bluuebunny/crossref_metadata_2025_split huggingface dataset:
861-P: Differences in Heart Failure Hospitalization Risk following Initiating SGLT2 Inhibitors vs. DPP4 Inhibitors across Race/Ethnicity and Rural/Urban Areas
Authors: GUO JINGCHUAN , LI YUJIA , BIAN JIANG , LACKLAND DANIEL T. , KIMMEL STEPHEN , SCHATZ DESMOND , WINTERSTEIN ALMUT G. 
Published: May 2022

Objective: Racial and rural disparities exist in the adoption of newer antidiabetic agents, including SGLT2 inhibitors. We aimed to evaluate whether the effectiveness of SGLT2 inhibitors varied across race/ethnicity and rural/urban areas.
Methods: Using claims data from 15% samples of national Medicare beneficiaries, we identified individuals who had type 2 diabetes and initiated SGLT2 inhibitors or DPP4 inhibitors (as the active control) between 1/1/2017-12/31/2018. Cohort entry was the day of the first filled prescription of any SGLT2 inhibitors or DPP4 inhibitors, defined as no use of either in the prior year. The outcome was hospitalization for heart failure (HHF) . Inverse probability treatment weighting (IPTW) Cox regressions were applied, controlling for pre-exposure covariates. IPTW models were fitted separately across subgroups.
Results: Cohort, mean age was 72 (SD 10) , 53% were women and 2.2% (2,577 / 116,751) experienced HHF over a median follow up of 363 days. Compared with DPP4 inhibitors, SGLT2 inhibitors were associated with a lower risk of HHF (HR, 0.73; CI, 0.65-0.80) . In the subgroup analyses, the beneficial effect of SGLT2 inhibitors vs. DPP4 inhibitors were comparable across non-Hispanic White (HR, 0.77; CI, 0.68-0.87) , non-Hispanic Black (HR, 0.67; CI, 0.49-0.91) and Hispanic (HR, 0.68; CI, 0.50-0.92) groups. SGLT2 inhibitors associated decreased risk of HHF was only seen in individuals living in urban areas (HR, 0.69; CI, 0.61-0.78) but not rural areas (HR, 0.95; CI, 0.76-1.19) .
Conclusion: Use of SGLT2 inhibitors, vs. DPP4 inhibitors, was associated with a lower risk of HHF and the effectiveness were comparable across racial and ethnics groups. However, SGLT2 inhibitors’ HHF benefit appeared to have been attenuated in those living in rural areas. Future studies are warranted to understand the mechanisms underlying the potential rural-urban disparities in treatment outcomes.

Disclosure
J.Guo: None. Y.Li: None. J.Bian: None. D.T.Lackland: None. S.Kimmel: Other Relationship; Janssen Pharmaceuticals, Inc. D.Schatz: Advisory Panel; Abbott Diabetes, Medtronic. A.G.Winterstein: Consultant; Genentech, Inc., Research Support; Merck & Co., Inc.
874-P: Potential Anti-Inflammatory Effects of Canagliflozin in Tumour Necrosis Factor-α and Interferon-ϒ-Stimulated Endothelial Cells
Authors: ALSHNBARI AFNAN S. , KHAN RAHEELA N. , IDRIS ISKANDAR R. 
Published: May 2022

Background: This study investigates the potential direct anti-inflammatory effects of the SGLT2 inhibitors (canagliflozin, C; dapagliflozin D; or empagliflozin, E) on cultured endothelial cells.
Methods: Human umbilical vein endothelial cells (HUVECs) or Human cardio microvascular endothelial cells (HCMECs) were pre-incubated in the presence or absence of C (0.5μM, 1μM, and 10μM) , D (0.5μM, 1μM, and 10μM) and E (0.5μM, 1μM, and 10μM) for 1 hr and NaCl (150 mM) for 24 hr. The cells were then stimulated with TNF-α (ng/mL) and IFN-Υ (ng/mL) for 24 hrs. Expression of IL-6 and was analysed using Quantikine ELISA kits. The expression of SGLT2 mRNA was assessed using RT-PCR in cDNA prepared from two independent cultures of HUVECs and HCMECs using cDNA from human kidney cortex as a positive control.
Results: TNF-α and IFN-Υ and significantly induced expression of IL-6 in both HUVECs and HCMECs compared to controls (p = &lt;0.0001) . The effects were significantly inhibited by canagliflozin 0.1μM, 1μM, and 10μM (p=0.0099, p&lt; 0.0001, and p&lt;0.0001, respectively) in HUVECs. In HCMECs, C, (0.5μM, 1μM, and 10μM) significantly inhibit the TNF-α and IFN-Υ IL-6 secretion (p&lt; 0.0001, p&lt; 0.0001, and p&lt;0.0001, respectively) . No significant effect of D and E was observed. High NaCl had no influence on C (0.5μM, 1μM, and 10μM) inhibition of TNF-α and IFN-Υ induced of IL-6 secretion, and high salt alone had no influence on the secretion of IL-6 secretion. SGLT2 mRNA levels were below the detection level in HUVECs and HCMECs alone and on high glucose and TNF-α and IFN-Υ conditions.
Conclusion: This result indicates that SGLT2-I directly inhibits endothelial pro-inflammatory cytokines secretions. This striking anti-inflammatory of the SGLT2 inhibitor class merits further mechanistic research.

Disclosure
A.S.Alshnbari: None. R.N.Khan: None. I.R.Idris: None.
877-P: Safety of Dapagliflozin in Patients with Type 2 Diabetes Mellitus in China: Results from the DONATE Study
Authors: GUO LIXIN , WANG JING , LI LI , YUAN LIN , CHEN SHENG , WANG HUI , LI TONGHUAN , QI LIN , YANG HONG 
Published: May 2022

Background: Dapagliflozin significantly improves glycemic control, body weight and blood pressure in Asian patients with type 2 diabetes mellitus (T2DM) , but safety data from studies with a large population are lacking. The DONATE study investigated the real-world safety of dapagliflozin in Chinese patients with T2DM.
Methods: This observational study enrolled patients with T2DM from 88 hospitals in China, who had received ≥1 dose of dapagliflozin between August 2017 and July 2020. Patients were followed for 6 months, or 7 days after discontinuing study drug. Primary outcome was the incidence of adverse events (AEs) and serious adverse events (SAEs) , particularly urinary tract infections (UTIs) , genital tract infections (GTIs) and hypoglycemia. Exploratory outcomes included the incidence of AEs of specific interest (AESI) and absolute changes in metabolic factors. Results: Of 3000 patients enrolled, 2990 patients were included in the safety analysis set; 1059 (35.4%) reported ≥1 AE, including 186 (6.2%) with ≥1 SAE. Adverse drug reaction was reported in 268 (9.0%) patients. In total, there were 70 (2.3%) , 39 (1.3%) and 32 (1.1%) patients with UTI, GTI and hypoglycemia, respectively. The occurrence of other AESIs was also low: polyuria (0.7%) , volume depletion (0.3%) , renal impairment (0.3%) , hepatic impairment (0.2%) , haematuria (0.2%) and diabetic ketoacidosis (0.1%) . There were no abnormal electrolytes events reported. At Week 24 (metabolic analysis set) , mean change from baseline in HbA1c was −1.318%; 161/417 (38.6%) achieved HbA1c &lt;7.0%; Mean change from baseline in FPG, 2h-PPG, weight and waist circumference was −1.826 mmol/L, −5.466 mmol/L, −1.89 kg and -2cm, respectively.
Conclusion: Dapagliflozin showed a good safety profile in real-world clinical practice in China, with a low incidence of AEs, especially AESI. Meanwhile, a trend of improvement was found in blood glucose control as well as other metabolic factors.
887-P: Productivity and Medical Costs Due to Diabetes in Adults Aged 18–64 Years with Large Employer-Sponsored Insurance
Authors: PARK JOOHYUN , LUMAN ELIZABETH , ZHANG PING 
Published: May 2022

Despite a substantial economic burden of type 2 diabetes (T2D) on the working population, the costs of T2D for employers are not well characterized. We estimated productivity losses and medical costs due to T2D among employees aged 18-64 years using 2018-20MarketScan® databases. We estimated missed days due to absences, short-term disability (STD) , and long-term disability (LTD) attributable to T2D, overall and by age and sex. We converted these losses into costs by multiplying them by an average hourly wage. We used two-part and generalized linear models (controlling for age, sex, state of residence, employer industry type, and Charlson Comorbidity Index score) to estimate the productivity costs and medical costs in total and by service type. All costs were in 20USD. Overall, employees with T2D had 68% higher costs measured in productivity losses and medical services than those without diabetes (Table) , yielding a total cost attributable to T2D of $6,933. Most of the extra cost (90%) was from medical costs, followed by productivity costs due to STD (7%) , absences (2%) , and LTD (1%) . The youngest group had higher STD days and outpatient costs. Females had more absences and STD days and higher outpatient costs than males. Our estimates may assist employers in assessing potential financial gains from improved efforts to prevent and manage T2D in the workplace.

Disclosure
J.Park: None. E.Luman: None. P.Zhang: None.
891-P: Health Care Economic Burden and Resource Utilization in Adults with Type 2 Diabetes and Myocardial Infarction
Authors: KING AARON A. , RAJPURA JIGAR J. , LIANG YUANJIE , PAPROCKI YUREK M. , UZOIGWE CHIOMA 
Published: May 2022

Objectives: To evaluate health care resource utilization and cost in adults with type 2 diabetes mellitus (T2DM) and myocardial infarction (MI) .
Methods: We conducted a retrospective cohort study using the Optum® Clinformatics® Data Mart claims database. Patients ≥ 18 years of age with T2DM, with or without incident MI, were identified between January 1, 2012 and December 31, 2020. Healthcare resource utilization and cost were measured in the 12 months following index. MI was defined as a hospitalization with a qualifying primary discharge diagnosis code. Patient cohorts were compared using an inverse probability of treatment weighting approach.
Results: Incidence of MI was 0.7% (n = 13,681) in the one year following T2DM diagnosis. For the weighted analysis, 9,474 patients with T2DM and incident MI (mean age, 73.6; mean Charlson comorbidity index [CCI], 4.6) were compared to 9,536 patients with T2DM alone (mean age, 73.7; mean CCI, 4.7) . Compared to patients with T2DM alone, patients with T2DM and MI were more likely to have an inpatient (IP) visit (adjusted rate ratio [ARR], 5.4; 95% CI, 5.2-5.6; p &lt; 0.01) , outpatient (OP) visit (ARR, 1.6; 95% CI, 1.6-1.6; p &lt; 0.01) , or emergency room (ER) visit (ARR, 1.8; 95% CI, 1.7-1.8; p &lt; 0.01) , and had longer IP length of stay (ARR, 5.4; 95% CI, 5.4-5.5; p &lt; 0.01) . Healthcare costs from IP visits, OP visits, ER visits, and pharmacy costs were all higher in patients with T2DM and MI compared to patients with T2DM alone (Total costs, $10,929 per patient per month [PPPM] vs. $2,997 PPPM; p &lt; 0.01) . In a hypothetical health plan population of one million adults with T2DM, we project patients with T2DM and MI would have +$676 million higher annual costs than patients with T2DM alone.
Conclusions: Having MI in addition to T2DM increased healthcare resource utilization and costs. Proactively managing patients’ T2DM to reduce risk of MI and the increased healthcare utilization and costs associated with MI may improve clinical outcomes and reduce overall costs.

Disclosure
A.A.King: Advisory Panel; Novo Nordisk, Board Member; JDRF, Speaker's Bureau; Abbott, Dexcom, Inc., Lilly Diabetes, MannKind Corporation, Medtronic, Novo Nordisk. J.J.Rajpura: Employee; Novo Nordisk. Y.Liang: Employee; Novo Nordisk. Y.M.Paprocki: Employee; Novo Nordisk, Stock/Shareholder; Novo Nordisk. C.Uzoigwe: Employee; Novo Nordisk, Stock/Shareholder; Novo Nordisk.
895-P: External Validation of the BRAVO Diabetes Model Using Data from the EXSCEL Study
Authors: SHAO YIXUE , NIU SHU , SHI LIZHENG , FONSECA VIVIAN , SHAO HUI 
Published: May 2022

We developed an individual-level discrete-time microsimulation model, namely the Building, Relating, Assessing, and Validating Outcomes (BRAVO) diabetes model. The BRAVO model was externally validated using cohort-level data in people with type 2 diabetes (T2D) . This study further externally validated the BRAVO diabetes model using patient-level data from the Exenatide Study of Cardiovascular Event Lowering Trial (EXSCEL) . Baseline characteristics and trajectories of key biomarkers, including A1c, LDL, SBP, and BMI, were retrospectively extracted from the EXSCEL study database. To protect patients’ private information, variables of age and BMI were masked in ranges from the EXSCEL study (e.g., BMI 35 coded as BMI&gt;30) . To convert the ranges back into specific values to support the simulation, we used the National Health and Nutrition Examination Survey (NHANES) data for the data imputations. We used the median value for each population subgroup from NHANES to replace the ranges. The BRAVO diabetes model was applied to the EXSCEL baseline data to predict the 7-year EXSCEL study outcomes. We assessed the BRAVO model’s discrimination power using C-statistics and calibration using the Brier score. The model demonstrated good discrimination and calibration in predicting the first occurrence of non-fatal myocardial infarction (C-index 0.620 [95% CI 0.590-0.650] and Brier Score (BS) 0.080 [0.074-0.085]) , non-fatal stroke (C-index 0.696 [0.634-0.758] and BS 0.031 [0.028-0.034]) , heart failure (C-index 0.700 [0.666-0.733] and BS 0.037 [0.034-0.041]) , revascularization (C-index 0.664 [0.590-0.738] and BS 0.036 [0.033-0.039]) , and all-cause mortality (C-index 0.746 [0.711-0.781] and BS 0.102 [0.098-0.106]) , respectively. Although the majority of the data obtained from EXSCEL trial was obtained in range instead of specific values, the BRAVO model remained robust in prediction performance in diabetes complications and mortality.

Disclosure
Y.Shao: None. S.Niu: None. L.Shi: None. V.Fonseca: Consultant; Abbott, Asahi Kasei Corporation, Bayer AG, Novo Nordisk, Sanofi, Research Support; Fractyl Health, Inc., Jaguar Gene Therapy, Stock/Shareholder; Abbott, Amgen Inc., BRAVO4Health, Mellitus Health. H.Shao: Board Member; BRAVO4HEALTH, LLC.

Funding
Astrazeneca
908-P: Shared Decision-Making for Diabetes Prevention: 24-and 36-Month Results from the Prediabetes Informed Decision and Education (PRIDE) Trial
Authors: DURU O. KENRIK , MOIN TANNAZ , TURK NORMAN , TSENG CHIHONG , NORRIS KEITH C. , MANGIONE CAROL 
Published: May 2022

Background: Intensive lifestyle change (e.g., the Diabetes Prevention Program) and metformin reduce type 2 diabetes risk, but uptake is low. Our team has shown that shared decision-making (SDM) for diabetes prevention resulted in greater uptake of DPP and/or metformin and weight loss at 12 month follow-up. In this analysis, we examine weight loss at 24 and 36 month follow-up.
Methods: We led a pragmatic cluster RCT in 20 primary care clinics in a regional health system. We enrolled 5overweight/obese adults with prediabetes (BMI ≥ 24 kg/m2, HbA1c 5.7-6.4%) from intervention clinics. We used propensity score matching to select 1,502 control patients from usual care clinics. We assessed the difference in follow-up weight between groups as recorded in the EHR. We adjusted for age, sex, race, and ethnicity and trimmed the top and bottom 2.5% of change in weight to remove outliers. Intervention: A single SDM visit with a pharmacist who used a decision aid to discuss diabetes prevention options: DPP, DPP +/- metformin, metformin only, usual care.
Results: The greater mean 12-month weight loss among intervention participants versus controls (-4.0 lbs, 95% CI -5.1, -2.9) persisted with ongoing follow-up, although there was some weight regain. Specifically, intervention participants maintained greater mean weight loss than controls at 24 months (-3.1 lbs, 95% CI -4.2, -1.9) and 36 months (-2.7 lbs, 95% CI -3.9, -1.4) .
Conclusion: An intervention with a single SDM session increased engagement in evidence-based diabetes prevention, resulting in weight loss that was largely maintained for three years. Prediabetes SDM is a promising approach to enhance prevention among patients at increased diabetes risk. To achieve greater and more sustained weight loss, periodic reinforcement may be required.

Disclosure
O.Duru: None. T.Moin: None. N.Turk: None. C.Tseng: None. K.C.Norris: None. C.Mangione: n/a.

Funding
National Institutes of Health (R18DK105464)
909-P: Diabetes Assessment in El Paso, Texas, Using ADA Chronic Care Model
Authors: BAJPEYI SUDIP , CONCHA JEANNIE B. , PORTILLO DENISE N. 
Published: May 2022

Hispanics are affected at a greater rate, with 14.3% diagnosed or predicted to have type 2 diabetes, and 50% more likely to die from diabetes compared to non-Hispanic Whites. El Paso, located at the border region of Texas and Mexico, have predominantly Hispanic population (∼87%) , faces significant health concerns associated with diabetes. Purpose: 1) to determine whether appropriate community resources exist to meet the American Diabetes Association (ADA) recommended standards of medical care and 2) to identify community/culture-centered strategies for the County of El Paso to best meet the recommended standards of care. Methods: The ADA Chronic Care Model (CCM) were used to develop interview guides. Focus groups were conducted with three certified diabetes care and education specialists (CDCES) and people with diabetes (PWD) . A survey was sent out to members of the focus groups and the members of the Diabetes leadership council to rank the ADA standards (S) based on priority and feasibility for the city of El Paso. Results: Interviews revealed that the ADA standard to refer PWD to diabetes community resources and DSMES programs (S1, S5) are not fully met. CDCES noted the need for mental health assessments and referrals to resources (S4) . PWD indicated promotion and awareness about diabetes resources is needed. PWD ranked S1 (Improving Care and Promoting Health in Populations) (29%) , S2 (Diabetes Diagnosis) (24%) and S3 (Diabetes Prevention and Delay) (19%) as the top three standards. CDCES ranked S1 (29%) and S3 (24%) as top two and S4 (Comprehensive Medical Evaluations) , S5 (Lifestyle Management) and S6 (Obesity Management) (14%) as the third priority. Diabetes Leadership Council ranked S6 (29%) , S5 (24%) and S3 (17%) as the top standards. Conclusion: There are several diabetes community resources and existing evidence based programs in El Paso. Leveraging CDCES professionals as a critical component to the education bridge between the Health System and the Community may help meet the diabetes Standards of Care.

Disclosure
S.Bajpeyi: n/a. J.B.Concha: n/a. D.N.Portillo: None.
916-P: Evaluation of an Enhanced Primary Care Team Model to Improve Diabetes Care
Authors: HERGES JOSEPH , MATULIS JOHN , KESSLER MAYA , RUEHMANN LISA L. , MARA KRISTIN , MCCOY ROZALINA G. 
Published: May 2022

Purpose: Primary care practices manage most patients with diabetes, and face significant operational, regulatory, and reimbursement pressures to improve care quality. The Enhanced Primary Care Diabetes (EPCD) model was developed to leverage the expertise of care team registered nurses and pharmacists to improve diabetes care.
Methods: Utilizing a retrospective, interrupted time series design, we evaluated the EPCD model’s impact on a composite publicly reported quality measure of diabetes care (D5) , including indicators of glycemic control, blood pressure control, low-density lipoprotein, tobacco use, and aspirin use. We compared three groups of practices (32 total) that care for adults (age 18-75 years) with diabetes: staff clinician (physician and Advanced Practice Provider) practices with access to EPCD (5761 patients) , resident physician practices with access to EPCD (1887 patients) , and staff clinician practices without access EPCD (10,079 patients) . The primary outcome was a comparison of the pre-implementation trend (7 months) to the post-implementation trend (months) in the three groups for the percentage meeting the D5.
Results: There was a positive difference in pre to post-implementation trends for patients meeting the D5 in the staff clinician practices in the EPCD group (Pre IRR 0.995, Post IRR 1.005; P= 0.01) . There was no difference in the trend for the trainee physician practices with access to EPCD (Pre IRR 0.999, Post IRR 1.011; P= 0.14) , and a significant negative trend in the staff clinician practices without access to EPCD (Pre IRR 1.001, Post IRR 0.994; P= 0.05) .
Conclusion: The EPCD model significantly improved diabetes care quality. Further study of proactive, multidisciplinary chronic disease management led by care team nurses integrating clinical pharmacists is warranted.

Disclosure
J.Herges: None. J.Matulis: None. M.Kessler: None. L.L.Ruehmann: None. K.Mara: None. R.G.Mccoy: Consultant; Emmi.

Funding
National Institute of Diabetes and Digestive and Kidney Diseases (K23DK114497)
958-P: Associations between Effect of Body-Mass Index (BMI) and HbA1c among Children and Young Adults with Type 1 Diabetes: A U.S. Based Multicenter Study
Authors: MEKHOUBAD ALLISON B. , HSIEH SUSAN , NOOR NUDRAT , EBEKOZIEN OSAGIE , ROMPICHERLA SAKETH , OSPELT EMMA L. , ROBERTS ALISSA J. , SANCHEZ JANINE , FERRO DIANA , MIYAZAKI BRIAN , LEE JOYCE M. 
Published: May 2022

Background: The primary objective of this U.S. based multi-center study was to examine the association of overweight and obesity with A1c levels for children and adolescents with type 1 diabetes (T1D) .
Methods: Electronic health record data spanning 2017-2021 for children and adolescents from the T1D Exchange Quality Improvement (T1DX-QI) Collaborative was analyzed. BMI percentiles were calculated using the Centers for Disease Control and Prevention growth curves, and children were categorized into normal weight, overweight, obese and severely obese groups. Normal weight was defined as a BMI &lt; 85th percentile for age and sex. Overweight was defined as a BMI ≥ 85th to &lt; 95th percentile. Obesity was defined as having a BMI &lt;120% of the 95th percentile whereas severe obesity was defined as having BMI ≥120% of the 95th percentile. HbA1c levels and BMI were from last in-person encounter.
Results: Of 14,484 T1D patients aged &lt; 18 years, 2,063 (14%) were underweight, 9,320 (65%) normal weight, 1,769 (12%) overweight, 977 (7%) obese and 333 were severely obese (2%) . More people of Black (12%) and Hispanic (18%) race/ethnicity were in the obese group relative to the normal weight group (8% and 10% respectively; p&lt;0.001) . HbA1c levels were higher in the obese/severely obese group compared to normal weight patients (HbA1c Mean (SD) : Obese (9.1 (2.3)) /severely obese (9.1 (2.2) vs. Normal weight: 8.7 (2.0) ; p&lt;0.001) .
Conclusion: In this extensive real-world study, we found obese children and adolescents with T1D were more likely of Black or Hispanic race/ethnicity and have higher HbA1c levels compared to those with healthy weight.

Disclosure
A.B.Mekhoubad: None. B.Miyazaki: None. J.M.Lee: Advisory Panel; GoodRx, Consultant; Tandem Diabetes Care, Inc. S.Hsieh: None. N.Noor: None. O.Ebekozien: None. S.Rompicherla: None. E.L.Ospelt: None. A.J.Roberts: None. J.Sanchez: None. D.Ferro: None.

Funding
The Leona M. and Harry B. Helmsley Charitable Trust