bluuebunny/crossref_metadata_2025_split huggingface dataset:
1273-PUB: A Comparison of Efficacy and Safety of Remogliflozin and Vildagliptin as Second-Line Treatment in Patients with Type 2 Diabetes Inadequately Controlled with Metformin Alone over One Year in Real-World Settings in India
Authors: SINHA AJAY K. 
Published: June 2021

Background: Remogliflozin had recently got approval in India as new SGLT2i and also there was a storm of Vildagliptin generics after it loses its exclusive marketing patent.
Method: This was a 48 weeks prospective observational study (N=254, age ≥ 35 years with HbA1c ≥ 7%). According to investigator decision, eligible patients were assigned either remogliflozin 100 mg BD ( N=980) or Vildagliptin 50 mg BD (N= 1420) in patients who were initially uncontrolled on metformin 1000 mg alone in single or divided doses for atlas 6 weeks. Primary outcome was change in HbA1c, FBS and PPBS, secondary outcome was proportion of patients with HbA1c&lt;7% and change in SBP and DBP.
Results: Initially 300 patients were selected but 254 patients completed the study. At baseline, mean age was 57.8±6.3 years, HbA1c 8.2±1.2%, BMI 30.1±1.7 kg/m2, and diabetes duration 5.2±1.2 years. Mean HbA1c, FBS and PPBS was significantly reduced in both the group (p&lt;0.001) from the baseline. Between the two groups there was no statistically significant differences in mean reduction of FBS and PPBS levels (p&gt;0.05). However, mean HbA1c% was slightly more reduced in remogliflozin plus metformin group (-1.2±0.3%; 8.1±1% to 6.9±0.5%, p&gt;0.001) than vildagliptin plus metformin (-1±0.3%;8.3±1.3% to 7.3±0.6%, p&gt;0.001). 62% patients on remogliflozin were achieved target HbA1c level within 24 weeks where as it was 57% with vildagliptin group. Differences were found in: SBP -7.92 mmHg (p &lt;0.0001); DBP -3.67 mmHg (p &lt;0.0001) in remogliflozin group while in other group it was no significant. There was a significant change in weight (-2.34 kg, p &lt;0.0001) with remogliflozin as compare to vilda group (-1.1 Kg, p&lt;0.005). The incidence of hypoglycemia was low in all groups (&lt;2%).
Conclusion: In conclusion, both therapies yielded similar improvements in glucose control. However, the adherence was better with remogliflozin.

Disclosure
A. K. Sinha: None.
1278-PUB: Acid-Base Alterations after Isotonic Fluid Resuscitation of Patients in Suspected DKA in the Pediatric Emergency Department
Authors: GERA SONIA , SHETH SALONI P. , KUTNEY KATHERINE A. , MALAY SINDHOOSHA 
Published: June 2021

Introduction: Pediatric patients presenting to the emergency department (ED) for diabetic ketoacidosis (DKA) often present with dehydration, with admission to the intensive care unit (ICU) dependent on measures of dehydration and acidosis.
Objective: The objective of this study was to assess the effect of fluid resuscitation in the ED on patient disposition to the ICU or floor based on changes in markers of dehydration and acidosis.
Methods: This investigation was a single-center, retrospective study of patients 6 to 18 years old presenting to the ED for concern of DKA from 2016-2019. Patients with pre-bolus and post-bolus venous blood gas (VBG) were included. Each pre-bolus and post-bolus VBG was classified as meeting ICU or floor criteria. Based on the protocol developed at Rainbow Babies and Children’s Hospital, ICU criteria were pH &lt; 7.3 and/or bicarbonate (HCO3) &lt; 15 (on VBG or renal function panel). Dehydration was assessed using heart rate and blood urea nitrogen (BUN), adjusted by age. Continuous variables were analyzed using Kruskal-Wallis test, and categorical variables were analyzed with the chi-square test or Fisher’s exact test.
Results: In this study, 187 patients met inclusion criteria. Post-bolus pH was increased in 52%, decreased in 41%, and unchanged in 7%. Post-bolus bicarbonate was increased in 44%, decreased in 53%, and unchanged in 2%. Of 145 patients with initial disposition to the ICU, 26 (17.9%) met floor criteria post-bolus, and no marker for dehydration distinguished this cohort (p=0.054 for heart rate, p=0.93 for BUN). Of 40 patients with initial disposition to the floor, 7 (17.5%) met ICU criteria post-bolus, and no marker for dehydration distinguished this cohort (p=0.68 for heart rate and p=1 for BUN).
Conclusion: Patients presenting to the ED in DKA may have a decrease in pH or HCO3 following a normal saline bolus. In patients initially meeting criteria for the floor, up to 17.5% may change disposition to the ICU after a normal saline bolus.

Disclosure
S. Gera: None. S. P. Sheth: None. K. A. Kutney: None. S. Malay: None.
1287-PUB: SGK1-NDRG1 Signal Axis as a Key Marker Associated with Insulin Resistance and Impaired Incretin Profile in Subcutaneous and Omental Fat Depots among Obese Patients
Authors: STAFEEV IURII , SKLYANIK IGOR , MAMONTOVA ELIZAVETA , MICHURINA SVETLANA , SHESTAKOVA EKATERINA , YAHYAEV KAMIL , YURASOV ANATOLIY , RATNER ELIZAVETA , MENSHIKOV MIKHAIL , VOROTNIKOV ALEXANDER V. , PARFYONOVA YELENA V. , SHESTAKOVA MARINA V. 
Published: June 2021

Objective: We have performed the comparative study of basal state of SGK-dependent signaling among obese patients with/without type 2 diabetes mellitus (T2DM). We have accomplished correlation analysis of glucose metabolism and incretin profile parameters against phosphorylation and expression parameters for SGK1 and its substrate NDRG1.
Methods: 36 patients with long (&gt;10 years) and morbid (BMI&gt;35 kg/m2) obesity, 18 of which had normal glucose tolerance (NGT) and 18 had T2DM were enrolled in this study. Hyperinsulinemic-euglycemic clamp test and HOMA-IR were used to evaluate the insulin resistance. Blood samples taken at 0, 30 and 120 min of food load test were used to assess incretin profile, insulin and glucose levels. Biopsies from subcutaneous and omental fat depots were obtained during bariatric surgery for all patients and signaling states were analyzed by western blot.
Results: Analysis of SGK signaling for subcutaneous fat has shown single significant intergroup difference: enhancing of pSGK-S422 phosphorylation in T2DM group, but also pNDRG-T346 level has tendency to accumulation in subcutaneous fat of NGT patients. Analysis of SGK signaling for omental fat has shown similar results: in this case accumulation of pNDRG-T346 in NGT patients was statistically significant. Correlation analysis has shown strong direct correlation of pNDRG-T346 level with BMI and AUC for GLP-1 and reverse correlation of pNDRG-T346 with Hb1Ac and AUC for glucagon. For pSGK-S422 we have observed opposite characters of correlations with the similar parameters of carbohydrate metabolism and incretin profile.
Conclusions: In present work we have taken more patients and have shown critical relevance and general character of stress-dependent SGK1-NDRG1 signal axis as a marker of insulin resistance for different fat depots.

Disclosure
I. Stafeev: None. A. V. Vorotnikov: None. Y. V. Parfyonova: None. M. V. Shestakova: None. I. Sklyanik: None. E. Mamontova: None. S. Michurina: None. E. Shestakova: None. K. Yahyaev: None. A. Yurasov: None. E. Ratner: None. M. Menshikov: None.

Funding
Russian Science Foundation (17-15-01435)
143-LB: Changes in Perceptions and Confidence of Health Care Professionals across Medical Specialties Regarding Use of SGLT2 and GLP-1 for Cardiorenal Benefit in Type 2 Diabetes
Authors: ZYTNICK DEENA , WOOLLEY RYAN , BRUNS MICHELLE , SHAY CHRISTINA M. 
Published: June 2021

Sodium-glucose cotransporter (SGLT2) inhibitors and glucagon like peptide 1 (GLP-1) receptor agonists have been demonstrated to provide cardio-renal benefits in patients with type 2 diabetes (T2D). Little is known about confidence and perceptions of healthcare professionals (HCPs) across medical specialties to utilize these agents in clinical practice. An online survey was conducted among a national sample of 1,006 physicians, nurse practitioners, and physician assistants in cardiology, endocrinology, nephrology, and primary care. They were asked about current and past perceptions and confidence in prescribing SGLT2s and GLP-1s for cardio-renal benefit. Survey results were analyzed using weighting for gender, region, and practice type. Participants were 56% male, 53% had &gt;10 years of experience, and 32% saw &gt;100 patients/month with T2D. Two-thirds of HCPs reported greater confidence now in prescribing SGLT2s compared to one year ago, with highest proportions among cardiologists (77%) and nephrologists (76%). Over half of HCPs (55%) were more confident now compared to one year ago with prescribing GLP-1s. A greater proportion of participants felt HCPs across all specialties are more responsible now for prescribing SGLT2s and GLP-1s compared to one year ago. Specifically, cardiologists (84%) and nephrologists (76%) felt their own specialties are now responsible for prescribing these agents for cardio-renal protection. These results suggest confidence to prescribe SGLT2s and GLP-1s for cardio-renal benefit has recently increased among medical specialties involved in T2D care. Lower HCP confidence to prescribe GLP-1s compared to SGLT2s may be due to the injectable mode of administration for GLP1s. These results also indicate a growing perception that prescribing these agents is not just the responsibility of a single specialty but is a shared responsibility across the T2D care team.

Disclosure
D. Zytnick: None. R. Woolley: None. M. Bruns: None. C. M. Shay: None.
145-OR: Annual Wellness Visits Are Associated with Increased Use of Diabetes Preventive Services in the Diabetes Belt and Surrounding Counties
Authors: MCMURRY TIMOTHY L. , KIM SOYOUN , LOBO JENNIFER M. , KANG HYOJUNG , SOHN MIN-WOONG 
Published: June 2021

Background: The Affordable Care Act created annual wellness visits (AWVs) for Medicare beneficiaries to have one yearly visit to primary care physicians and discuss preventive care for the upcoming year. We assessed whether AWVs were associated with increased use of these preventive services in Medicare patients with diabetes living in the Diabetes Belt and surrounding counties.
Methods: We used claims files from a longitudinal sample of ∼1,000,000 Medicare patients with diabetes living in the diabetes belt or surrounding counties, covering years 2014-2015. The Diabetes Belt was identified by the CDC as 644 counties across Appalachian and southeastern counties in the US that had diabetes prevalence ≥ 11% in 2008. We used these data to examine associations between AWVs and preventive service use in the next year. We examined four preventive services recommended annually for patients with diabetes by the ADA, including A1c tests, foot exam, eye exam, and microalbuminuria (MA) tests.
Results: Of all patients, only 19.6% used AWVs in 2015. Eye exams (61% vs. 56%), foot exams (92% vs. 83%), A1C tests (78% vs. 73%), and MA tests (42% vs. 31%) were more common among patients who had an AWV in the preceding year compared with those who did not. These differences remained after adjusting for patient demographics, comorbidities, county level medical resources, and geographic factors: eye exam (Odds Ratio 1.13, 95% CI 1.12-1.15); A1c Test (1.28, CI 1.26-1.31); Foot Exam (2.06, CI 2.01-2.11); MA Test (1.45, CI 1.42-1.47).
Conclusions: This study shows that AWVs were significantly associated with increased recommended preventive care use among patients with diabetes living in and near the diabetes belt. The low rates of AWV utilization by patients with diabetes in and around the Diabetes Belt is concerning and should receive more policy attention.

Disclosure
T. L. Mcmurry: None. S. Kim: None. J. M. Lobo: None. H. Kang: None. M. Sohn: None.

Funding
National Institute of Diabetes and Digestive and Kidney Diseases (R01DK113295)
15-LB: Prediction of Chronic Kidney Disease (CKD) in People with Diabetes
Authors: AFSHAR NADER , HUSCHTO TONY , ANDORRÀ MAGÍ , CHITTAJALLU SIVA , RINGEMANN CHRISTIAN , ODEGARD JOHN T. , MIKULSKI HEATHER , BABINSKY VALERIE N. , KÖNIG HELENA , SINGH INDERJIT 
Published: June 2021

Background: People with diabetes in general have a higher risk of developing Chronic Kidney Disease (CKD). The early detection of CKD in people with diabetes helps their health care providers to adjust their therapy to slow down the disease progression to higher stages, prevent complications, and reduce cardiovascular-related conditions. It also takes a great financial burden off the insurance companies in the long run by way of future treatment costs. We have developed a model that uses the historical data from the past 2 years of people with diabetes (PwD) and predicts the chance of them having CKD in the next 3 years.
Methods: Our model employed the XGBoost (eXtreme Gradient Boosting) algorithm. It used more than 860,000 PwD data from the IBM EHR (Electronic Health Records) database for training and optimizing the model parameters. It was then independently verified using more than 500,000 PwD data from the CPRD (Clinical Praxis Research Datalink) database from the UK, and close to 140,000 PwD data from the INPC (Indiana Network for Patient Care) database from the US. We considered an incident of CKD based on the appearance of a relevant ICD code. The major benefit of the XGBoost algorithm in the context of risk prediction based on EHR data is that there is no need for imputation of the missing values.
Results: We evaluated the performance of the Roche XGBoost model for CKD in terms of the area under the receiver operating characteristic curve (AUC). While we obtain comparable results for the US-based data sets (prediction model: AUCExplorys=0.83, AUCINPC=0.84), we observe a performance decrease for the validation on CPRD data (AUCCPRD=0.74). However, on all data sources our XGBoost model shows a superior performance when compared to appropriate benchmark algorithms from literature.
Conclusions: The XGBoost model for CKD disease prediction has a superior performance over benchmark models from literature.

Disclosure
N. Afshar: Employee; Self; Roche Diabetes Care. I. Singh: Employee; Self; Roche Diabetes Care. T. Huschto: Employee; Self; Roche Diabetes Care. M. Andorrà: Advisory Panel; Self; Attune Neurosciences Inc., Employee; Self; Roche Diabetes Care, Stock/Shareholder; Self; Bionure, S. L., Goodgut, S. L. S. Chittajallu: Employee; Self; Roche Diabetes Care. C. Ringemann: Employee; Self; Roche Diabetes Care. J. T. Odegard: Employee; Self; Roche Diabetes Care. H. Mikulski: None. V. N. Babinsky: Employee; Self; Roche Diabetes Care. H. König: Employee; Self; Roche Diabetes Care.
150-LB: Changes in OGTT-Derived Biomarkers following Lifestyle Intervention among High-Risk Youth
Authors: PENA ARMANDO , KIM JOON YOUNG , REYES JESSICA A. , VANDER WYST KILEY B. , OLSON MICAH , AYERS STEPHANIE , WILLIAMS ALLISON , SHAIBI GABRIEL Q. 
Published: June 2021

Background: Previous studies have identified biomarkers derived from glucose concentrations during a 2-h Oral Glucose Tolerance Test (OGTT) that differentiate type 2 diabetes risk phenotypes. Such markers include 1-h glucose concentrations (1hG), shape of the glucose response curve (GRC), and time to glucose peak (TGP). Lifestyle intervention is the first line approach to diabetes prevention, yet no studies have examined changes in OGTT-glucose phenotypes.
Methods: Latino adolescents with obesity (n=48, age 15.4±1.0, BMI% 98.2±1.4, Girls 56.3%) completed a 12-week lifestyle intervention that included physical activity (3 d/wk) and nutrition education (1 d/wk). At baseline and 12 weeks, youth completed a 2-h OGTT with glucose concentrations assessed at 0’, 30’, 60’, 90’, and 120’ to derive the 3 biomarkers used to classify low and high risk phenotypes. For 1hG, ≥155mg/dL served as the threshold that classified 1hG&lt;155mg/dL (low risk) and 1hG≥155mg/dL (high risk) phenotypes. For GRC, Biphasic (low risk) phenotypes reached peak glucose levels before dropping ≥4.5mg/dL and increasing again ≥4.5mg/dL, whereas remaining youth were Monophasic (high risk). For TGP, phenotypes were distinguished by whether glucose peaked at 30’ (Early Peak, low risk) or ≥30’ (Late Peak, high risk). Changes in OGTT-glucose phenotypes were assessed by Chi-square test.
Results: At baseline, there was substantial heterogeneity in the prevalence of OGTT-glucose phenotypes with 38% 1hG≥155mg/dL, 81% Monophasic, and 58% Late Peak. In response to the intervention, the prevalence of Monophasic decreased to 14% (p=0.048), while the prevalence of 1hG≥155mg/dL decreased to 28% (p=0.054). The decrease in prevalence of Late Peak phenotypes was not significant (-29%, p=0.200).
Conclusion: Lifestyle intervention may improve OGTT-glucose phenotypes among high-risk youth populations. Whether changes in OGTT-glucose phenotypes are associated with changes in type 2 diabetes risk factors has yet to be established.

Disclosure
A. Pena: None. J. Kim: None. J. A. Reyes: None. K. B. Vander wyst: None. M. Olson: None. S. Ayers: None. A. Williams: None. G. Q. Shaibi: None.

Funding
National Institutes of Health (P20MD002316U54, MD002316R01, DK107579F31, DK125037)
151-LB: Impact of Concurrent Use of Selective Serotonin Reuptake Inhibitors and Second-Generation Antipsychotic Medications on Cardiometabolic Health in Children
Authors: THANDI RUPINDER , WIEDEMAN ALEJANDRA M. , DEVLIN ANGELA M. , PANAGIOTOPOULOS CONSTADINA 
Published: June 2021

Around 20% of Canadian children are diagnosed with a mental health disorder. Selective serotonin reuptake inhibitors (SSRIs) and second-generation antipsychotics (SGAs) are common treatments. Treatment with SSRIs or SGAs is associated with increased cardiometabolic complications, and risk for type 2 diabetes in children. Little is known about the metabolic effects of concurrent use of SSRIs with SGAs. Our aim was to determine if the combination of SSRI and SGA treatment was associated with cardiometabolic complications in children. Cross-sectional data were collected from children with mental health disorders (aged 5-18 years), recruited from Child and Adolescent Psychiatry at BC Children’s Hospital. Children were classified as naïve (n=242), SSRI-treated (n=123), SGA-treated (n=112), or SSRI+SGA treated (n=98). Anthropometric data and a fasting blood sample were collected. Relationships between treatment groups and cardiometabolic risk factors were determined by adjusted linear and logistic regression models. SSRI+SGA-treated children had higher waist circumference z-scores (0.91 ± 0.89 vs. 0.48 ± 0.95; P&lt;0.05) and a greater odds of waist circumference ≥90th percentile (OR=2.63, 95% CI: 1.34, 5.18; P&lt;0.05) compared to SSRI-treated children. SSRI+SGA-treated children had higher plasma total cholesterol (4.63 ± 0.93 vs. 4.34 ± 0.84 mmol/L; P&lt;0.05, adjusted by age, sex, and BMI z-scores) and a greater odds of plasma total cholesterol ≥5.18 mmol/L (OR=2.36, 95% CI: 1.05, 5.30; P&lt;0.05, adjusted by age, sex, and BMI z-scores) than SGA-treated children. No differences in plasma fasting glucose, insulin, or insulin resistance (HOMA-IR) were observed between the treatment groups. Concurrent SSRI+SGA treatment is associated with elevated waist circumference and plasma total cholesterol in children. Our findings suggest greater cardiometabolic complications in children concurrently treated with SSRIs and SGAs.

Disclosure
R. Thandi: None. A. M. Wiedeman: None. A. M. Devlin: None. C. Panagiotopoulos: Advisory Panel; Self; Dexcom, Inc., Speaker’s Bureau; Self; Eli Lilly and Company.

Funding
BC Mental Health and Substance Use Services
152-OR: Glargine Timing during Fasting Ramadan in Patients with Type 1 Diabetes: A Randomized Controlled Trial
Authors: ALAMOUDI REEM , KHOGEER GHOFRAN S. , QARNI ALI AL , SALEH YOUSEF M. , ALJAWHRJI ABDULRHMAN , ALSUBAIEE MARAM R. , ZARIF HAWAZEN A. , ALAIDAROUS SALWA B. , KHASHWAYN SEHAM A. , HASSANEIN MOHAMED 
Published: June 2021

IDF-DaR guidelines recommend change of basal insulin timing to early evening. Randomized trials examining timing of basal insulin during fasting are lacking.
Objective: To compare glucose profiles in T1DM patients taking Glargine at early evening (6-7 pm) versus bedtime (10-12 night) during fasting Ramadan.
Methods: Multicenter open label randomized controlled trial. Patients recruited in 4 centers from 4 cities in Saudi Arabia. Data collected using pre- and post-Ramadan questioners. Glucose data collected via self-monitoring (Roche AccuCheck glucometer/the Abbott Freestyle Libre), and Envision iPro CGM.
Results: 185 T1DM patients randomized; 91 to glargine at 6-7pm (early), and 94 at 10-12 night (late). 32.4% ≤18 years, 53% female, and average duration of DM 11 ±11. No significant differences between the two groups in demographics or DM complications. Early vs. late group: Pre Ramadan A1c 9 ±2.7 vs. 8.75 ±2.1, p=0.35, post Ramadan A1c 8.4 ±2.9 vs. 8.7 ±2.7, p=0.5. Breaking of fast reported in 66 (75.9%) vs. 71 (76.3%), p=0.94; average number of days 4±6 vs. 4±4, p=0.5, and due to hypoglycemia in &gt;90% of cases for both groups. Hypoglycemia most common in Morning 32 (59.3%) vs. 38 (60.35%), p=0.85. Severe hypoglycemia reported in 2 vs. 5 patients, and 1 DKA admission in each group. Combined CGM data during Ramadan: A1c 7.6 ±1.7 vs. 7.7 ±2.1, p=0.63. Average Time in range of 70-180 mg/dl 44.6% vs. 46.1%, p=0.7, Time below range (&lt;70mg/dl) 7.9% vs. 6.4%, p=0.35, and Time above range (&gt;180mg/dl) 47.5 vs. 47.5%, p=0.99. Total hypoglycemic episodes detected by SMBG 4 ±6 vs. 3 ±8, p=0.3, and Low excursions detected by iPro CGM 5 ±6 vs. 4 ±5.5, p=0.22, with AUC below limit 0.5 ±1 vs. 0.15 ±0.85, p=0.03.
Conclusion: Changing glargine timing during Ramadan to early evening hours carries no significant advantage over keeping at bedtime in regards to hypoglycemia and overall glucose profiles.
ClinicalTrials.gov: NCT04383990.

Disclosure
R. Alamoudi: None. M. Hassanein: None. G. S. Khogeer: None. A. Al qarni: None. Y. M. Saleh: Advisory Panel; Self; American Association of Clinical Endocrinologists, Boehringer Ingelheim Pharmaceuticals, Inc., Novo Nordisk, Research Support; Self; Servier Laboratories, Speaker’s Bureau; Self; Abbott Diabetes, Amgen Inc., Ascensia Diabetes Care, Lilly Diabetes, Sanofi-Aventis. A. Aljawhrji: None. M. R. Alsubaiee: None. H. A. Zarif: Advisory Panel; Self; Pfizer Foundation, Speaker’s Bureau; Self; Medtronic. S. B. Alaidarous: Other Relationship; Self; AstraZeneca, Novo Nordisk. S. A. Khashwayn: None.

Funding
King Abdullah International Research Center