bluuebunny/crossref_metadata_2025_split huggingface dataset:
1096-P: DPP-4 Inhibitor Teneligliptin Improves the Vascular Endothelial Function via Mechanism Different from Changes of EPCs Levels and Blood Glucose Metabolism
Authors: AKASHI NAOYUKI , UMEMOTO TOMIO , HODAKA YAMADA , FUJIWARA TAKAYUKI , YAMAMOTO KEI , TANIGUCHI YOUSUKE , SAKAKURA KENICHI , WADA HIROSHI , MOMOMURA SHIN-ICHI , FUJITA HIDEO 
Published: June 2020

Background: DPP-4 inhibitors have been reported to have beneficial effects on endothelial function as sitagliptin increases circulating endothelial progenitor cells (EPCs) via inhibition of plasma stromal derived factor-1 alpha (SDF-1α). However, its mechanisms are unclear. We evaluated whether DPP-4 inhibitor teneligliptin increases the number of circulating EPCs through inhibition of SDF-1α metabolism and improves flow mediated vascular dilatation (FMD) in type 2 diabetes mellitus (T2DM) patients with acute coronary syndrome (ACS) or its risk factors.
Methods: This study was a prospective, single-center, open-label, randomized controlled trial. A total of 16 patients with present or past history of ACS or multiple cardiovascular risk factors were enrolled, and who take any medicine for diabetes, whose HbA1c &gt; 7.5% and/or peak CPK &gt; 2000 IU/ml, were excluded. Variable of glucose and lipids, the number of EPCs, activity levels of DPP-4 and SDF-1α and FMD were evaluated at baseline and at 28±4 weeks after enrollment in all patients. They were randomly assigned into 2 groups either 20mg per day teneligliptin or control. Finally, 8 patients were included in teneligliptin group and 8 in control. All data were analyzed by paired t-test, and p &lt; 0.05 was considered statistically significant.
Results: DPP-4 activity (∆-509.5±105.7 vs. ∆32.8±53.4 μU/ml) and SDF-1α levels (∆-695.6±443.2 vs. ∆11.1±193.7 pg/ml) were significantly decreased after 28 weeks in teneligliptin group compared to control, respectively. Number of EPCs, and variables of glucose and lipids were not significantly different between two groups before and after 28 weeks. However, FMD was significantly improved in the teneligliptin group compared to control (∆3.8±2.1 vs. ∆-0.3±2.9%, p = 0.006) after 28 weeks treatment.
Conclusion: These results indicate that teneligliptin improves FMD by different mechanisms from the increase of blood EPC number via SDF-1α.

Disclosure
N. Akashi: None. T. Umemoto: None. Y. Hodaka: None. T. Fujiwara: None. K. Yamamoto: None. Y. Taniguchi: None. K. Sakakura: None. H. Wada: None. S. Momomura: None. H. Fujita: None.
1117-P: Cardiovascular and Glycemic Benefits of Bexagliflozin as an Adjunct to Metformin for the Treatment of Type 2 Diabetes in Adults: A 24-Week, Randomized, Double-Blind, Placebo-Controlled Trial
Authors: HALVORSEN YUAN-DI C. , LOCK JOHN P. , FREEMAN MASON W. 
Published: June 2020

Bexagliflozin is a potent and selective sodium glucose co-transporter 2 inhibitor. To evaluate the safety and effectiveness of bexagliflozin as an adjunct to metformin for the treatment of type 2 diabetes mellitus, participants (317) were randomized to receive bexagliflozin or placebo in addition to ongoing treatment with metformin. The primary endpoint was the placebo-adjusted change in HbA1c from baseline to week 24. Changes in systolic blood pressure (SBP), fasting plasma glucose (FPG) and body mass were secondary endpoints. The study also enrolled an open label arm of participants with elevated HbA1c. Including post-rescue observations, the mean change in HbA1c was 1.09% (95% CI 1.24%, 0.94%) in the bexagliflozin arm and 0.56% ( 0.71%, 0.41%) in the placebo arm, for a difference of -0.53% ( 0.74%, 0.32%; p &lt; 0.0001). By the last-observation-carried-forward method, the intergroup difference was -0.70% ( 0.92, 0.48; p &lt; 0.0001). The open label cohort experienced a mean change in HbA1c of 2.82% ( 3.23%, -2.41%). The placebo-adjusted changes from baseline SBP, FPG and body mass and SBP were 7.07 mm Hg ( 9.83, -4.32; p &lt; 0.0001), -1.35 mmol L-1 (-1.83, -0.86; p &lt; 0.0001) and 2.51 kg (-3.45, -1.57; p &lt; 0.0001). Adverse events were experienced by 42.4% and 47.2% of subjects in the bexagliflozin and placebo arms, respectively, and fewer subjects in the bexagliflozin arm experienced serious adverse events. Bexagliflozin produced clinically meaningful and statistically significant improvement in measures of cardiovascular health and glycemic control in a population of diabetic adults inadequately controlled by metformin alone. ClinicalTrials.gov Identifier: NCT03259789.

Disclosure
Y.C. Halvorsen: Research Support; Self; Theracos, Inc. J.P. Lock: None. M.W. Freeman: Research Support; Self; Theracos, Inc.
1156-P: Correlates of Analog vs. Human Basal Insulin Use and Glycemic Control among Adults with Type 2 Diabetes in the United States
Authors: CROMER SARA , WEXLER DEBORAH J. , KAZEMIAN POOYAN 
Published: June 2020

There has been a shift from use of less expensive human basal insulins to costlier analog basal insulins for type 2 diabetes since the early 2000s. It is not known whether this trend has been uniform across patient groups or if these newer insulins are associated with improved outcomes in a nationwide sample. We performed statistical analyses using six consecutive cross-sectional National Health and Nutrition Examination Survey (NHANES) cycles between 2005 and 2016 to determine patient characteristics and glycemic management associated with use of analog compared to human basal insulin. NHANES respondents were included if they had a diagnosis of diabetes, reported currently taking basal insulin, and did not meet criteria for type 1 diabetes. Demographic factors (age, sex, race), socioeconomic factors (educational attainment, health insurance status), and NHANES cycle were included in a logistic regression model predicting use of analog versus human basal insulin; subsequently all variables were included in models predicting HbA1c. Between NHANES cycles 2005-2006 and 2015-2016, 723 participants met inclusion criteria. Basal insulin use increased from 9.6% to 17.2% among respondents with type 2 diabetes. Among basal insulin users, analog basal insulin use rose from 58% in 2005-2006 to 88% in 2015-2016. Compared to non-Hispanic white respondents, African American respondents were less likely to report use of analog basal insulin (aOR 0.42, 95% CI 0.24-0.74), as were Hispanic respondents (aOR 0.54, 95% CI 0.30-0.96), after adjusting for age, sex, education, and health insurance status. Older age and having health insurance, but not type of basal insulin, correlated with achievement of HbA1c goals. The use of analog or human basal insulin is associated with race and ethnicity, but not with other demographic and socioeconomic measures. Increased use of analog basal insulins in the United States between 2005-2016 was not associated with improved glycemic control.

Disclosure
S. Cromer: Employee; Spouse/Partner; Johnson & Johnson. D.J. Wexler: Other Relationship; Self; Novo Nordisk A/S. P. Kazemian: None.

Funding
National Institutes of Health (T32DK007028)
1158-P: Cost-Effectiveness of Empagliflozin vs. Liraglutide as Second-Line Therapy for Type 2 Diabetes in the United States
Authors: REIFSNIDER ODETTE , PIMPLE PRATIK , STARGARDTER MATTHEW J.D. , BRAND SARAH , DESAI NIHAR , SHETTY SHARASH 
Published: June 2020

Background: The ADA’s “Standards of Medical Care in Diabetes” recommends use of an SGLT2 inhibitor or GLP-1 receptor agonist as one of the six drug classes after metformin (MET) in T2D patients. These therapies are preferred among T2D patients with cardiovascular disease (CVD) based on clinical trial results demonstrating significant improvement in clinical outcomes. We sought to examine the economic implications of sequential use of these therapies.
Methods: An economic simulation model evaluating treatment in U.S. T2D patients after MET with empagliflozin (EMPA) as 2nd line and liraglutide (LIRA) as 3rd line vs. LIRA as 2nd line and EMPA as 3rd line was used to estimate the lifetime health and cost outcomes of T2D-related complications and adverse events (AEs). Complications, including CV death, myocardial infarction, stroke, and renal outcomes, were predicted using United Kingdom Prospective Diabetes Study risk equations and EMPA-REG OUTCOME data. A meta-analysis informed treatment-induced changes in HbA1c, SBP, and weight in patients without CVD. For each complication in patients with CVD, an indirectly estimated hazard ratio of LIRA vs. EMPA was applied. Costs ($2019), AE rates, and utilities were sourced from published literature.
Results: Compared with LIRA as 2nd line, use of EMPA added 0.32 quality-adjusted life-years (QALYs) and led to lower lifetime costs (by $11,422/patient), suggesting dominance over 2nd line LIRA (improved health outcomes at lower cost). These results were similar across CVD subgroups. Patients with CVD at baseline compared to those without CVD showed larger gains in incremental QALYs (0.42 with CVD, 0.29 without CVD) with somewhat lower cost savings (by $9,550, $12,392, respectively) for 2nd line EMPA vs. LIRA, showing dominance in both subpopulations.
Conclusion: For T2D patients with and without CVD, the use of EMPA on background MET was a dominant strategy for U.S. payers, associated with improved outcomes and lower costs as compared with LIRA.

Disclosure
O. Reifsnider: Consultant; Self; Boehringer Ingelheim International GmbH, Boehringer Ingelheim Pharmaceuticals, Inc. P. Pimple: Employee; Self; Boehringer Ingelheim Pharmaceuticals, Inc. Employee; Spouse/Partner; CVS Caremark. M.J.D. Stargardter: Consultant; Self; Boehringer Ingelheim International GmbH, Boehringer Ingelheim Pharmaceuticals, Inc. S. Brand: Consultant; Self; Boehringer Ingelheim International GmbH, Boehringer Ingelheim Pharmaceuticals, Inc. N. Desai: None. S. Shetty: Employee; Self; Boehringer Ingelheim Pharmaceuticals, Inc.
1170-P: Provider Response to Critical Action Hypoglycemia in the Ambulatory Setting
Authors: ASHOK ADITYA , ABUSAMAAN MOHAMMED S. , MATHIOUDAKIS NESTORAS 
Published: June 2020

Objective: There is no standardized defined threshold for outpatient critical action value (CAV) hypoglycemia and a scarcity of literature on provider responses to it. The aim of this study was to characterize patient demographics of, provider/patient responses to, and clinical sequelae of CAV hypoglycemia.
Methods: This was a retrospective EMR-based cohort study of all ambulatory patients with a serum glucose &lt;50 mg/dL measured at the clinical laboratories of Johns Hopkins Hospital and Johns Hopkins Bayview Medical Center between April 1, 2013 and January 31, 2017. Manual chart review was conducted using an electronic questionnaire.
Results: Two hundred nine CAV hypoglycemic episodes from 106 unique patients were identified. The median (IQR) hypoglycemic BG value was 43 (37.0, 47.0) mg/dL, and the median time from BG specimen collection to result was 158.0 min. The majority (72.2%) of patients had diabetes mellitus. The next 3 most common comorbidities were CHF (29.2%), HIV (19.6%), and ESRD (8.6%). The median age was 58 yrs and the majority (67.0%) were black; there was roughly equal gender distribution (53.6% male). Providers contacted patients in 128 (61.2%) of these episodes, and most commonly no hypoglycemic etiology (63.3%) and no signs or symptoms of hypoglycemia (80.5%) were documented. The most common documented symptoms were weakness/fatigue (32.0%), dizziness (16.0%), and tremor (12.0%). Only 4 serious adverse events were found, 3 of which had a related ED visit within 24 hrs of CAV, 1 of which involved loss of consciousness, and 2 of which involved glucagon administration.
Conclusion: Though CAV hypoglycemia tended to occur in individuals over 50 with common comorbidities and without documented hypoglycemic signs/symptoms, providers inconsistently reached out to patients and there were few serious adverse events. Further research is needed to identify optimal CAV glucose thresholds and responses, especially considering the delay between lab draw and provider/patient communication.

Disclosure
A. Ashok: None. M.S. Abusamaan: None. N. Mathioudakis: None.

Funding
National Institute of Diabetes and Digestive and Kidney Diseases (1K23DK111986-01)
1171-P: Endocrine Final Recommendation Note (EFR) Embedded in the Electronic Medical Record (EMR) Improves the Discharge Process for Hospitalized Patients with Diabetes (DM)
Authors: PINKHASOVA DIANA , DONIHI AMY , FETERIK KRISTIAN , KORYTKOWSKI MARY T. , FRENCH ESRA KARSLIOGLU 
Published: June 2020

Hospitalized patients with DM represent a group at high risk for readmission. Variability in how instructions for home DM management are provided at discharge can contribute to this risk.
At our institution, recommendations made by the endocrine consult service were not always accurately translated into patient discharge orders by the primary service.
Therefore, the EFR embedded within the EMR was developed. We investigated its effectiveness by reviewing the EMR of 48 patients discharged with insulin prior to (group 1) and following implementation (group 2) for fidelity of recommendations carried out by the primary service. Accuracy of the diabetes-related discharge regimen was defined as correct type and dose of insulin, correct administration supplies (syringes vs. pen needles), and provision of appropriate glucose monitoring supplies by the primary team.
About 50% of patients had a change in their DM regimen at discharge. Insulin was added as a new medication in 29% vs. 44% of patients in groups 1 and 2 respectively.
There was significant improvement in the accuracy of the diabetes-related discharge regimen (68% vs. 96%, p = 0.001).
These results demonstrate that deficiencies in the discharge process can be ameliorated by EMR tools which facilitate a safer transition of care from inpatient to outpatient settings for patients with DM.

Disclosure
D. Pinkhasova: None. A. Donihi: None. K. Feterik: None. M.T. Korytkowski: None. E. Karslioglu French: None.
1180-P: Better Care Strategies Are Necessary to Address Poor Medication Adherence
Authors: SPERL-HILLEN JOANN M. , ANDERSON JEFFREY P. , HAAPALA JACOB , CHUMBA LILIAN , EKSTROM HEIDI , APPANA DEEPIKA , DESILVA MALINI B. , O’CONNOR PATRICK J. 
Published: June 2020

Background: As part of a clinical decision support (CDS) and pharmacist outreach interventional study to improve medication adherence, we analyzed rates and clinical implications of poor adherence for diabetes (DM), hypertension (HTN) and lipid control.
Methods: In two high performing care delivery systems in MN, 28 clinics were randomized to an adherence CDS intervention or control. The CDS uses web-based algorithms to assess clinical data and objectively capture poor adherence using an Epic based measurement of Proportion of Days Covered (ePDC) calculated using SureScripts dispense data with a moderate or high confidence rating. For 16 weeks in 2019, the CDS ran silently in all primary care encounters of patients age 18-75 to determine how many patients qualified for study eligibility using the following criteria: 1.DM cohort: A1c ≥8% with a non-insulin glycemic medication ePDC &lt; 80%.
2. HTN cohort: BP ≥140/90 on two separate consecutive dates with a BP medication ePDC &lt; 80%.
3. Lipid cohort: ACC/AHA criteria for statin use, on a statin with ePDC &lt; 80%, excluding for LDL &lt; 70 mg/dl.
Results: Of 142,879 patients, 138,252 remained after excluding for cancer, pregnancy, hospice or nursing home. A non-insulin DM medication was identified in 15,546 (11%). Of these, 3890 (25%) had A1C ≥ 8%, and of these 1467 (59%) had poor adherence. Among the DM cohort, the mean A1C was 9.6% and 30% had A1C ≥10%. Of patients identified with DM in the HTN cohort (494/1711, 29%), 60% had a systolic blood pressure ≥ 150 mm Hg. Of patients identified with DM in the lipid cohort (2298/4564, 50%), 19% had an LDL ≥130 mg/dl.
Conclusion: Over 14 weeks, large numbers of DM patients were identified at primary care encounters with difficulty achieving A1C, BP and lipid goals in association with poor medication adherence, which was often unrecognized. Based on extremely high A1C, BP and LDL levels in these patients, there is a tremendous clinical opportunity to identify and address poor adherence using CDS and/or pharmacist care team involvement.

Disclosure
J.M. Sperl-Hillen: None. J.P. Anderson: None. J. Haapala: None. L. Chumba: None. H. Ekstrom: None. D. Appana: None. M.B. DeSilva: None. P.J. O’Connor: None.
1200-P: Use of SGLT2 Inhibitors in Hospitalized Patients in an Academic Center
Authors: PALERMO NADINE E. , GOODBERLET MELANIE , CROMWELL GRACE , SMITH COLLEEN M. , BILODEAU AMY , SZUMITA PAUL M. , MCDONNELL MARIE E. 
Published: June 2020

Recent data shows significant cardiovascular and renal benefit due to SGLT2 inhibitor (SGLT2i) therapy. However, use in the acute setting is limited and deferred due to concern of ketoacidosis especially in the setting of decreased nutrition intake and illness. Between 5/1/19 and 11/25/19 in one hospital, the inpatient formulary allowed the use of SGLT2i in patients with diabetes on the cardiology service as part of a supervised pilot program. As a result, 94 hospitalized patients were exposed to at least one dose of SGLT2i, 24 (25%) directed by the pilot program (PILOT), and 70 (75%) undirected (UND). In the UND group, 12 (13%) were newly started on SGLT2i and 58 (62%) were continued from home. Among all patients, 29.8 % were women, mean age 65, A1c 8.3% and GFR 67 mL/min. 17 patients (18%) had GFR ≤ 45, who were 5 years older on average (p= 0.04). In hospital there was no incident metabolic acidosis or clinically significant hypoglycemia. 79.8% of patients remained on SGLT2i at 1 month. 55 patients had data within 3 months post discharge. Of those still taking SGLT2i at 1 month, there was no significant change in systolic BP (SBP) at 1 or 3 months across all groups. In the UND group, there was no significant change in GFR. By comparison, in the PILOT group there was both a significant decrease in estimated GFR at 1 month (-6.95 mL/min, p= &lt;0.01) and in SBP of -4.62 mmHg (p=0.04). Of all those newly started on SGLT2i, 6 had ≥ 25% reduction in GFR and moved up one CKD stage by 3 months; one moved from CKD stage 4 to 5. Among the patients with 3 month data, 40% were readmitted within 90 days, 0.3% for CHF, 36% other cardiac and 6% infection. Baseline GFR did not affect readmission risk.
In conclusion, permitting use of SGLT2i in the acute setting to select populations is likely to increase overall exposure of the drug to the general inpatient diabetes population. While we did not identify ketoacidosis, which is rare, reduction in GFR is common. Substantial education and direction is needed for inpatient clinicians in both the inadvertent and intended use of SGLT2is.

Disclosure
N.E. Palermo: None. M. Goodberlet: None. G. Cromwell: None. C.M. Smith: None. A. Bilodeau: None. P.M. Szumita: None. M.E. McDonnell: None.
1203-P: Safety Implications of Insulin Prescribing in the Emergency Department
Authors: PATTERSON SIMONE L. , EKINCI ELIF I. , DRISCOLL ANDREA , RASMUSSEN BODIL 
Published: June 2020

Background: Despite being a common comorbidity, diabetes is often overlooked when patients present to the emergency department (ED) with nondiabetic emergencies.
Aims: To examine the associations between insulin treated patients presenting to the ED with nondiabetic emergencies and;
(i) adverse glycaemia (AG); including hypoglycaemia (&lt; 70 mg/dL) and hyperglycaemia (&lt; 180 mg/dL) and insulin prescribing errors,
(ii) glycaemic variability and AG following ED evaluation and ward diabetes management.
Methods: A two-year retrospective medical record audit of discharged insulin treated adult patients (≥ 18 years) was conducted at a quaternary hospital. All patients presented to the ED with nondiabetic emergencies and admitted to general wards for &gt; 24 hours and &lt; 30 days.
Results: Of the 103 patients (Table), 25 (24%) had one or more prescribing errors charted in the ED. Thirty-nine (37.8%) patients experienced hypoglycaemia. Of these, 21 (53.8%) were prescribed sliding scale insulin (SSI) in the ED (p = 0.05). Despite uncontrolled hyperglycaemia, 40 (47.6%) patients had no change to their diabetes treatment during admission (p = 0.04).
Conclusions: Half of insulin treated patients experienced uncontrolled hyperglycaemia. Use of SSI regimens prescribed in the ED were associated with higher risk of AG. Safety for insulin treated patients should be prioritised from the time the hospital journey begins in ED to after discharge.

Disclosure
S.L. Patterson: None. E.I. Ekinci: None. A. Driscoll: None. B. Rasmussen: None.
1209-P: A Quality Improvement Initiative to Increase Utilization of Continuous Glucose Monitors Results in Improved Glycemic Outcomes in a Pediatric Diabetes Clinic
Authors: OBRYNBA KATHRYN , INDYK JUSTIN A. , GANDHI KAJAL , BUCKINGHAM DON A. , WELLS TRAVIS , WAYNE WYNOLA N. , KAMBOJ MANMOHAN K. 
Published: June 2020

A minority of youth with type 1 diabetes (T1D) achieve HbA1c goals recommended by the ADA. Continuous glucose monitoring (CGM) is shown to improve glycemic control and reduce complications of disease. Despite this evidence, CGM utilization is low among youth with T1D. In this quality improvement project, we aimed to increase percentage utilization of CGM amongst our pediatric T1D clinic population from a baseline mean of 9% in 2017. Targeted interventions to achieve this goal included identification and tracking of utilizers vs. non-utilizers, creation of a standardized clinic workflow to initiate a new CGM device within the EMR, and identification of barriers to insurance coverage. CGM utilization in our pediatric T1D clinic increased from a mean 9% in 2017 to 53% in 2019. Over this same period, our clinic observed a 7% increase in patients who achieved goal HbA1c. Targeted interventions to increase CGM utilization in a pediatric T1D clinic secondarily led to improved glycemic outcomes.

Disclosure
K. Obrynba: None. J.A. Indyk: None. K. Gandhi: None. D.A. Buckingham: None. T. Wells: None. W.N. Wayne: None. M.K. Kamboj: Research Support; Self; Type 1 Diabetes TrialNet, Unitio, Inc.