bluuebunny/crossref_metadata_2025_split huggingface dataset:
951-P: A Clinical Decision Support System for Basal-Bolus Insulin Therapy Is Moving to Hospital Routine Care: Efficacy, Safety, and Usability Confirmed
Authors: LICHTENEGGER KATHARINA M. , ABERER FELIX , TUCA ALEXANDRU C. , DONSA KLAUS , HÖLL BERNHARD , SCHAUPP LUKAS , PLANK JOHANNES , BECK PETER , FRUHWALD FRIEDRICH , PIEBER THOMAS R. , MADER JULIA K. 
Published: June 2019

Glycemic goals of inpatients should consider the prevention of hypoglycemia and hyperglycemia. To achieve glycemic control in the hospital, guidelines recommend basal-bolus insulin therapy as the preferred method for treatment of persistent hyperglycemia and the use of clinical decision support systems. The aim of this study was to investigate the efficacy, safety and usability of the GlucoTab® decision support system in hospital routine care of non-critically ill patients with type 2 diabetes at 3 general wards of a university medical center. In total, 150 patients with type 2 diabetes requiring insulin therapy (56 female, age 68 ± 11 years, HbA1c 77 ± 24 mmol/mol, diabetes duration 15 ± 11 years, BMI 30 ± 6 kg/m2, length of hospital stay 9 ± 7 days) were treated with basal-bolus insulin therapy guided by GlucoTab®, a mobile decision support system providing automated workflow tasks and suggestions for insulin dosing to nurses and physicians. In total 4879 capillary blood glucose values (BG) were documented. By using the GlucoTab® system in routine care, a mean daily BG of 159 ± 32 mg/dl could be achieved. 68.8% of all BG measurements were in the acceptable range (70-&lt;180 mg/dl). The percentage of BG values &lt;40, &lt;70 and ≥300 mg/dl was 0.02%, 2.2% and 2.3%, respectively. Health care professional’s adherence to the suggested insulin doses (n=7407) and workflow tasks (n=9927) was high (&gt;93% and 91%, respectively). The study confirmed that the GlucoTab® system supports a safe, efficacious and user-friendly glycemic management of basal-bolus insulin therapy in hospital routine care. Further research will include decision support for alternative therapy types for patients with less stringent goals to prevent hypoglycemia in hospital routine care.

Disclosure
K.M. Lichtenegger: None. F. Aberer: None. A.C. Tuca: None. K. Donsa: Stock/Shareholder; Self; decide Clinical Software GmbH. B. Höll: Employee; Self; decide Clinical Software GmbH. L. Schaupp: None. J. Plank: None. P. Beck: Employee; Self; decide Clinical Software GmbH. Stock/Shareholder; Self; decide Clinical Software GmbH. F. Fruhwald: None. T.R. Pieber: Advisory Panel; Self; ADOCIA, Arecor Limited, AstraZeneca, Novo Nordisk A/S, Sanofi. Speaker's Bureau; Self; Novo Nordisk A/S. J.K. Mader: Advisory Panel; Self; Boehringer Ingelheim International GmbH, Eli Lilly and Company, Prediktor Medical, Roche Diabetes Care, Sanofi. Speaker's Bureau; Self; Abbott, AstraZeneca, Dexcom, Inc., Novo Nordisk Inc. Stock/Shareholder; Self; decide Clinical Software GmbH.

Funding
Research Studio Austria "GlucoTab“ (844737)
955-P: Evaluating Early Initiation of Continuous Glucose Monitoring (CGM) among Youth Diagnosed with Type 1 Diabetes (T1D)
Authors: WONG JESSIE J. , CLAY SUSAN MICHELLE , FORLENZA GREGORY P. , HANES SARAH , WADWA R. PAUL , HOOD KOREY K. 
Published: June 2019

Background: CGM has glycemic and psychosocial benefits. The current study sought to evaluate the specific impact of introducing CGM soon after diagnosis of T1D.
Methods: A sample of 55 youth recently diagnosed with T1D were randomized to either an intervention (start Dexcom G5 CGM within 1 month of diagnosis) or control (monthly blinded CGM use) condition. HbA1c data and youth and parent surveys were collected at baseline, 13 and 26 weeks and glucose levels were measured via blinded or unblinded CGM. T-tests were used to compare groups based on glycemic and psychosocial outcomes.
Results: Participant ages ranged from 3-18 (mean 11.1 ± 3.6years). On average, youth in the intervention group spent less time in hypoglycemia at 13 (2.0% vs. 7.5%, p=0.002) and 26 (1.9% vs. 4.9%, p=0.056) weeks and had elevated scores on the Diabetes Self Management Profile at week 13 (54.5 vs. 43.9 p=0.021) and more openness with glucose monitoring at weeks 13 (15.0 vs. 12.2, p=0.057) and 26 (16.42 vs. 12.12, p=0.014). Conversely, intervention group youth reported worse quality of life (QoL) at 13 weeks (8.5 vs. 3.0, p=0.020). At 26 weeks, the intervention group had slightly higher diabetes distress among youth (32.2 vs. 25.4, p=0.089) but lower diabetes distress among parents (42.5 vs. 50.9, p=0.050). Adding to prior reports from this study, these results show reduced hypoglycemia, improved attitudes toward diabetes technology, and satisfaction with glucose monitoring as well as decreased parent reported youth QoL.
Conclusion: Introducing CGM soon after diagnosis appears to have substantial benefits, including prevention of hypoglycemia and bolstering youth self-management practices and openness to glucose monitoring. Given that early CGM initiation may negatively impact QoL in youth with T1D, as indicated by both youth and parent report, youth with T1D may benefit from education around use of CGM as well as psychosocial support for those with lower QoL.

Disclosure
J.J. Wong: None. S. Clay: None. G.P. Forlenza: Advisory Panel; Self; Dexcom, Inc. Consultant; Self; Medtronic MiniMed, Inc., Tandem Diabetes Care. Research Support; Self; Dexcom, Inc., Insulet Corporation, Medtronic MiniMed, Inc., Tandem Diabetes Care. S. Hanes: None. R. Wadwa: Advisory Panel; Self; Eli Lilly and Company. Research Support; Self; Beta Bionics, MannKind Corporation, Novo Nordisk Inc., Tandem Diabetes Care, Xeris Pharmaceuticals, Inc. Other Relationship; Self; Dexcom, Inc. K.K. Hood: Consultant; Self; Lilly Diabetes. Research Support; Self; Dexcom, Inc. Speaker's Bureau; Self; Johnson & Johnson Diabetes Institute.

Funding
Dexcom, Inc.
958-P: Analysis of Accuracy of Flash Glucose Monitoring in Japanese Subjects without Diabetes
Authors: YOSHINO SATOSHI , YAMADA EIJIRO , OKADA SHUICHI , SAITO TSUGUMICHI , YAMADA MASANOBU 
Published: June 2019

Background: The Abbott FreeStyle Libre Flash glucose monitoring system (FGM) is one of the recently introduced personal continuous glucose monitoring systems. While FGM use has spread widely, few reports have examined the factors that determine its accuracy.
Methods: We performed oral glucose tolerance tests (OGTTs) in 25 Japanese subjects without diabetes.
Results: The mean absolute relative difference (MARD) in sensor glucose values of FGM (FGM-SG) with reference to self-monitoring of blood glucose (SMBG) levels was 10.9±4.1% during OGTTs. However, surprisingly, the MARD in FGM-SG with reference to plasma glucose (PG) levels was 20.3±10.3% during OGTTs, demonstrating the problems in accuracy of FGM-SG compared with that of PG levels in our study setting; however, this issue was not observed on comparison with accuracy of SMBG levels. Parkes error grid analyses showed that FGM-SG with either SMBG or PG levels as reference met the criteria of the International Organization for Standardization. Moreover, the MARD showed negative correlations with fasting blood sugar, homeostasis model assessment insulin resistance index, area under curve (AUC)-PG, and body mass index (BMI); multiple regression analyses revealed that BMI was the most contributing factor to the MARD between FGM-SG and PG levels. In other words, lean people showed more MARDs.
Conclusions: Inaccurate FGM data could potentially increase the risk of inappropriate treatment. Consideration of such factors might be critical while using FGM.

Disclosure
S. Yoshino: None. E. Yamada: None. S. Okada: None. T. Saito: None. M. Yamada: None.
972-P: Expanded Real-World Use Reaffirms Strong Correlation between Scanning Frequency of Flash Glucose Monitoring and Glucose Control
Authors: LANG JORDAN , JANGAM SUJIT , DUNN TIMOTHY , HAYTER GARY 
Published: June 2019

Previous analysis of real-world flash glucose monitoring data showed a strong correlation between higher scan frequency and improved glucose control. Robust adoption since then has resulted in a ten-fold increase in data available to confirm these findings. Deidentified data between September 2014 to September 2018, comprising of 592,328 readers and 5,842,193 sensors worldwide, were analyzed. Scan rate per reader was determined and each reader was sorted into twenty equally-sized rank-ordered groups, categorized by scan frequency. Glucose parameters were calculated for each group, including estimated HbA1c, time above, below and within range identified as 70 -180 mg/dL. Users performed an average of 12 scans per day (median:10, interquartile range: 7-14) with a total of 1.71 billion hours of readings and 896 million scans. The estimated HbA1c decreased from 8.2% to 6.7% (66.2 to 50.0 mmol/mol) as scan rate increased from lowest to highest scan groups (3.5 and 38.5 scans/day, respectively; p &lt; 0.001). The time below 54 mg/dL decreased by 26% (p &lt; 0.001), from 31.6 to 23.4 min/day. Time above 240 mg/dL decreased from 5.9 to 2.2 h/day (63%, p &lt; 0.001). Time in range increased from 11.7 h/day to 16.8 h/day (43%, p &lt; 0.001). Overall, 63.0% of readers had time in range &gt;12 hours/day, while comparing those below and above 10 scans per day were 52.1% and 73.1%, respectively. The expanded real-world analysis confirms prior observations that higher rates of scanning to self-monitor glucose strongly correlate with improved glucose measures, including decreased mean glucose and time in hyper- and hypoglycaemia as well as increased time in range.

Disclosure
J. Lang: Employee; Self; Abbott. S. Jangam: Employee; Self; Abbott Laboratories. Employee; Spouse/Partner; Abbott Laboratories. T. Dunn: Employee; Self; Abbott Laboratories. G. Hayter: Employee; Self; Abbott.
976-P: Post Market Clinical Follow-Up (PMCF) Registry to Demonstrate the Long Term Safety of the Eversense CGM System
Authors: CARLSON GRACE , TWEDEN KATHERINE S. , MDINGI COLLEEN , HARIDAS HARITHA 
Published: June 2019

Background: Eversense CGM is the first implantable long-term continuous glucose monitoring system. Prior studies evaluated the safety of the system using a study design of one insertion and removal cycle. The purpose of this prospective PMCF registry was to assess the long-term safety of the Eversense CGM System after repeated insertions.
Methods: Eversense users from 15 European countries were followed prospectively until the first 100 participants completed their 4th insertion cycle. Visits were made every 90 to 180 days (dependent on sensor configuration) to replace sensors once sensor end life was reached. At each visit, Adverse Events (AEs) that occurred during the visit or during use since the previous visit were recorded. The primary endpoint was the rate of serious adverse events (SAEs) that were device-related, procedure-related, or drug (dexamethasone acetate) related through the sensor insertion/removal cycles.
Results: 3066 participants were enrolled in the study with 43% on 2 or more sensor cycles. There were no device- or procedure-related SAEs reported. A total of 130 potentially-related AEs were reported, of which 106 were adjudicated as related or possibly/probably related to the device or insertion/removal procedure.
Conclusion: Repeat insertions of the Eversense CGM confirmed the promising safety profile of prior studies and show it to be safe for long-term continuous use.

Disclosure
G. Carlson: Consultant; Self; Abbott Laboratories, Edwards Lifesciences Corporation, Senseonics, St. Jude Medical. K.S. Tweden: Employee; Self; Senseonics. C. Mdingi: Employee; Self; Senseonics. H. Haridas: Employee; Self; Senseonics.
981-P: GIP and GLP-1 Potentiate Sulfonylurea-Induced Insulin Secretion in HNF1A Diabetes
Authors: CHRISTENSEN ALEXANDER S. , HAEDERSDAL SOFIE , STORGAARD HEIDI , ROSE KATHRINE , HANSEN NINA L. , HOLST JENS J. , HANSEN TORBEN , KNOP FILIP K. , TINA VILSBØLL 
Published: June 2019

Sulfonylurea (SU) is considered first-line treatment of hepatocyte nuclear factor 1-alpha (HNF1A)-diabetes but rarely provides lasting glycemic control. In a randomized, double-blinded, cross-over study, we evaluated the insulinotropic effect of exogenous glucose-dependent insulinotropic peptide (GIP) and glucagon-like-peptide 1 (GLP-1), respectively, with and without SU in patients with HNF1A-diabetes. Ten patients with HNF1A-diabetes ([mean±SD] BMI 22.4±1.5 kg/m2; HbA1c 6.0±0.6% [42.3±6.6 mmol/mol]) and 10 matched healthy controls (BMI 22.2±2.4 kg/m2; HbA1c 5.1±0.3% [31.9±2.8 mmol/mol]) were subjected to six 2 h glucose clamps (time 0-60 minutes at fasting plasma glucose (FPG) and 60-120 minutes at 1.5 × FPG) preceded by administration of 1 mg of glimepiride or placebo (PLA) at time -90 min. Two-hour infusion of either GIP (1.5 pmol/kg/min), GLP-1 (0.5 pmol/kg/min) or saline (NaCl) was initiated at time 0 min. Insulin secretion was quantified as baseline-subtracted area under the curve (bsAUC) from 0 to 120 minutes (Figure). In patients with HNF1A-diabetes both SU+GIP and SU+GLP-1, respectively, showed significantly greater insulin secretion vs. PLA+GIP, PLA+GLP-1, SU+NaCl and PLA+NaCl, while this was only the case for SU+GLP-1 in controls.
In conclusion, GIP and GLP-1 potentiate SU-induced insulin secretion in patients with HNF1A-diabetes and in nondiabetic controls.

Disclosure
A.S. Christensen: None. S. Haedersdal: None. H. Storgaard: Advisory Panel; Self; Boehringer Ingelheim Pharmaceuticals, Inc. K. Rose: None. N.L. Hansen: None. J.J. Holst: Advisory Panel; Self; Novo Nordisk A/S. T. Hansen: None. F.K. Knop: Advisory Panel; Self; AstraZeneca, MedImmune, Merck Sharp & Dohme Corp., Mundipharma, Novo Nordisk A/S, Sanofi. Consultant; Self; Amgen Inc., Carmot Therapeutics, Novo Nordisk A/S. Research Support; Self; AstraZeneca, Novo Nordisk A/S. Speaker's Bureau; Self; AstraZeneca, MedImmune, Merck Sharp & Dohme Corp., Mundipharma, Norgine, Novo Nordisk A/S. T. Vilsbøll: None.
984-P: Real-World Adherence and Discontinuation of GLP-1 Receptor Agonist (GLP-1RA) Therapy in Type 2 Diabetes (T2D) Patients in the U.S.
Authors: WEISS TRACEY , IGLAY KRISTY , CARR RICHARD D. , MISHRA AJAY PRATAP , YANG LINGFENG , RAJPATHAK SWAPNIL 
Published: June 2019

Background: GLP-1 RAs are an incretin-based, injectable, therapeutic option for the treatment of T2D. However, there are limited data related to patients’ adherence to, or discontinuation of, GLP-1 RA therapy in the real-world.
Methods: Using the Optum Research Database (2010-2016), we conducted a retrospective cohort study of U.S. T2D patients ≥ 18 years initiating GLP-1 RAs as monotherapy or as dual therapy with metformin to evaluate GLP-1 RA adherence and discontinuation. GLP-1 RA adherence was assessed using the proportion of days covered (PDC) among all GLP-1 RA initiators with two or more prescription fills. Discontinuation was defined as any GLP-1 RA therapy gap &gt;90 days after end of days of supply from medication fill during follow-up. Multivariable logistic regression was used to evaluate factors associated with non-adherence and discontinuation.
Results: Of 4,791 patients included, 42% were female and median age was 56 years. The proportion of patients characterized as non-adherent (PDC &lt;80%) was 49.1% within 1 year. The proportion of patients who discontinued therapy was 47.7% within 1 year. Factors associated with poor adherence/discontinuation within 1 year included male sex, older age, Southern geographic region, and Medicare insurance.
Conclusion: A substantial proportion of U.S. T2D patients are non-adherent to GLP-1 RA therapy and nearly half of patients discontinue GLP-1 RA therapy within a year. Further investigation on the impact of adherence on real-world effectiveness, including weight loss and HbA1c, is warranted.

Disclosure
T. Weiss: Employee; Self; Merck & Co., Inc. K. Iglay: Employee; Self; Merck & Co., Inc. Stock/Shareholder; Self; Merck & Co., Inc. R.D. Carr: Employee; Self; Merck & Co., Inc. Speaker's Bureau; Spouse/Partner; Eli Lilly and Company, Merck & Co., Inc. A.P. Mishra: None. L. Yang: Employee; Self; Bristol-Myers Squibb Company, Merck & Co., Inc. S. Rajpathak: None.
99-LB: Meta-analysis of Three Real-World, Chart Review Studies to Determine the Effectiveness of FreeStyle Libre Flash Glucose Monitoring System on HbA1c in Adults with Type 2 Diabetes
Authors: KROEGER JENS , FASCHING PETER , HANAIRE HELENE 
Published: June 2019

Three retrospective chart review studies evaluated the effectiveness of the FreeStyle Libre Flash Glucose Monitoring SystemTM on HbA1c when used by adults with type 2 diabetes (T2DM) as their standard of care in a real-world setting. Each study aimed to determine the effect of FreeStyle Libre when used for between 3 months to 6 months on HbA1c. Each study population included adults on a basal-bolus insulin regimen for at least 1 year who had been using FreeStyle Libre regularly for at least 3 months (either self-funded or prescribed) and with HbA1c between 8.0 and 12.0% (64 to 108 mmol/mol). Pregnant patients were excluded, as were patients on dialysis. This meta-analysis comprised of a total of 363 records from insulin using patients with T2DM from 18 medical centres in Austria, France and Germany. On average, HbA1c was 8.9±0.9% (73.3±9.8 mmol/mol) prior to FreeStyle Libre use, age was 63.5±11.0 years and average duration of insulin use 8.3±5.8 years (mean±SD), 67.8% of patients were on oral antidiabetic medications (metformin, SU, TZD, DPP-4 or SGLT2) and 56.4% were male. CVD, renal and retinopathy complications were reported by 36.4%, 33.9% and 19.6% of patients, respectively. HbA1c results were recorded between 90 and 194 days from the start of use of FreeStyle Libre, between January 2015 and August 2018. Overall mean change in HbA1c, after at least 3 months of using FreeStyle Libre, was significantly reduced by 0.9±0.05% (mean±SE); p&lt;0.0001, with no heterogeneity between countries (Q=0.7, I2=0, p=0.7113). No significant differences were detected between: age group, sex, BMI or duration of insulin use. This meta-analysis of three real-world, chart review studies concludes that people with T2DM on insulin therapy, using FreeStyle Libre for between 3 to 6 months significantly reduced HbA1c.

Disclosure
J. Kroeger: Board Member; Self; Abbott. Consultant; Self; Abbott. P. Fasching: None. H. Hanaire: Research Support; Self; Abbott, Eli Lilly and Company, LifeScan, Inc., Novo Nordisk A/S. Other Relationship; Self; Eli Lilly and Company, Novo Nordisk A/S.
990-P: Therapeutic Effect of a Novel Long-Acting GLP-1/GIP/Glucagon Triple Agonist (HM15211) in a NASH and Fibrosis Animal Model
Authors: KIM JUNG KUK , LEE JONG SUK , KIM DAEJIN , PARK EUNJIN , KIM YOUNG HOON , CHOI IN YOUNG 
Published: June 2019

NASH, a severe form of NAFLD, can lead to end stage liver disease such as cirrhosis. Despite increasing prevalence and as a burden for public health, advances in the development of therapeutics are slow with yet no approved drug for NASH treatment. Since liver fat accumulation and inflammation are associated with NASH progression, targeting both aspects may contribute to NASH resolution and fibrosis improvement. Thus, to directly aid those aspects, we developed a novel long-acting, GLP-1/GIP/Glucagon triple agonist, HM15211. With a unique activity profile, HM15211 showed a liver preferential distribution, and exerted potent hepatic triglyceride (TG) reduction in addition to efficient weight loss in DIO mice, suggesting HM15211 as a novel therapeutic option for NASH treatment. Here, we evaluated the therapeutic potential of HM15211 in NASH and fibrosis animal models including monkeys. In MCD-diet mice (6 weeks induction), HM15211 led to significant decrease in hepatic TG content (-82.6% vs. vehicle), which coincided with reduction of elevated ALT and bilirubin. Time course MRI confirmed the progressive resolution of steatosis. Histological analysis also indicated a significant reduction both in hepatic inflammatory gene expression and NAFLD activity score (1.3 for HM15211, 3.4 for liraglutide, and 2.7 for vehicle). To further evaluate the therapeutic potential in fibrosis, MCD-diet mice were used for an extended period (up to 12 weeks induction) for overt liver fibrosis induction. In line with NASH improvement, HM15211 reduced hepatic hydroxyproline and the fibrosis score markedly. Finally, obese and NASH monkeys were administered with HM15211, and efficient weight loss, improvement of lipotoxicity and improvement of histological NASH/fibrosis markers were confirmed in primates too. Based on these results, HM15211 may provide efficacy for the treatment of NASH and fibrosis. Further studies are needed to assess the clinical relevance of these findings.

Disclosure
J. Kim: None. J. Lee: None. D. Kim: None. E. Park: None. Y. Kim: None. I. Choi: Employee; Self; Hanmi Pharm. Co., Ltd.
995-P: Semaglutide in Patients with Type 2 Diabetes: Real-World Analysis in the Canadian LMC Diabetes Registry: The SPARE Study
Authors: BROWN RUTH E. , LIU AIDEN R. , MAHBUBANI REENA , ARONSON RONNIE 
Published: June 2019

The Canadian LMC Diabetes Registry will evaluate real-world clinical outcomes in GLP-1 RA naïve patients with T2D who initiate once weekly semaglutide as part of their usual diabetes therapy in the first year of semaglutide availability in Canada. Primary outcome is change in A1C at 3 - 6 months follow-up. In this interim retrospective analysis of the first six months of semaglutide availability, 542 patients who initiated semaglutide were eligible (37% on 1.0 mg dose and 63% on 0.5 mg dose). They had a mean age of 57.3 ± 10.1 years, T2D duration of 12.0 ± 7.4 years, and baseline A1C of 8.23 ± 1.34%. At 3-6 months follow-up, 466 patients who remained on-treatment showed an A1C reduction of 0.88 ± 1.15% (p&lt;0.01), with 36% of patients achieving an A1C reduction ≥1.0% and 43% of patients achieving A1C ≤7.0%. Similar benefit in A1C lowering was seen in subgroups based on prior diabetes therapy, concomitant insulin use and prior use of DPP-4i (Figure). Mean weight reduction was 3.1 ± 3.6 kg and 23.6% of patients achieved a weight loss ≥ 5%. Reductions were also seen for systolic BP (5.1 ± 13.0 mmHg, p&lt;0.01), diastolic BP (2.2 ± 9.3 mmHg, p&lt;0.01) and alanine aminotransferase (1.7 ± 12.9 U/L, p=0.03). In this real-world analysis of a large Canadian cohort, patients initiating semaglutide had significant reductions in A1C and weight at three to six months, regardless of prior and concomitant diabetes therapy.

Disclosure
R.E. Brown: None. A.R. Liu: Employee; Self; Novo Nordisk A/S. R. Mahbubani: Employee; Self; Novo Nordisk Inc. R. Aronson: Research Support; Self; AstraZeneca, Becton, Dickinson and Company, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Janssen Pharmaceuticals, Inc., Medtronic, Merck & Co., Inc., Novo Nordisk Inc., Sanofi, Senseonics.

Funding
Novo Nordisk Canada Inc.