bluuebunny/crossref_metadata_2025_split huggingface dataset:
Effect of Testosterone Therapy on Renal and Endothelial Functions in Men with Type 2 Diabetes Mellitus
Authors: KHRIPUN IRINA A. , BOVA ELENA V. , VOROBYEV SERGEY V. 
Published: June 2018

Recently, the attention of researchers is attracted to the problem of testosterone (T) deficiency in men. Its negative effect on the cardiovascular system has been established, but the data about the effect of T deficiency on the renal function in patients with type 2 diabetes mellitus (T2DM) haven’t been studied yet.
Aim: Evaluate the effect of T therapy on glycemic control, the renal function and the biochemical parameters of endothelial function in men with T2DM having an androgen deficiency.
Materials and Methods: The study included 80 men (mean age 51.5±6.3 years), with T2DM and T deficiency. Patients were randomized into 2 groups: the 1st-40 men receiving transdermal T (Androgel 50 mg/day) during 9 months and the 2nd group - 40 men who were not assigned to T. Patients underwent a clinical examination, analysis of biochemical parameters of carbohydrate metabolism (fasting glycemia, HbA1c), renal (creatinin, glomerular filtration rate (GFR)) and endothelial functions (p-, e-selectins, ICAM-1, VCAM-1). Statistical analysis was performed with Mann-Whitney and Wilcoxon tests using the Statistica 10 software package.
Results: T therapy in men with T2DM, along with a decrease in body weight by 5.02±0.99 kg (p=0.003) and waist circumference by 6.5±1.6 sm, led to an improvement in carbohydrate metabolism - fasting glycemia by 22.2% and HbA1c by 1% (p=0.00001). At the same time, a statistically significant decrease in the creatinine concentration and an increase in the GFR by 12.5% ​​(p=0.01), as well as a decrease in the levels of endothelial dysfunction markers (ICAM-1 by 56% and p -selectin by 7.7 times (p=0.01)) were found. No significant changes in the 2nd group were found.
Conclusion: T therapy in men with T2DM and androgen deficiency leads not only to a decrease of visceral obesity and an improvement in carbohydrate metabolism, but also ameliorates the renal and endothelial functions, which could reduce the rate of progression of vascular complications of diabetes.

Disclosure
I.A. Khripun: None. E.V. Bova: None. S.V. Vorobyev: None.
Health Economics Analysis of Point-of-Care HbA1c Monitoring in Belgian, German, and Swiss Patients with Diabetes Mellitus Type 2
Authors: BOLTYENKOV ARTEM T. , NAVARRO FELIPE , HREN ROK 
Published: June 2018

Objectives: In patients with diabetes mellitus (DM) type 2 monitoring of glycated hemoglobin (HbA1c) level is essential to ensure glycemic control. In this study, we assessed overall financial impact of HbA1c monitoring in the point-of-care setting in Belgium, Germany, and Switzerland.
Methods: We developed a health economics model comparing the strategy of using point-of-care (POC) HbA1c monitoring with the strategy of using conventional laboratory-diagnostics (LD) in patients suffering from DM type 2. We followed cohorts of patients diagnosed with DM type 2 in Belgium, Germany and Switzerland for the period of 15 years and estimated the costs of complications (amputation, cataract extraction, kidney failure, heart failure, stroke, and microvascular disease or myocardial infarction) using the local data. To assess the validity of the assumptions and robustness of the model, a thorough sensitivity analysis was undertaken.
Results: In patients with DM type 2, POC HbA1c monitoring resulted in savings of €59.3 million (on average, €182 per patient in the cohort) in Belgium when compared to conventional LD monitoring; corresponding savings in Germany were €848 million (on average, €233 per patient in the cohort) and in Switzerland savings amounted to €118 million (on average, €422 per patient in the cohort). The sensitivity analysis showed robustness of our findings.
Conclusions: Our health economics analysis suggests that the POC HbA1c monitoring in patients suffering from DM type 2 may reduce overall heath care costs in Belgium, Germany, and Switzerland.

Disclosure
A.T. Boltyenkov: Employee; Self; Siemens. F. Navarro: None. R. Hren: None.
Remission of Type 2 Diabetes in 12% (16 of 133) Hypogonadal Men Receiving Long-Term Testosterone Therapy in a Real-Life Registry Study
Authors: HAIDER AHMAD , HAIDER KARIM S. , SAAD FARID 
Published: June 2018

Background: According to 2016 AACE/ACE obesity guidelines, hypogonadism should be assessed and treated in indicated in men with type 2 diabetes mellitus (T2DM).
Methods: In a registry of hypogonadal men (testosterone ≤12.1 nmol/L) conducted since 2004 in a urological setting, 133/400 patients (33.3%) had T2DM diagnosed and treated in a diabetes center. All men received testosterone undecanoate (TU) injections 1000 mg/12 weeks (T-group) following an initial 6-week interval. Anthropometric and metabolic parameters were measured at least twice a year and fasting insulin obtained from the diabetes center to calculate HOMA-IR.
Results: Mean follow-up was 6.9, maximum 11 years. 16 patients (12%) were in remission at the last measurement. Their average baseline age was 60.1 years. HbA1c dropped from 8.3% at baseline to 5.7% at the last measurement, fasting glucose from 7.8 mmol/L to 5.4 mmol/L. Fasting insulin declined from 24.7 to 7.6 µU/mL. HOMA-IR dropped from 8.7 to 1.8. Triglycerides decreased from 3.2 to 2.2 mmol/L. Anthropometric parameters: Body weight declined progressively from 107 to 89 kg, waist circumference from 1to 97 cm. All patients had been on oral antidiabetic medication (metformin) at baseline. Five patients were on insulin at an average dose of 21.6 units per day. The average observation time was 106.3 months (8.9 years). The average time to discontinuation of diabetes medication was 74.8 months (6.2 years). One patient was diagnosed with low-grade prostate cancer and developed new onset T2DM while off TU. He went into remission 48 months after resuming TU therapy. Medication adherence to TU was 100 per cent as all injections were administered in the urology office and documented.
Discussion: The registry was not designed to study the effects of testosterone on T2DM. Remission of T2DM has not been described in the literature and was unexpected.
Conclusions: Long-term testosterone treatment in hypogonadal men may result in remission of T2DM.

Disclosure
A. Haider: Research Support; Self; Bayer AG. K.S. Haider: Other Relationship; Self; Bayer AG. F. Saad: Employee; Self; Bayer AG. Stock/Shareholder; Self; Bayer AG, Novo Nordisk A/S.
A Clinical Training Program for Hybrid Closed-Loop Therapy in a Pediatric Diabetes Clinic
Authors: BERGET CARI , THOMAS SARAH , MESSER LAUREL H. , OWEN SUSAN , THIVENER KATIE , SLOVER ROBERT H. , PAUL WADWA R. , ALONSO GUY T. 
Published: June 2018

Background: The first hybrid closed loop (HCL) system became commercially available in the U.S. in 2017, and there is no standard process for training patients. The goal of this quality improvement project was to optimize transition to HCL for pediatric patients at a large diabetes center.
Methods: Our multidisciplinary team developed a novel HCL training program, meeting monthly over 4 months to review data and refine training with a Plan-Do-Study-Act model. The HCL training plan for current insulin pump users included 1) in-person group class to reinforce conventional insulin pump and CGM use on the new system, 2) a live videoconference class to teach HCL use, 3) three follow-up phone calls in the first 6 weeks after HCL training to assess system use, make insulin adjustments, and provide targeted re-education.
Results: Seventy-two patients (age 14 ± 4.3y; 46% female) with type 1 diabetes (HbA1c 8.7 ± 1.4%) were trained over 4 months. Mean sensor wear time was 83% and HCL time was 73%. Sensor time in target range (70-180 mg/dl) increased from 49% to 62% between week 1 and week 4 (p= &lt;.001). Sensor wear and HCL time did not change. All patients completed both classes, and 79% and 48% completed 2 and 3 follow-up calls respectively. Mean phone call time was 16 minutes. Trainers strengthened carbohydrate ratios to increase mealtime insulin doses in 75% of patients, with most changes made at breakfast (68% of patients). The most common reason for HCL exit was high sensor glucose (1.98/week). The most common topics during calls were importance of meal boluses, correction boluses for high blood glucose, and responding to system alerts to prevent HCL exits.
Conclusion: Ongoing educational support is vital in the early weeks of HCL use. Scheduled telephone contact helped address barriers and reinforce behaviors essential for success. Patients benefited from increased meal boluses in HCL compared to traditional pump mode. Future work will clarify the support necessary to optimize long- term outcomes with HCL.

Disclosure
C. Berget: None. S. Thomas: None. L.H. Messer: Other Relationship; Self; Medtronic MiniMed, Inc.. S. Owen: None. K. Thivener: None. R.H. Slover: None. R. Wadwa: Advisory Panel; Self; Eli Lilly and Company. Research Support; Self; MannKind Corporation, Dexcom, Inc., Xeris Pharmaceuticals, Inc., Bigfoot Biomedical. G.T. Alonso: None.
Basal-Bolus Insulin Therapy May Not Be the Optimal Strategy in a "Real-World" Hospital Setting for Inpatient Hyperglycemia Management
Authors: SADHU ARCHANA R. , PATHAM BHARGAVI , VADHARIYA AISHA , JOHNSON MICHAEL L. 
Published: June 2018

Basal bolus insulin therapy (BB) is recommended for glucose control in noncritically ill inpatients based on two small RABBIT2 trails. However, BB is complex and has limited data in large scale “real world” settings.
This is a retrospective analysis of 4,558 noncritical, medical-surgical admissions from 1/2013 to 9/2015 in patients ≥18 years who received SC but not IV insulin for ≥ 75% of the stay. Insulin therapy was identified within the first 2 days as BB (long + rapid, n=2319), sliding scale (SS, rapid only, n=1855) or Basal Only (BO, long only, n=384). A propensity score analysis adjusted for clinical, demographic and physician variables affecting choice of therapy. Point of care glucose (mg/dl) was used to define patient days as hypo- (any &lt;70), hyper- (mean &gt;180) or euglycemic (no &lt;70 AND mean ≤180). Negative binomial regression analyzed glucose outcomes (number of hypo-, hyper- and euglycemic days, mean glucose); linear regression modeled log of length of stay (LOS); logistic regression modeled odds of 30 and 60 day readmission. All analyses were conducted overall and by medical or surgical DRG.
BB had worse glucose control but less LOS in medical DRG. BO had better hyper-, euglycemic and mean glucose. BB and BO had more hypo- days. This suggests that BO may be superior and simpler than BB for hyperglycemia but medical patients may benefit from BB for reasons beyond glucose control.
Insulin groupsOVERALL (n= 4,558)MEDICAL DRG (n =3,211)SURGICAL DRG (n= 1,347)Length of stay*BB vs SS0.97 (0.141)0.94 (0.003)1.02 (0.540)BO vs SS1.01 (0.711)0.99 (0.741)1.03 (0.665)Hyperglycemic days*BB vs SS0.99 (0.700)0.97 (0.416)1.00 (0.922)BO vs SS0.69 (&lt;0.001)0.69 (&lt;0.001)0.69 (&lt;0.001)Hypoglycemic days*BB vs SS2.45 (&lt;0.001)2.29 (&lt;0.001)2.78 (&lt;0.001)BO vs SS2.71 (&lt;0.001)2.37 (&lt;0.001)3..40 (&lt;0.001)Euglycemic days*BB vs SS0.91 (0.008)0.85 (&lt;0.001)1.01 (0.823)BO vs SS1.15 (0.012)1.11 (0.151)1.20 (0.063)Mean glucose*BB vs SS1.01 (0.415)1.69 (0.266)-1.18 (0.589)BO vs SS-17.27 (&lt;0.001)-17.95 (&lt;0.001)-15.91 (&lt;0.001)1Results for 30 and 60 day readmission are not significantly different across the groups and are not presented in the table;*Results above shown as: Estimate (p-value)

Disclosure
A.R. Sadhu: None. B. Patham: None. A. Vadhariya: None. M.L. Johnson: None.
Duration of Insulin Supply in Type 1 Diabetes—Is 90 Days Better or Worse than 30 Days?
Authors: ROGERS MARY A.M. , KIM CATHERINE , TIPIRNENI RENUKA , BANERJEE TANIMA , LEE JOYCE 
Published: June 2018

We evaluated whether the duration of insulin supply was associated with hemoglobin A1c. Data were obtained through the Clinformatics® Data Mart Database, from 2001-2015. Patients were grouped according to the duration of insulin supply: 30 days, 90 days, and a combination of both 30 day and 90 day prescriptions. Generalized estimating equations which account for repeated measures within patients were used, with robust estimates of variance. Prescription duration was regressed on HbA1c (dependent variable) with alpha=0.(2-tailed). There were 16,725 eligible patients (9362 with 30-day, 1280 with 90-day, and 6083 with both 30- and 90-day prescriptions). The mean number of HbA1c tests/patient was 3.1. Patients who used 30-day prescriptions had HbA1c values that were 0.65 greater than those with 90-day prescriptions (p&lt;0.001). Patients who used a combination of 30-day and 90-day prescriptions had HbA1c values that were 0.37 greater compared to 90-day prescriptions (p&lt;0.001). The predicted HbA1c values were 8.33% (95% CI: 8.31%, 8.36%) for 30-day, 8.05% (95% CI: 8.03%, 8.08%) for the combination, and 7.69% (95% CI: 7.64%, 7.73%) for 90-day prescriptions. Results were similar when stratified by age. For those &lt;20 years of age, the predicted HbA1c values were 8.95% for 30-day, 8.71% for the combination, and 8.33% for 90-day prescriptions. For those ≥20 years of age, the results were 8.26%, 7.96% and 7.64%, respectively. Patterns were similar when stratified by sex. Mailed prescriptions were also associated with lower HbA1c (p&lt;0.001). Predicted HbA1c was 7.58% (95% CI: 7.53%, 7.63%) when all prescriptions were mailed and 8.21% (95% CI: 8.19%, 8.23%) when not. After simultaneous adjustment for age, sex, duration of supply, and mailed status, both 90-day prescriptions and mailed prescriptions were associated with lower HbA1c values (p&lt;0.001 for both). In patients with type 1 diabetes, 90-day insulin prescriptions and mailed prescriptions were both independently associated with lower HbA1c values.

Disclosure
M.A.M. Rogers: None. C. Kim: None. R. Tipirneni: None. T. Banerjee: None. J. Lee: Consultant; Self; Unitio.
Dulaglutide Has Higher Adherence and Persistence than Liraglutide and Exenatide QW—One-Year Follow-Up from U.S. Real-World Data
Authors: MODY REEMA , HUANG QING , YU MARIA , ZHAO RUIZHI , PATEL HIREN , GRABNER MICHAEL , LANDO LAURA FERNANDEZ 
Published: June 2018

The objective of this retrospective real-world observational study was to compare 1-year adherence and persistence among patients initiating GLP-1 receptor agonists (GLP-1RA), dulaglutide (DULA) vs. liraglutide (LIRA) or DULA vs. exenatide QW (EQW) in the U.S., using claims data between November 2014 and May 2016 (index date=earliest GLP-1RA fill date) from the HealthCore Integrated Research Database (HIRD®).
Patients ≥18 years old, with T2DM, no claim for index drug in the 6 months pre-index period, and continuous enrollment 6 months pre- and 1-year post-index were included. DULA users were propensity-matched 1:1 to LIRA (2,427 pairs) or EQW (1,8pairs) users. Matched cohorts were balanced in baseline characteristics and the mean age was 54 years with around 52% males.
The key adherence and persistence outcomes are included in the table. At 1-year, DULA users were more likely to be adherent [Proportion of Days Covered (PDC)≥80%] than LIRA (odds ratio [OR]=1.76, 95% CI=[1.56, 1.99]) or EQW users (OR=2.31, 95% CI=[2.00, 2.66]). Cox regression showed that DULA users were less likely to discontinue therapy than LIRA (hazard ratio [HR]=0.75, 95% CI=[0.69, 0.81]) or EQW users (HR=0.58, 95% CI=[0.53, 0.63]).
At 1-year follow-up, patients initiating DULA had higher medication adherence, and were more persistent to their treatment compared to patients initiating either LIRA or EQW.
Table: 1-Year Follow-up Adherence and Persistence Outcomes Among GLP-1 RA InitiatorsMatched DULA vs. LIRA CohortsMatched DULA vs. EQW1 CohortsDULALIRAp-value2DULAEQW1p-value2N=2,427N=2,427N=1,808N=1,808Proportion of Days Covered (PDC), mean (SD) in %67.3% (32.1)59.5% (32.6)&lt;0.00166.8% (32.2)51.3% (34.6)&lt;0.001Adherence (PDC ≥ 80%), %51.2%38.2%&lt;0.00150.7%31.9%&lt;0.001Patients who discontinued therapy, %51.1%62.0%&lt;0.00151.1%70.9%&lt;0.001Persistence3, mean (SD) days251.9 (135.7)217.3 (143.0)&lt;0.001250.5 (136.8)191.6 (139.3)&lt;0.0011The study included only exenatide QW pen users.2P-values for categorical variables were obtained using Chi-square tests; p-values for continuous variables were obtained using Wilcoxon rank sum tests.3The number of days of continuous index GLP-1 RA therapy since initiation, allowing for a maximum gap (between fills) of 45 days. Patients who were censored at the end of the 1-year follow-up period were included.

Disclosure
R. Mody: Employee; Self; Eli Lilly and Company. Q. Huang: Other Relationship; Self; Eli Lilly and Company. M. Yu: Employee; Self; Eli Lilly and Company. R. Zhao: Other Relationship; Self; Eli Lilly and Company. H. Patel: Employee; Self; Eli Lilly and Company. Stock/Shareholder; Self; Eli Lilly and Company. M. Grabner: Employee; Self; HealthCore, Inc. L. Fernandez Lando: Employee; Self; Eli Lilly and Company. Stock/Shareholder; Self; Eli Lilly and Company.
Institutional Inpatient Diabetes Management—We're Still Not Doing It Right
Authors: KRAVCHENKO MARIA , WARDIAN JANA L. , GRAYBILL SKY 
Published: June 2018

Introduction: Morbidity and mortality increase with substantial glucose excursions during hospitalizations. The American Diabetes Association recommends an optimal glucose target of 140-180mg/dL for most inpatients with diabetes; glucose ranges of 80-180mg/dL are acceptable. They recommend against using correctional insulin alone; however, previous surveys have shown widespread use. The aim of this project was to identify current glycemic management patterns in our institution and find areas for improvement.
Methods: We investigated inpatient admissions to San Antonio Military Medical Center from March to September 2017. Patients included adults on medical or surgical services who received subcutaneous insulin, regardless of diabetes status. Data were collected for insulin orders, administration times, glucose values, and HbA1c levels.
Results: There were 1656 patients; 59% received only correctional insulin; 27% received basal and correctional insulin; 13% received basal/bolus insulin. Most patients (73%) did not reach glycemic targets; rates of hypoglycemia were 4-23%, which was higher than expected. Patients with HbA1c values of 8-9% were more likely to receive basal insulin; despite this, glycemic control remained poor. Troublingly, 13% of patients receiving correctional insulin alone had normoglycemia or normal baseline HbA1c values; 19% of these patients developed hypoglycemia during hospitalization.
Conclusion: Despite national guidelines, the majority of patients in our institution received only correctional insulin and did not achieve glucose targets. Additionally, most patients receiving basal/bolus insulin did not achieve glucose targets, suggesting inadequate titration. This requires systematic interventions to improve inpatient diabetes management.
Disclaimer: The views expressed are those of the authors and do not reflect the official views or policy of the Department of Defense or its Components.

Disclosure
M. Kravchenko: None. J.L. Wardian: None. S. Graybill: None.
Incorporating Cardioprotective Effects of Once-Weekly Semaglutide in Estimates of Health Benefits for Patients with Type 2 Diabetes
Authors: EVANS MARC , JOHANSEN PIERRE , VRAZIC HRVOJE 
Published: June 2018

Economic modeling of type 2 diabetes (T2D) relies on sets of risk equations (e.g., UKPDS 68) to predict cardiovascular (CV) events and mortality as mediated through changes in risk factors (e.g., HbA1c). Recent CV outcomes trials (CVOTs) have shown significant benefits in events over a short time period (between 2-4 years), along with beneficial changes in risk factors such as blood pressure, HbA1c, and weight. The contributions of these changes to the observed outcomes within these CVOTs are unclear. In patients with high CV risk, the SUSTAIN 6 trial of once-weekly semaglutide+standard of care (SoC) reported a statistically significant reduction in stroke (HR=0.61) after 104 weeks vs. placebo+SoC. We sought to establish the contribution of risk factor changes to this observed outcome, by evaluating the performance of traditional risk equations in predicting outcome benefits seen with once-weekly semaglutide. As a secondary objective, the impact of incorporating the stroke benefit on estimated long term health benefits was assessed. The IQVIA Core Diabetes Model was used to assess predictive accuracy of the UKPDS 68 risk equations on the observed stroke benefit. Secondly, the model was calibrated to preserve the ratio of the observed cumulative incidence of stroke between treatment arms. Finally, results were extrapolated over 50 years. The UKPDS 68 equations were able to predict 64% of the observed 2-year stroke risk reduction, suggesting a drug-mechanistic effect other than changes in risk factors. Calibration results indicate that a relative risk of stroke of 0.83 (17% reduction) applied to once-weekly semaglutide was required to preserve the cumulative incidence ratio. Results of extrapolation increased quality-adjusted life-years by 0.18 and life-years by 0.29 vs. placebo+SoC. Results of this analysis may have implications on future approaches assessing the long term economic impact of new therapies in T2D in this era of multiple CVOTs.

Disclosure
M. Evans: Advisory Panel; Self; Novo Nordisk A/S. Consultant; Self; Novartis AG, Boehringer Ingelheim Pharmaceuticals, Inc., Janssen Pharmaceuticals, Inc., Merck Sharp & Dohme Corp. P. Johansen: Consultant; Self; Janssen Global Services, LLC.. Employee; Self; Novo Nordisk A/S. H. Vrazic: Employee; Self; Novo Nordisk A/S.
Electronic Messaging Use via a Patient Portal Is Associated with Primary Care Utilization in Patients with Type 2 Diabetes
Authors: SUN RAN , SEREIKA SUSAN M. , SAUL MELISSA , KORYTKOWSKI MARY T. , LI DAN , BURKE LORA E. 
Published: June 2018

Background: Electronic messaging via a patient portal is being used with increasing frequency for patient-provider communication, especially for the ongoing management of type 2 diabetes (T2DM). Providing patients online access to providers may reduce the need for face-to-face contact; yet little is known about the usage pattern and its association with the frequency of office visits to primary care providers (PCP).
Methods: A cross-sectional analysis was conducted using the data from the ambulatory electronic health records of UPMC Physician Services. Adults with T2DM who were seen in UPMC PCP offices between Jan 2015 and Dec 2016 were included. The number of days messaging was used, and the number of PCP visits for each patient were calculated during the study period. Descriptive statistics were applied. Negative binomial regression was performed to examine the association of messaging use with the number of PCP visits, adjusting for age, gender, race, education, income, insurance type, and the number of comorbidities.
Results: The sample (N=42,746) was 85.5% white and 49.9% female with a mean age of 65.2±11.9 years. About a third (36.7%, n=15,698) used the messaging feature at least once during the study period. The median number of days that patients used the messaging feature was 13.0 (range 1-395). Negative binomial regression revealed that greater use of messaging was associated with a greater number of PCP visits (Incidence Rate Ratio 1.0014, 95% CI, 1.0011-1.0018).
Conclusion: In our study, over one-third of the patients used the messaging feature via the portal. More frequent use of messaging was associated with a greater number of PCP visits, suggesting that both measures represent patient engagement in health care services. However, the frequency of PCP visits may not be an accurate indicator of clinical outcomes. Future studies that include patient outcome measures, such as HbA1c, according to portal use are needed as use of this technology increases.

Disclosure
R. Sun: None. S.M. Sereika: None. M. Saul: None. M.T. Korytkowski: Advisory Panel; Self; Novo Nordisk Inc.. Other Relationship; Self; JAEB Center For Health Research. D. Li: None. L.E. Burke: None.