bluuebunny/crossref_metadata_2025_split huggingface dataset:
1268-P: Evaluation of Inpatient Insulin Dose Requirements and Glycemic Control of Patients Using U-500 Regular Insulin Prior to Admission
Authors: ZADEH PARIA SANATY , LUTZ MARK F. , FELEKE AFOMIA A. 
Published: June 2019

Objective: Questions remain regarding the appropriate use of U-500 insulin particularly, in the hospital setting. The objective of this study was to evaluate the inpatient insulin dose requirements and glycemic control of patients using U-500 insulin prior to admission.
Methods: A retrospective chart review of adult patients using U-500 insulin prior to admission to Beaumont Hospitals between March 2012 and July 2017 was conducted. Inpatient insulin dose requirements and glycemic control were compared between those who were continued on U-500 insulin and those transitioned to a U-100 insulin regimen.
Results: A total of 95 patients were included in the study. Seventeen patients were continued on U-500 insulin while the remaining 78 received U-100 insulin during their inpatient stay. U-500 insulin group received significantly more units of insulin per day (181 units versus 99.65 units; p = 0.0048). However, the proportion of insulin administered inpatient relative to the prior to admission dose was similar between the two groups (59% in the U-500 group and 46% in U-100 group; p = 0.1344). Glycemic control was similar between the groups except for significantly more hypoglycemia events in the U-500 group compared to the U-100 group (p &lt; 0.0001). When patients were further stratified by prior to admission dose or HbA1c, significantly more hypoglycemia was observed in the U-500 group with HbA1c &lt; 8% and those with prior to admission dose between 300-600 units.
Conclusions: Our retrospective review demonstrated that only very few patients were continued on a U-500 insulin regimen during their hospitalization. Inpatient use of U-500 insulin posed higher risk of hypoglycemia even when used at much lower doses than the established home regimen. Continued use of U-500 insulin in the hospital requires careful assessment of the risks and further investigation is needed to determine the appropriate dosing.

Disclosure
P. Sanaty Zadeh: None. M.F. Lutz: None. A.A. Feleke: None.
1269-P: Assessing the Performance of the UKPDS 82 Risk Equations to Predict Cardiovascular Events in the DECLARE-TIMI 58 Trial Population
Authors: MCEWAN PHILIP , FOOS VOLKER , BENNETT HAYLEY , KARTMAN BERNT , EDMONDS CHRISTOPHER , GAUSE-NILSSON INGRID ANNA 
Published: June 2019

Risk equations (RE) from the UK Prospective Diabetes Study (UKPDS) remain the most commonly used within economic models of type 2 diabetes mellitus (T2DM). However, clinical practice has evolved since UKPDS reported and the applicability of these RE to contemporary T2DM patients is uncertain. The Dapagliflozin Effect on Cardiovascular Events (DECLARE)-TIMI 58 trial assessed cardiovascular (CV) outcomes in a broad T2DM population treated with dapagliflozin (DAPA) versus placebo (PLA). This study aimed to assess the performance of the UKPDS 82 RE in the DECLARE-TIMI 58 population. RE for myocardial infarction (MI), heart failure (HF) and stroke were applied to baseline characteristics and 12-month effects of DAPA versus PLA on HbA1c, weight and blood pressure from DECLARE-TIMI 58. Predicted annual probabilities were converted to event rates per 1,000-person years and associated relative risks (RR) for DAPA versus PLA derived for comparison to trial outcomes. Due to misalignment of the UKPDS and DECLARE-TIMI 58 endpoints, predictions of congestive heart failure were compared to observed incidence of hospitalization for HF and stroke to ischemic stroke, respectively. Predicted (study reported) rates per 1,000 person years for MI, HF and stroke were 8.15 (11.7), 2.47 (6.20) and 3.28 (6.90) for DAPA, and 8.53 (13.2), 2.59 (8.50) and 3.46 (6.80) for PLA. Predicted RR of MI, HF and stroke for DAPA versus PLA were 0.96, 0.95, 0.95, respectively, compared to reported hazard ratios of 0.89 (95% CI: 0.77, 1.01), 0.73 (0.61, 0.88) and 1.01 (0.84, 1.21) in DECLARE-TIMI 58. UKPDS 82 RE did not predict the reduction in CV events demonstrated for DAPA versus PLA based on risk factor improvements observed in DECLARE-TIMI 58. These findings add to a growing body of evidence that suggests the CV effects of sodium-glucose co-transporter inhibitors such as DAPA cannot be fully described via treatment-induced changes in conventional prognostic factors.

Disclosure
P. McEwan: Consultant; Self; AstraZeneca. Employee; Self; Health Economics and Outcomes Research Ltd. V. Foos: Employee; Self; Health Economics and Outcomes Research Ltd., IQVIA. H. Bennett: Consultant; Self; AstraZeneca. Employee; Self; Health Economics and Outcomes Research Ltd. B. Kartman: Employee; Self; AstraZeneca. Stock/Shareholder; Self; AstraZeneca. C. Edmonds: Employee; Self; AstraZeneca. I.A. Gause-Nilsson: Employee; Self; AstraZeneca.

Funding
AstraZeneca
1292-P: Projected Long-Term Clinical Benefit and Cost-Effectiveness of Empagliflozin Compared with Glimepiride in Patients with Type 2 Diabetes in China
Authors: LAMOTTE MARK , SALEM AHMED , METTAM SAM R. , USTYUGOVA ANASTASIA V. , ZHANG EDMUND , RAMOS MAFALDA 
Published: June 2019

In a 4-year clinical trial in patients with type 2 diabetes (T2D), uncontrolled by metformin alone, limepiride showed a higher occurrence of cardiovascular death, non-fatal myocardial infarction (MI) and stroke compared to empagliflozin. The current modelling study aimed to extrapolate lifelong the results of the 4-year study and to assess the cost-effectiveness of empagliflozin versus glimepiride in China.
The IQVIA Core Diabetes Model, a well-established model, was calibrated to reproduce the 4-year outcomes of the trial for both arms. Baseline characteristics and observed effects on physiological parameters (HbA1c, BMI, blood pressure, lipids) were used as inputs. The effects of the trial were applied up until treatment switch (reaching HbA1c of 8.5%) after which the UKPDS82 risk equations predicted events based on physiological parameters. Insulin-glimepiride was the next line therapy after reaching an HbA1c of 8.5%. The Chinese payer’s perspective was taken. Discounting of 3% was applied.
CDM projected 11.414 and 11.137 quality-adjusted life-years (QALYs) and 42,802 USD and 42,620 USD total lifetime costs for empagliflozin and glimepiride, respectively. The incremental cost-effectiveness ratio of empagliflozin versus glimepiride was 659 USD/QALY. On average 8% of cardiovascular events can be avoided.
In patients with T2D, uncontrolled with metformin, empagliflozin has the potential to reduce the risk of cardiovascular events for a good cost-effectiveness versus glimepiride.

Disclosure
M. Lamotte: Employee; Self; IQVIA. Employee; Spouse/Partner; Janssen Research & Development. A. Salem: None. S.R. Mettam: Employee; Self; Boehringer Ingelheim International GmbH. A.V. Ustyugova: Employee; Self; Boehringer Ingelheim International GmbH. E. Zhang: Employee; Self; Boehringer Ingelheim China. M. Ramos: Employee; Self; IQVIA.

Funding
Boehringer Ingelheim Pharma GmbH
1308-P: Improved Transition in Young Adults with Diabetes: A Pragmatic Clinical Trial
Authors: BUTALIA SONIA , MCGUIRE ASHLEE , CRAWFORD SUSAN , DYJUR DAVE , MERCER JULIA , PACAUD DANIÈLE 
Published: June 2019

Background: The transition from pediatric to adult diabetes care is a vulnerable period for youth with diabetes. During transition, youth with diabetes are at high risk for loss to follow-up, worsening glycemic control, and increased hospitalizations.
Objective: Our objective was to assess the effect of a technology enhanced transition coordinator on loss to follow-up in youth with diabetes transitioning from pediatric to adult diabetes care.
Methods: This open label, pre-post pragmatic clinical trial, assessed the effect of a technology enhanced transition coordinator in transitioning young adults with diabetes from pediatric to adult diabetes care. Our primary outcome was the rate of loss to follow-up defined as no outpatient diabetes appointments in the one year following transfer. The usual care (control) cohort were youth with diabetes who received usual care (i.e., transition preparation during pediatric diabetes appointments prior to transfer). The intervention cohort received the usual care and had a transition coordinator who assisted them through the transition period with regular, per protocol contact, by texting, emailing, Twitter®, and/or postings on a private Facebook® page.
Results: Baseline average hemoglobin A1c was not different between the intervention cohort [number (n) = 101, 47.5% females] versus the usual care cohort (n= 209, 49.3% female) [8.9 ± 2.0 standard deviation (SD) versus 9.1 ± 2.4 SD, p=0.28] in the year prior to transfer. In the year following transfer, 49.3% of young adults in the usual care cohort versus 11.8% of young adults in the intervention group did not attend any outpatient diabetes appointments (p&lt; 0.01) in the year following transfer.
Conclusions: Our technology enhanced transition coordinator intervention was successful in reducing loss to follow-up in transitioning young adults with diabetes. Importantly, this program used simple readily accessible technologies which increases the transferability and sustainability of this intervention.

Disclosure
S. Butalia: None. A. McGuire: None. S. Crawford: None. D. Dyjur: None. J. Mercer: None. D. Pacaud: Other Relationship; Self; Novo Nordisk A/S, Sandoz, TOLMAR.

Funding
Lawson Foundation
1342-P: Development of Type 2 Diabetes (T2D) in Obese Adolescent Girls with Polycystic Ovary Syndrome (PCOS)
Authors: HUDNUT-BEUMLER JULIA , KAAR JILL , PYLE LAURA , KELSEY MEGAN M. , NADEAU KRISTEN J. , ZEITLER PHILIP , CREE-GREEN MELANIE 
Published: June 2019

PCOS is a common endocrine disorder that starts in adolescence and, when accompanied by obesity, is associated with a 4-fold risk of T2D. Adolescent onset of T2D carries significant morbidity and decreased life expectancy; rates of T2D are 12.5 cases/100,000/year in the general youth population. The incidence and prevalence of T2D in teen girls with PCOS and obesity are unknown. We conducted a retrospective chart review at a large tertiary care center. Using ICD9/10 codes for PCOS, girls aged 11-21 years with clinic visits between 7/1/2013-8/15/2018 and a BMI %ile &gt; 85th were identified. Diagnosis of PCOS and T2D were confirmed using Endocrine Society and ADA guidelines, respectively. Key demographic and diagnostic information, including time of T2D diagnosis relative to PCOS diagnosis, was extracted. Prevalence of T2D in the PCOS cohort was calculated 1) from the entire T2D cohort and 2) only the incident T2D cases, as our site may have excess new T2D diagnosis referrals. We identified 600 cases of PCOS (15.2 ± 1.8 years, BMI %ile 96.2 ± 12.1) and 54 of these also had T2D, of whom 23 were diagnosed with PCOS prior to T2D (incident cohort). The prevalence of T2D in girls with PCOS and overweight/obesity was 4% including only incident cases and 9% with inclusion of all T2D. The incidence of T2D among adolescents with obesity and PCOS is 129 cases/1000/year and T2D presents 26 ± 19 months after PCOS diagnosis. Girls with T2D were more likely to be Hispanic (67% vs. 49%; p&lt;0.0001) have obstructive sleep apnea (32% vs. 17%; p=0.01) and a 1st-degree relative with T2D (56% vs. 22%; p&lt;0.001) than those who didn’t develop T2D. Girls with PCOS and obesity are at high-risk for developing T2D in adolescence, with 1 in 23 developing T2D within 2 years of diagnosis with PCOS. Girls at higher risk include those with a strong family history of T2D and Hispanic ethnicity. Further work is needed to confirm these rates in the overall adolescent population and to develop strategies for prevention of T2D in these high-risk youth.

Disclosure
J. Hudnut-Beumler: None. J. Kaar: None. L. Pyle: None. M.M. Kelsey: None. K.J. Nadeau: None. P. Zeitler: Consultant; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Janssen Research & Development, Merck & Co., Inc., Novo Nordisk Inc. M. Cree-Green: None.

Funding
National Institute of Diabetes and Digestive and Kidney Diseases (K23DK107871)
135-OR: A Novel Thiazolidinedione (TZD) with Minimal PPAR-γ Activity Maximized for Mitochondrial Pyruvate Carrier (MPC) Modulation: Six-Month Analysis of Glycemia in a 12-Month Nonalcoholic Steatohepatitis (NASH) Study
Authors: CUSI KENNETH , KOLTERMAN ORVILLE G. , HARRISON STEPHEN A. , DITTRICH HOWARD C. 
Published: June 2019

The MPC facilitates entry of pyruvate into the Krebs cycle and in the setting of over nutrition, is critical to adverse manifestations including T2D and NASH. MSDC-0602K is a novel insulin sensitizer engineered to modulate pyruvate utilization with minimal ppar-γ activity. The EMMINENCE study is examining its effects on NASH and glycemia. U.S. sites (57) enrolled 402 patients with liver biopsy evidence of NASH and fibrosis; &gt;50% of subjects with T2D (not taking insulin/pioglitazone) with entry HbA1c ≤ 9.5%. Randomization was 1:1:1:1 to daily oral doses of MSDC-0602K (62.5, 125, and 250mg) or placebo. Safety and glycemia were examined when 328 subjects reached 6 mo visit: 59% female, median age 57, 52% diabetic. (See Table) No meaningful changes in lipids, heart rate or BP were noted. The % of subjects reporting 1 or more adverse events was equal across all 4 cohorts. Importantly, the frequency of peripheral edema was 11% at baseline and unchanged across cohorts at 6 months. MSDC-0602K shows potent effects on glycemic control parameters and insulin sensitization with modest expected weight gain and no evidence of peripheral edema at 6 months, a key ppar-γ related side effect of first generation TZDs. This drug shows promise for glycemic control in NASH patients with T2D/insulin resistance.

Disclosure
K. Cusi: Consultant; Self; Allergan, AstraZeneca, Genentech, Inc., Novo Nordisk Inc., Poxel SA, ProSciento. Research Support; Self; Cirius Therapeutics, Echosens, Eli Lilly and Company, Inventiva Pharma, Janssen Research & Development, Novartis AG, Novo Nordisk Inc. O.G. Kolterman: Advisory Panel; Spouse/Partner; Intarcia Therapeutics, Inc. Advisory Panel; Self; Zafgen, Inc. Board Member; Self; American Diabetes Association, GlySens Incorporated, Viacyte, Inc. Consultant; Self; ADOCIA, Cirius Therapeutics Inc, DiaVacs Inc, JDRF, Nanoprecisionmedical, NuSirt Biopharma, Inc., Renova Therapeutics, Sensulin, LLC. Employee; Self; Whole Biome Inc. Stock/Shareholder; Self; Corcept Therapeutics, GI Therapeutics, Xeris Pharmaceuticals, Inc. Other Relationship; Spouse/Partner; American Diabetes Association. S.A. Harrison: Advisory Panel; Self; Gilead Sciences, Inc. H.C. Dittrich: Employee; Self; Cirius Therapeutics.
1353-P: Baseline Assessment of Transition Preparedness in Youth with Type 1 Diabetes
Authors: KRISHNA KANTHI BANGALORE , REALL MACY 
Published: June 2019

Background: Transition planning should start early and topics covering healthcare navigation and autonomy be discussed, however, whether this is consistently implemented is unclear. At our center, we are working on implementing transition readiness classes to better prepare our youth (age 16-19) for transitioning care. A standardized questionnaire assessing transition readiness (Table 1) was administered prior to attending this class.
Results: n=21. ∼60% of subjects stated that they were unprepared or neither prepared nor unprepared. Figure 1 shows the subject’s perspective of their transition readiness.
Discussion: There are clear deficits in several key aspects of healthcare navigation and autonomy. These findings support the need for a structured transition program which should include periodic assessments of transition readiness.

Disclosure
K. Bangalore Krishna: None. M. Reall: None.
136-LB: Effective Treatment of T2D Patients Uncontrolled on Multiple Diabetes Medications by Adding Afrezza Mealtime Ultra-Rapid Insulin
Authors: LEVIN PHILIP , BROMBERGER LEE A. , BRUCE SIMON R. 
Published: June 2019

Fourteen T2D subjects in a real-world practice setting, uncontrolled on oral/injectable combo therapy (mean A1C 9%), received inhaled human insulin (INH-Afrezza), added to current therapy and titrated weekly for up to 12 weeks. A1C and 2-week continuous glucose monitoring (CGMS) profiles (Libre Pro) were collected at baseline and after 3 months.
All subjects started INH 4 units (u) prior to each meal and titrated rapidly to 12 u/meal over 9 days. Thereafter, INH was adjusted for each meal once weekly, based on PPG at 2-2.5 hours measured on days 1 and 2 of each week, as follows: Add 4 u if PPG &gt; 160 mg/dl, no change if PPG 90-160 mg/dl and decrease by 4 u if PPG &lt; 90 mg/dl. More than 1/2 of subjects were taking basal insulin.
Addition of the only available inhaled ultra-rapid rapid mealtime insulin (Afrezza) lowered glucose safely in patients with T2D inadequately controlled on oral and/or injectable therapy. Initiation and titration, following a simple algorithm, resulted in significant A1c reduction (-1.6%, p&lt;.0001), a decrease in mean daily glucose (∼50 mg/dl), and a 76% increase in time-in-range on CGMS, with no significant increase in hypoglycemia (Time&lt;70 mg/dL). No severe hypoglycemia occurred. Final mealtime Afrezza doses achieved were 18, 16 and 20 u at breakfast, lunch, dinner respectively.

Disclosure
P. Levin: Research Support; Self; MannKind Corporation, Novartis AG, Novo Nordisk Inc. Speaker’s Bureau; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Janssen Pharmaceuticals, Inc., Lilly Diabetes, Merck & Co., Inc., Sanofi. L.A. Bromberger: None. S.R. Bruce: Consultant; Self; Dance Biopharm Holdings Inc., MannKind Corporation, Oramed Pharmaceuticals.

Funding
MannKind Corporation
1401-P: Universal vs. Selective Screening for Hyperglycemia First Diagnosed during Pregnancy, Including Early Hyperglycemia: Diagnostic and Prognostic Value in 4,518 Women
Authors: COSSON EMMANUEL , VICAUT ERIC , BANON DORIAN SANDRE , CUSSAC-PILLEGAND CAMILLE , BAUDRY CAMILLE , VALENSI PAUL , CARBILLON LIONEL 
Published: June 2019

The aim of the study was to evaluate the prevalence of hyperglycemia first diagnosed during pregnancy (Hgly), including gestational diabetes mellitus appearing early (eGDM) or after 22 weeks of gestation (GDM) or diabetes in pregnancy (DIP) and their prognosis whether women had risk factors (RFs) for Hgly or not. We included the women without known diabetes who had in our department (2012-2016) a universal screening (first: FPG measurement in early pregnancy, with immediate care without any further screening in women with eGDM or early DIP; second: OGTT after 22 WG in the other women). We considered 4 mutually exclusive groups of women according to the presence of Hgly and of RFs according to our national guidelines (maternal age ≥ 35 years or pregravid overweight or family history of diabetes or personal history of Hgly or of macrosomic infant). We considered a predefined composite endpoint (preeclampsia or large for gestational age infant or shoulder dystocia). We included 4518 women, of whom 23.5% had Hgly (eGDM 10.4%, GDM 12.2% and DIP 0.9%) and 71.1% had ≥1 RF. The four groups were: Hgly-RF- (n=1144), Hgly-RF + (n=2313), Hgly+RF - (n=163), Hgly+RF+ (n=898). Hgly was more frequent in those with RFs (OR 2.7 [95% CI 2.3-3.3]). The incidence of the composite criterion differed (p&lt;0.0001) across groups: Hgly-RF- 6.3%; Hgly+RF- 8.6%; Hgly-RF + 13.2%; Hgly+RF+ 17.1% (Hgly effect p&lt;0.05, RFs effect &lt;0.001, interaction Hgly.RF p=0.94) and increased with the number of RFs (no RF: 6.3%/1: 10.8%/2: 14.7%/3: 28.0% and 4-5: 25.0%; p&lt;0.0001). Our observational study shows that a selective screening during pregnancy leads to misdiagnose 15.3% of HGly and that the women with treated Hgly but no RF have however a very good prognosis. On the contrary, women with RFs have a poor prognosis whatever their glycemic status, suggesting that early management for women with overweight -the only modifiable RF here- might be useful to improve outcomes.

Disclosure
E. Cosson: Board Member; Self; Abbott, Boehringer Ingelheim Pharmaceuticals, Inc., LifeScan, Inc., Lilly Diabetes, Medtronic, Merck Sharp & Dohme Corp., Novartis France, Novo Nordisk A/S, Roche Diagnostics France, Sanofi. Research Support; Self; Air Liquide, Lilly Diabetes, Novo Nordisk A/S, Roche Diagnostics France, Roche Foundation, Sanofi. E. Vicaut: Consultant; Self; Abbott, Bristol-Myers Squibb Company, Lilly Diabetes, Novartis France, Pfizer Inc., Pierre FABRE, Roche Pharma. D. Sandre Banon: None. C. Cussac-Pillegand: None. C. Baudry: None. P. Valensi: None. L. Carbillon: None.

Funding
Lilly France; Roche Diagnostics France
1434-P: Definition of Hypertriglyceridemia during Pregnancy: A Search on the Cutoffs
Authors: CHEN SAIGE , LI HUNG-YUAN 
Published: June 2019

Objective: A high plasma triglyceride (TG) concentration during pregnancy is associated with adverse pregnancy outcomes. It is important to define a cutoff to initiate interventions. Since it remains unknown if there is a threshold, our aim is to explore the cutoff values of plasma TG in the first and second trimesters.
Research Design and Methods: A prospective cohort study was conducted which included 837 pregnant women. Fasting plasma TG were measured in the first and second trimesters and were divided into seven categories according to its percentile, respectively. The presence of adverse pregnancy outcome was defined if anyone of the following condition developed, including gestational diabetes mellitus (GDM), pregnancy-induced hypertension (PIH), preeclampsia, preterm delivery, and large for gestational age (LGA).
Results: For the relationship between plasma TG and adverse pregnancy outcomes, there was a threshold between the highest and the second-highest categories in the first and second trimesters. The adjusted odds ratios (95% confidence interval) of adverse pregnancy outcomes for the 7 categories were 1, 0.75 (0.28-1.96), 1.46 (0.59-3.59), 1.83 (0.74-4.51), 1.19 (0.48-2.95), 1.11 (0.43-2.86), and 3.34 (1.35-8.25) for plasma TG in the first trimester, and 1, 1.81 (0.82-4.02), 2.07 (0.94-4.57), 2.50 (1.15-5.46), 2.19 (1.00-4.80), 2.14 (0.97-4.71), and 3.53 (1.62-7.69) for plasma TG in the second trimester. Using the threshold as the cutoff values, women with high plasma TG concentrations in the first trimester or second trimesters were associated with increased risk for adverse pregnancy outcomes (≥150 mg/dL in the first trimester, OR 2.75, 95% CI 1.45-5.24, p = 0.002; ≥246 mg/dL in the second trimester, OR 1.78, 95% CI 1.11-2.85, p = 0.017).
Conclusions: There are inflection points for plasma TG in the first and second trimesters. The risk of adverse pregnancy outcomes increase significantly if plasma TG exceed this point, which may also be a cutoff to initiate interventions in the future.

Disclosure
S. Chen: None. H. Li: None.