bluuebunny/crossref_metadata_2025_split huggingface dataset:
1152-P: Effect of Initiating Empagliflozin vs. Glucagon-Like Peptide-1 Receptor Agonists on Health-Care Costs among Patients with Type 2 Diabetes
Authors: PIMPLE PRATIK , RAJU ADITYA , STAFKEY-MAILEY DANA , SHETTY SHARASH 
Published: June 2020

The 2019 ADA’s Standards of Medical Care in Diabetes recommends use of SGLT2 inhibitor (SGLT2i) or GLP-1 receptor agonist (GLP-1RA) as one of the six drug classes after metformin (MET) in T2D patients, and is recommended as the treatment of choice among patients with cardiovascular disease (CVD; empagliflozin [EMPA] and liraglutide showing stronger evidence). To understand the economic impact of these recommendations, we evaluated the effect of EMPA vs. GLP-1 RA initiation on all-cause (AC) healthcare costs in patients with T2D. This retrospective cohort study utilized an U.S. commercial claims database to identify patients with T2D who newly initiated EMPA or a GLP-1RA between 08/2014 - 12/2016. First prescription date (index date) for EMPA or a GLP-1RA was used to classify patients into respective cohorts. T2D diagnosis and baseline covariates were assessed during 1-year pre-index period. During a post-index period of up to 1 year, AC costs were computed on a per patient per month (PPPM) basis; and evaluated using generalized linear models that controlled for pre-index covariates. Compared to the GLP-1RA cohort (N = 13,216), patients in the EMPA cohort (N= 3,857) were younger, more likely to be male, and had lower rates of obesity in the 1-year baseline period; all other measured pre-index covariates were similar. After covariate adjustment, the adjusted total AC PPPM cost difference ($1,137 vs. $1,370; difference (Δ) = -$233 PPPM) remained significantly lower for the EMPA cohort (P&lt;0.001), as compared to GLP-1 RA cohort. Both medical (Δ = -$26 PPPM, p=0.06), and pharmacy (Δ = -$197 PPPM, p&lt;0.001) costs were lower in EMPA cohort, as compared to GLP-1 RA cohort. Use of empagliflozin vs. GLP-1 RA in T2D patients was associated with lower all-cause healthcare costs. Together with ADA guidelines, these findings can aid health care stakeholders in treatment decisions and optimizing clinical and economic outcomes for patients with T2D.

Disclosure
P. Pimple: Employee; Self; Boehringer Ingelheim Pharmaceuticals, Inc. Employee; Spouse/Partner; CVS Caremark. A. Raju: Consultant; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Bristol-Myers Squibb. D. Stafkey-Mailey: None. S. Shetty: Employee; Self; Boehringer Ingelheim Pharmaceuticals, Inc.
1155-P: Durable vs. Disposable Insulin Pumps for Type 1 Diabetes: Health Care Costs and Utilization
Authors: SHAH MONA , ZHU CYRUS 
Published: June 2020

Objectives: To compare the economic impact of using a durable versus disposable insulin pump over a 4-year period (i.e., the typical warranty period) in individuals with type 1 diabetes (T1D).
Methods: This population-based, longitudinal analysis used a large repository of healthcare claims data were used to compare healthcare costs (in 2017 U.S. dollars) and utilization in individuals with T1D using durable pumps (N=2,013) to those using disposable pumps (N=642), before and after pump adoption. T-test was used to examine the between-group difference in pump-related costs, and a generalized linear model regression was used to estimate the difference-in-difference effect of pump type on other outcomes.
Results: Mean pump-related costs over the 4-year period were $6,606 less for durable pump users versus disposable pump users (Figure; p&lt;0.0001). Mean out-of-pocket pump-related costs for the same time period were $1,037 less for durable pump versus disposable pump users (p&lt;0.0001). There were no statistically significant differences between durable and disposable pump users for any other variables studied (continuous glucose monitoring costs, insulin costs, inpatient costs, emergency room costs, outpatient costs, hospital admissions, or emergency room visits).
Conclusions: Use of a durable versus disposable insulin pump is associated with significantly lower pump-related costs.

Disclosure
M. Shah: Employee; Self; Medtronic. C. Zhu: Employee; Self; Medtronic.
1157-P: Out-of-Pocket and Health Plan Spending on Diabetes Drugs, 2006-2018
Authors: LIPSKA KASIA J. , MCCOY ROZALINA G. , HOUTEN HOLLY VAN , YAO XIAOXI , ROSS JOSEPH , ALTAN AYLIN E. , SHAH NILAY 
Published: June 2020

The rising cost of managing diabetes is of major concern.
To examine trends in expenditures on diabetes drugs, we used OptumLabs Data Warehouse to identify commercially insured and Medicare Advantage enrollees with type 2 diabetes who filled ≥1 diabetes drug between 2006 and 2018. In each year, we examined mean health plan and patient out of pocket (OOP) spending, stratified by health plan (commercial vs. Medicare Advantage), for generic vs. brand, and for insulin vs. non-insulin drugs. We assessed trends using logistic regression. All costs were adjusted to 2018 U.S. dollars. 1,592,663 unique type 2 diabetes patients were included (commercially-insured: 698,725, Medicare Advantage: 893,938). Total mean diabetes drug expenditures increased among all patients (Figure). Among commercially insured patients, OOP spending increased for brand drugs and insulin but decreased for generics (p for trends &lt;0.001). Health plan spending also increased for brand drugs and insulin (p&lt;0.001) but did not change for generics (p=0.32). Among Medicare Advantage enrollees, OOP spending for brand drugs and insulin did not change (p=0.69 and 0.41, respectively), but decreased for generics (p&lt;0.001). Health plan spending increased for brand drugs and insulin (p&lt;0.001) but decreased for generics (p=0.02). Health plan and OOP spending on diabetes drugs increased 2006-2018, particularly among commercially insured patients, those using brand drugs and insulin.

Disclosure
K.J. Lipska: None. R.G. McCoy: None. H. Van Houten: None. X. Yao: None. J. Ross: Research Support; Self; Centers for Medicare and Medicaid Services, Janssen Pharmaceuticals, Inc., U.S. Food and Drug Administration. A.E. Altan: None. N. Shah: None.
1164-P: Trends in Diagnosed Diabetes among Medicare Beneficiaries in 2006-2015
Authors: SOHN MIN-WOONG , KIM SOYOUN , KANG HYOJUNG , MCMURRY TIMOTHY L. , LOBO JENNIFER M. 
Published: June 2020

Objective: As the U.S. population ages, there have been projections that the number of people living with diabetes would double in the next two decades. Our objective is to track how diabetes prevalence rates have changed over time before and after the Affordable Care Act (ACA) among Medicare beneficiaries residing in the Diabetes Belt compared to those residing outside.
Methods: We used complete Medicare Beneficiary Summary Files for 2006 - 2015 (A/B/C/D and Chronic Conditions segments) to compute prevalence rates of diabetes as identified in the CMS Chronic Conditions Warehouse. The Diabetes Belt in this study was defined as 644 counties across southeastern counties in the U.S. that had diabetes prevalence ≥ 11% in 2008 (Barker et al. 2012).
Results: Overall diabetes prevalence increased from 24.4% in 2006 to 27.2% in 2011 and slightly decreased to 26.7% in 2015. In the Diabetes Belt, the prevalence rates were 29.1% in 2006, reaching 32.0% in 2012. The prevalence rates were 5.2% higher in absolute percentages in the Belt than outside in 2006. This difference steadily increased to 5.6% in 2015. After adjusting for age, sex, race, rurality, health professional shortage area designation, and economic level in counties, individuals in the Diabetes Belt experienced 8.1% higher risk (OR = 1.081; 95% CI = 1.078, 1.083) of having diabetes compared to those outside the Belt in 2015.
Discussion: Diabetes prevalence was stable among Medicare beneficiaries in 2011-2015, but the gap between the Diabetes Belt and the non-Belt counties widened throughout the study period. The ACA and the concerted efforts at diabetes prevention have succeeded in “bending the curve” on the projected increased in the number of persons with diabetes, but growing disparities in diabetes prevalence between the Diabetes Belt and other regions is a concern that requires more policy attention.

Disclosure
M. Sohn: None. S. Kim: None. H. Kang: None. T.L. McMurry: None. J.M. Lobo: None.

Funding
National Institutes of Health (R01DK113295)
1165-P: Costs of Diabetes Complications: Hospital-Based Care and Production Loss for 392,200 People with Type 2 Diabetes and Matched Controls
Authors: ANDERSSON EMELIE , PERSSON SOFIE , HALLÉN NINO , ERICSSON ÅSA , THIELKE DESIRÉE , LINDGREN PETER , CARLSSON KATARINA STEEN , JENDLE JOHAN H. 
Published: June 2020

Background: The prevalence of type 2 diabetes (T2D) has increased rapidly over the last decades. The risks of complications and the medical consequences are well known, where hospital costs have been identified as a key driver of total costs. Less evidence has been generated on the impact of individual diabetic complications on the overall societal burden.
Objective: To analyse costs of hospital-based health care and of work absence related to individual microvascular and macrovascular complications of T2D in Sweden in 2016.
Method: The study used data from a Swedish retrospective observational database cross-linking 20 years of individual-level data (1997-2016) from national population-based health, social insurance and socio-economic registers for 392,200 people with T2D and matched controls (5:1). T2D status and presence of complications were derived from years 1997-2016 while the costs of hospital-based care and of production loss due to diabetes complications were estimated for 2016. Regression analysis was used for comparison to controls, to attribute production loss to individual complications, and to account for joint presence of complications.
Results: Hospital-based care costs were U.S. $622/person and production loss costs directly attributed to diabetes complications were U.S. $1,958/person in 2016. Additional costs were U.S. $523/person for early mortality in working ages and USD 377/person for medications in risk-factor treatment. Costs linked to angina pectoris and heart failure were key drivers of costs of macrovascular complications, and retinopathy and kidney disease of microvascular complications.
Conclusion: This study shows that the burden of complications in T2D is substantial. Costs of productivity loss were found to be greater than hospital-based care highlighting the need for considering outcomes beyond the health sector in treatment development and policy.

Disclosure
E. Andersson: Research Support; Self; Novo Nordisk A/S. S. Persson: Research Support; Self; Novo Nordisk A/S. N. Hallén: Employee; Self; Novo Nordisk A/S. Å. Ericsson: Employee; Self; Novo Nordisk Scandinavia AB. D. Thielke: Employee; Self; Novo Nordisk A/S. P. Lindgren: Research Support; Self; Novo Nordisk A/S. K. Steen Carlsson: Research Support; Self; Novo Nordisk A/S. J.H. Jendle: Advisory Panel; Self; Abbott, AstraZeneca, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Medtronic, Novo Nordisk A/S, Sanofi. Research Support; Self; Novo Nordisk A/S. Speaker’s Bureau; Self; AstraZeneca, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Novo Nordisk A/S, Sanofi.

Funding
Novo Nordisk A/S
1166-P: Cost Analysis of a Flash Glucose Monitoring System in Type 2 Diabetes Receiving ≥2 Insulin Doses a Day in Spain
Authors: GOMEZ-PERALTA FERNANDO , OYAGÜEZ ITZIAR , ARTOLA SARA , CARRASCO FRANCISCO JAVIER , GOMEZ JUANA CARRETERO , GARCIA-SOIDAN FRANCISCO JAVIER , GOMEZ-HUELGAS RICARDO , MERINO TORRES JUAN FRANCISCO , PÉREZ ANTONIO 
Published: June 2020

FreeStyle Libre2 system is a sensor-based flash monitoring (FM) system, which assesses interstitial fluid glucose. The study aimed to estimate the cost associated with the use of FM compared to self-monitoring of blood glucose (SMBG) in type 2 diabetes mellitus (T2DM) population from the Spanish National Health System perspective. The cost for glucose monitoring in T2DM patients treated with ≥2 insulin doses a day was modelled. The cost estimation considered the annual resource consumption for glucose monitoring (strips, lancets and FM sensors) and clinical management of hypoglycemia episodes. Severe hypoglycemia episodes (SHE) and non-severe hypoglycemia episodes (NSHE) published event rates (2.5 and 17.0 episodes/patient/year) were considered. Event reductions associated to FM system use were applied (48.8% [SHE]; 27.7% [NSHE]), derived from REPLACE trial findings. Based on published evidence, hospital attendance was required in 20.5% of SHEs (further hospitalization in 16.0%). Daily strip and lancet-consumption in T2DM patients was fixed at 4.81 for SMBG users, and 0.2 for FM system users according the REPLACE findings. FM sensor annual consumption per patient was 26. Unitary costs (€,2019 excluding VAT) derived from national databases and literature were: €0.28/strip; €0.09/lancet; €3.09/daily FM sensor; €3,774/hospitalized SHE; €1,779/hospital-attended non-admitted SHE; €385/community attended SHE and €15/NSHE. Yearly cost was €2,779 and €2,295 per patient using SMBG or FM system, respectively. For a cohort of 1,000 T2DM patients using ≥2 insulin doses a day; 1,221 SHEs (48 hospitalizations for SHE) and 4,715 NSHEs, yearly could be avoided with FM use. The use of the FM system in 1,000 patients could generate annual cost-savings up to €483,031 compared to SMBG (-17.4% of cost reduction).
In conclusion, FM system is a potential cost-saving strategy in T2DM patients treated with ≥2 insulin doses a day, in Spain.

Disclosure
F. Gomez-Peralta: Advisory Panel; Self; Abbott, Menarini Group, Novartis AG, Sanofi. Speaker’s Bureau; Self; Abbott, Boehringer Ingelheim International GmbH, Lilly Diabetes, Novartis AG, Novo Nordisk A/S, Sanofi. I. Oyagüez: None. S. Artola: None. F. Carrasco: None. J. Carretero Gomez: None. F. Garcia-Soidan: None. R. Gomez-Huelgas: None. J. Merino Torres: None. A. Pérez: None.

Funding
Abbott Diabetes Care
1182-P: Strategies and Factors Associated with Top Performance in Primary Care for Diabetes: Insights from Mixed Methods
Authors: SOLBERG LEIF , PETERSON KEVIN A. , FU HELEN N. , EDER MILTON , JACOBSEN RACHEL 
Published: June 2020

Background: Diabetes care quality has changed little over the past 12 years. To learn what strategies and factors seem most important for improvement, we conducted a mixed method analysis of clinic interviews and characteristics of clinics that are in the high, middle, and low quartiles on a composite measure for diabetes.
Method: We interviewed 31 leaders from 17 primary care clinics selected from the 416 that agreed to participate in a larger observational study of diabetes performance improvement. Semi-structured interviews on barriers and facilitators of diabetes care were recorded, transcribed, and analyzed for both comparison among clinics at different levels of performance on the outcome measure. We combined interview data with quantitative data about clinic performance on a standardized composite measure of diabetes outcomes and a survey of the presence of care management processes.
Results: Interview analysis identified 10 themes that provided unique insights into the factors and strategies that were associated with differences in performance level. The main difference among them was the degree to which top performing clinics used patient data to guide proactive and outreach methods to intensify treatment and monitor impact. Top clinics also reported fewer barriers and more facilitators than lower ranked ones, while all recognized key help from the larger organizations of which most were a part.
Conclusions: Top performing clinics’ approach to diabetes care differs from lower performing clinics focusing on proactive care occurring outside of the traditional practice setting. Although confirmatory studies are needed for these preliminary findings, clinical leaders might benefit by considering the value of replicating these differences.

Disclosure
L. Solberg: None. K.A. Peterson: None. H.N. Fu: None. M. Eder: None. R. Jacobsen: None.

Funding
National Institute of Diabetes and Digestive and Kidney Diseases (R18DK110732)
119-OR: Total Pancreatectomy with Islet Autotransplantation in Diabetic and Prediabetic Patients with Intractable Chronic Pancreatitis
Authors: BACHUL PIOTR J. , BOREK PETER , ANTEBY ROI , BASTO LINDSAY , PEREA LAURENCIA , GOLAB KAROLINA , WANG LING-JIA , TIBUDAN MARTIN L. , PEREZ-GUTIERREZ ANGELICA , KOMORNICZAK MICHAL , NAGPAL SAJAN , LUCANDER AARON C. , DIMITROV MICHAEL , FUNG JOHN , MATTHEWS JEFFREY B. , WITKOWSKI PIOTR 
Published: June 2020

Introduction: Total pancreatectomy with islet autotransplantation (TPIAT) is an effective treatment option for nondiabetic patients with intractable chronic pancreatitis. The outcome and potential benefits for prediabetic and diabetic patients are less well established.
Method: Thirty-four patients underwent TPIAT were retrospectively divided into 3 groups according to pre-operative glycemic control: diabetes mellitus (DM) (n=5, 15%), Pre-DM (n=11, 32%) and Non-DM (n=18, 54%).
Results: Preoperative fasting c-peptide was detectable and similar in all 3 groups. Islet mass in the DM group was comparable to Pre-DM and Non-DM groups: (median 191,800), 111,800 and 232,000, respectively). Patients received islet mass of over the target level of 2,000 IEQ/kg in Pre-DM and DM at lower but clinically meaningful rates compared to the Non-DM group 45% (5/11) and 60% (3/5) for a combined 50% (8/16) rate, respectively, compared to 83% (15/18) for the non-DM group. At 1 year, fasting c-peptide and HbA1c did not differ between DM and Pre-DM groups but c-peptide was significantly higher in Non-DM. Islet transplantation failed (negative c-peptide) only in one patient. Preoperatively, all patients experienced pancreatic pain with daily opioid dependence in 60-70%. Pancreatic-type pain gradually subsided completely in all groups with no differences in other painful somatic symptoms.
Conclusions: Patients with diabetes and measurable preoperative c-peptide can achieve similar benefit from TPIAT, with comparable outcomes to prediabetic and nondiabetic patients including pain relief. Not surprisingly, endocrine outcomes for diabetic and prediabetic patients are substantially worse than in those with normal preoperative glucose control.

Disclosure
P.J. Bachul: None. P. Borek: None. R. Anteby: None. L. Basto: None. L. Perea: None. K. Golab: None. L. Wang: None. M.L. Tibudan: None. A. Perez-Gutierrez: None. M. Komorniczak: None. S. Nagpal: None. A.C. Lucander: None. M. Dimitrov: None. J. Fung: None. J.B. Matthews: None. P. Witkowski: None.
12-LB: Subcutaneous Administration of the Novel Somatostatin Receptor 2 Antagonist ZT-01 Restores the Glucagon Response to Hypoglycemia in STZ-Diabetic Rats to Normal Levels
Authors: FARHAT RAWAD , SIMONSON ERIC , RIDDELL MICHAEL , LIGGINS RICHARD , CHAN OWEN 
Published: June 2020

Restoration of the lost glucagon response to hypoglycemia may be an effective means to prevent the onset of hypoglycemia in patients with type 1 diabetes (T1D). Elevation of the inhibitory hormone somatostatin in T1D may act on alpha cells, via the somatostatin receptor 2 (SSTR2), to suppress glucagon release during hypoglycemia. We previously demonstrated that a novel SSTR2 antagonist, ZT-01, exhibited superior efficacy at restoring the glucagon response to hypoglycemia compared to an established SSTR2 antagonist, PRL-2903, when given intraperitoneally at a dose of 10 mg/kg. In this study, we first evaluated the pharmacokinetics of ZT-01 in healthy Sprague-Dawley rats. Within one hour after intraperitoneal administration of a 10 mg/kg dose, ZT-01 achieved 10-fold higher plasma Cmax compared to PRL-2903; however, pancreas concentration at 6 h post-dose was almost 4-fold higher for PRL-2903 compared to ZT-01 and plasma concentrations were similar for both 24 h post-dose. We subsequently conducted a dose de-escalation study to identify the lowest dose of ZT-01 that could improve glucagon secretion in poorly controlled insulin-treated streptozotocin (STZ)-diabetic Sprague Dawley rats, under hypoglycemic clamp conditions. ZT-01 was administered subcutaneously one hour prior to the induction of hypoglycemia (blood glucose &lt;60 mg/dL) at doses ranging from 0.1 µg/kg to 3 mg/kg. Administration of ZT-01 at 0.3 or 1 mg/kg improved the glucagon response by 5.3 or 6.3-fold, respectively (P&lt;0.05), relative to the diabetic control group. The glucagon response in this dose range was comparable to that observed in nondiabetic rats administered vehicle. We therefore conclude that ZT-01 at doses ranging from 0.3 to 1 mg/kg normalized the glucagon response to hypoglycemia in STZ-diabetic rats and may be an effective compound for the prevention hypoglycemia in patients with T1D.

Disclosure
R. Farhat: None. E. Simonson: None. M. Riddell: Advisory Panel; Self; Zucara Therapeutics Inc. Consultant; Self; Lilly Diabetes. Research Support; Self; Dexcom, Inc., Insulet Corporation. Speaker’s Bureau; Self; Medtronic, Novo Nordisk A/S. R. Liggins: Advisory Panel; Self; Zucara Therapeutics Inc. Stock/Shareholder; Self; Zucara Therapeutics Inc. O. Chan: None.

Funding
JDRF; The Leona M. and Harry B. Helmsley Charitable Trust
1202-P: Association and Trends of Current Prevention Guidelines in Reducing Hospitalizations in People with Diabetes
Authors: ALBRIGHT RACHEL H. , FLEISCHER ADAM E. 
Published: June 2020

Background: Specific outpatient services have been recommended to prevent diabetes complications. The purpose of this study is to assess the utilization and trends of preventative outpatient visits to providers in a population of people with diabetes, and evaluate which preventative services may offer the most protection against poor outcomes.
Methods: The National Health and Nutrition Examination Survey (NHANES) was used to examine the relationship between select outpatient services and risk of all-cause hospitalization in people with diabetes. We assessed five outpatient services commonly recommended: (1) examination from a physician (2) assessment of hemoglobin A1C (3) eye exam with pupil dilation (4) foot exam and (5) assessment from a diabetes specialist. Logistic regression models were performed to assess the independent association of outpatient services used in the past 1 year, and hospitalization within that same year.
Results: Ninety-nine percent of patients with diabetes engaged in at least one outpatient service every year between 2011 and 2016. Patients receiving a preventative foot exam within the last year experienced a protective effect against hospitalization within that year (OR 0.67, 95%CI 0.46, 0.96). Visiting a diabetes specialist produced a protective effect against hospitalization (OR 0.56, 95%CI 0.39, 0.82) if the visit occurred more than one year before the hospitalized event. No other outpatient services were associated with hospitalization. Findings of the final regression model were robust to sensitivity analysis.
Conclusion: Outpatient Services are consistently being used annually by the diabetic population, however, the services that show the most protection against all-cause hospitalization are utilized the least. Receiving a preventative foot exam and visiting a diabetes specialist were most effective at protecting patients from all-cause hospitalization, resulting in a 33% and 44% decreased risk, respectively.

Disclosure
R.H. Albright: None. A.E. Fleischer: None.