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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. 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. 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. 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.

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.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.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 (p0.001), and pen profiles with advanced features were preferred over those without (p0.001). Preferences differed by age but not diabetes type, country of residence, or insulin regimen.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.

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.

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.

Background: CGM is increasingly used as tool in the management of diabetes, supporting improvements in glycemic control and quality of life. Objectives: The aim of this retrospective study was to evaluate the association between CGM use and healthcare resource utilization (HCRU) and cost. Methods: Using medical claims from Clarivate™ Real-World Evidence repository and CGM data from Glooko®, US people with diabetes (≥18 years) (PwD) and on insulin were assigned to mutually exclusive cohorts based on CGM usage status and matched in terms of age, gender, and diabetes type. First CGM use (index) was required to occur within January 1, 2015 - July 30, 2019. HCRU and costs were assessed 12 months post-index. Results: After matching, 3,918 PwD were assigned into each cohort. Significantly more CGM vs. non CGM users (p After adjusting for demographics, diabetes type, CCI, and insurance, the use of CGM vs. no CGM was associated with a 27-70% and 32-76% reduction in HCRU and costs (p Conclusion: The use of CGM (vs. no CGM use) was associated with lower HCRU and costs, which may result in lower healthcare burden for PwD and payers. Disclosure M. Perez-nieves: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company. E. R. Hankosky: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company. L. Fan: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company. F. Gelsey: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company. E. L. Eby: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company. T. J. Sims: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company. E. Umeh: None. R. Juneja: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company. Funding Eli Lilly and Company

Background: Continuous glucose monitoring (CGM) systems generate real-time information on blood glucose trends in PwD, providing regular feedback that may help inform care decisions. This study aimed to describe real-world CGM use and CGM-derived glucometrics in insulin-using PwD. Methods: Data for adults (≥18 years) with T1D and T2D using insulin therapy and CGM were identified from Glooko’s cloud-based data storage and linked with Decision Resources Group™ Real-World Evidence repository (Jan 1, 2015-Jul 30, 2019). Summary statistics on 1-year aggregated CGM data and glucometrics are presented. Results: Over one year, CGM data were uploaded on average 215.7 days (59%) for people with T1D (n = 4896) and 191.5 days (52%) for people with T2D (n = 582). Among people with T1D and T2D, time in range (TIR) was 59.9% and 62.6%, coefficient of variation (CV) was 36.0% and 30.7%, time above range (TAR; level 2) was 13.3% and 12.2%, and time below range (TBR; level 2) was 0.8% and 0.3%, respectively (Table1). Conclusion: In this sample of PwD using insulin, level 2 TBR and CV were within the international consensus guideline recommendations, but TIR was below the recommended 70%, potentially driven by time spent in level 2 TAR. There is still an unmet clinical need for PwD to achieve guideline recommended targets; advancements in medications and technologies may help to achieve these goals. Disclosure M. Perez-nieves: Employee; Self; Eli Lilly and Company. R. Juneja: Employee; Self; Eli Lilly and Company. E. R. Hankosky: Employee; Self; Eli Lilly and Company, Stock/Shareholder; Self; Eli Lilly and Company. L. Fan: Employee; Self; Eli Lilly and Company, Stock/Shareholder; Self; Eli Lilly and Company, Stock/Shareholder; Spouse/Partner; Eli Lilly and Company. F. Gelsey: Employee; Self; Eli Lilly and Company, Stock/Shareholder; Self; Eli Lilly and Company. E. L. Eby: Employee; Self; Eli Lilly and Company, Stock/Shareholder; Self; Eli Lilly and Company. T. J. Sims: Employee; Self; Eli Lilly and Company. E. Umeh: None. M. Betts: None. C. Lavallee: None. Funding Eli Lilly and Company

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.

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 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.

Research has shown that many patients with type 2 diabetes (T2D) are not adherent to their medication regimen.To examine the association between adherence to insulin therapy and all-cause health care costs for patients with T2D.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 aged18 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.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,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.

Objective: Examine trends of insulin regimens, delivery devices and glucose monitoring among people with type 1 diabetes (T1D) or type 2 diabetes (T2D) in the U.S. from 2009-2017. Methods: The IBM® MarketScan® Commercial and Medicare databases were used to identify trends for insulin use over 9 years among people with T1D or T2D who filled a prescription for insulin in a calendar year. Total annual sample size ranged from 373,975 to 660,512. The analyses examined insulin regimen, method of delivery, and use of glucose monitoring systems separately for people with T1D or T2D. Generalized estimating equations were used to test whether trends were statistically significant. Results: For people with either T1D or T2D, use of short/rapid insulin only and use of analog insulins increased while premix insulin use decreased (all P Conclusion: Results suggest that insulin prescribing continues to change with advances in insulin delivery technology and glucose monitoring systems. Disclosure M. Perez-Nieves: Employee; Self; Eli Lilly and Company. Stock/Shareholder; Self; Eli Lilly and Company. R. Juneja: Employee; Self; Eli Lilly and Company. L. Fan: Employee; Self; Eli Lilly and Company. Stock/Shareholder; Self; Eli Lilly and Company. E. Meadows: Employee; Self; Eli Lilly and Company. Employee; Spouse/Partner; Eli Lilly and Company. Stock/Shareholder; Spouse/Partner; Eli Lilly and Company. Stock/Shareholder; Self; Eli Lilly and Company. M.J. Lage: Consultant; Self; Eli Lilly and Company. Consultant; Spouse/Partner; Eli Lilly and Company. E.L. Eby: Employee; Self; Eli Lilly and Company.

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...

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.

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.

To assess factors predictive of all-cause, 30 day hospital readmission among patients with type 2 diabetes in the United States.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.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.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.

Describe the characteristics, costs, and adherence of patients receiving human regular U-500 insulin (U-500R) compared with those of patients receiving high-dose (≥150 units/day) U-100 insulin.Data from Truven Health MarketScan Research Databases, July 1, 2008, through December 31, 2010, were used. The U-100 cohort received ≥150 units/day of U-100 insulin for ≥31 days during the first 60 days after the index date. The U-500R cohort received ≥2 prescriptions of U-500R after the index date. Analyses were performed on propensity-matched cohorts. The changes in annualized costs were compared between the 2 cohorts using paired t tests. Adherence was assessed by the proportion of days covered (PDC) and compared using a 2-sample t test. Glycemic efficacy data were not available in this database.There were 1,044 U-500R-treated patients (19.1% with type 1 diabetes [T1D]) and 11,520 U-100-treated patients (23.8% with T1D) identified, from which 1,039 matched pairs were obtained. The mean decrease of $1,290 in annual pharmacy costs for the U-500R cohort was significantly different from the mean increase of $2,586 for the U-100 cohort (P.001; 95% confidence interval, -$4,345 to -$3,422). More U-500R patients experienced hypoglycemia (17.3% vs. 11.8%; P.001), but the hypoglycemia rate per person and related costs were not significantly different between cohorts. Finally, the mean 12-month PDC was 65.0% for U-500R versus 47.6% for U-100 patients (P.0001).Compared with treatment with ≥150 units/day of U-100 insulin, treatment with U-500R was associated with decreases in pharmacy costs, a higher percentage of patients experiencing hypoglycemia, and greater treatment adherence.

To compare all-cause and diabetes-related resource utilization and healthcare charges among adults with type 2 diabetes mellitus who initiated therapy with mealtime insulin disposable pens or vials.Data were obtained from the Innovus inVision database from January 1, 2006 through June 30, 2010. Generalized linear models with a gamma distribution and log link estimated the association between medical charges and use of mealtime insulin pens vs vials in the 1 year post-index date, while generalized linear models with a negative binomial distribution estimated resource utilization.Controlling for patient characteristics, general health, and patient copayments, insulin therapy initiation with disposable pens, compared to vials, was associated with significantly fewer all-cause hospitalizations (1.45 vs. 1.66; p 0.0001) as well as a significantly shorter hospital length of stay (2.16 days vs. 3.53 days; p 0.0001). Pen use, compared to vials, was also associated with significantly fewer diabetes-related hospitalizations (1.36 vs. 1.47; p 0.0001), and shorter hospital length of stay (1.12 days vs. 1.72 days; p 0.0001). Despite higher diabetes-related drug charges ($3593 vs. $2755; p 0.0001) associated with the use of pens, results showed significantly lower all-cause total healthcare charges ($42,150 vs. $53,340; p 0.0001) and significantly lower diabetes-related total healthcare charges ($12,722 vs. $14,540; p 0.0001) for patients who initiated therapy on mealtime insulin with pens compared to vials.Data were drawn from administrative claims and included only patients with medical and outpatient prescription drug benefit coverage. Hence, the results may not be generalizable. The retrospective analyses relied on diagnostic codes to identify patients, assess patient general health, and determine other values, rather than formal, clinical assessments. The analyses did not include indirect healthcare costs.The administration of mealtime insulin via disposable pens, compared to vials, was associated with a significant reduction in all-cause and diabetes-related resource utilization and total healthcare charges.

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.

High out-of-pocket expenditures for prescription medications could lead people with chronic illnesses to restrict their use of these medications. Whether adults experience adverse health outcomes after having restricted medication use because of cost is not known.We analyzed data from 2 prospective cohort studies of adults who reported regularly taking prescription medications using 2 waves of the Health and Retirement Study (HRS), a national survey of adults aged 51 to 61 in 1992, and the Asset and Health Dynamics Among the Oldest Old (AHEAD) Study, a national survey of adults aged 70 or older in 1993 (n = 7991). We used multivariable logistic and Poisson regression models to assess the independent effect on health outcomes over 2 to 3 years of follow up of reporting in 1995-1996 having taken less medicine than prescribed because of cost during the prior 2 years. After adjusting for differences in sociodemographic characteristics, health status, smoking, alcohol consumption, body mass index (BMI), and comorbid chronic conditions, we determined the risk of a significant decline in overall health among respondents in good to excellent health at baseline and of developing new disease-related adverse outcomes among respondents with cardiovascular disease, diabetes, arthritis, and depression.In adjusted analyses, 32.1% of those who had restricted medications because of cost reported a significant decline in their health status compared with 21.2% of those who had not (adjusted odds ratio [AOR], 1.76; confidence interval [CI], 1.27-2.44). Respondents with cardiovascular disease who restricted medications reported higher rates of angina (11.9% vs. 8.2%; AOR, 1.50; CI, 1.09-2.07) and experienced higher rates of nonfatal heart attacks or strokes (7.8% vs. 5.3%; AOR, 1.51; CI, 1.02-2.25). After adjusting for potential confounders, we found no differences in disease-specific complications among respondents with arthritis and diabetes, and increased rates of depression only among the older cohort.Cost-related medication restriction among middle-aged and elderly Americans is associated with an increased risk of a subsequent decline in their self-reported health status, and among those with preexisting cardiovascular disease with higher rates of angina and nonfatal heart attacks or strokes. Such cost-related medication restriction could be a mechanism for worse health outcomes among low-income and other vulnerable populations who lack adequate insurance coverage.

Examine how patients diagnosed with type 2 diabetes mellitus (T2DM) are treated with oral antidiabetic (OAD) agents and the relationship between treatment patterns and glycemic control.Data were obtained from the i3 Invision Data Mart database (OptumInsight, Eden Prairie, MN, USA). The analyses examined 4627 individuals who received a first prescription for an OAD (with first date identified as index date) and received at least one HbA1c test in both the 1 year prior and 2 years post index date. Patients were categorized based upon their level of glycemic control pre index date and logistic multivariate analyses were used to examine the probability of a patient's first treatment pattern change being a switch, augmentation, or discontinuation compared to continuation on the intent-to-treat (ITT) OAD.Men tended to have worse glycemic control at OAD initiation. During the post-period, younger patients were more likely to switch, augment or discontinue therapy, while patients initially treated with metformin were more likely to switch or augment therapy. Results indicated that patients with moderate or poor glycemic control, compared to those with good glycemic control, were significantly more likely to switch or augment therapy. Practice patterns revealed minimal use of insulin although, on average, many patients were above target HbA1c levels at initiation. Interpretation of results are limited by the fact that only a small subset of patients had valid HbA1c data and that the analyses was not able to account for other factors, such as race and weight, that may also impact the analyses.Patient initial level of glycemic control was associated with changes in treatment patterns in the 2 years post initiation on an OAD, with patients with moderate or poor control more likely to switch or augment their ITT therapy, compared to individuals with good control.

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.

Elizabeth L Eby,1 Kate Van Brunt,2 Cynthia Brusko,3 Bradley Curtis,4 Maureen J Lage5 1Global Patient Outcomes and Real World Evidence, Eli Lilly andCo., Indianapolis IN USA; 2Eli Lilly andCo., Windlesham, UK; 3LillyUSA, LLC, Indianapolis, IN, USA; 4EliLilly and Co., Indianapolis, IN, USA; 5HealthMetrics Outcomes Research, LLC, Bonita Springs, FL, USA Objective: To examine costs, resource utilization, adherence, and hypoglycemic events among various doses of U-100 insulin regimens among elderly patients (age ≥65years) 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 10–100units/day followed by >300units/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 10–100units/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 >100–150units/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. Keywords: insulin, diabetes, costs, resource utilization, adherence, hypoglycemia&nbsp

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/m2. 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