bluuebunny/crossref_metadata_2025 huggingface dataset:
A RARE PEDIATRIC CASE OF CHRONIC ARSENIC POISONING FROM AYURVEDIC MEDICATION
Authors: DHATI RAVI MANDYAM , BABU TIRIN , PANACHIYIL GEORGE MATHEW , SEBASTIAN JUNY
Published: June 2020

Ayurveda is an indigenous system of medicine becoming more popular around the world in recent years. In various Ayurvedic formulations, the arsenical compounds are intentionally added as the main active ingredients or as an auxiliary agent to assist the efficacy of herbal drugs. The chronic arsenic poisoning following the use of Ayurvedic medication is reported rarely in the literature. This report describes a rare pediatric case of chronic arsenic poisoning from Ayurvedic medication in a 15-year-old girl. She was a known case of seizure disorder and was on treatment with Ayurvedic medication for 1 year. The generalized hyperpigmentation and thickening of soles were noticed in the girl 7 months after taking the herbal tablet. The plasma-coupled atomic absorption spectroscopy of herbal tablet was performed in a laboratory and the result showed 4.3 mg of arsenic present in each herbal tablet. The patient was advised to stop the Ayurvedic medication and as an alternate drug, tablet levetiracetam (250 mg, twice a day) was started for the treatment of seizure disorder. During the follow-up, her cutaneous manifestations improved and is doing well.
ANTI-INFLAMMATORY PROFILING OF SEED AND RIND EXTRACTS OF AMOMUM SUBULATUM
Authors: AGNIHOTRI SUPRIYA
Published: June 2020

Objective: The study aimed to evaluate the anti-inflammatory activity of Amomum subulatum (greater cardamom) seed and rind extracts in Wistar rats.

Methods: The seed and rind of A. subulatum were air-dried in the shade, powdered, and subjected to 80% hydroalcoholic extraction in the Soxhlet apparatus. The anti-inflammatory activity of the seed and rind extracts of A. subulatum was evaluated by in vivo and in vitro methods.

Results and Discussion: In vivo studies, namely, carrageenan-induced rat paw edema, cotton pellet granuloma, and formaldehyde-induced arthritis model confirmed the anti-inflammatory potential of seed and rind extracts of A. subulatum. It was found that rind extract exhibited better inhibition of inflammation as compared to seed extract. A. subulatum rind extract at the dose of 500 μg/ml exhibited best results for in vitro studies, namely, inhibition of albumin denaturation (73% inhibition), antiproteinase action (58% inhibition), membrane stabilization, heat-induced hemolysis, hypotonicity-induced hemolysis (54% inhibition), anti-lipoxygenase activity.

Conclusions: The results of the study showed that the rind extract of A. subulatum (greater cardamom) possesses significant anti-inflammatory potential in various in vivo and in vitro anti-inflammatory models in the experimental animals.
El trabajo desde la perspectiva de género
Authors: Montalvo Romero Josefa
Published: June 2020

Muchos pensamos que con el auge de los Derechos Humanos en los últimos años las mujeres podrían alcanzar la anhelada igualdad laboral, pero no ha sido así.Esta investigación analiza diferentes escenarios del mundo del trabajo desde una pers-pectiva de género centrada en la mujer trabajadora. Nos movemos en la idea general y sencilla de que la perspectiva de género implica indagar, para evidenciar la discriminación de que las mujeres han sido y son objeto en materia laboral. Así, se identifican brechas de igualdad de género que tienen que ver, entre otras temáticas, con diferencias de salarios, dificultades de acceso a un empleo formal, conciliación laboral y vida familiar, la poca participación de las mujeres en cargos directivos o gerenciales, etc.
The Curriculum of Early Childhood Education: Indonesia and United Kingdom
Authors: Husein Saddam
Published: June 2020

This paper aims to investigate the curriculum of early childhood education in Indonesia and the United Kingdom (UK) and how they pertain to each other. Library research was conducted to gather information intended. The findings confirm that the curriculum of early childhood education in Indonesia applies curriculum 2013 which consists of aspect development of curriculum structure, and the learning process with a scientific approach. While the UK applies the curriculum according to the statutory Early Years Foundation Stage (EYFS) framework which recognizes the importance of play and a balance of adult-led and child-initiated activities. Moreover, there is a basic difference between these two curriculum aspects, which Indonesia includes the religious and moral values to the body of the curriculum, while the UK does not. However, both Indonesia and UK are closely similar which promotes a balance between the development of academic and literacy skills, socio-emotional development, and creative and physical development.
Real Time Dynamics and Confinement in the Zn Schwinger-Weyl lattice model for 1+1 QED
Authors: Magnifico Giuseppe , Dalmonte Marcello , Facchi Paolo , Pascazio Saverio , Pepe Francesco V. , Ercolessi Elisa
Published: June 2020

We study the out-of-equilibrium properties of 1+1 dimensional quantum electrodynamics (QED), discretized via the staggered-fermion Schwinger model with an Abelian Zn gauge group. We look at two relevant phenomena: first, we analyze the stability of the Dirac vacuum with respect to particle/antiparticle pair production, both spontaneous and induced by an external electric field; then, we examine the string breaking mechanism. We observe a strong effect of confinement, which acts by suppressing both spontaneous pair production and string breaking into quark/antiquark pairs, indicating that the system dynamics displays a number of out-of-equilibrium features.
Las pruebas periciales genéticas en el proceso penal en México en el marco los derechos humanos
Authors: Cobos Campos Amalia Patricia
Published: June 2020

A raíz de la reforma constitucional en México, se ha gestado una fuerte polémica en cuanto a los alcances de la responsabilidad del juzgador en materia de derechos humanos, se ha hablado de un nuevo sistema de control difuso de la constitucionalidad, opinión que no ha sido avalada por la Suprema Corte de Justicia de la Nación, quien ha determinado que dicho control le corresponde en facultad exclusiva. Resulta, por consecuencia, complejo para el juzgador ordinario medir cuáles son sus responsabilidades y alcances en la salvaguarda de los derechos humanos, en especial cuando se habla de pruebas genéticas que revisten ya de suyo un alto grado de complejidad en su ofrecimiento, admisión y desahogo. En la presente investigación se analiza desde una perspectiva teórica, las posturas doctrinales y jurisprudenciales al respecto, realizándose una amplia revisión bibliográfica, hemerográfica, jurisprudencial y de orden legislativo que sustentan las conclusiones, que nos permiten determinar que en México no existen parámetros debidamente regulados para la realización de las referidas probanzas bajo el esquema de una adecuada salvaguarda de los derechos humanos del imputado y que, en todo caso nuestra legislación parece inclinarse por lo que la doctrina ha denominado derecho penal del enemigo
Clinical and microbiological effects of photodynamic therapy applied in non-surgical treatment of periodontitis
Authors: Arsic Zoran , Jovanovic Radovan , Djordjevic Aleksandar , Sehalic Meliha , Marjanovic Dragan , Mikic Mirko , Vlahovic Zoran , Mladenovic Rasa
Published: June 2020

Background/Aim. Treatment of periodontitis undergoes several treatment phases. Non-surgical periodontal treatment (NSPT) represents the basic treatment stage, and it is applied to all the patients undergoing periodontal treatment. Adjunctive antimicrobial photodynamic therapy (aPDT) is one of several contemporary and relatively new possibilities with a role to inactivate microorganisms responsible for the occurrence and progression of the disease. The aim of this study was to comparatively analyze the clinical and microbiological effects of the NSPT alone, as well as combined with aPDT. Methods. A split-mouth method design was used in a prospective randomized controlled trial. The following clinical parameters were registered and monitored: plaque index (PI), bleeding on probing, probing depth (PD), and clinical attachment level (CAL). The presence of microorganisms Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, and Treponema denticola was detected by the polymerase chain reaction (PCR) method. Samples were tested before the therapy, as well as three months after the therapy. Therapeutic modalities of NSPT and NSPT with adjunct aPDT were examined. Results. All of the analyzed clinical parameters proved statistically significant improvement after the application of both treatment modalities (p < 0.001). Microbiological analyses showed that the total number of microorganisms was statistically significantly lower after the application of both methods (p < 0.001). Following the treatment, there was a statistically significantly reduced number of microorganisms Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, and Treponema denticola (p < 0.001). NSPT combined with aPDT led to a statistically significant improvement of both clinical parameters and microbiological status compared to NSPT applied on its own. Conclusion. The study showed improvement of all clinical indicators after the application of both treatment modalities. The total number of microorganisms was reduced as well as the number of specific microorganisms. Combining aPDT with NSPT led to a statistically significantly higher reduction in the number of microorganisms compared to NSPT alone.
100-LB: Closed-Loop Control Reduces Hypoglycemia without Increased Hyperglycemia in Subjects with Increased Prestudy Hypoglycemia: Results from the iDCL DCLP3 Randomized Trial
Authors: LEVY CAROL J. , O’MALLEY GRENYE , BROWN SUE A. , FORLENZA GREGORY P. , KUDVA YOGISH C. , BECK ROY , KOLLMAN CRAIG , LUM JOHN , RAGHINARU DAN , KOVATCHEV BORIS
Published: June 2020

Closed Loop Control (CLC) has the ability to reduce both hypoglycemia and hyperglycemia. We conducted a post-hoc analysis of data from the iDCL DCLP3 randomized trial comparing CLC with Control-IQ versus sensor augmented pump therapy (SAP) for 6 months in participants who had baseline CGM below 70mg/dL ≥4.0% of the time (N= 41 CLC, 14 SAP, mean±SD age of 33±16yrs, 49% female). CLC use led to a greater reduction in time below 70mg/dL (least square mean change from baseline of -4.6% in CLC vs. -3.1% in SAP, mean-adjusted treatment difference -1.5% or 22 min/d, 95% CI -2.2% to -0.9%, P<0.0001), increased time in range 70-180 mg/dL (mean-adjusted difference +10.4% or 2.5 hr/d, P<0.0001), decreased time above 180mg/dL (mean-adjusted difference -8.5% or 2.0 hr/d, P=0.0001), decreased mean glucose (mean-adjusted difference -10.4 mg/dL, P=0.005), and lower HbA1C (mean-adjusted difference -0.28%, P=0.06). CLC improves HbA1C and reduces both hypoglycemia and hyperglycemia in people with T1D with elevated levels of hypoglycemia prior to starting CLC.

Disclosure

C.J. Levy: Consultant; Self; Dexcom, Inc. Employee; Spouse/Partner; Allergan plc. Research Support; Self; Abbott, Dexcom, Inc., Insulet Corporation. G. O’Malley: Research Support; Self; Abbott, Dexcom, Inc. S.A. Brown: Research Support; Self; Dexcom, Inc., Insulet Corporation, Roche Diabetes Care, Tandem Diabetes Care, Tolerion, Inc. G.P. Forlenza: Advisory Panel; Self; Medtronic. Consultant; Self; Dexcom, Inc., Insulet Corporation, Tandem Diabetes Care. Research Support; Self; Abbott, Dexcom, Inc., Insulet Corporation, Medtronic, Tandem Diabetes Care. Y.C. Kudva: Research Support; Self; Dexcom, Inc., Roche Diabetes Care. Other Relationship; Self; Abbott. R. Beck: None. C. Kollman: Other Relationship; Self; Dexcom, Inc., Tandem Diabetes Care. J. Lum: None. D. Raghinaru: None. B. Kovatchev: Advisory Panel; Self; Dexcom, Inc. Research Support; Self; Dexcom, Inc., Tandem Diabetes Care. Speaker’s Bureau; Self; Dexcom, Inc., Sanofi, Tandem Diabetes Care. Other Relationship; Self; Dexcom, Inc., Johnson & Johnson, Sanofi.

Funding

National Institute of Diabetes and Digestive and Kidney Diseases (UC4108483); University of Virginia Strategic Investment Fund (Project 88); Tandem Diabetes Care
1000-P: A Feasibility Study Assessing the Accuracy of a Simplified Meal-Time Bolus Calculation Option
Authors: ROY ANIRBAN , GROSMAN BENYAMIN , LINTEREUR LOUIS J. , PARIKH NEHA , WU DI , SHULMAN DOROTHY I. , CHRISTIANSEN MARK P. , SLOVER ROBERT H. , WEYDT PATRICK E. , VIGERSKY ROBERT
Published: June 2020

Carbohydrate counting is a significant source of burden for individuals using insulin to mitigate postprandial glucose excursion. To address this, a meal simplification (MS) algorithm was developed that allows one to choose a ready and user-specific small, medium, large, extra-large (S/M/L/XL) carb-entry size for meal-time boluses.

Subjects with T1D (N=12, 15-76 yrs) underwent a 4-week learning phase where traditional carb-counting and entry were carried out via the MinMed™ 670G system. At the end of the learning phase, the MS algorithm used machine-learning techniques and insulin pump data to identify clusters of meals (a set of S/M/L/XL meal sizes along with a corresponding centroid carb value) on which a meal bolus would be calculated. Immediately after, there was a 2-week study phase where subjects announced carbs based on their personalized S/M/L/XL meal sizes.

Postprandial SG levels after S/M/L/XL announcements did not differ from those after traditional carb-counting (Table) and suggest that the personalized S/M/L/XL option is a valid alternative for carbohydrate counting. It may alleviate some of the burden associated with meal-time carb-counting, and potentially improve meal-time bolusing compliance.

Disclosure

A. Roy: Employee; Self; Medtronic. B. Grosman: Employee; Self; Medtronic. L.J. Lintereur: Employee; Self; Medtronic. N. Parikh: None. D. Wu: None. D.I. Shulman: Advisory Panel; Self; Medtronic. M.P. Christiansen: Research Support; Self; Abbott, Ascensia Diabetes Care, Biolinq, Dexcom, Inc., Eli Lilly and Company, Lexicon Pharmaceuticals, Inc., Medtronic, Merck & Co., Inc., Novo Nordisk A/S, Sanofi-Aventis, Senseonics, ViroMed Laboratories, Xeris Pharmaceuticals, Inc. R.H. Slover: None. P.E. Weydt: Employee; Self; Medtronic. R. Vigersky: Employee; Self; Medtronic.
1006-P: Personalized Hybrid Closed-Loop Therapy Using a Digital Twin in Patients with Type 1 Diabetes: At-Home Data
Authors: GROSMAN BENYAMIN , ROY ANIRBAN , WU DI , PARIKH NEHA , LINTEREUR LOUIS J. , SCHNEIDER NICOLE , BRAZG RONALD L. , GARG SATISH K. , VIGERSKY ROBERT
Published: June 2020

Background: MiniMed™ 670G system user-dependent settings influence glycemic outcomes in persons with type 1 diabetes. The ability of a mathematical model-based digital-twin program to personalize and automate user-dependent MiniMed™ 670G settings was assessed.

Method: A small feasibility study recruited experienced MiniMed™ 670G system users (N=19 users, >14yrs) to complete an at-home 3-weeks run-in phase with Auto Mode enabled followed by a 2-weeks study phase. Run-in data were used to generate a digital twin that personalized system settings during the study phase that comprised a non-randomized Auto Mode and Manual Mode arm. System use and glycemic outcomes were assessed.

Results: Personalized Auto Mode (Auto Mode+) reduced the mean(SD) of sensor glucose (SG) from 151.1(12.3)mg/dL to 149.3(11.6)mg/dL and increased time spent in target SG range from 74.0% to 75.9% (Table). Personalized Manual Mode (Manual Mode+) demonstrated a mean SG and TIR of 150.1mg/dL and 67.4%, respectively.

Conclusions: Improved Auto Mode therapy and acceptable Manual Mode (sensor-augmented pump) therapy were observed utilizing a digital-twin program to personalize MiniMed™ 670G system settings in subjects whose glycemic control was excellent at baseline. This is the first demonstration that a digital-twin can successfully automate and personalize insulin pump therapy.

Disclosure

B. Grosman: Employee; Self; Medtronic. A. Roy: Employee; Self; Medtronic. D. Wu: None. N. Parikh: None. L.J. Lintereur: Employee; Self; Medtronic. N. Schneider: None. R.L. Brazg: None. S.K. Garg: Advisory Panel; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Medtronic, Novo Nordisk A/S, Roche Diagnostics France. Research Support; Self; Dexcom, Inc., Eli Lilly and Company, Medtronic. R. Vigersky: Employee; Self; Medtronic.
1008-P: 3D Acoustic Radiation Force Impulse Virtual Imaging of Whole Human Abdominal Subcutaneous Tissue Imaging with “Insulin Ball”
Authors: SATO GENKI , UCHINO HIROSHI , SHIMIZU YOSUKE , ISHII KEN , ISHIKO AKIRA , MORITA TOSHISUKE , KUMASHIRO NAOKI , HIROSE TAKAHISA
Published: June 2020

Introduction: Current evidence suggests that subcutaneous “insulin ball”, a feature of the tissue-dystrophy, provokes hormonal perturbation in insulin absorption. Unforeseen 3-dimension (3D) whole human abdominal subcutaneous tissue within the insulin injecting subjects, we tried to elucidate a novel 3D ultrasound acoustic radiation force impulse (3D-ARFI) to quantitates the entire “tissue-dystrophy” volume in human.

Methods: Seven patients with daily insulin injected diabetes were enrolled and the 3D-ARFI was applied to measure tissue displacement. To generate the elasticity gradients along the depth axis of the whole abdominal subcutaneous tissue, we compared lateral region of the abdomen as internal-control. A subcutaneous insulin tolerance test was conducted to validate the rate of insulin absorption at the site of the tissue-dystrophyand control. We also analyzed the volume of whole insulin induced tissue-dystrophy with entire abdominal wall volume governed by consecutive ARFI slice imaging.

Results: Subcutaneous tissue stiffness measured by ARFI revealed that ARFI enabled the elastic characterization (p<.01). The 3D-ARFI demonstrated the differentiated elastic layers in the 3D model of entire human abdominal wall, and calculatedthe 3D volume of the tissue-dystrophy from entire abdominal subcutaneous volume (2.59±1.20%). The serum concentration area-under the curve (0-240min) after the 0.1U/kg IAsp injection was 33% lower at the tissue-dystrophylesions compared to the control lesion (p<.05).

Conclusion: We present the first example of virtual touch quantification imaging with the 3D-ARFI of human abdominal subcutaneous tissue, focusing on insulin injected diabetes and demonstrate its application for the biomedical 3D structure.

Disclosure

G. Sato: None. H. Uchino: None. Y. Shimizu: None. K. Ishii: None. A. Ishiko: None. T. Morita: None. N. Kumashiro: Research Support; Self; Boehringer Ingelheim Pharmaceuticals, Inc. Speaker’s Bureau; Self; Novo Nordisk Inc., Ono Pharmaceutical Co., Ltd., Takeda Pharmaceutical Company Limited. T. Hirose: Research Support; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Daiichi Sankyo, Mitsubishi Tanabe Pharma Corporation, Ono Pharmaceutical Co., Ltd., Takeda Pharmaceutical Company Limited. Speaker’s Bureau; Self; AstraZeneca, Lilly Diabetes, Novo Nordisk Inc., Sanofi, Sumitomo Dainippon Pharma Co., Ltd.

Funding

Japan Society for the Promotion of Science (17K01425)
102-LB: Cross-Study Comparisons Done Right: An Illustration Using Two Pivotal Trials of Closed-Loop Systems
Authors: BRETON MARC D. , BECK ROY , BERGENSTAL RICHARD M. , KOVATCHEV BORIS
Published: June 2020

Outcomes are regularly compared across studies frequently leading to inaccurate conclusions due to sampling differences. We introduce distribution-adjusting methods allowing for more adequate cross-study comparisons.

To illustrate these methods, we use time-in-range 70-180mg/dl (TIR) from two closed loop system pivotal clinical trials: CLS1 for MiniMed 670G (Medtronic), and CLS2 for Control-IQ (Tandem). TIR was the key outcome measure for both, but baseline TIRs were different (Table 1).

Furthermore, CLS1 did not have a control group; rendering the otherwise best option, a comparison of the experimental vs. control deltas, inapplicable. A second-best option is to compare the increments from baseline to active-treatment TIRs, which causes two opposing statistical artifacts: (1) with higher baseline, active-treatment TIR would be higher, and (2) with higher baseline, the TIR increment would be lower due to a ceiling effect.

Three methods were used to mitigate these artifacts by matching baseline TIRs distributions: sample truncation, weighted resampling, and baseline cumulative distribution functions mapping. All three resulted in similar Adjusted TIRs (Table 1).

Comparing results across studies is possible, if limited to the relative improvements from baseline to active treatment. However, comparing absolute results will not be accurate without proper baseline adjustments.

Disclosure

M.D. Breton: Research Support; Self; Dexcom, Inc., Novo Nordisk A/S, Sanofi, Tandem Diabetes Care. Speaker’s Bureau; Self; Dexcom, Inc., Tandem Diabetes Care. R. Beck: None. R.M. Bergenstal: Consultant; Self; Ascensia Diabetes Care, Johnson & Johnson. Other Relationship; Self; Abbott, Dexcom, Inc., Hygieia, Lilly Diabetes, Medtronic, Novo Nordisk A/S, Onduo, Roche Diabetes Care, Sanofi, UnitedHealth Group. B. Kovatchev: Advisory Panel; Self; Dexcom, Inc. Research Support; Self; Dexcom, Inc., Tandem Diabetes Care. Speaker’s Bureau; Self; Dexcom, Inc., Sanofi, Tandem Diabetes Care. Other Relationship; Self; Dexcom, Inc., Johnson & Johnson, Sanofi.

Funding

National Institute of Diabetes and Digestive and Kidney Diseases (UC4DK108483)
1022-P: Efficacy of Sliding Scale Insulin for Inpatient Glycemic Control in a Multinational Propensity-Matched Cohort Study
Authors: MIGDAL ALEXANDRA , FORTIN CHARLIE , GUO YI , HOCHBERG IRIT , MAGEE MICHELLE F. , PASQUEL FRANCISCO J. , UMPIERREZ GUILLERMO E.
Published: June 2020

Sliding scale insulin (SSI) continues to be widely used for glycemic management of inpatients with T2D despite condemnation in clinical guidelines. To confirm the accuracy of this clinical guideline recommendation, we determined the efficacy and safety of using SSI for the management hyperglycemia of non-critical patients with T2D in a large multinational, propensity-matched cohort study. A total of 53,516 patients with ICD 9/10 code of T2D were included in the dataset. Patients were categorized as having received SSI only vs. basal insulin, and were matched according to age, BMI, Charlson Comorbidity Index, and admission blood glucose (BG). Among patients with admission BG <180 mg/dL treated with SSI, 69% achieved and maintained good glycemic control (mean hospital BG <180 mg/dl), compared to 52% of patients treated with basal insulin (p <.001). Patients treated with basal insulin had higher rates of hypoglycemia than patients treated with SSI (30 vs. 16%, p <.001). There were no differences in rates of lactic acidosis, acute MI, pneumonia, or bacteremia (p=NS). A total of 14.93% of patients initially treated with SSI alone failed to achieve adequate glycemic control and were started on basal insulin during the hospital stay. Those who failed SSI had significantly higher admission BG (227.4±90 vs. 175.8±71 mg/dl), greater rates of CKD (31 vs. 24%), CHF (29 vs. 24%), CAD (35 vs. 31%), and higher Charlson score (4.3±2.7 vs. 3.8±2.7) than patients who remained well controlled on SSI alone (all, p<.001).

Conclusion: In a multicenter, international, propensity-matched cohort study, 69% of patients with T2D with admission BG <180 mg/dL treated with SSI achieved good glycemic control. Patients admitted with higher BG and greater comorbidities are more likely to fail treatment with SSI alone. These data suggest that SSI may be appropriate for patients with mild/moderate hyperglycemia, thus simplifying recommendations for inpatient glycemic management.

Disclosure

A. Migdal: None. C. Fortin: None. Y. Guo: None. I. Hochberg: None. M.F. Magee: Consultant; Self; Mytonomy. Employee; Spouse/Partner; U.S. Food and Drug Administration. Research Support; Self; AstraZeneca, Eli Lilly and Company, National Institute of Diabetes and Digestive and Kidney Diseases. Speaker’s Bureau; Self; American Diabetes Association, Pri-Med LLC. Other Relationship; Self; Endocrine Society. F.J. Pasquel: Advisory Panel; Self; AstraZeneca, Eli Lilly and Company. Consultant; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Merck Sharp & Dohme Corp. Research Support; Self; Dexcom, Inc., Merck Sharp & Dohme Corp., National Institutes of Health. G.E. Umpierrez: None.

Funding

Jacobs Research Foundation
1026-P: Physician-Related Factors Associated with Delay Insulin Initiation in Type 2 Diabetes Mellitus Patients with Oral Antihyperglycemic Agent Treatment Failure
Authors: SITASUWAN TULLAYA , CHOKSAKUNWONG SAWARAJ , SRIVANICHAKORN WEERACHAI
Published: June 2020

Aims: Despite the availability of numerous glucose-lowering therapies and clear guidelines for T2DM management, only 1/3 of the patient with T2DM in Thailand can achieve their glycemic targets. Timely initiation of insulin therapy has been suggested as one of the strategies to solve this problem. Therefore, the purpose of this study was to identify physician’s attitudes among the internal medicine residents regarding insulin initiation.

Methods: The questionnaire adapting from Physician Attitudes to Insulin Therapy questionnaire was used to conduct a questionnaire-based survey among the internal medicine residents in Siriraj Hospital, Mahidol University.

Results: The questionnaire was sent to 100 internal medicine residents. The response rate was 80%. The majority of respondents (60%, n=48/80) were willing to initiate insulin therapy for the patients with T2DM, who failed oral antihyperglycemic drug (OHD) treatment at HbA1c level between 7.5-9.5%. In addition, 45% (n=36/80) of respondents use HbA1c threshold of above 8.5% to initiate insulin treatment add on to OHD. However, if the internal medicine residents themselves were diabetes mellitus, they would decide to receive insulin at HbA1c level between 7.0-8.5%. The main reasons regarding insulin initiation barrier by physicians were a consideration of burden on the patients and families to initiate insulin therapy (88%, n=70/80), time-consuming for an explanation about insulin devices, monitoring and adjustment (74%, n=59/80) and difficult to advise the patients who fear the injection drugs to use insulin (70%, n=56/80).

Conclusions: Physician-related factors associated with delay insulin initiation need to be addressed for better diabetes management. Internal medicine resident aspects according to high HbA1c thresholds, high effort regarding explanation, and motivation, and the patients and family burdens are the main barriers for insulin initiation.

Disclosure

T. Sitasuwan: None. S. Choksakunwong: None. W. Srivanichakorn: None.
1028-P: Real-World Effectiveness and Safety of Insulin Glargine 300 U/mL (gla-300) in Insulin-Naïve Patients with Type 2 Diabetes (T2DM): Interim Analysis of the ATOS Study
Authors: GALSTYAN GAGIK R. , BHANSALI ANIL , VARGAS-URICOECHEA HERNANDO , TIROSH AMIR , SUN GUANNAN , NAQVI MUBARAK , PILORGET VALERIE , COUDERT MATHIEU , CHERKASOV DMITRY , KHAN NIAZ
Published: June 2020

ATOS is a prospective, 12-month, observational study assessing real-world effectiveness of the second-generation basal insulin analog Gla-300 in emerging markets. Insulin-naïve adults (≥18 years) with T2DM, HbA1c >7-≤11 % and previously treated with ≥1 oral antihyperglycemic drug were recruited in 18 countries. An interim analysis was undertaken when ≥50% of participants had 6-months’ follow-up data (cut-off July 1, 2019); this included 4527 eligible patients (Eastern Europe: 1748; Egypt: 214; India: 1269; Latin America and Caribbean: 317; Western Asia: 882; Southeast Asia: 46; Taiwan: 51). Mean (SD) age was 57.2 (10.8) years, BMI was 29.4 (5.3) kg/m2, and duration of diabetes was 10.2 (6.2) years; 48.4% were male. Physician-set individualized HbA1c (%) goals at baseline were <7: 13.7%; 7-<7.5: 70.3%; 7.5-<8: 11.9%; ≥8: 4.2%. The proportion of evaluable patients achieving HbA1c goal at Month 6 (primary outcome) was 25.1% (95% CI: 23.6 to 26.6); HbA1c decreases are shown in Table. Hypoglycemia incidence was low (<2%). Treatment-emergent adverse events (TEAEs) were reported in 230 (5.0%) patients, with 47 (1.0%) serious TEAEs (included population). ATOS showed high baseline HbA1c, suggesting delayed insulin initiation; introduction of Gla-300 led to marked improvements in HbA1c with a good safety profile in a real-world setting.

Disclosure

G.R. Galstyan: None. A. Bhansali: None. H. Vargas-Uricoechea: Speaker’s Bureau; Self; Sanofi-Aventis. A. Tirosh: Advisory Panel; Self; Novo Nordisk Inc., Sanofi. G. Sun: None. M. Naqvi: Employee; Self; Sanofi. V. Pilorget: Employee; Self; Sanofi. M. Coudert: Employee; Self; Roche Pharma, Sanofi-Aventis. D. Cherkasov: None. N. Khan: None.

Funding

Sanofi (ATOS/NCT03703869)
1035-P: Real-World Safety and Effectiveness of Insulin Glargine 300 U/mL (Gla-300) in People with Type 2 Diabetes (T2DM) Who Fast during Ramadan: Regional Analysis of the ORION Study
Authors: HASSANEIN MOHAMED , BUYUKBESE MEHMET A. , MALEK RACHID , PILORGET VALERIE , NAQVI MUBARAK , BERTHOU BAPTISTE , SHALTOUT INASS , SAHAY RAKESH
Published: June 2020

ORION, a prospective observational study, evaluated the safety and effectiveness of the second-generation basal insulin analog Gla-300 in people who fast during Ramadan. Adults (≥18 years) with T2DM who intended to fast for ≥15 days during Ramadan, had taken Gla-300 for ≥8 weeks before inclusion and intended to continue during Ramadan were enrolled in 11 countries (grouped by region; Table). Mean (SD) number of fasting days was 30.1 (3.2). Mean diabetes duration ranged from 7.9 to 13.5 years and ≥77.5% had moderate/low risk associated with fasting (investigator-assessed). Proportions of people with ≥1 severe and/or symptomatic documented hypoglycemia event were low for the overall population and in Groups 1-3; 1 severe hypoglycemia event was reported in pre-Ramadan. Glycemic control improved pre- to post-Ramadan in Groups 1-3 and Gla-300 dose adjustments were minimal. In Canada, 24% of people had ≥1 severe and/or symptomatic documented hypoglycemia event in Ramadan; there was no change in glycemic control, but pre-Ramadan HbA1c target achievement was high (30.4%). In this real-world study, people with T2DM who received Gla-300 and fasted for Ramadan generally had low incidence of hypoglycemia, with no severe events in Ramadan, and slightly improved glycemic control; results from Canada varied, possibly due to longer fasting hours.

Disclosure

M. Hassanein: Advisory Panel; Self; Novo Nordisk A/S. Speaker’s Bureau; Self; Lilly Diabetes, Merck Sharp & Dohme Corp., Novo Nordisk A/S, Sanofi. M.A. Buyukbese: Consultant; Self; Sanofi. R. Malek: None. V. Pilorget: Employee; Self; Sanofi. M. Naqvi: Employee; Self; Sanofi. B. Berthou: None. I. Shaltout: Advisory Panel; Self; Sanofi, Novartis, MSD, Astra Zeneca, Novo Nordisk, Lilly, Servier and Abbott. Speaker’s Bureau; Self; Sanofi, Novartis, MSD, Astra Zeneca, Novo Nordisk, Lilly, Servier and Abbott. R. Sahay: Advisory Panel; Self; Boehringer Ingelheim, Dr. Reddy’s Laboratories, Eli Lilly and Company, Sanofi. Speaker’s Bureau; Self; Boehringer Ingelheim, Eli Lilly and Company, Novo Nordisk A/S, Sanofi.

Funding

Sanofi; World Health Organization (CTRI/2019/02/017636)
1041-P: Randomized Controlled Trial on the Efficacy of Supplemental Rapid-Acting Insulin during Basal-Bolus Regimen in Non-ICU Patients with Type 2 Diabetes
Authors: VELLANKI PRIYATHAMA , CARDONA SAUMETH , URRUTIA MARIA A. , GALINDO RODOLFO J. , DAVIS GEORGIA , HAW J. SONYA , FAYFMAN MAYA , MIGDAL ALEXANDRA , GUO YI , PASQUEL FRANCISCO J. , UMPIERREZ GUILLERMO E.
Published: June 2020

The administration of rapid-acting insulin per sliding scale (SSI) for correction of hyperglycemia in non-ICU patients with type 2 diabetes (T2D) is used with most basal-bolus insulin (BBI) regimens; however, the safety and efficacy of using SSI has not been tested in RCTs. In this non-inferiority RCT, we tested whether correction of hyperglycemia before meals and bedtime improves glycemic control in patients treated with BBI regimens.

Patients with T2D with a blood glucose (BG) > 140 mg/dl treated with BBI were randomized to SSI for BG >140 mg/dl (intensive supplement) or to SSI for BG >260 mg/dl (non-intensive supplement). Primary outcome was difference in mean BG levels between the groups during hospital stay. There were no differences in baseline characteristics between the intensive and non-intensive supplement groups. There were no differences between groups in mean daily BG, length of stay (LOS), hypoglycemia (BG < 70 or < 54 mg/dl), severe hyperglycemia (BG > 350 mg/dl), and total, basal, prandial or supplemental daily insulin doses (U/day). In patients with any BG 140-260 mg/dl and without BG > 260 mg/dl, mean BG did not differ but non-intensive group needed more prandial insulin.

Conclusion: Adding correction/supplement SSI in non-ICU T2D patients with mild to moderate hyperglycemia (<260 mg/dl) on basal bolus regimen does not improve glycemic control.

Disclosure

P. Vellanki: Consultant; Self; Boehringer Ingelheim Pharmaceuticals, Inc. S. Cardona: None. M.A. Urrutia: None. R.J. Galindo: Advisory Panel; Self; Lilly Diabetes. Consultant; Self; Valeritas, Inc. Research Support; Self; Novo Nordisk Inc. Other Relationship; Self; UpToDate. G. Davis: None. J. Haw: None. M. Fayfman: None. A. Migdal: None. Y. Guo: None. F.J. Pasquel: Advisory Panel; Self; AstraZeneca, Eli Lilly and Company. Consultant; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Merck Sharp & Dohme Corp. Research Support; Self; Dexcom, Inc., Merck Sharp & Dohme Corp., National Institutes of Health. G.E. Umpierrez: None.

Funding

National Institutes of Health
1045-P: Basal Insulins in Advanced Renal Failure: Time for a Paradigm Shift
Authors: CHAUDHURI SOUMYABRATA ROY , MAJUMDER ANIRBAN , SANYAL DEBMALYA
Published: June 2020

Aim: To compare efficacy and safety of IDeg and IGlarU100 in T2DM patients with Stage 3 or 4 CKD.

Methods: This single-centered, retrospective, observational study evaluates efficacy and safety of insulin glargine and insulin degludec in CKD with eGFR 60 and below. T2DM patients with DKD receiving IGlarU100 or IDeg for 24 weeks and beyond were included. Data relating to anthropometry, blood pressure, renal parameters, and glycaemic control were analysed.

Results: In advanced renal failure, IDeg caused statistically significant less hypoglycemia than IGlarU100. Ironically, reverse occurred in CKD stage 3A which may be contributed by concomitant usage of SUs. Both drugs were found to be similarly efficacious in this population.

Conclusion: IDeg has lower rate of hypoglycemia in advanced renal failure T2DM patients and may be a safer option to use in this scenario.

Disclosure

S. Roy Chaudhuri: None. A. Majumder: None. D. Sanyal: None.
1046-P: Effect of Age on HbA1c, Postprandial Glucose (PPG) Control, and Hypoglycemia in Patients with T2D Treated with Ultra-Rapid Lispro (URLi) or Humalog: PRONTO-T2D
Authors: CHANG ANNETTE M. , HARDY THOMAS , ZHANG QIANYI
Published: June 2020

URLi is a novel prandial insulin lispro formulation developed to more closely match physiological insulin secretion. PRONTO-T2D, a Phase 3, double-blind, treat-to-target study in pts with T2D, showed URLi, in a basal-bolus regimen with glargine or degludec, was non-inferior for HbA1c with superior PPG control vs. Humalog. Subgroup analyses were performed in pts <65 vs. ≥65 years. Baseline characteristics were similar except age and duration of T2D (Table 1). With 26 weeks of study treatment, HbA1c improved in both treatment/age groups with endpoint mean HbA1c 6.8-6.9%. URLi significantly reduced 1- and 2-hour PPG excursions with standardized meal tests vs. Humalog in both age groups. Insulin dosing was not significantly different. Severe hypoglycemia incidence was low. While there was no treatment difference in documented hypoglycemia (glucose <54 mg/dL), relative rate (URLi/Humalog) was lower in pts ≥65 vs. < 65 years, with a significant treatment-by-age interaction. Nocturnal hypoglycemia was not significantly different between groups. Incidence of overall treatment-emergent adverse events was similar between treatment/age groups. URLi in a basal-bolus regimen resulted in endpoint HbA1c <7% and significantly lower PPG excursions vs. Humalog in both age groups, with reduced documented hypoglycemia in older vs. younger pts.

Disclosure

A.M. Chang: Employee; Self; Eli Lilly and Company. Stock/Shareholder; Self; Eli Lilly and Company. T. Hardy: Other Relationship; Self; Eli Lilly and Company. Q. Zhang: Employee; Self; Eli Lilly and Company. Stock/Shareholder; Self; Eli Lilly and Company.

Funding

Eli Lilly and Company
1047-P: The Change of HOMA-IR Predicted the Remission Time in Patients with Newly Diagnosed Type 2 Diabetes after Intensive Insulin Therapy
Authors: XUESI WAN , HUANG ZHIMIN , LIU LIEHUA , LI YANBING
Published: June 2020

Objectives: Insulin resistance is one of strong predictions on the remission in patients with newly diagnosed type 2 diabetes (T2DM) after short-term insulin intensive therapy (SIIT). Therefore, the purpose of this study is to explore if the short-term change of insulin resistance can predict the long-time remission.

Methods: This study enrolled 160 patients with newly diagnosed type 2 diabetes mellitus (103 male, aged 49.8±10.4 yrs,HbA1c11±2.1%). All of them have been treated by 2-week continuous subcutaneous insulin infusion as SIIT when new diagnosed. HOMA-IR was compared just at the termination of SIIT and later then follow up every 3 months regularly for 5 years.

Results: After short-term intensive treatment, up to 84.4%, 81.3% and 26.9% of patients achieved disease remission with T2DM at the termination of CSII, the 3rd month and 5th year follow up without use of medication. The average remission time were 27+/-615 months. The average changes of HOMA-IR in the first 3 months after SIIT were 30%+/-52%. This short-term change percent of HOMA-IR was positive related to the statue of remission at 5th-year follow-up (r = 0.778, p <0.0001). The ROC curve analysis showed below.

Conclusions: Maintaining the improving insulin resistance after short-term insulin intensive therapy is essential for the long-time remission from T2DM. Lifestyle interventions might be helpful.

Disclosure

W. Xuesi: None. Z. Huang: None. L. Liu: None. Y. Li: None.

Funding

National Key Research and Development Program of China (2018YFC1314100)
105-LB: Evening Oral Insulin (ORMD-0801) Glycemic Effects in Uncontrolled T2DM Patients
Authors: ELDOR ROY , FLEMING G. ALEXANDER , NEUTEL JOEL , HOMER KENNETH E. , KIDRON MIRIAM , ROSENSTOCK JULIO
Published: June 2020

ORMD-0801 is a novel oral human insulin formulated to increase hepatic insulin exposure, and subsequently reduce hepatic glucose production and improve glycemic control, with minimal hypoglycemia risk. In a recently completed randomized, placebo-controlled, multicenter, phase 2b, 12-week study, 354 subjects with T2DM uncontrolled by multiple oral antidiabetic drugs and with HbA1c levels ≥7.5%, received placebo or 8 mg, 16 mg or 32 mg ORMD-0801 capsules up to three times daily. Masked continuous glucose monitoring was performed during a 14-day run-in period and over the last 14 days of treatment. HbA1c levels improved from baseline for most active treatment regimens, with largest improvements recorded in the 8 mg once daily (QD) and twice daily (BID) cohorts. Glucose AUC improved from baseline following 8 mg or 32 mg QD and all tested BID treatments and was most pronounced in patients receiving 8 mg QD at bedtime. Hypoglycemia event rates were low and similar to the placebo arm. Body weight remained stable in all treatment arms and frequency of drug-related adverse events was similar across cohorts.

In summary, ORMD-0801 elicited clinically significant HbA1c reductions in poorly controlled T2DM patients on standard therapies and with mean HbA1c levels >8%, without increasing hypoglycemia rate or weight. The 8 mg QD regimen appears most effective, warranting further studies to confirm the efficacy of this once daily evening dose.

Disclosure

R. Eldor: Advisory Panel; Self; Oramed. Speaker’s Bureau; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Medtronic, Merck Sharp & Dohme Corp., Novo Nordisk Inc., Sanofi. Stock/Shareholder; Self; Oramed. G. Fleming: Consultant; Self; ADOCIA, Biocon, Caladrius Biosciences, Inc., Dance Biopharm Holdings, Inc., Diasome Pharmaceuticals, Inc., Intarcia Therapeutics, MannKind Corporation, NuSirt Biopharma, Inc., Oramed Pharmaceuticals, Sanofi, Tolerion, Inc. J. Neutel: None. K.E. Homer: None. M. Kidron: Employee; Self; Oramed Pharmaceuticals. Stock/Shareholder; Self; Oramed Pharmaceuticals. J. Rosenstock: Research Support; Self; AstraZeneca, Bristol-Myers Squibb, Genentech, Inc., GlaxoSmithKline plc., Lexicon Pharmaceuticals, Inc., Oramed Pharmaceuticals, PegBio Co., Ltd., Pfizer Inc., REMD Biotherapeutics. Other Relationship; Self; Applied Therapeutics, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Intarcia Therapeutics, Janssen Pharmaceuticals, Inc., Novo Nordisk Inc., Sanofi.
107-OR: Novel Genetic Risk Factors Influence Islet Autoimmunity Progression
Authors: ONENGUT-GUMUSCU SUNA , PAILA UMA DEVI , CHEN WEI-MIN , RATAN AAKROSH , ZHU ZHENNAN , STECK ANDREA , FROHNERT BRIGITTE I. , WAUGH KATHLEEN , WEBB-ROBERTSON BOBBIE-JO , NORRIS JILL M. , LANGE LESLIE , REWERS MARIAN , RICH STEPHEN S.
Published: June 2020

Background: Type 1 diabetes (T1D) is determined by unknown environmental factors in genetically susceptible individuals. The design of most genome wide association studies of T1D involves comparison of cases (with varying duration of disease) with controls; hence, the genetic variants associated with T1D reflect current disease, ignoring variants that play a key role in the initiation of islet autoimmunity and the progression of subclinical disease. In this study, we focus on the genetic contribution to progression of islet autoimmunity using whole-genome sequencing in a collection of participants of the Diabetes AutoImmunity Study in the Young (DAISY).

Methods: A total of 160 persistent islet autoantibody positive DAISY subjects were sequenced, including 87 subjects who progressed to T1D and 73 “non-progressors” over a mean of 11 years since seroconversion. Following whole genome sequence alignment, single nucleotide polymorphisms (SNPs) and small insertion/deletions (indels) were identified (∼6.8 million variants), and statistical analyses performed.

Results: Genes with multiple SNPs associated with progression to T1D in subjects with islet autoimmunity (P < 8.5x10-8) did not overlap with known T1D risk loci; instead, four novel regions were identified - 1q21.3 (MRPS21-PRPF3), 2p25.2 (NRIR), 3q22.1 (COL6A6), and 20p12.1 (TASP1). Functional mapping of the associated SNPs within these risk loci indicates pathways critical for response to viral infections and response to interferon signaling contribute to progression to T1D once islet autoimmunity is initiated.

Discussion: This study presents evidence that different genetic pathways may contribute to progression of islet autoimmunity from those identified once disease is established and support the need for follow-up studies to understand genetic risk factors that modulate progression of subclinical disease.

Disclosure

S. Onengut-Gumuscu: None. U. Paila: None. W. Chen: None. A. Ratan: None. Z. Zhu: None. A. Steck: None. B.I. Frohnert: None. K. Waugh: None. B. Webb-Robertson: None. J.M. Norris: None. L. Lange: None. M. Rewers: None. S.S. Rich: None.
1075-P: Long-Term Treatment with Testosterone Undecanoate Injections (TU) Improves Glycemic Control in Patients with Hypogonadism and Type 2 Diabetes (T2DM): Update of Real-World Data with 2,928 Patient-Years
Authors: SAAD FARID , HAIDER KARIM S. , HAIDER AHMAD
Published: June 2020

Background: Prevalence of hypogonadism has been reported as high as 50% in men with T2DM. ADA Guidelines recommend assessment of hypogonadism in men with T2DM.

Methods: In a registry of 858 men with hypogonadism, 356 men (41.5%) had T2DM. 178 received TU 1000 mg/12 weeks (T-group), 178 opted against treatment (CTRL). Changes over time between groups were compared and adjusted for age, weight, waist circumference, fasting glucose, blood pressure, lipids and quality of life to account for baseline differences between the two groups.

Results: Mean follow-up 8.2±2.9, baseline age: 61.5±5.4 (T-group) and 63.7±4.9 (CTRL) years. T-group: HbA1c progressively decreased by 3.4±0.1% at 11 years (from 9.4±1.4% to 5.8±0.3%). CTRL: HbA1c increased by 3.3±0.1% (from 7.8±0.7% to 10.5±1.4%). Estimated adjusted difference between groups: 6.7% (p<0.0001 for all). Fasting glucose (mmol/L) decreased in T-group by 1.8±0.1 (from 7.8±1.2 to 5.4±0.1) and increased in CTRL by 1.7±0.1 (from 6.3±0.7 to 8.0±1.6). Difference between groups: 3.6 (p<0.0001 for all). In the T-group, 87 men (48.9%) received insulin at baseline at a mean dose of 37.8±13.4 U/d. Dose requirement declined by 25.9±1.1 U/d during the observation period. In CTRL, 69 men (38.8%) received insulin at baseline at a mean dose of 31.3±6.2 U/d. Dose requirement increased by 19.3±1.1 U/d. Difference between groups: 45.2 U/d (p<0.0001 for all). In men who never received insulin (91 in T-group, 89 in CTRL), HOMA-IR decreased from 9.8±2.0 to 2.3±0.6 by 7.0±0.3 (T-group) and increased from 7.1±1.3 to 12.8±1.9 by 5.4±0.3 (CTRL). Difference between groups: 12.4 (p<0.0001 for all). In CTRL, 20 patients were started on insulin during the observation period.

Conclusions: Long-term testosterone therapy with TU in men with hypogonadism and T2DM progressively improved glycemic control which deteriorated in untreated men.

Disclosure

F. Saad: Consultant; Self; Bayer AG. Stock/Shareholder; Self; AbbVie Inc., Bayer AG. K.S. Haider: None. A. Haider: None.

Funding

Bayer AG
108-LB: Hypertriglyceridemic Pancreatitis (HTGP): Response to Continuous Insulin Infusion
Authors: PULIPATI VISHNU PRIYA , AMBLEE AMBIKA , YAP SARA ELIZABETH T. , SHAKA HAFEEZ , FOGELFELD LEON
Published: June 2020

Retrospective study of 77 HTGP patients (pt) to evaluate triglyceride (TG) response to continuous insulin infusion (CII) given in ICU using 0.1 U/kg. Median age 40 (IQR 32-45) y, 66% male, 58% Hispanic, 51% alcohol use, 74% diabetes (DM), A1c 9.5 (6-12) %, initial TG 3869 (2714-5444) mg/dl. TG goal (1000 ± 100 or less) achieved in 95% (Responder=R). The 4 pt not reaching TG goal had longer time from initial TG to CII start, 10 (2-37) vs. 3 (3-5.5) hours (h), and higher insulin needs 5.4 (1.3-6.5) vs. 1.9 (0.9-3.6) U/kg. In 73 R, time points to reach TG goal in Figure 1. R reaching TG goal in < 36 (49%) vs. >36 h had lower initial TG 2788 (1819-4486) vs. 4836 (3408-7053), A1C 6.7 (5.6-10.7) vs. 10.7 (8.4-12.7), BMI 28.7 (25-33) vs. 31.5 (28-37), insulin needs 0.92 (0.46-1.8) vs. 2.92 (2.0-4.7) and reached TG 50% (≤50% baseline TG) faster 13 (6-17) vs. 16 (12-32). Among R, DM (74%) vs. non-DM pt had higher initial TG 3990 (2859-6150) vs. 3512 (2142-4519), BMI 31.5 (28-36) vs. 27.7 (24-30), insulin needs 2.4 (1.3-3.8) vs. 0.82 (0.4-1.5) and took longer to reach TG 50% 16 (11-27) vs. 10 (5-15) and final TG 40 (25-57) vs. 15 (14-26). In multivariate analysis, quick TG response predictors were no DM, low initial TG, A1C. All results significant. CII was effective in reaching TG goal in 95% of pt, most within 2 days. Study suggests need for higher insulin dose in pt with late response predictors. Rate of TG 50% decline may be a real time indicator to adjust insulin rate for quicker response.

Disclosure

V. Pulipati: None. A. Amblee: None. S.T. Yap: None. H. Shaka: None. L. Fogelfeld: Research Support; Self; Bayer Healthcare Pharmaceuticals Inc., Gan & Lee Pharmaceuticals, Gilead Sciences, Inc., Merck & Co., Inc., Sanofi.