bluuebunny/crossref_metadata_2025_split huggingface dataset:
Old but (Unfortunately) Not Forgotten—The Alarming Use of Outdated Sulfonylureas (InHypo-DM Study)
Authors: AU NATALIE H. , RATZKI-LEEWING ALEXANDRIA , RYAN BRIDGET L. , MEQUANINT SELAM , BLACK JASON E. , REICHERT SONJA M. , BROWN JUDITH B. , HARRIS STEWART 
Published: June 2018

While sulfonylureas (SUs) are known to induce hypoglycemia, their low cost and ease-of-use has made them a mainstay therapy for T2DM. Second-generation SUs (SGSUs), compared to first-generation SUs (FGSUs), have been successful at reducing these events. Pragmatic evidence substantiating this association remains limited; this study leverages data from the population-based InHypo-DM study to describe the real-world patterns of SU use and impact on hypoglycemia incidence in Canada. A validated questionnaire (InHypo-DMPQ) was administered online to a nationwide panel consisting of adults with SU-treated T2DM. Questions related to respondents’ past hypoglycemia events, as well as socio-demographic and clinical traits. Negative binomial regression (NBR) was used to test the effect of SU type (FGSUs (chlorpropamide/tolbutamide) vs. SGSUs (glyburide/gliclazide/glimepiride)) on the annual rate of any hypoglycemia. A directed acyclic graph was constructed to identify the adjustment set. Of the 255 adults with SU-treated T2DM (56% male, mean age: 53.1 (SD: 14.4) years), 10.6% were on FGSUs (chlorpropamide: 7.5%, tolbutamide: 3.1%) and 89.5% on SGSUs (glyburide: 27.5%, gliclazide: 54.9%, glimepiride: 7.1%). Annualized crude event frequencies revealed that those on FGSUs, vs. SGSUs, were 1.57 times as likely to have ≥1 event; this group also experienced an average of 2.70 more events/person-year. Based on the NBR, FGSUs vs. SGSUs was associated with a 2.76 (95% CI: 1.07-7.11, p=0.035) factor increase in the rate of hypoglycemia, adjusting for drug coverage, T2DM duration, income, and clinician type. These results confirm that FGSUs induce a dangerous, real-world risk for hypoglycemia. It exposes a worrying trend for the continued use of outdated SUs for T2DM, despite the availability of safer alternatives in Canada. Our study serves as a pressing call-to-action to ensure that clinicians provide the safest and most effective therapeutic management for patients with T2DM.

Disclosure
N.H. Au: None. A. Ratzki-Leewing: None. B.L. Ryan: None. S. Mequanint: None. J.E. Black: None. S.M. Reichert: Other Relationship; Self; Novo Nordisk Inc., Sanofi, Abbott, AstraZeneca. Advisory Panel; Self; Servier. Speaker's Bureau; Self; Eli Lilly and Company. Other Relationship; Self; Boehringer Ingelheim Pharmaceuticals, Inc.. Speaker's Bureau; Self; Merck & Co., Inc., Janssen Pharmaceuticals, Inc.. J.B. Brown: None. S. Harris: Advisory Panel; Self; Novo Nordisk A/S, Sanofi, Merck, AstraZeneca, Amgen Inc., Lilly/Boehringer Ingelheim, Abbott, Janssen. Consultant; Self; Novo Nordisk A/S, Sanofi, Merck, AstraZeneca, Lilly/Boehringer Ingelheim, Abbott, Janssen. Research Support; Self; Novo Nordisk A/S, Sanofi, Merck, Abbott, AstraZeneca, Janssen. Other Relationship; Self; CIHR, CDA, The Lawson Foundation.
Risk Factors for Hospital Readmission following Implementation of a Diabetic Ketoacidosis (DKA) Power Plan
Authors: KARAJGIKAR NEHA , DONIHI AMY , SALATA ROSE A. , CODARIO RONALD , ACHARYA RUNA , MANROA POOJA , KORYTKOWSKI MARY T. 
Published: June 2018

Patients admitted to the hospital with DKA are at high-risk for readmission. We have previously demonstrated that implementation of a DKA PowerPlan (PP) that guides IV insulin dosing following acute management and transition to SC insulin reduces the frequency of recurrent DKA and rebound hyperglycemia during the index hospitalization. The purpose of this study was to determine whether the DKA PP reduces all cause and diabetes-related (recurrent DKA, hyperglycemia, hypoglycemia) hospital readmissions at 30 days and 1 year following an index hospitalization, as well to examine the contribution of high risk co-morbidities (psychiatric illness and/or history of alcohol/polysubstance abuse) associated with readmission risk in this group of patients. Retrospective chart review was performed for patients admitted with primary diagnosis of DKA prior to (pre-PP, n=60) and following DKA PP implementation (Post-PP, n=60). The groups were similar in age (Pre- vs. Post-PP: 38 ± 13.5 vs. 40 ± 16.6), BMI (26 ± 6.7 vs. 27 ± 7 kg/m2), gender (%Male: 38% vs. 48%), HbA1c (11.7 ± 2.4 vs. 11.3 ± 2.9%), admission BG (560 vs. 615 mg/dl) and anion gap (AG) (27.6 vs. 27.4), but differed in the prevalence of comorbidities which were higher in the pre-PP group (58 vs. 40%, p = 0.045). All cause readmissions were similar at 30 days (Pre vs. Post-PP: 1.4 ± 0.8 vs. 1.2 ± 0.4) but were lower at 1 year in the post-PP group (5.2 ± 4.7 vs. 3.5 ± 2.7, p = 0.07). Patients with co-morbidities in the post-PP group had lower all-cause (p = 0.023) but not diabetes related readmissions at 1 year, compared to patients with co-morbidities in the pre-PP group.
In summary, these findings suggest that a DKA PP may be associated with a reduction in all cause hospital readmission in high risk patients with underlying psychiatric or substance abuse disorders. These results emphasize the need to identify and address patient specific factors that contribute to readmission in this high risk group.

Disclosure
N. Karajgikar: None. A. Donihi: None. R.A. Salata: None. R. Codario: None. R. Acharya: None. P. Manroa: None. M.T. Korytkowski: Advisory Panel; Self; Novo Nordisk Inc.. Other Relationship; Self; JAEB Center For Health Research.
Patient-Reported Outcome Labeling for Antidiabetic Agents Approved in the United States, 2011–2017
Authors: ZETTLER MARJORIE E. , SANDOVAL RENATO 
Published: June 2018

Background: Patient-reported outcomes (PROs), defined as any report on the status of a patient’s health condition that comes directly from the patient without interpretation by any other party, have been the subject of increased focus during drug development. The U.S. FDA issued final guidance on the use of PRO measures to support labeling claims in 2009, as a means of integrating patients’ experience. Diabetes is a chronic condition requiring patient self-management. Achieving optimal glycemic control necessitates patient engagement and commitment to treatment adherence. Given the significant patient burden, data regarding quality of life (QoL) and treatment satisfaction may be important to patients and clinicians in considering treatment options. This paper evaluates the incorporation of PROs into labeling for antidiabetic agents approved by the FDA between 2011 and 2017.
Methods: The FDA’s Novel New Drug Summaries (2011-2017) were reviewed to identify antidiabetic agents. Drug approval packages and product labels were accessed via the Drugs@FDA database and analyzed for PRO endpoints, measures, and labeling claims. Clinical trial designs were ascertained via the ClinicalTrials.gov website.
Results: Of 250 novel drugs approved by the FDA between 2011 and 2017, 11 (4.4%) were for antidiabetic indications. None of the 11 incorporated PROs in their labeling. However, 5 of the 11 (45.5%) collected QoL or treatment satisfaction data as a secondary or tertiary endpoint in at least 1 of the trials supporting approval. Measures included the EQ-5D, SF-36, and the Diabetes Treatment Satisfaction Questionnaire.
Conclusions: Although nearly half of all antidiabetic agents approved in the past 7 years assessed PROs during drug development, none acquired PRO label claims. As diabetes can have a significant impact on patients’ day-to-day functioning and QoL, failure to integrate PROs into labeling may represent a missed opportunity for patients, clinicians, and industry sponsors.

Disclosure
M.E. Zettler: None. R. Sandoval: None.
Optimization of Blood Pressure Control, Metabolic Parameters, and Target Organs Protection with Perindopril + Indapamide Fixed Combination in Hypertensive Patients with Obesity and Prediabetes
Authors: NEDOGODA SERGEY V. , BARYKINA IRINA , SALASYUK ALLA , SMIRNOVA VIKTORIA O. , POPOVA EKATERINA 
Published: June 2018

The study objective was to evaluate the ability of the fixed combination (FC) of perindopril + indapamide (P+I) to reduce insulin resistance and low intensive noninfectious inflammation as well as to improve arterial elasticity in patients with hypertension, obesity and prediabetes on previous successful antihypertensive therapy with losartan + hydrochlorothiazide (L+HTZ) 100/12.5 mg. A 12-week open-label study included 50 patients (age 54.8 ± 6.6 years, body mass index (BMI) 32.5 ± 3.2 kg/m2). All patients underwent a 24-hour ambulatory blood pressure monitoring, applanation tonometry (assessment of augmentation index (AI), central blood pressure (CBP)), pulse wave velocity (PWV) measurement and laboratory investigations (lipid profile, fasting glucose, the homeostatic model assessment (HOMA) index, homocysteine, leptin, adiponectin, high-sensitive C-reactive protein (hsCRP)).
Results: The switch of patients from L+HTZ to a FC of P+I resulted in an additional decrease in systolic BP and diastolic BP by 3.9% and 5.4%, respectively (p &lt;0.05). Significant decrease in the BP load and variability was observed. PWV, AI, central SBP, vascular age decreased by 2.2%, 9.4%, 2.1% and 6.0% (p &lt;0.05 for all). Fasting glycemia, insulinemia, and HOMA index decreased by 4.9%, 6.0% and 10.3% (p &lt;0.05 for all). Triglycerides (TG) decreased by 13.5% (p&lt;0.05) and high density lipoproteins (HDL) increased by 9.6% (p &lt;0.05). Leptin and hsCRP levels decreased by 14.4% and 11.0%, adiponectin increased by 9.9% (p &lt;0.05 for all). Clinically significant results were obtained in weight and BMI reduction on 6,0% and 1,2%.
Conclusions: FC of P+I is superior to the L+HTZ in BP control, improvement of arterial elasticity and promotes a decrease in BMI, suppression of insulin-resistance and low intensive noninfectious inflammation in patients with hypertension, associated obesity and prediabetes.

Disclosure
S.V. Nedogoda: None. I. Barykina: None. A. Salasyuk: None. V.O. Smirnova: None. E. Popova: None.
Different Sampling and Modeling Strategies Affect Analyses of Readmission Risk among Diabetes Patients
Authors: ZHAO HUAQING , TANNER SAMUEL , GOLDEN SHERITA , FISHER SUSAN G. , RUBIN DANIEL J. 
Published: June 2018

Readmissions are an undesirable outcome for which hospitals are being held accountable. Despite a growing literature, there is little consensus on the optimal method of sampling hospitalizations for calculating readmission rate and modeling methods for analyzing risk factors.
We compared 2 sampling and 3 multivariable predictive modeling strategies in a retrospective cohort of adult patients with diabetes discharged from an academic medical center between 2004 and 2012. Diabetes was defined by ICD-9-CM code 250 or documentation of taking a diabetes-specific medication. The outcome for all models was all-cause readmission within 30 days of discharge (30d readmission). Models were built on 46 sociodemographic, clinical and administrative variables.
With sampling only the first discharge per patient (N=17,284), the 30d readmission rate was 10.2% vs. 20.3% for all discharges per patient (N=44,203). Model performance varied by sampling and modeling strategy. Logistic regression (LR) without generalized estimating equations (GEE) using all discharges had the highest overall performance.
Sampling only the first discharge per patient underestimates the readmission rate and is associated with misleading measures of model performance. LR without GEE may yield overly optimistic measures of model performance. Because commonly used approaches may produce misleading results, consensus is needed.
Performance of logistic regression models to predict all-cause 30d readmission.Model and Sampling StrategyPerformance Measurement(95% CI)First Discharges without GEEAll Discharges without GEEAll Discharges with GEEAll Discharges with weighted GEEArea Under ROC Curve (C-statistic)0.821 (0.806, 0.835)0.811 (0.803, 0.818)0.803 (0.796, 0.811)0.791 (0.783, 0.798)Correlation Coefficient0.366 (0.345, 0.386)0.450 (0.438, 0.462)0.437 (0.425, 0.449)0.415 (0.403, 0.427)Coefficient of Determination, %14.96 (14.06, 15.86)21.00 (20.39, 21.61)18.40 (17.85, 18.96)15.83 (15.32, 16.34)Brier Score0.080 (0.075, 0.084)0.129 (0.126, 0.132)0.132 (0.128, 0.135)0.135 (0.132, 0.139)GEE=generalized estimating equations with an exchangeable correlation structure

Disclosure
H. Zhao: None. S. Tanner: None. S. Golden: None. S.G. Fisher: None. D.J. Rubin: Research Support; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc..
Safe Ramadan Fasting Is Possible for Subjects with Poorly Controlled Type 2 Diabetes Mellitus
Authors: CHEE YING JIE , NG SHONDA , KWEK KEVIN J. , ABDUL SHAKOOR SHAIKH ABDUL KADER 
Published: June 2018

Background: Poorly controlled diabetic patients (PCDP) are at increased risk during Ramadan fasting. International guidelines caution against Ramadan fasting among PCDP. However, many PCDP fast against medical advice. To our knowledge, no studies have specifically addressed the safety of Ramadan fasting by PCDP and hence, we aimed to study this.
Methods: Adults with type 2 DM attending a tertiary hospital’s Endocrinology clinic, who had fasted for at least 2 weeks in Ramadan, were evaluated. The safety and biochemical parameters were compared between the 2 groups based on pre- Ramadan glycemic control-Group 1 (HbA1c &lt;9%) and group 2 (PCDP, HbA1C ≥ 9%).
Results: We evaluated 139 Ramadan fasts by 113 participant-70 fasts were by PCDP, of which 26 were studied twice (2016 and 2017). The results are summarised below.
Hypoglycemia was more frequent in group 1 compared to PCDP (p = 0.017). However, there was no significant difference in other safety parameters between both groups. None of the PCDP suffered from hyperglycemia related complications.
Conclusion: Most of the PCDP in our cohort were able to fast safely during Ramadan. Our findings need to be confirmed with prospective studies in different ethnic and geographic settings. PCDP with no prior hyperglycemic crisis can fast during Ramadan safely if specific education is offered and may even harness the beneficial effects of Ramadan such as metabolic memory.
CharacteristicsGroup 1 (N = 69; mean HbA1c 7.8%)Group 2 (N = 70; mean HbA1c 10.8%)No. of days fasted (Mean)26.927.7Polydipsia (N)813Hypoglycemia (N)149Hyperglycemia (capillary blood glucose &gt; 16 mmol/L, N)912Need to break fast due to hypoglycemia (N)149Need to break fast due to hyperglycemia (N)00Hyperglycemic crisis/ DM related hospital admissions (N)00Mean HbA1c change (%) pre and post-Ramadan+ 0.18- 0.28

Disclosure
Y. Chee: None. S. Ng: None. K.J. Kwek: None. S. Abdul Shakoor: None.
Awareness of Preconception Care for Women with Type 1 Diabetes—From Family Members' Perspective
Authors: WANG CHAOFAN , LUO SIHUI , ZHENG XUEYING , HU XILING , YAN JINHUA , GUO YAN , XIONG SHANSHAN , YANG DAIZHI , QIU LILING , YAO BIN , WENG JIANPING 
Published: June 2018

Background: Preconception care (PCC) can improve pregnancy outcomes in women with type 1 diabetes (T1D). Little was known on current status of PCC in China. We aimed to investigate the current practice and attitude about PCC from the perspective of the patients’ family members.
Method: We conducted in-depth interviews with family members of T1D women. By purposive sampling we included their husbands, parents and parents-in-law. Transcripts of the interviews were coded into themes by 3 researchers via thematic framework method and analyzed in NVIVO 11. The recruitment ended when no new themes emerged.
Results: We interviewed 16 family members of 14 T1D women (10 husbands, 4 mothers, 1 father and 1 mother-in-law) and rendered 9 themes. 1. Knowledge of T1D and PCC: most demonstrated little knowledge of both due to lack of education. 2. Content of PCC: dietary guidance and glycaemic control were most required. 3. Timing of starting PCC: adulthood was most recommended while the rest adolescence. 4. Approach of PCC: internet and on-site consultation were well recognized while tutorials and materials as supplements. 5. Multi-disciplinary cooperation: most suggested that endocrinology professionals take the main responsibility of PCC with other professionals. 6. Attitude on pregnancy: most thought women had the obligation of childbearing while the rest showed respect to the women’s own decision. 7. Concern: worries on complications during pregnancy, inheritance of T1D, social discrimination and economic cost. 8. Doctor-patient communication: most considered the information and consultation time provided by doctors were inadequate. 9. Peer support: peer communication was mainly supported in order to convey experience and confidence while the minority opposed it fearing the spread of negative information.
Conclusions: Family members of T1D women scarcely owned knowledge of PCC and suffered various concerns. Their participation in PCC should be encouraged and mental support should be enhanced.

Disclosure
C. Wang: None. S. Luo: None. X. Zheng: None. X. Hu: None. J. Yan: None. Y. Guo: None. S. Xiong: None. D. Yang: None. L. Qiu: None. B. Yao: None. J. Weng: None.
Patient-Centered Outcomes of a Randomized Trial of Blood Glucose Monitoring Technology and Family-Centered Goal Setting
Authors: HALPER JILLIAN B. , HANNON TAMARA , YAZEL-SMITH LISA 
Published: June 2018

Adequate frequency of self-monitoring of blood glucose (SMBG) is important to maintain glycemic control. Real-time sharing of adolescent SMBG data with parents and providers is possible, however, adolescents may be reluctant to adopt this technology. The objective of this research was to determine patient-centered outcomes of adolescent-parent research participant pairs who were randomized to utilize: (1) a glucometer that shared blood glucose data among patients, parent, and providers, and allowed for communication; (2) family-centered goal setting; and (3) a combination of (1) and (2). We evaluated data from 97 adolescent-parent pairs in the form of 10 validated surveys; we modeled longitudinal changes in survey responses from baseline to 6 months. Differences between treatment groups were evaluated using ANOVAs and changes within patients over time were evaluated using paired t-tests. Patient and parent satisfaction was high at the onset of the intervention; 4.31 out of 5 and 4.55 out of 5, respectively. Parent Satisfaction Survey (p = 0.04) and Parental Environment Questionnaire (p = 0.006) results decreased over time; there was no significant change for any other surveys. Our data suggest that it is important to individualize therapy to meet patient-centered goals and acknowledge this when designing interventions to improve health outcomes in adolescents with T1D.

Disclosure
J.B. Halper: None. T. Hannon: Consultant; Self; Eli Lilly and Company. L. Yazel-Smith: None.
Does Initiation of Basal Insulin Analogs in Patients with Type 2 Diabetes Mellitus Confer Advantages over Neutral Protamine Hagedorn (NPH) for Severe Hypoglycemia and Glycemic Control?
Authors: LIPSKA KASIA J. , PARKER MELISSA M. , MOFFET HOWARD H. , HUANG ELBERT , KARTER ANDREW J. 
Published: June 2018

In clinical trial populations, long-acting insulin analogs modestly reduce the risk of nocturnal hypoglycemia compared with neutral protamine Hagedorn (NPH) in type 2 diabetes, but cost 2-4 times more. In real-world clinical practice, insulin performance may vary due to greater heterogeneity of patient characteristics and behaviors.
To compare rates of severe hypoglycemia and changes in glycemic control associated with insulin analogs vs. NPH, we conducted a propensity-score matched cohort analysis using data from Kaiser Permanente Northern California (20to 2015). We included patients with type 2 diabetes if they started a long-acting insulin analog or NPH, and we censored follow-up at death, loss of health plan coverage, change in type of insulin used, change in sulfonylurea treatment, or end of follow-up. Main outcomes were time to hypoglycemia-related utilization (emergency department visit or hospitalization with a primary or principal discharge diagnosis of hypoglycemia) and change in hemoglobin A1c within 1 year of insulin initiation.
Among 1,928 patients with type 2 diabetes who started insulin analogs and 23,561 who started NPH, there were 31 and 319 hypoglycemic events, respectively. After propensity score matching, the hazard ratio for severe hypoglycemia associated with insulin analog use was 0.95 (95% CI, 0.57, 1.46) and did not change significantly after additional adjustment for prior severe hypoglycemia and time-dependent diabetes medication use (HR 0.97, 95% CI 0.58, 1.54). Hemoglobin A1c decreased from 9.4% to 8.1% after initiation of insulin analogs and from 9.4% to 7.9% after initiation of NPH (difference-in-difference -0.19% (95% CI, -0.06, -0.34)).
In real-world clinical practice, the use of basal insulin analogs is not associated with a substantial reduction in hypoglycemia-related utilization or improvement in glycemic control compared with NPH insulin.

Disclosure
K.J. Lipska: Other Relationship; Self; Centers for Medicare and Medicaid Services. Research Support; Self; National Institutes of Health. M.M. Parker: Research Support; Self; Eli Lilly and Company. H.H. Moffet: Research Support; Self; Regeneron Pharmaceuticals, Inc., AstraZeneca. E. Huang: None. A.J. Karter: None.
Economic Evaluation of Dapagliflozin vs. Other Oral Hypoglycemic Drugs in China via Idealized Model
Authors: ZHENG JUAN , LONG LU , YE ZI , CHEN LULU 
Published: June 2018

Objective: To analyze and compare economic values of cardiovascular benefits from dapagliflozin to the ones from other oral hypoglycemic drugs in China using the idealized model.
Methods: An idealized model for type 2 diabetes in China with an assumed number of cases (n=2000) was established. Half of cases (Dapa group; n=1000) are treated with 10 mg of dapagliflozin and another half (Other hypoglycemic drug group; n=1000) are treated with other oral hypoglycemic drugs as monotherapy. Cardiovascular benefits resulting from the CVD-REAL study were used as the evaluation criteria for predictions of cardiovascular events. Information about the direct economic loss brought by cardiovascular events reported in relevant literatures from 20to the present (Data source including the Web of Science, PubMed, Google scholar, Wanfangdata, CNKI and Cqvip) was collected as the standard for cost calculation.
Results: Compared with other oral hypoglycemic drugs, the application of dapagliflozin allows each type 2 diabetic patient to save an average of 14279.57 CNY on cardiovascular events annually in China. The annual per capita treatment cost for patients receiving dapagliflozin in the control of blood glucose and cardiovascular events was 66.98% of that of patients in the first and second-line treatment regimens, and was 65.83% of that of patients in the second-line treatment regimen.
Conclusions: Based on this idealized model, dapagliflozin is expected to save 33.02% of annual cost on hyperglycemia control and cardiovascular complications in patients with type 2 diabetes compared to patients treated with the first and second-line treatment regimens and to save 34.17% of annual cost compared to patients treated with the second-line treatment regimen in China.

Disclosure
J. Zheng: None. L. Long: Employee; Self; AstraZeneca. Z. Ye: Employee; Self; AstraZeneca. L. Chen: None.