initial and 23 days for replacement. Incremental healthcare expenditures by treatment intensity categories for initial implant patients at 1 year were $16 651, $104 077, $45 291, and $279 744. For replacement patients, incremental expenditures at 1 year by treatment intensity categories were $26 857, $43 541, $48 759, and $362 606. CONCLUSIONS: The management of CIED infections results in a substantial healthcare burden with a significant increase in annual expenditures the year after implant when device infection occurs.

Insulin dosing and outcomes among commercially insured patients with type 2 diabetes in the United States.

PURPOSE: The purpose of this study was to examine costs, resource use, adherence, and hypoglycemic events among patients with type 2 diabetes mellitus (T2DM) treated with increasing doses of 100-U/mL (U-100) insulin regimens. METHODS: Data from Truven's Health Analytics Commercial Claims and Encounters database from January 1, 2008, through January 31, 2011, were used. Regressions were used to examine the associations among costs, resource use, adherence, and receipt of a hypoglycemic event and index dose of insulin. Specifically, general linear models with a γ-distribution and log link were used to examine costs, whereas logistic and negative binomial regressions were used to examine resource use and hypoglycemic events. All analyses controlled for patient characteristics, preindex comorbidities, general health, use of antidiabetic medications, and visits to an endocrinologist. FINDINGS: The study focused on 101,728 individuals with T2DM who received an outpatient prescription for U-100 insulin. In general, costs and resource use are highest among patients treated with the highest dose of insulin (>300 U/d). For example, all-cause and diabetes-related hospitalizations and office visits were highest in the highest-dose cohort. Costs generally followed the same pattern. Patients who were prescribed the lowest dose of insulin (10-100 U/d) generally had higher all-cause or diabetes-related inpatient and emergency department costs and resource use compared with those patients with an index dose >100 to 150, >150 to 200, and >200 to 300 U/d. There were generally no significant differences in rates of hypoglycemic events based on index dose. IMPLICATIONS: These results suggest significant differences in patient outcomes based on dosing of insulin. Those patients with T2DM using insulin at the highest and lowest dose ranges have the highest costs and resource use.

Dosing of U-100 insulin and associated outcomes among Medicare enrollees with type 1 or type 2 diabetes.

OBJECTIVE: To examine costs, resource utilization, adherence, and hypoglycemic events among various doses of U-100 insulin regimens among elderly patients (age ≥65 years) diagnosed with diabetes. METHODS: Truven Health Analytics Medicare databases from January 1, 2008 through December 31, 2011 were utilized. General linear models with a gamma distribution and log link were used to examine costs, while logistic and negative binomial regressions were used to examine resource utilization and hypoglycemic events. Analyses controlled for patient characteristics, pre-period comorbidities, general health, and use of antidiabetic medications as well as index dose of insulin. RESULTS: All-cause inpatient, emergency room, and outpatients costs, as well as diabetes-related inpatient costs, were highest among individuals who were treated with an index dose of 10-100 units/day followed by >300 units/day, while drug costs and total costs generally increased as index dosage increased. Resource utilization generally followed the same pattern as costs, with number of office visits increasing as the dose increased and the highest hospital length of stay, number of hospitalizations, number of emergency room visits, and number of diabetes-related hospitalizations were generally highest among those in the lowest and highest index dose cohorts. Compared to patients who initiated with an index dose of 10-100 units/day, all other patients were significantly less likely to achieve an adherence threshold of 80% based upon index dose range, and while those with an index dose of >100-150 units/day were significantly more likely to experience a hypoglycemic event. CONCLUSION: These results suggest that, for elderly individuals with diabetes, there is a higher patient burden among those who receive the lowest and highest insulin doses.

Initiation of human regular U-500 insulin use is associated with improved glycemic control: a real-world US cohort study.

AIM: Describe the characteristics of patients initiating human regular U-500 insulin (U-500R) and their subsequent glycemic control in a real-world setting. METHODS: US Humedica electronic health record system data (July 2007-September 2011) were used to identify patients with diabetes aged ≥18 years with ≥1 records for U-500R prescriptions, 6 months of preindex data, 12 months following first use of U-500R, and at least one glycated hemoglobin (HbA1c) value in both preindex and postindex periods. Paired t tests were used to measure the change in HbA1c from preindex to postindex periods (last or most recent values) and hypoglycemia. RESULTS: Among patients initiating U-500R (N=445), 96.9% had type 2 diabetes with mean age 57 years and mean body mass index 40.4 kg/m(2). Postindex prescriptions were written for U-500R alone (47.0%, group A) and concomitant U-500R/U-100 insulins (53.0%, group B). Concomitant oral antihyperglycemic agents (AHAs) and non-insulin injectable AHAs were used by 43.4% and 14.6% of patients, respectively. Following initiation of U-500R, mean HbA1c improved 0.68% in all patients (p<0.0001 compared with baseline), but the decrease in HbA1c did not differ significantly between groups (A: 0.78%; B: 0.60%). Overall, hypoglycemic events, largely captured in the outpatient setting, increased in incidence from 6.7% to 11.9% (p≤0.0001) and from 0.23 to 0.39 events/patient/year, an increase of 0.16 (p=0.003), from preindex to postindex. CONCLUSIONS: This real-world outcomes analysis demonstrates that U-500R initiation is associated with a clinically meaningful improvement in glycemic control over the subsequent 12-month period with modest increase in incidence and rate of hypoglycemia.

Health and Economic Outcomes Associated with Use of an Antimicrobial Envelope as a Standard of Care for Cardiac Implantable Electronic Device Implantation.

INTRODUCTION: Infection of cardiac implanted electrical devices (CIED) is a problem. In selected patients, use of an "antibacterial envelope" (AIGISRx®) is associated with low CIED infection rates. The value of this device when used as a standard of care is unclear. METHODS AND RESULTS: Retrospective analysis of all patients (N = 1,476) who underwent CIED implantation at a single hospital. During the study period, some implanters used the AIGISRx as a standard of care (Yes-AIGISRx Group, N = 365), whereas others did not use it at all (No-AIGISRx Group, N = 1,111). A risk score based on preoperative factors was calculated for each patient. Rates of CIED infection within 6 months were measured, and associated costs were estimated. The Yes-AIGISRx and No-AIGISRx groups had similar preoperative infection risk. In the No-AIGISRx group, 19 infections were observed (1.7%), versus 0 in the Yes-AIGISRx group (P = 0.006). The 6-month mortality rate among patients with infection was significantly greater than among those without infection (15.7% vs. 4.5%, P = 0.021). The average hospital duration for infection care was 13 days. By extrapolating the infection rate and costs observed in the No-AIGISRx group to the Yes-AIGISRx group, we estimated that there would have been 6.2 additional infections costing approximately $340,000. This cost was similar to the actual cost of the devices in the Yes-AIGISRx group, estimated at $320,000. CONCLUSIONS: Standard of care use of an antibacterial envelope as a standard of care was associated with a significantly lower rate of CIED infection, and appeared to be economically reasonable. Prospective trials to address these findings may be worthwhile.

Incidence, prevalence, and trend analysis of the use of insulin delivery systems in the United States (2005 to 2011).

OBJECTIVE: Estimate the incidence and prevalence rates and assess overall trends among patients with diabetes using insulin vial/syringe and pens over time. METHODS: A retrospective study was conducted using the Truven MarketScan database from 1 July 2004 to 31 December 2011. The database contained medical and pharmacy claims of >20 million US residents insured by commercial health plans. Patients with diabetes who utilized vial/syringe and pens were included. Incidence rate was defined as the proportion of patients initiating a new insulin type for the first time with vial/syringe and pens within each year from 2005 to 2011 among the total number of patients initiating that particular insulin type for the first time. Prevalence rate was defined as the proportion of patients using vial/syringe or pens among patients with diabetes using that insulin type within each year from 2005 to 2011. A linear trend over time was assessed by Cochran-Armitage Trend tests and Generalized Estimating Equations. RESULTS: Incidence of patients initiating vial/syringe decreased from 2005 to 2011 (basal analog [90.5% to 31.3%]; mealtime analog [67.6% to 37.1%]), while patients initiating pens increased (basal analog [9.5% to 68.7%]; mealtime analog [32.4% to 62.9%]). There was a significant trend over time indicating increased usage of pens relative to vial/syringe; the number of pen users increased (all p < 0.0001 except mealtime human). Prevalence of patients using vial/syringe decreased from 2005 to 2011 (basal analog [93.8% to 41.2%]; mealtime analog [71.0% to 50.6%]), while patients using pens increased (basal analog [6.2% to 58.8%]; mealtime analog [29.0% to 49.4%]). From 2005 to 2011, patients were more likely to use pens than vial/syringe (all p < 0.0001 except for human mixtures and mealtime human). CONCLUSIONS: The incidence and prevalence of patients using the traditional vial/syringe decreased over time, while the use of pens increased. Some patient populations may be under-represented, limiting generalizability of results.

Predictors of 30 day hospital readmission in patients with type 2 diabetes: a retrospective, case-control, database study.

OBJECTIVE: To assess factors predictive of all-cause, 30 day hospital readmission among patients with type 2 diabetes in the United States. METHODS: A retrospective, case-control study using deidentified Humedica electronic health record data was conducted to identify patients ≥18 years old with ≥6 months of data prior to index hospitalization (pre-period) and ≥30 days of data after discharge (post-period). Combined methods of bootstrap resampling and stepwise logistic regression were used to identify factors associated with readmission. RESULTS: Among 52,070 patients with type 2 diabetes and an initial hospitalization for any reason, 5201 (10.0%) patients were readmitted within 30 days and 46,869 (90.0%) patients showed no evidence of readmission. Diabetic treatment escalation; race; type 2 diabetes diagnosis prior to the index stay; pre-period heart failure; and number of pre-period, inpatient healthcare visits were among the strongest predictors of 30 day readmission. From a receiver-operating characteristic plot (mean area under curve of 0.693), the predictive accuracy of the final logistic regression model is considered modest. This result might be due to the unavailability of some variables or data. CONCLUSIONS: These results highlight the importance of the appropriate recognition of and treatment for type 2 diabetes, prior to and during hospitalization and following discharge, in order to impact a subsequent hospitalization. In our analysis, escalation of diabetic treatments (especially those escalated from having no records of anti-diabetic medications to treatment with insulin) was the strongest predictor of 30 day readmission. Limitations of this study include the fact that hospitalizations and other encounters, outside the Humedica network, were not captured in this analysis.

Comparison of vials and prefilled pens of a rapid-acting insulin analog on pharmacy budgets in a long-term care setting.

OBJECTIVE: Estimate budgetary impact for skilled nursing facility converting from individual patient supply (IPS) delivery of rapid-acting insulin analog (RAIA) 10-mL vials or 3-mL prefilled pens to 3-mL vials. DESIGN: A budget-impact model used insulin volume purchased and assumptions of length of stay (LOS), daily RAIA dose, and delivery protocol to estimate the cost impact of using 3-mL vials. SETTING: Skilled nursing facility. PARTICIPANTS: Medicare Part A patients. INTERVENTIONS: Simulations conducted using 12-month current and future scenarios. Comparisons of RAIA use for 13- and 28-day LOS. MAIN OUTCOME MEASURES: RAIA costs and savings, waste reduction. RESULTS: For patients with 13-day LOS using 20 units/day of IPS insulin, the model estimated a 70% reduction in RAIA costs and units purchased and a 95% waste reduction for the 3-mL vial compared with the 10-mL vial. The estimated costs for prefilled pen use were 58% lower than for use of 10-mL vials. The incremental savings associated with 3-mL vial use instead of prefilled pens was 28%, attributable to differences in per-unit cost of insulin in vials versus prefilled pens. Using a more conservative scenario of 28-day LOS at 20 units/day, the model estimated a 40% reduction in RAIA costs and units purchased, resulting in a 91% reduction in RAIA waste for the 3-mL vial, compared with 10-mL vial. CONCLUSION: Budget-impact analysis of conversion from RAIA 10-mL vials or 3-mL prefilled pens to 3-mL vials estimated reductions in both insulin costs and waste across multiple scenarios of varying LOS and patient daily doses for skilled nursing facility stays.