bluuebunny/crossref_metadata_2025_split huggingface dataset:
SELECTIVE TRACE LEVEL DETERMINATION OF 1,4-DIOXANE CONTENT IN SODIUM LAURETH SULFATE RAW MATERIAL BY GAS CHROMATOGRAPHIC-FLAME IONIZATION DETECTION METHOD
Authors: RAO KATAKAM LAKSHMI NARASIMHA , DONGALA THIRUPATHI 
Published: June 2020

Objective: The study spotlights on a new gas chromatographic (GC) method with flame ionization detection technique that has been developed and validated for the selective determination of 1,4-dioxane content in sodium laureth sulfate (SLS), raw material.
Methods: The method was developed using a Thermo Scientific TR-1 (30 m×0.25 mm×1.0 μm) column with a carrier gas used as helium. The diluent used as purified water and the flow pressure of the carrier gas is 9.0 psi with a split ratio of 1:5. The optimized method was validated as per the ICH Q2 guidelines.
Results: Regression analysis confers a correlation coefficient for the stated compounds that are found to be greater than 0.999. The limit of quantitation and limit of detection are established at a sensitive determination level of 9 ppm and 3 ppm, respectively.
Conclusion: The validated and rugged GC method developed for the determination of 1,4-dioxane using a specific GC method in the SLS raw material. The recovery results prove the sound judgment in the determination of accuracy toward its evaluation. Hence, the validated analytical method was specific, selective, economical, and accurate for the determination of 1,4-dioxane by gas chromatographic method with flame ionization detection technique.
FORMULATION AND EVALUATION OF TRANSDERMAL FILMS CONTAINING CELECOXIB INCLUSIONS FOR TREATING PSORIATIC ARTHRITIS
Authors: J MANASA , G SAI KUMAR , IRIVENTI PADMINI 
Published: June 2020

Objective: The main objective of the present work was to prepare and evaluate transdermal films and creams of celecoxib inclusions which are nonsteroidal anti-inflammatory drug to treat psoriatic arthritis.
Methods: Celecoxib inclusions were prepared using β-cyclodextrin to increase the solubility. These inclusions were incorporated in transdermal films. Hydroxy Propyl Methyl Cellulose (HPMC), dibutyl phthalate, propylene glycol, and glycerin were used to prepare the film. Fourier transform infrared and differential scanning calorimetry studies were carried out for pure celecoxib and inclusions. Morphological properties, weight variation, surface pH, percentage elongation, folding endurance, in vitro disintegration, and in vitro diffusion studies were carried out for films.
Results: All the results obtained were within the limits and confirmed the prolonged drug release and increased solubility of celecoxib inclusions.
Conclusion: From the results obtained, increase in solubility of celecoxib drug was confirmed by forming inclusions using β-CD as polymer.
PREFORMULATION STUDIES OF PILOCARPINE HYDROCHLORIDE AS NIOSOMAL GELS FOR OCULAR DRUG DELIVERY
Authors: JAIN NEELAM , VERMA ANURAG 
Published: June 2020

Objective: Pilocarpine hydrochloride is a direct acting cholinergic parasympathomimetic agent which directly stimulates cholinergic receptor (M3). It is a drug used in the treatment of chronic open-angle glaucoma for over 100 years. Designing a new ophthalmic dosage form for pilocarpine hydrochloride compels performing preformulation studies for drug. Therefore, the current aim of the study was to investigate some of the important physicochemical properties of pilocarpine hydrochloride which can help to select subsequent approaches during the development of niosomal gel for ocular use.
Methods: Preformulation studies of drug were carried out for identification (physical appearance, melting point, and UV spectrophotometric analysis), solubility profile, lipophilicity (partition coefficient), compatibility studies by Fourier-transform infrared (FTIR) spectroscopy, and thermal behavior by differential scanning calorimetry (DSC).
Results: The melting point of pilocarpine hydrochloride was found to be 204 ± 3○C. The log P value was found to be 1.12 ± 0.02, from which it can be interpreted that drug is highly hydrophilic in nature. The scanned λmax was found to be 215 nm. No significant changes were found when FTIR spectra of physical mixture compared with FTIR spectra of pure drug and excipients. This indicates absence of any possible interaction between the drug and excipients which confirms the identity and purity of drug. DSC thermogram of pure drug showed a sharp exothermic peak at 191.923○C (area=68.890 mJ, delta H = 22.963 J/g), indicating the crystal melting point of the drug.
Conclusion: These results suggest that the pilocarpine hydrochloride serves as suitable candidate for ocular drug delivery system.
DYSMENORRHEA AMONG FEMALE MEDICAL SCIENCES STUDENTS IN MACHS: PREVALENCE, PREDICTORS AND OUTCOME
Authors: KANNAN LATHA S , EG HASSAN , Lewis Sharell , Sivapalan Nisha , CASINGAL BERNADETTE , RM PALANIVEL 
Published: June 2020

Objective: This study intended to determine the prevalence, predictors, and outcome of dysmenorrhea among female medical sciences students at Mohammed Al-Mana College for Medical Sciences (MACHS), Dammam, Saudi Arabia.
Methods: A cross-sectional study was adopted, and 292 female medical sciences students of MACHS were selected using stratified random sampling. A semi-structured and self- administrated questionnaire was used to collect personal and socio-demographic information from the selected female medical sciences students. The information about the menstrual history, stress, and smoking were also gathered. The data analysis was carried out using the descriptive statistics and Chi-square test.
Results: The prevalence of dysmenorrhea was 73.28% among female medical sciences students. Concerning the signs and symptoms of dysmenorrhea, the abdominal pain was predominant symptoms among 73.28% of the respondents, and it was found to be statistically significant (p≤0.05). Sleep disturbance was observed as the prominent outcome of dysmenorrhea, as reported by 64% of the respondents.
10-LB: Dasiglucagon Ameliorates Postprandial Hypoglycemia after Roux-en-y Gastric Bypass
Authors: NIELSEN CASPER K. , OEHRSTROEM CAROLINE , KIELGAST URD , HANSEN DORTE L. , LUND ASGER , VILSBØLL TINA , KNOP FILIP K. 
Published: June 2020

Introduction: Postprandial hypoglycemia is a frequent and debilitating complication following Roux-en-Y gastric bypass (RYGB) without effective treatments. In a proof-of-concept study, we investigated the effects of dasiglucagon, a novel, stable glucagon analog, on postprandial hypoglycemia after RYGB.
Methods: Ten RYGB-operated individuals with confirmed symptomatic postprandial hypoglycemia (plasma glucose concentration (PG) &lt;3.5 mmol×L-1) completed a randomized crossover study consisting of three study days each including a standardized liquid mixed meal test (25 kJ per kg body mass; 50% carbohydrates, 35% fat and 15% protein). A subcutaneous injection of either placebo, 80 or 200 µg dasiglucagon (D80µg and D200µg) was administered after the postprandial PG peak, ten minutes before the projected time point where PG returned to fasting levels, using a subject-specific linear regression model. Blood sampling and assessment of hypoglycemic symptoms (Edinburgh Hypoglycemia Symptom Scale) were performed at fixed time intervals. Data were analyzed using linear mixed models and Tuckey’s corrections model for multiple comparisons.
Results: Compared with placebo, treatment with both D80µg and D200µg significantly increased nadir PG (placebo: 3.0±0.2 mmol×L-1; D80µg: 3.9±0.3 mmol×L-1; D200µg: 4.5±0.2 mmol×L-1; P=0.002 and P=0.0002) and PG incremental area under the curve (iAUC70-240min) after drug administration (placebo: 752±19 mmol×L-1×min; D80µg: 917±22 mmol×L-1×min; D200µg: 992±28 mmol×L-1×min; P&lt;0.0001 and P&lt;0.0001). Moreover, both doses reduced time spent in hypoglycemia (&lt;3.9 mmol×L-1) (placebo: 62.0±8 min; D80µg: 27.5±12 min; D200µg: 14.0±9 min; P=0.05 and P=0.003). There were no significant changes in hypoglycemic symptoms between the three study days.
Conclusion: Administration of dasiglucagon effectively ameliorates postprandial hypoglycemia representing a promising new therapeutic option for management of postprandial hypoglycemia after RYGB.

Disclosure
C.K. Nielsen: None. C. Oehrstroem: None. U. Kielgast: None. D.L. Hansen: None. A. Lund: Speaker’s Bureau; Self; AstraZeneca, Novo Nordisk A/S, Sanofi. T. Vilsbøll: Advisory Panel; Self; AstraZeneca, Mundipharma International, Novo Nordisk A/S, Sun Pharmaceutical Industries Ltd. Consultant; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Lilly Diabetes, Medscape, Merck Sharp & Dohme Corp., Sanofi. F.K. Knop: Advisory Panel; Self; AstraZeneca, Merck Sharp & Dohme Corp., Mundipharma International, Novo Nordisk A/S, Sanofi. Consultant; Self; Carmot Therapeutics, Inc., Eli Lilly and Company, Novo Nordisk A/S. Research Support; Self; AstraZeneca, Gubra, Novo Nordisk A/S, Sanofi, Zealand Pharma A/S. Speaker’s Bureau; Self; AstraZeneca, Lupin Pharmaceuticals, Inc., Merck Sharp & Dohme Corp., Norgine B.V., Novo Nordisk A/S.
10-OR: Implementing CGM with a Family Behavioral Intervention (FBI) Reduces Psychosocial Distress in Parents of Children 2-8 Y/O: A Pre–Post Comparison
Authors: COMMISSARIAT PERSIS V. , KANAPKA LAUREN , MILLER KELLEE , HILLIARD MARISA E. , ANDERSON BARBARA , DIMEGLIO LINDA , LAFFEL LORI M. 
Published: June 2020

Parents of young children with T1D face daily psychosocial stressors that may be mitigated or worsened by the use of diabetes technologies. We assessed psychosocial functioning in parents before and after beginning CGM supported by a FBI in youth 2-&lt;8 y/o in the Strategies to Enhance New CGM Use in Early Childhood (SENCE) Study. SENCE had three treatment arms: CGM + FBI, CGM alone, and standard BG monitoring (BGM). We analyzed data from 44 children in the BGM group (47% male, 63% non-Hispanic white, age 6.7±1.8 yrs, T1D duration 3.2±2.0 yrs; 43% pump-treated, A1c 8.1±0.8%) who initiated CGM (Dexcom G5™) with FBI (behavioral support of CGM use) after 6 months. Parents completed validated measures of diabetes family impact (DFIS), technology satisfaction (DTQ), fear of hypoglycemia (FOH), and diabetes distress (PAID) at 6 (CGM start) and 12 months. Longitudinal models assessed change in psychosocial functioning. After 6 months of CGM use, parents reported greater technology satisfaction, reduced FOH (total and worry), and decreased diabetes distress (all p≤0.003), with a trend towards reduced family impact (p=0.06) (Figure). Implementing CGM in young children within the context of a tailored FBI intervention was associated with improved psychosocial outcomes for parents, reaffirming primary results of the SENCE Study and benefits of supported technology use.

Disclosure
P.V. Commissariat: None. L. Kanapka: None. K. Miller: None. M.E. Hilliard: None. B. Anderson: None. L. DiMeglio: None. L.M. Laffel: Advisory Panel; Self; Roche Diabetes Care. Consultant; Self; Boehringer Ingelheim Pharmaceuticals, Inc., ConvaTec Inc., Dexcom, Inc., Insulet Corporation, Insulogic LLC, Janssen Pharmaceuticals, Inc., Lilly Diabetes, Novo Nordisk Inc., Sanofi US.

Funding
The Leona M. and Harry B. Helmsley Charitable Trust
1017-P: Effects of the T:slim X2 Insulin Pump with Basal-IQ Technology on Glycemic Control in a Pediatric Urban Academic Diabetes Practice
Authors: WEINER ALYSON , ROBINSON ELIZABETH , GANDICA RACHELLE 
Published: June 2020

The predictive low glucose suspend (PLGS) algorithm of the t:slimx2 insulin pump with Basal-IQ technology, which is used with the Dexcom G6 continuous glucose monitor (CGM), has been shown to reduce hypoglycemia, though the effect on glucose variability longitudinally in a real-world pediatric population is unknown.
We hypothesized that children and adolescents who obtain their care at an urban, academic diabetes center and use the PLGS algorithm would have improved glycemic outcomes, compared to their previous method of diabetes care.
We recruited pediatric patients aged 6-18 years old with T1D for &gt;1 year prior to starting the PLGS system. At baseline, glycemic control was assessed using CGM or fingerstick glucose metrics. For the 3 month timepoint, Tandem T:connect software was used.
Of the 97 pediatric patients at our center with T1D for &gt;1 year using the PLGS system, 41 pediatric subjects (51.2% female) with a median age of 13.6 years (range 6.6-17.8) and 3 month follow-up data were eligible for analysis. Baseline CSII and CGM use were 87.8% and 92.7%, respectively. Subjects were using Basal-IQ for a median of 92% of the time with 6 suspensions per day in the 2 weeks prior to 3 month follow-up. HbA1c, mean glucose, and percent time in range improved from 7.5%, 186 mg/dl and 51.9% on their previous diabetes care to 7.35%, 171 mg/dl and 57% after 3 months of Basal-IQ use (p= 0.005, p=0.03 and p=0.001). Percent time glucose below 55 mg/dl was a median of 0% at baseline and also at follow-up. There were no significant differences in coefficient of variation, percent time glucose below 70 mg/dl, and percent time glucose above 180 mg/dl. There were also no episodes of DKA or severe hypoglycemia after initiation of Basal-IQ in this cohort.
The t:slim x2 insulin pump with Basal-IQ technology resulted in improved HbA1c, mean glucose, and percent time in range in pediatric patients after 3 months of use, without an increase in hypoglycemia or adverse events. 6 month data is being analyzed.

Disclosure
A. Weiner: None. E. Robinson: None. R. Gandica: None.

Funding
National Institutes of Health (T32DK065522-14)
103-OR: Change in Lifetime Risk for Diabetes in the United States, 1997-2015
Authors: CHENG YILING J. , GREGG EDWARD W. , BRINKS RALPH , SAYDAH SHARON H. , ALBRIGHT ANN L. , IMPERATORE GIUSEPPINA 
Published: June 2020

Lifetime risk (LR), a cumulative incidence estimate, is a key metric of disease burden that reflects the impact of baseline prevalence, incidence, and mortality risk. Previous studies in developed countries estimated LR of diabetes (DM) to be ∼35%. Since 2008 both DM incidence and mortality in persons with DM have decreased. The impact of those changes on LR of DM and years of potential life lost (YPLL) to DM is not known. We used data from 558,225 participants aged ≥20 years from the National Health Interview Survey to estimate LRs and YPLLs up to age 80 years by period: 1997-2000, 2001-2005, 2006-2010, and 2011-2015. The age-specific incidence of diagnosed DM and mortality by DM were estimated using Poisson regression. Multistate difference equation accounting for competing risk was used to model LR and YPLL. Age-sex-race adjusted DM incidence (%) for the four periods was 0.6, 0.7, 0.8, and 0.7, respectively (overall P &lt; .001). LR followed the change in incidence and decreased significantly during last period (Figure); YPLL steadily decreased from 12.0 (11.8-12.2) in 1997-2000 to 8.9 (8.7-9.1) in 2011-2015. In 2011-2015, LR (%) and YPLL (years) were 36.6 (95% CI 36.2-37.0) and 9.7 (9.5-9.9) for men, and 36.5 (36.0-36.9) and 8.2 (8.0-8.4) for women, 32.3 (32.0-32.8) and 8.4 (8.2-8.6) for whites, and 46.8 (46.1-47.4) and 10.6 (10.3-11.0) for blacks. In the United States, LR and YPLL have declined, but disparities still persist.

Disclosure
Y.J. Cheng: None. E.W. Gregg: None. R. Brinks: None. S.H. Saydah: None. A.L. Albright: None. G. Imperatore: None.
1040-P: Ultra-Rapid Lispro (URLi) Accelerates Insulin Lispro Absorption and Insulin Action vs. Humalog (Lispro) Consistently across Study Populations: A Meta-analysis of Pharmacokinetic and Glucodynamic Data
Authors: LEOHR JENNIFER , DELLVA MARY A. , CARTER KALLIN , LABELL ELIZABETH S. , LINNEBJERG HELLE 
Published: June 2020

URLi is a novel insulin lispro formulation developed to more closely match physiological insulin secretion and improve postprandial glucose control. This meta-analysis compared and assessed the consistency of the pharmacokinetics and glucodynamics between URLi and Humalog® in healthy subjects and patients with T1D or T2D. The analysis included 4 randomized, double-blind, crossover, single dose studies [healthy subjects (n=74), patients with T1D (n=80), and T2D (n=38)], evaluating subcutaneous doses of 7, 15, or 30 U of URLi and Humalog®. An 8 to10-h euglycemic clamp was conducted to assess pharmacodynamics. Meta-analysis showed a ∼5 min faster (95% CI:-5.38, -4.12 min) onset of appearance with URLi vs. Humalog. The early insulin exposure was ∼8 times greater (95% CI:6.63, 8.51) in first 15 min and 3 times greater (95% CI:2.74, 3.22) in the first 30 min after URLi vs. Humalog. URLi reduced the late insulin exposure after 3 hours by 43% (ratio 0.57; 95% CI:0.53, 0.60) and the duration of exposure by 68 min (95% CI:-76.86, -59.53 min) vs. Humalog. URLi had a faster onset of action occurring 10 min earlier (95% CI:-12.01, -8.64 min), and early action was increased 3-fold in the first 30 min (95% CI:2.72, 3.50 min) with URLi vs. Humalog. Late insulin action (glucose infused 4 h to end of the clamp) was reduced by 35% (ratio 0.65; 95% CI:0.61, 0.70) and duration of action was 44 min shorter with URLi (95% CI:-58.60, -29.02 min). Total exposure and glucose infused during the clamp was similar between URLi vs. Humalog across the dose range and in each study population. Across the studied dose range and study populations, URLi consistently had faster absorption, reduced late exposure, and an overall shorter exposure duration compared to Humalog. URLi demonstrated an earlier insulin action while reducing the late insulin action compared to Humalog across the studied dose range and study populations.

Disclosure
J. Leohr: None. M.A. Dellva: Employee; Self; Eli Lilly and Company. K. Carter: None. E.S. LaBell: Employee; Self; Eli Lilly and Company. Stock/Shareholder; Self; Eli Lilly and Company, Johnson & Johnson, Novartis AG. H. Linnebjerg: Employee; Self; Eli Lilly and Company. Stock/Shareholder; Self; Eli Lilly and Company.

Funding
Eli Lilly and Company
1044-P: The Impact of Basal Insulin Type, Prandial Dosing Plan, and Baseline Postprandial Glucose (PPG) on Glycemic Control after Treatment with Ultra-Rapid Lispro (URLi) or Humalog in Type 1 Diabetes: Planned Subgroup Analyses from PRONTO-T1D
Authors: BUE-VALLESKEY JULIANA M. , CHO JANG IK , HARDY THOMAS 
Published: June 2020

URLi is a novel prandial insulin lispro formulation developed to more closely match physiological insulin secretion and improve PPG control. In PRONTO-T1D, a phase 3, 26-week, treat-to-target study comparing URLi to Humalog in patients with T1D on a multiple daily injection regimen with insulin glargine or degludec, mealtime URLi was non-inferior to mealtime Humalog for change from baseline HbA1c and superior for PPG control, with a similar safety profile to Humalog. Randomization to treatment was stratified by basal insulin type, baseline HbA1c and prandial insulin dosing plan (carb counting, yes/no). The impact of these subgroups and baseline 2-hour PPG on the efficacy and safety of URLi was assessed from the double-blind treatment groups: mealtime URLi (n=451) and mealtime Humalog (n=442). No significant treatment-subgroup interactions were noted (all p&gt;0.1) but occasional treatment differences were seen within each subgroup (p&lt;0.05) (Table 1.). Numerically, results suggest that basal insulin type, starting PPG, and starting HbA1c, but not prandial dosing plan, may influence the magnitude of the HbA1c improvement and/or hypoglycemia risk reduction among patients treated with URLi.

Disclosure
J.M. Bue-Valleskey: Employee; Self; Eli Lilly and Company. J. Cho: None. T. Hardy: Other Relationship; Self; Eli Lilly and Company.

Funding
Eli Lilly and Company
1049-P: Preexisting Chronic Kidney Disease Stage 3 Does Not Reduce Glycemic Efficacy of Metformin in U.S. Veterans with Type 2 Diabetes
Authors: GOSMANOVA ELVIRA , GEMOETS DARREN E. , KAMINSKY LAURENCE S. , KOVESDY CSABA P. , GOSMANOV AIDAR R. 
Published: June 2020

Background: Metformin (MET) is approved for treatment of type 2 diabetes (T2D) in patients with chronic kidney disease stage 3 (CKD3); however, data on its glycemic efficacy in CKD3 is lacking.
Methods: This was a retrospective study including 85,997 U.S. veterans with T2D and estimated glomerular filtration rate (eGFR)≥30 ml/min/1.73m2 treated with MET monotherapy with adequate adherence (defined by proportion of days covered ≥80%) between 01/2010 and 08/2018. CKD3 was defined as eGFR 30-59 ml/min/1.73m2. Twelve-month time-averaged A1c changes from baseline were compared in patients without and with CKD3 using univariate and multivariate linear regression analyses adjusted for case-mix.
Results: The mean±SD age for the total cohort was 60.8±9.9 yrs, 95.2% were males, 76.3 and 13.0% were Whites and Blacks, respectively. Average daily mean±SD MET dose was 1341±202 mg. Pre-existing CKD3 was present in 7,566 (9.7%) of individuals. Baseline characteristics by CKD3 status are shown in Table 1. In unadjusted analysis, mean A1c reduction was 0.59±1.0 vs. 0.52±0.9 % in patients without and with CKD3 (p&lt;0.001). The difference in A1C between two groups was lost after adjustments for baseline characteristics and MET dose (p=0.058).
Conclusions: In this large retrospective study, presence of preexisting CKD stage 3 did not affect glycemic efficacy of metformin monotherapy in T2D patients.

Disclosure
E. Gosmanova: None. D.E. Gemoets: None. L.S. Kaminsky: None. C.P. Kovesdy: Consultant; Self; Amgen, AstraZeneca, Bayer AG, Cara Therapeutics, Reata, Takeda Pharmaceutical Company Limited, Tricida. A.R. Gosmanov: None.