bluuebunny/crossref_metadata_2025_split huggingface dataset:
2154-PUB: Determination of Non-HDL Cholesterol in Type 1 Diabetic Patients
Authors: FERNANDES VIRGINIA O. , PEREIRA RAISSA B.O. , SALES MAYARA T.A. , SOUSA MILENA S. , ARAGÃO LUCIANA F.F. , CARVALHO ANNELISE B. , LINHARES NANCY , CASTELO MARIA HELANE , MONTENEGRO RENAN M. , MONTENEGRO ANA PAULA D. 
Published: June 2020

Aim: To describe non-HDL cholesterol levels (non-HDL-c) and the factors that might interfere with these levels in children with type 1 diabetes (T1D), determining their cost-effectiveness compared to LDL-cholesterol (LDL-c) in clinical practice and the laboratory cut-off point suggestion for intervention.
Method: Cross-sectional descriptive study with analysis of cholesterol levels, especially non-HDL-c, in children (under 19 years old) with T1D and in a control group (children under 19 years without diabetes).Were evaluated 144 T1D and 138 controls. The variables were anthropometric data, pubertal staging, glycated hemoglobin (A1c) and lipid profile. Patients with disease or on medications that could cause dyslipidemia were exclude from this study. The variables were analyze using RedCap and Jamovi.
Results: A total of 282 children participated in this study. The non-HDL-c was 122.64 ± 37.67 and in the control was 108.70 ± 28.10, with no significant difference between them. Non-HDL-c was significantly correlated with A1c (p= 0,001), but did not correlate with gender, BMI, disease duration and pubertal stage. There was observed that LDL-c and had a strong correlation with each other R = 0.929. According to LDL-c abnormality values proposed for children (where values between 100 and 130 mg/dl, should initiate lifestyle change and above 130 mg/dl, drug therapy) the ROC curve presented a cutoff value of non-HDL-c of 125mg ∕ dl and 147mg ∕ dl.
Conclusion: In this population, glycemic control seems to interfere with the lipid profile, which wasn’t observed with BMI and index and pubertal stage. This study also suggest a lower cut-off point of non-HDL-c for therapeutic intervention.

Disclosure
V.O. Fernandes: None. R.B.O. Pereira: None. M.T.A. Sales: None. M.S. Sousa: None. L.F.F. Aragão: None. A.B. Carvalho: None. N. Linhares: None. M. Castelo: None. R.M. Montenegro: None. A.D. Montenegro: None.
2160-PUB: Development of an Evidence-Based Tool to Facilitate Individualized Treatment in the Clinic for Patients with Type 2 Diabetes
Authors: KAHKOSKA ANNA R. , BUSE JOHN B. , HARRING SIGNE , HOLST INGRID , KNOP FILIP K. , KVIST KAJSA , PRATLEY RICHARD E. 
Published: June 2020

Type 2 diabetes (T2D) is a heterogeneous disease with many therapies available. Current guidelines recommend individualized therapy, and this could be facilitated by using estimates of outcomes based on individual characteristics instead of population-level outcomes. There are challenges to defining and implementing individualized therapy in a data-driven and patient-oriented way. We propose criteria to aid implementation of individualized medicine, including: 1) robust insights based on high-quality clinical data, to guide treatment selection; 2) integration of patient-oriented outcomes with engagement of providers and patients; 3) provision of a user-friendly, efficient tool for use in the clinic. We are developing an interactive tool that draws on data from a wide range of randomized controlled trials, e.g., all treatment arms from the full phase 3a program for once-weekly semaglutide. The tool selects the appropriate trial from a database and shows the predicted change in outcomes on initiation/continuation with different therapies over 26-30 weeks. Estimates are based on characteristics such as age, BMI, and T2D duration (Figure).
In conclusion, a tool such as this could help clinicians and patients use high-quality, large-scale data from contemporary trials to select individualized treatment regimens.

Disclosure
A.R. Kahkoska: Other Relationship; Self; Novo Nordisk A/S. J.B. Buse: Consultant; Self; Cirius Therapeutics, CSL Behring, Neurimmune. Research Support; Self; American Diabetes Association, National Institutes of Health, Novo Nordisk A/S, Patient-Centered Outcomes Research Institute, Sanofi, Tolerion, Inc., vTv Therapeutics. Stock/Shareholder; Self; Mellitus Health, Pendulum Therapeutics, PhaseBio Pharmaceuticals, Inc., Stability Health. Other Relationship; Self; ADOCIA, AstraZeneca, Dance Biopharm Holdings, Inc., Eli Lilly and Company, MannKind Corporation, NovaTarg Therapeutics, Novo Nordisk A/S, Senseonics, Inc, vTv Therapeutics, Zafgen, Inc. S. Harring: Employee; Self; Novo Nordisk A/S. Stock/Shareholder; Self; Novo Nordisk A/S. I. Holst: Employee; Self; Novo Nordisk A/S. F.K. Knop: Advisory Panel; Self; AstraZeneca, Merck Sharp & Dohme Corp., Mundipharma International, Novo Nordisk A/S, Sanofi. Consultant; Self; Carmot Therapeutics, Inc., Eli Lilly and Company, Novo Nordisk A/S. Research Support; Self; AstraZeneca, Gubra, Novo Nordisk A/S, Sanofi, Zealand Pharma A/S. Speaker’s Bureau; Self; AstraZeneca, Lupin Pharmaceuticals, Inc., Merck Sharp & Dohme Corp., Norgine B.V., Novo Nordisk A/S. K. Kvist: Employee; Self; Novo Nordisk A/S. R.E. Pratley: Other Relationship; Self; AstraZeneca, Eli Lilly and Company, GlaxoSmithKline plc., Glytec, Janssen Scientific Affairs, LLC., Lexicon Pharmaceuticals, Inc., Ligand Pharmaceuticals Incorporated, Merck & Co., Inc., Novo Nordisk Inc., Sanofi.

Funding
Novo Nordisk A/S
2166-PUB: Surprisingly High Prevalence of Vitamin D Deficiency in Japanese Diabetic Patients
Authors: KASHIMA NAOYASU , HAMANO KUMIKO 
Published: June 2020

Vitamin D is known to regulate many cellular functions such as insulin secretion, cardiac function, immune system, skeletal muscle in addition to bone mineral metabolism. With respect to diabetes, diabetes prevention trials by vitamin D supplementation and reports showing an association between low levels of blood vitamin D and cardiovascular events, bone fractures, falls and most recently the life prognosis have been published. However, reports on Japanese diabetic patients and vitamin D is scarce. We measured serum 25 (OH) D concentration (ECLIA) in 133 patients (M/F: 85/48) with type 1 (n=15) and type 2 diabetes patients (118). Age, sex, BMI and biochemical indicators (serum Ca, P, Alb, HbA1c, LDL-C, TG, CPR and atherosclerosis indices (urinary albumin, NT-proBNP, baPWV and max IMT) were investigated. The subjects mean age was 59.1±14.0 years (mean±SD) and HbA1c9.1 ±2.6%, and BMI25.0±4.3. Serum 25 (OH) D concentration state was only 3% in sufficient group(&gt;30ng/ml), 11% insufficient group and 86% was in deficiency (&lt;20ng/ml). This was the same regardless of type 1 or type 2. Correlations with the aforementioned indicators including HbA1c was not observed. However, serum 25 (OH) D concentration and max IMT in HbA1c above 8% group had a weak but significant reverse correlation, which was consistent with the previous metaanalysis. The limitation of this study is a single center based, and it does not include data on dieting status, or exposure to sunlight. However, subjects have a history of medical nutritional education and they are residents of urban areas with adequate ADL, it is unlikely that they are particularly biased diabetes populations. In an aging society, it is important to prevent sarcopenia, and fractures in diabetes. The present results shed a new insight in Japanese medical nutritional therapy. For vitamin D deficiency cohort, interventions and bone salt quantification are going to be carried out and osteoporosis, fractures, and cardiovascular risk are evaluated in a prospective manner.

Disclosure
N. Kashima: None. K. Hamano: None.
2177-PUB: Improved Time-in-Range and Glycemic Variability in Adults with Type 1 Diabetes: An Analysis of 12-Week Flash Glucose Monitoring Data from a Multicenter Prospective Trial
Authors: GUO LIXIN , ZHANG MEI , KUANG HONGYU , LI YUXIU , XIAO XINHUA , JIA XIAOFAN , YANG TAO 
Published: June 2020

Aims: Studies have demonstrated that CGM can improve HbA1C and reduce glucose variability in individuals with type 1 diabetes (T1D). We aim to assess the efficacy of flash glucose technology on glycemic accuracy control in T1D by lifestyle and/or medication modification and to use the CGM time in range (TIR) as outcomes of measures.
Methods: The program is a multicenter, prospective, RCT enrolled adults from 5 Chinese diabetes centers. Individuals were eligible to participate if they had T1D and were deemed technically capable of using flash glucose technology. All participants had no experience with Flash before participating the study and received the education of diabetes self-care at baseline. Based on the glucose reports, dietary, excise and insulin therapy changes were made by self-care behaviors. Data from 153 adults who using flash glucose monitoring for 12 weeks were analyzed.
Results: After 153 participants who had no experience with flash used flash for 12 weeks, HbA1C was reduced from (7.96± 1.78) % at baseline to (7.54±1.20) % at 12 weeks (P&lt;0.05). An increase in TIR70-180 was from 51.49% to 54.68%. The TAR &gt;250 drop from 12.65% to 7.77%, with a concurrent decrease in TBR54-69 from 9.96% to 8.31% and TBR&lt;54 from 4.21% to 3.19%(P&lt;0.005). And the CV reduced from 39.5% to 37.3% in these patients(P&lt;0.05).
Conclusion: T1D patients who had no experience with flash achieved a better glycemic profile from the flash glucose monitoring. Flash glucose technology is useful for improving glycemic control of T1D patients by changes to patient’s lifestyle and/or insulin therapy.

Disclosure
L. Guo: None. M. Zhang: None. H. Kuang: None. Y. Li: None. X. Xiao: None. X. Jia: None. T. Yang: None.
2179-PUB: Trends in the Use of Diabetes Technologies in Germany
Authors: HEINEMANN LUTZ , HERMANNS NORBERT , EHRMANN DOMINIC , KULZER BERNHARD 
Published: June 2020

Since 2018, an annual survey is conducted to assess the use of diabetes technology in Germany. In this year’s evaluation of current use of diabetes technology, 326 diabetologists participated in the online survey. On average, the participating diabetologists reported that they had 189 people with type 1 diabetes and 850 people with type 2 diabetes in their clinical unit. We compared the use of insulin pumps (CSII), Flash Sensor-based Glucose Monitoring use (FSGM) and real-time Continuous Glucose Monitoring (rtCGM) in 2018 and 2019. In type 1 diabetes, the number of insulin pump users rose from 56 to 75 persons per clinical unit representing an increase of 34%, the number of FSGM users increased by 38% from 81 to 112 persons per clinical unit, and the number of rtCGM users rose by 76% from 33 to 58 persons per clinical unit. Per clinical unit, three users with a commercially available closed loop system and on average one user with a self-constructed closed loop system were reported. In the year 2019 the diabetologist reported that 22.3% of all persons type 1 diabetes used rtCGM; 44.2% used FSGM and 27.9% were CSII users. Overall 67% of type 1 diabetes used one of these key diabetes technologies. In type 2 diabetes, FSGM was the most common used diabetes technology. Its use increased by 38% from 81 to 112 persons per clinical unit; insulin pumps were rather rarely used with only 4 and 3 users per unit in 2018 and 2019, respectively. rtCGM was only used by 10 persons per clinical unit in 2019, representing an increase of 25% compared to 2018. In type 2 diabetes the overall the use of diabetes technology was much smaller than in type 1 diabetes; 1% were rtCGM users, 12% used FSGM and only 0.3% used CSII. The use of diabetes technology is clearly more prominent in type 1 diabetes, in which 2 out of 3 persons are using at least one of the key diabetes technologies. There is also a clear trend of an increased use of diabetes technology in type 1 and type 2 diabetes in Germany.

Disclosure
L. Heinemann: Consultant; Self; Becton, Dickinson and Company, LifeCare, Inc., Roche Diabetes Care. Stock/Shareholder; Self; Profil Institute for Clinical Research. N. Hermanns: Advisory Panel; Self; Roche Diabetes Care. Research Support; Self; Abbott, AstraZeneca, Berlin-Chemie AG. D. Ehrmann: Speaker’s Bureau; Self; Abbott, Berlin-Chemie AG, Glooko, Inc. Other Relationship; Self; Dexcom, Inc., Roche Diabetes Care. B. Kulzer: Research Support; Self; Abbott, AstraZeneca, Berlin-Chemie AG, Roche Diabetes Care. Speaker’s Bureau; Self; Abbott, Ascensia Diabetes Care, Berlin-Chemie AG, Eli Lilly and Company, Medtronic, Novo Nordisk Inc., Roche Diabetes Care.

Funding
Berlin-Chemie AG
2180-PUB: Integration of Continuous Glucose Monitoring in Diabetes Self-Management Education for Type 2 Diabetes Improves Glycemic Control
Authors: FORTMANN ADDIE L. , BASTIAN ALESSANDRA , LENSING CODY J. , HOVERSTEN SHANE , LUU KIMBERLY , BARGER KELLY , TALAVERA LAURA , PHILIS-TSIMIKAS ATHENA 
Published: June 2020

Continuous glucose monitors (CGM) are an integral aspect in the glucose management of many individuals with type 1 diabetes, and a growing number of people with insulin-requiring type 2 diabetes (T2D). A 2019 meta-analysis of 7 randomized controlled trials that investigated CGMs for T2D reported that CGM users had significantly lower HbA1c and shorter time spent with hypoglycemia compared with self-monitoring blood glucose comparison groups. However, little is known about optimal, real world approaches for integrating CGM in the routine management of patients with T2D. A pragmatic, feasibility pilot (n=6) was conducted to document the preliminary effectiveness and acceptability of introducing CGM in the context of a 5-class diabetes self-management education (DSME) series at Scripps Health, a large, non-profit, private insurance-based health system in San Diego, CA. Prior to class 2, English- (n = 3) and Spanish-speaking (n = 3) adults with T2D self-inserted the CGM and received enough sensors to wear the CGM until 6 weeks post-DSME (10 weeks total). During classes 3-5, time was devoted to reviewing the past week’s CGM data report and participants were encouraged to make associations between glucose trends and eating and exercise patterns. CGM wear ranged from 5 to 10 weeks (M =7.8 ± 1.7 weeks). Time-in-range (70-180 mg/dL) and mean average glucose improved from 54% and 185.1 ± 67.9 mg/dL at baseline to 74% and 159.1 ± 50.5 mg/dL by the end of DSME, and to 84% and 142.7 ± 30.6 mg/dL at 4-weeks post-DSME. Self-report surveys indicated improvements in healthful eating and physical activity over this time, and participants reported very high satisfaction with the CGM; the majority expressed a desire to continue CGM use post-study. Findings highlight DSME as a promising environment for effectively integrating CGM in the management of T2D. Future research should pinpoint the duration and frequency of CGM use for optimal clinical benefit in the general T2D population.

Disclosure
A.L. Fortmann: None. A. Bastian: None. C.J. Lensing: Employee; Self; UnitedHealth Group. Employee; Spouse/Partner; UnitedHealth Group. S. Hoversten: Employee; Self; UnitedHealth Group. K. Luu: None. K. Barger: None. L. Talavera: None. A. Philis-Tsimikas: Advisory Panel; Self; Lilly Diabetes, Medtronic, Novo Nordisk A/S, Sanofi. Employee; Spouse/Partner; Ionis Pharmaceuticals, Inc. Research Support; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Dexcom, Inc., Lilly Diabetes, Medtronic, Novo Nordisk A/S, Sanofi.

Funding
UnitedHealth Group; Dexcom, Inc.
2187-PUB: Identifying Risk Predictors for Gastrointestinal Adverse Events with Once-Weekly Semaglutide
Authors: VILSBØLL TINA , HARRING SIGNE , HOLST INGRID , KNOP FILIP K. , KVIST KAJSA , LINGVAY ILDIKO 
Published: June 2020

Gastrointestinal adverse events (GI AEs) are common with glucagon-like peptide-1 receptor agonists (GLP-1RAs). We aimed to identify risk predictors for GI AEs with once-weekly semaglutide to support clinicians identify high-risk patients. Data from SUSTAIN 1-10 and two SUSTAIN Japanese trials were used to assess the effects of age, region, ethnicity, diabetes duration, gender, renal function, smoking status, HbA1c, body weight (BW), alanine aminotransferase and bilirubin on the incidence of GI AEs with semaglutide vs. non-GLP-1RA comparators (exenatide extended release, dulaglutide and liraglutide were excluded). Changes in HbA1c and BW were assessed by GI AE status. Frailty (age, renal impairment, smoking) and female gender were associated with marginally higher risk of GI AEs than non-frailty and male gender, regardless of treatment. With semaglutide, patients with lower baseline BW were at higher risk of GI AEs vs. those with higher BW. With comparators, lower baseline BW was associated with lower risk than higher BW. These results were confirmed by formal statistical analysis (data not shown). Semaglutide reduced HbA1c and BW across the trials, regardless of GI AEs (Figure). In conclusion, GI AEs are hard to predict although they tend to be more common in frail vs. non-frail patients and females vs. males, regardless of treatment. Semaglutide reduced HbA1c and BW regardless of the presence/absence of GI AEs.

Disclosure
T. Vilsbøll: Advisory Panel; Self; AstraZeneca, Mundipharma International, Novo Nordisk A/S, Sun Pharmaceutical Industries Ltd. Consultant; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Lilly Diabetes, Medscape, Merck Sharp & Dohme Corp., Sanofi. S. Harring: Employee; Self; Novo Nordisk A/S. Stock/Shareholder; Self; Novo Nordisk A/S. I. Holst: Employee; Self; Novo Nordisk A/S. F.K. Knop: Advisory Panel; Self; AstraZeneca, Merck Sharp & Dohme Corp., Mundipharma International, Novo Nordisk A/S, Sanofi. Consultant; Self; Carmot Therapeutics, Inc., Eli Lilly and Company, Novo Nordisk A/S. Research Support; Self; AstraZeneca, Gubra, Novo Nordisk A/S, Sanofi, Zealand Pharma A/S. Speaker’s Bureau; Self; AstraZeneca, Lupin Pharmaceuticals, Inc., Merck Sharp & Dohme Corp., Norgine B.V., Novo Nordisk A/S. K. Kvist: Employee; Self; Novo Nordisk A/S. I. Lingvay: Consultant; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Intarcia Therapeutics, Janssen Pharmaceuticals, Inc., MannKind Corporation, Novo Nordisk A/S, Sanofi, TARGET PharmaSolutions, Valeritas, Inc. Other Relationship; Self; Novo Nordisk A/S.

Funding
Novo Nordisk A/S
2205-PUB: New Strategy for Treating Diabetes with Traditional Chinese Medicine
Authors: HUA XIANGRONG , HUANG AMY Y. 
Published: June 2020

Introduction: Diabetes is a group of metabolic disorders characterized by high blood glucose in patients. In spite of numerous progresses have been achieved in diabetes research and care, it is still challenging to cure diabetes. The objective of this study was to explore a new approach to treat diabetes with Traditional Chinese Medicine.
Materials and Method: The Traditional Chinese Medicine used in this study was a natural bio-product(s) (NBP) which has been used for humans for several hundred years. This NBP was dried and grinded into powders and capsulated (patent pending). Based on the degree of severity determined by OGTT data analysis, patients took 4.5g - 30g of this NBP orally per day for 3 to 24 months, and might take prescribed medicines (Gliclazide MR, Metformin, and/or Saxagliptin) at the initial stage of therapy. Starting on the first day of therapy, the patients discontinued the insulin injection if they had relied on it.
Results: The patients ranged from 34 yo to 73 yo (mean=55.6 yo, n=18). Before therapy, six of 18 patients were on a regular insulin injection with various dosages, and the mean HbA1c was 7.65 (SD=1.97, n=18). After therapy (without any insulin injection) for an average of 231 days (97-748 days), the mean HbA1c was 6.61 (SD=0.86, n=18). The difference was statistically different (t-test, p=0.008). Ten of 18 patients were on western medicines for an average of 77 days while the rest took NBP only. The insulin resistance (estimated by HOMA-IR) decreased and the disposition index (estimated at 2-h OGTT) increased in 12 of the 18 patients.
Discussion and Conclusion: This NBP can effectively control plasma glucose level by reducing the insulin resistance and enhancing the beta cell functions. However, its exact mechanism is not clear, partially because this NBP is a compound which may affect multiple systems simultaneously. This method might not be suitable for all patients with T2DM. Further studies are needed in order to fully understand its mechanisms for controlling plasma glucose level.

Disclosure
X. Hua: Board Member; Self; CYX Biotechnology Ltd. A.Y. Huang: Research Support; Self; CYX Biotechnology Co.
2211-PUB: Safety and Efficacy of Hydroxychloroquine (HCQ) in Management of Patients with T2D
Authors: CHAWLA MANOJ S. , CHAWLA PURVI M. , SAYYED ALFALAK , SHAH AMI , MURTHY NANDITA 
Published: June 2020

Chronic inflammation is implicated in the pathophysiology of type 2 diabetes (T2D), and therefore targeting inflammation may ameliorate diabetes, slowing its progression and complications. HCQ, an anti-inflammatory agent used since several decades in rheumatology, is approved in India for the management of T2D. We assessed the real-life safety and effectiveness of HCQ in 95 T2D patients uncontrolled on 2 or more OHAs with or without insulin. HCQ was started only in patients with normal retina on fundoscopy, which was repeated again within 52 weeks. Mean duration of diabetes was 9.09 years; 51 and 38 patients were receiving statins and anti-hypertensives, respectively at baseline. There was a reduction in A1c and other glycemic parameters at Week 12 and week 24 from baseline. Total cholesterol and LDL also reduced with HCQ use. Mean body weight reduced from 73.59 kg at baseline to 72.84 kg at Week 24. Reassuringly, there were no cases of HCQ-induced retinopathy in any of the patients followed till week 52; 1 patient was detected with mild NPDR at week 12 and drug was discontinued. Of the 12 AEs reported, 11 were mild in intensity and unlikely related to HCQ. There was no incidence of derangement in hepatic or renal parameters. Thus, HCQ could be a well-tolerated and effective therapeutic option for patients with T2D uncontrolled on 2 or more OHAs. Long term data for safety and efficacy of HCQ needs to be studied from other centers too.

Disclosure
M.S. Chawla: Speaker’s Bureau; Self; Abbott, Alkem Laboratories, AstraZeneca, Biocon. Speaker’s Bureau; Spouse/Partner; Boehringer Ingelheim Pharmaceuticals, Inc. Speaker’s Bureau; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Glenmark Pharmaceuticals Limited, Lupin Pharmaceuticals, Inc., Novartis AG, Novo Nordisk A/S. Speaker’s Bureau; Spouse/Partner; Novo Nordisk Inc., Sanofi. Speaker’s Bureau; Self; Sanofi, Serdia Pharmaceuticals (India) Pvt. Ltd. P.M. Chawla: Speaker’s Bureau; Spouse/Partner; Abbott, Alkem Laboratories, Boehringer Ingelheim Pharmaceuticals, Inc. Speaker’s Bureau; Self; Boehringer Ingelheim Pharmaceuticals, Inc. Speaker’s Bureau; Spouse/Partner; Eli Lilly and Company, Lupin Pharmaceuticals, Inc. Speaker’s Bureau; Self; Novo Nordisk A/S. Speaker’s Bureau; Spouse/Partner; Novo Nordisk A/S. Speaker’s Bureau; Self; Sanofi. Speaker’s Bureau; Spouse/Partner; Sanofi. A. Sayyed: None. A. Shah: None. N. Murthy: None.