bluuebunny/crossref_metadata_2025_split huggingface dataset:
1240-P: Differences in Initial Care and Outcomes Comparing Adults with Early vs. Usual Onset Type 2 Diabetes
Authors: BLATCHINS MARUTA A. , MISHRA PRANITA , GRANT RICHARD W. , GOPALAN ANJALI 
Published: June 2019

The prevalence of newly diagnosed type 2 diabetes (T2D) among American adults under age 45 is increasing. Given the lasting benefits conferred by early glycemic control, we examined initial diabetes care and subsequent glycemic control at one year following diagnosis, comparing adults with early onset (21-&lt;45 years old) vs. usual onset (45-&lt;65 years old) T2D.
Using data from a large, integrated care delivery system, we identified adults who had a first diabetes-defining Hemoglobin A1c value (≥6.5% “index A1c”) between Jan. 2010 and Dec. 2016, followed by clinical diagnosis of T2D (visit with T2D ICD code or T2D on problem list) within 3 months of the index A1c. We excluded anyone with evidence of prior T2D, gestational diabetes or T1D. We compared baseline characteristics by onset age using t- or chi-2 tests. Adjusting for index A1c and other patient characteristics, we used logistic regression to examine initial management and GEE models to examine glycemic control (goal A1c &lt;7%) at one-year following diagnosis, comparing early vs. usual age onset status.
We identified 32,137 adults with new T2D, including 8,496 with early onset (26.4%, age 37.6 ± 5.3 years) and 23,641 with usual onset (73.6%, age 54.4 ± 5.5 years). Adults with early onset had a higher index A1c (A1c 8.9% vs. 8.4% for usual onset, p&lt;0.001). Compared to usual onset, adults with early onset were more likely to initiate metformin (adjusted odds ratio [aOR] 1.20, 95% CI [1.12-1.27]), but less likely to receive a retinal exam (aOR 0.80, 95% CI [0.76-0.85]) or diabetes-related education (aOR 0.84, 95% CI [0.80-0.89]) during the first year of care. Adults with early onset were less likely to achieve goal glycemic control at one year following diagnosis (aOR 0.85, 95% CI [0.79-0.91]).
In conclusion, individuals with early onset T2D were less likely to achieve goal A1c (&lt;7%) at one year following diagnosis. This suggests a need for tailored strategies to improve early T2D care for this high-risk population of adults presenting with T2D at younger ages.

Disclosure
M.A. Blatchins: None. P. Mishra: None. R.W. Grant: None. A. Gopalan: None.

Funding
National Institute of Diabetes and Digestive and Kidney Diseases
125-OR: Child Growth Tracking and Type 2 Diabetes Risk: A Life Course Analysis
Authors: OLAIYA MUIDEEN T. , KNOWLER WILLIAM C. , HANSON ROBERT L. , KOBES SAYUKO , NELSON ROBERT , SINHA MADHUMITA 
Published: June 2019

Background: Knowing vulnerable periods of growth for predicting type 2 diabetes (T2D) incidence may help focus interventions for prevention. Using life course data, we identified critical growth periods in childhood that predict T2D risk.
Methods: This analysis of a longitudinal study of American Indians, aged ≥ 5 years, comprised subjects representing three growth periods (pre-, early, and late adolescence). Age-sex-height-adjusted mean attained weight and weight velocity (change/year) were computed in each growth period. Subjects were followed from the end of each growth period until T2D diagnosis or their last research examination. Poisson regression was used to model the effects of the mean attained weight or weight velocity in a growth period on T2D incidence.
Results: There were 290 incident T2D cases among 2100 subjects representing the pre-adolescence growth period, 315 cases among 1558 in the early adolescence period, and 380 cases among 1418 in the late adolescence period. In each growth period, the mean attained weight significantly predicted T2D incidence, especially in the first 5 years of follow-up (Figure, A-C). There were significant effects of weight velocity in pre-adolescence and modest effects in late adolescence on T2D incidence (Figure, D-F). Attained weight pre-adolescence had the strongest effect on T2D incidence.
Conclusions: Pre-adolescence is an especially vulnerable period for predicting later T2D.

Disclosure
M.T. Olaiya: None. W.C. Knowler: None. R.L. Hanson: None. S. Kobes: None. R. Nelson: None. M. Sinha: None.

Funding
National Institute of Diabetes and Digestive and Kidney Diseases
1254-P: Increased Health-Care Resource Utilization (HRU) and Costs among Nonalcoholic Fatty Liver Disease/Nonalcoholic Steatohepatitis (NAFLD/NASH) Patients with Advanced Fibrosis (AF) having Diabetes Mellitus (DM)
Authors: GORDON STUART , KACHRU NANDITA , OZBAY A. BURAK , WONG ROBERT 
Published: June 2019

Objective: NAFLD/NASH patients with AF (bridging fibrosis/F3 and compensated cirrhosis/F4) have an increased risk of liver disease progression leading to higher costs, which may be compounded by presence of DM. The study evaluated the impact of DM on HRU and associated healthcare costs among NAFLD/NASH-AF patients in the U.S.
Methods: Adult NAFLD/NASH-AF patients with available lab results were identified from 2008-2016 Optum Research claims database, to calculate their Fibrosis-4 (FIB-4) score. Using the FIB-4 score, patients were categorized as F3 or F4 (first date of FIB-4 cut-off score marked the index date), and then stratified by DM (ICD codes). Mean annual HRU/costs were obtained via per patient per month values (2016 USD).
Results: Among 91,122 NAFLD/NASH patients with FIB-4 scores, 2,482 (2.7%) had F3, among which 36% had DM, and 939 (1.0%) had F4, among which 35% had DM. The mean annual costs of F3 and F4 patients with DM were 12-53% higher than non-DM (Figure) before and after the development of AF.
Conclusions: NAFLD/NASH-AF patients with DM had higher mean annual HRU-associated costs compared to those without DM - primarily driven by ambulatory and pharmacy costs. Management options are needed to improve clinical care and optimize healthcare costs among NAFLD/NASH-AF patients with DM.

Disclosure
S. Gordon: Consultant; Self; Gilead Sciences, Inc., Intercept Pharmaceuticals, Inc. N. Kachru: Employee; Self; Gilead Sciences, Inc. Stock/Shareholder; Self; Gilead Sciences, Inc. A. Ozbay: Employee; Self; Gilead Sciences, Inc. Stock/Shareholder; Self; Gilead Sciences, Inc. R. Wong: Advisory Panel; Self; Gilead Sciences, Inc. Consultant; Self; Gilead Sciences, Inc. Research Support; Self; Gilead Sciences, Inc. Speaker's Bureau; Self; Gilead Sciences, Inc.
1259-P: Adherence and Persistence for Dulaglutide (DU) vs. Basal Insulin (BI) in Injection-Naïve Patients with Type 2 Diabetes (T2D): The DISPELTM Study
Authors: MODY REEMA , HUANG QING , YU MARIA , WANG LIYA , ZHANG XIAN , GRABNER MICHAEL , PATEL HIREN 
Published: June 2019

Adherence and persistence are key considerations in patient-centric treatment selection for T2D management. The objective of this retrospective real-world study was to assess 1-year adherence and persistence using different measures among injection naïve patients with T2D initiating DU vs. BI. A U.S. claims database was used to identify patients with T2D initiating DU or BI between Nov’14 - Apr’17 (index date=earliest fill date). Patients ≥18 years, with no claim for any antidiabetic injectable in the 6 months pre-index period (baseline), continuous enrollment and ≥1 HbA1c result at baseline and 1-year post-index were included. Two widely used measures for assessing persistence of injectables in the real-world were implemented. DU users were propensity-matched 1:1 to BI users. Matched cohorts (903 pairs) were balanced in baseline patient characteristics with mean age of 54 years. Key study outcomes are included in the Table. Using the 45-day gap measure, more BI vs. DU patients discontinued their therapy but more BI patients restarted their index therapy. More DU vs. BI patients discontinued based on the 90th percentile measure, and more DU patients restarted their index therapy. In this real-world study, DU demonstrated higher adherence than BI. Given the results, the most appropriate persistence measure may vary for different classes of antidiabetic injectables.

Disclosure
R. Mody: Employee; Self; Eli Lilly and Company. Q. Huang: None. M. Yu: Employee; Self; Eli Lilly and Company. Employee; Spouse/Partner; Lifelabs. Stock/Shareholder; Self; Eli Lilly and Company. L. Wang: Employee; Self; HealthCore. Employee; Spouse/Partner; Janssen Pharmaceuticals, Inc. X. Zhang: None. M. Grabner: None. H. Patel: Employee; Self; Eli Lilly and Company. Stock/Shareholder; Self; Eli Lilly and Company.

Funding
Eli Lilly and Company
1261-P: Assessing Data Availability and Benchmarking Performance of Quality Measures for the T1D Exchange Quality Improvement Collaborative
Authors: CABRERA ALYSSA B. , ALONSO GUY T. , CORATHERS SARAH , LEE JOYCE M. , PRAHALAD PRIYA , RIOLES NICOLE 
Published: June 2019

The T1D Exchange QI Collaborative was formed in 2016 to accelerate quality improvement (QI) at clinics serving people with type 1 diabetes (T1D).
Through an evidence-based review and idealized design process, the collaborative chose seven process and outcome measures to be the focus of improvement activities directed at high-risk T1D patients (2 or more A1c values &gt;9% in the preceding year) aged 12-26 years. We report monthly aggregate statistics from seven Collaborative clinics for the measures and show the statistics for May and August 2018.
A substantial percent of patients meet high risk criteria across all centers, and there is wide variation in performance measures. No center has the capacity to report on all measures, but there are incremental improvements in data availability. Outcomes remain suboptimal, particularly in this high-risk population. These measures will be continuously tracked to define network progress and to design QI interventions to improve glycemic outcomes. The work of the Collaborative and the creation of a technology platform will improve reporting capacity and drive QI activities.

Disclosure
A.B. Cabrera: None. G.T. Alonso: None. S. Corathers: None. J.M. Lee: Consultant; Self; Taiho Oncology, Inc. P. Prahalad: None. N. Rioles: None.

Funding
The Leona M. and Harry B. Helmsley Charitable Trust
1267-P: Psychometric Development of a Multidimensional Patient-Reported Outcomes Questionnaire and Clinical Dialogue Platform for Routine Diabetes Care
Authors: SKOVLUND SOREN E. , NØRGAARD LISE MELLERGAARD , STEFANSEN SIMON , DE LICHTENBERG TRINE HONNENS , TROELSEN LISE , PIETRASZEK ANNA , KJÆR PERNILLE H. , LARSEN HANNE RAVN , JAKOBSEN POUL ERIK O. , EJSKJAER NIELS 
Published: June 2019

Aim: To develop a multi-dimensional Patient Reported Outcomes (PRO) questionnaire to improve person-centered care for type 1 and 2 diabetes across sectors in Denmark.
Methodology: A stepwise cross-regional multi-stakeholder multi-disciplinary co-development process was undertaken: 1) Patient-important PRO domains for value based diabetes care defined (ADA 2018), 2) Multi-sector strategy for active use of PRO to benefit People With Diabetes (PWD) and care quality 3) Conceptual measurement model and psychometric methodological foundation, 4) Literature review and mapping of PRO items/scales 5) Iterative item selection/testing and design of PRO dialogue tool 7) Qualitative, clinical and psychometric evaluation.
Results: The final e-PRO questionnaire (53-78 items) consisted of pre-existing/adapted items (from e.g., WHO-5, PROMIS-10, MDI, DSC-R) and newly developed global essence domain and single items covering: General health, social support, life stress, psychological well-being, symptom distress (neuropathic pain, heart, gastro-intestinal, sexual, sleep, fatigue, foot problems), diabetes well-being, worries, limitations and support, self-care, lifestyle and technology confidence, wishes for support, confidence in care access, medicine burden and satisfaction, blood sugar regulation (stability, moderate/severe hypoglycemia), preferred topics for next visit. Workshops and selective item testing (n=85) supported item acceptability and content coverage. A novel web dialogue tool with algorithms/resources to enable PWD and providers to interpret and follow-up on each PRO output was designed as part of the project.
Conclusions: A systematic collaborative process led to a new PRO questionnaire and dialogue tool for use in routine diabetes care. Research is now ongoing to validate scoring and evaluate benefits of real-world use of intervention for PWD, clinicians and payers.

Disclosure
S.E. Skovlund: Stock/Shareholder; Self; Novo Nordisk A/S. L. Nørgaard: None. S. Stefansen: None. T. Honnens de Lichtenberg: None. L. Troelsen: None. A. Pietraszek: None. P.H. Kjær: None. H. Ravn Larsen: None. P.O. Jakobsen: None. N. Ejskjaer: None.

Funding
Danish Health Care System
1288-P: The Association between CDSS Use and Diabetes Management
Authors: DAVLYATOV GANISHER , BAIDWAN NAVNEET KAUR , MEHTA TAPAN 
Published: June 2019

Research Objective: Healthcare providers’ decision-making can be aided by a computerized decision support system (CDSS) that might include alerts for drug allergies, checks for drug-drug interactions, and reminders for preventive screening tests. Over 30 million Americans suffer from diabetes. Diabetes prevalence and management success rates vary based on the patient’s age, gender, race, socioeconomic status, and location. The effectiveness of CDSS on overall patient outcomes haven’t been fully evaluated. This project aims to test the association between CDSS use and diabetic patients’ blood glucose level.
Study Design: We used FQHC annual report for the period 2014-2017. The outcome variable was the percentage of patients 18-75 years of age with diabetes who had hemoglobin (HbA1c) less than 8.0 percent during the measurement period. The independent variable was the use of CDSS. The study controlled for organizational and patient characteristics. To uncover the average effect of a covariance over the entire sample, generalized estimating equations model with state and year fixed effects was utilized.
Principal Findings: The use of CDSS at FQHCs was associated with 6.2 percent improvement in diabetic control (p=0.037). Moreover, 1 percent increase in patients with Medicare coverage was significantly associated with better diabetic control (0.36, p&lt;0.001). Likewise, an increase in patients with private insurance was associated with better diabetic control (0.13, p=0.003). Asian and Hispanics, compared to whites, were more likely to maintain their blood glucose at adequate levels (0.26, p&lt;0.001, and 0.07, p=0.008, respectively).
Conclusions: Study suggests the use of CDSS may lead to better health outcomes for patients with diabetes at FQHC. The findings of this study can help tailor treatment to vulnerable populations, inform funding agencies with respect to policies to incentivize and encourage FQHCs to adopt and use CDSS. Further, FQHC administrators can gain insight to make informed decisions to invest in CDSS.

Disclosure
G. Davlyatov: None. N. Baidwan: None. T. Mehta: None.
129-LB: Similar Efficacy, Safety, and Immunogenicity in People with Diabetes Using SAR341402 or Insulin Aspart: Gemelli 1 Study
Authors: GARG SATISH K. , WERNICKE-PANTEN KARIN , WARDECKI MAREK , KRAMER DANIEL , DELALANDE FRANCOIS , SHAH VIRAL N. , FRANEK EDWARD , SADEHARJU KARITA , MONCHAMP TRAVIS 
Published: June 2019

SAR341402 (SAR-Asp) was developed as a biosimilar/follow-on product to rapid-acting insulin NovoLog®/NovoRapid® (NN-Asp).
This 6-month randomized, controlled, open-label, phase 3 study compared efficacy and safety of SAR-Asp and NN-Asp in adults with type 1 diabetes (T1D) or type 2 diabetes (T2D) also using insulin glargine (GLA100) as basal insulin. In total 597 adults with diabetes were randomized (1:1; 497 with T1D, 100 with T2D) to a multiple daily injection regimen of SAR-Asp or NN-Asp along with using once daily GLA100. Glucose targets levels were &lt;180 mg/dL (2h-postprandial) and 80-130 mg/dL (fasting and pre-prandial) while avoiding hypoglycemia. Primary endpoint was HbA1c change (non-inferiority margin of 0.3%) from baseline to week 26 (tested for non-inferiority of SAR-Asp vs. NN-Asp). Immunogenicity was assessed by anti-insulin aspart antibody (AIA) status (positive/negative) and titers during the study.
SAR-Asp was non-inferior to NN-Asp for change in HbA1c, with similar insulin dosages. There was no difference in the percentage of patients reporting hypoglycaemia. Immunogenicity and safety profiles (adverse events, hypersensitivity events and injection site reactions) were similar for SAR-Asp and NN-Asp (Table).
We conclude that biosimilar/follow-on SAR-Asp is safe, effective and well-tolerated as insulin aspart in adults with T1D or T2D.

Disclosure
S.K. Garg: Advisory Panel; Self; Eli Lilly and Company, Roche Pharma, Sanofi-Aventis, Zealand Pharma A/S. Research Support; Self; Eli Lilly and Company, WebMD. K. Wernicke-Panten: Employee; Self; Sanofi-Aventis Deutschland GmbH. M. Wardecki: Employee; Self; Sanofi Research & Development. Stock/Shareholder; Self; Sanofi. D. Kramer: Employee; Self; Sanofi-Aventis Deutschland GmbH. Stock/Shareholder; Self; Sanofi-Aventis Deutschland GmbH. F. Delalande: None. V.N. Shah: Advisory Panel; Self; Sanofi US. Consultant; Self; Dexcom, Inc. E. Franek: Advisory Panel; Self; Boehringer Ingelheim International GmbH, Novartis AG, Novo Nordisk Inc. Speaker’s Bureau; Self; AstraZeneca, Bioton, Boehringer Ingelheim International GmbH, Medtronic, Novartis AG, Novo Nordisk Inc., Polfa Tarchomin S.A. K. Sadeharju: Research Support; Self; AstraZeneca, Bayer AG, ICON plc., Sanofi. T. Monchamp: Research Support; Self; Amarin Corporation, Novo Nordisk Inc., Sanofi, TrialNet.

Funding
Sanofi
1295-P: Economic Evaluation of Drug Combination Strategy for Type 2 Diabetes in China
Authors: GU SHUYAN , SHEN YI , SHI LIZHENG , DONG HENGJIN 
Published: June 2019

Introduction: There are multiple antidiabetic drugs for type 2 diabetes in China, which vary in efficacy and cost. Chinese guideline recommends a stepwise escalation treatment strategy in diabetes care which consists of 3 therapy lines; and using combination therapy of antidiabetic drug + metformin (MET) for patients failed on MET. This study aims to develop 10 alternative drug combination strategies and compare their cost-effectiveness.
Method: Based on Chinese guideline, 8 classes of antidiabetic drugs were included: 1st line drug (MET), 2nd line drug (α glycosidase inhibitor=AGI, sulfonylurea=SU, glinide=NIDE, DPP-4 inhibitor=DPP-4I, thiazolidinedione=TZD), 3rd line drug (insulin=INS, GLP-1 receptor agonist=GLP-1RA); 10 drug combination strategies were developed: use MET as 1st therapy line, one of the five 2nd line drug + MET as 2nd therapy line, one of the two 3rd line drug + MET as 3rd therapy line. From societal perspective, Cardiff model was used to estimate cost-effectiveness of 10 drug combination strategies vs. non-drug treatment. Clinical data on Chinese patients were obtained from systematic literature review and meta-analysis of 325 studies. Costs were obtained from claims database study of 1164 patients. Utilities were obtained from EQ-5D survey of 868 patients. Simulation was 40 years. Discount rate was 3%. Sensitivity analysis was performed.
Result: All drug combination strategies were cost saving (increase QALYs but save costs) vs. non-drug treatment. Ranking strategies by considering incremental QALY and cost, strategy 5b (MET, MET+NIDE, MET+INS) was optimal, followed by strategy 6b (MET, MET+NIDE, MET+GLP-1RA), strategy 3b (MET, MET+SU, MET+INS), strategy 1b (MET, MET+AGI, MET+INS), strategy 4b (MET, MET+SU, MET+GLP-1RA), strategy 2b (MET, MET+AGI, MET+GLP-1RA), strategy 7b (MET, MET+DPP-4I, MET+INS), strategy 10b (MET, MET+TZD, MET+GLP-1RA), strategy 8b (MET, MET+DPP-4I, MET+GLP-1RA), strategy 9b (MET, MET+TZD, MET+INS).
Conclusion: Strategy 5b is worthy of clinical use.

Disclosure
S. Gu: None. Y. Shen: None. L. Shi: None. H. Dong: None.
1299-P: The Paediatric Diabetes Service in England and Wales—An Improvement Journey
Authors: PENG MEGAN FENGMEI , WARNER JUSTIN , ROBINSON HOLLY , MUSZYNSKA KASIA , EARDLEY SUE , CAMPBELL FIONA M. 
Published: June 2019

The clear trajectory of improvement in paediatric diabetes outcomes in England and Wales since 2009 can be traced to a co-ordinated national programme of support for the 173 multi-disciplinary teams that care for 29,153 children and young people with diabetes and their families. With the introduction of a Best Practice Tariff in England by the Department of Health in 2011 and the National Paediatric Diabetes Audit (NPDA) alongside formation of 11 regional networks and an overarching national network, there has been a marked reduction in national median HbA1c levels from 73mmol/mol in 2009 to 64mmol/mol in 2017. To maintain momentum towards achieving further improvement and build on existing progress demonstrated by the NPDA and Patient Reported Experience Measures, a new way to engage teams and their host organisations has been developed. A National Children and Young People’s Diabetes Quality Programme encompassing peer review, self-assessment and quality improvement collaborative has been established to close the audit loop and provide teams with the support and tools to identify, design and analyse their own interventions specific to the needs of the children and young people they care for. The aim is to drive sustainable development of paediatric diabetes services in England and Wales and help bring transformative improvements to the wellbeing and care of children and young people with diabetes and their families for the future.

Disclosure
M.F. Peng: None. J. Warner: None. H. Robinson: None. K. Muszynska: None. S. Eardley: None. F.M. Campbell: None.
130-LB: Comparative PK and PD of the Rapid-Acting Insulin Aspart Product SAR341402, NovoLog, and NovoRapid in Subjects with T1D
Authors: KAPITZA CHRISTOPH , NOSEK LESZEK , LEHMANN ANNE , SCHMIDER WOLFGANG , ROTTHAEUSER BAERBEL , NOWOTNY IRENE K. 
Published: June 2019

SAR341402 (SAR-Asp), NovoLog (NN-Asp-US) and NovoRapid (NN-Asp-EU) are rapid-acting insulin aspart products.
Exposure (PK) to and activity (PD) of SAR-Asp (T) NN-Asp-US (R1) and NN-Asp-EU (R2) were compared in a single-center, randomized, double-blind, 3-treatment, 3-period, crossover, euglycemic clamp study. Thirty male T1D subjects (22-59 years) were randomized to receive 0.3 U/kg T, R1 and R2 in separate periods; 29 subjects completed all 3 treatment periods. PK and PD (Glucose Infusion Rate, GIR) by euglycemic clamp were assessed up to 12 hours.
Mean concentration and body weight standardized GIR vs. time profiles for T, R1 and R2 were similar. Exposure to and activity of T, R1 and R2 were similar between treatments, as the 90% CIs for the treatment ratios for the primary and main secondary PK and PD endpoints were within the predefined acceptance range (0.80-1.25) (Table). Within-subject variability of exposure and activity was low across the 3 clamps, indicating high day-to-day reproducibility in clamp performance, irrespective of the individual product. Adverse events were similar for T, R1 and R2. No safety concerns were noted in laboratory, vital signs, or ECG data.
In summary, this study demonstrated similar insulin aspart exposure profiles and PD activity for SAR-Asp to NN-Asp-US and NN-Asp-EU and between NN-Asp-US and NN-Asp-EU, rendering SAR-Asp a biosimilar/follow-on product.

Disclosure
C. Kapitza: Research Support; Self; ADOCIA, Biocon, Boehringer Ingelheim Pharmaceuticals, Inc., Dance Biopharm Holdings Inc., Eli Lilly and Company, Gan & Lee Pharmaceuticals, MedImmune, Mylan, Nestlé, Nordic Bioscience, Novo Nordisk A/S, Poxel SA, Sanofi-Aventis, Wockhardt, Xeris Pharmaceuticals, Inc., Zealand Pharma A/S. L. Nosek: None. A. Lehmann: Employee; Self; Sanofi-Aventis Deutschland GmbH. W. Schmider: Employee; Self; Sanofi. B. Rotthaeuser: Employee; Self; Sanofi. Stock/Shareholder; Self; Sanofi. I.K. Nowotny: Employee; Self; Sanofi-Aventis Deutschland GmbH. Stock/Shareholder; Self; Sanofi.

Funding
Sanofi