bluuebunny/crossref_metadata_2025_split huggingface dataset:
Serum Galectin-3 and All-Cause Mortality in Type 2 Diabetes
Authors: TAN KATHRYN C.B. , SHIU SAMMY , LAM JOANNE K.Y. , LEE ALAN C. , WONG YING 
Published: June 2018

Background and Aims: Galectin-3, a member of the multifunctional galectin family, is ubiquitously expressed and acts a broad-spectrum biological response modifier. It is involved in tissue fibrosis, tumorigenesis, immunity and inflammatory response. It can also act as a receptor for advanced glycation end products. Recent evidence suggests that galectin-3 is associated with heart failure and with progression of nephropathy in type 2 diabetes. We have therefore evaluated whether serum galectin-3 level is associated with all-cause mortality in patients with type 2 diabetes.
Materials and Methods: Galectin-3 was measured in the baseline serum samples by ELISA in 1495 type 2 diabetic patients followed up in a teaching hospital specialist diabetes clinic. All-cause mortality was ascertained from hospital electronic medical records.
Results: The mean age of the subjects was 55.3 ± 9.9 years and 54% were male. During a median follow-up of 11 years, 169 subjects died from all causes, and baseline serum galectin-3 levels were significantly higher in subjects with a fatal outcome (9.86 ± 3.11 ng/ml vs. 8.15 ± 2.73, p&lt;0.01). When galectin-3 was analyzed as quartiles, individuals in the third quartile [hazard ratio (HR) 2.0, 95% confidence interval (CI) 1.2-3.2, p&lt;0.01] and the highest quartile (HR 3.9, 95% CI 2.6-6.0, p&lt;0.01) had significantly elevated risk of a fatal outcome compared to those in the lowest quartile. Multivariable Cox regression analysis showed a significant association between serum galectin-3 level and all-cause mortality and the association remained significant even after adjustment for potential confounders including age, sex, body mass index, duration of diabetes, smoking, baseline HbA1c, systolic blood pressure, LDL and albuminuria status.
Conclusion: Elevated serum galectin-3 level was independently associated with all-cause mortality in patients with type 2 diabetes. Galectin-3 may potentially be useful as a predictor of adverse outcome.

Disclosure
K.C.B. Tan: None. S. Shiu: None. J.K.Y. Lam: None. A.C. Lee: None. Y. Wong: None.
Relationship between Frequency of Blood Glucose Testing and Reduction in HbA1c and Body Weight during Intensive Lifestyle Intervention in Patients with Type 2 Diabetes and Obesity
Authors: TOMAH SHAHEEN , MAHMOUD NOOR , MOTTALIB ADHAM , ALSIBAI KHALED , ASHRAFZADEH SAHAR , ELSEAIDY TAHA , HAMDY OSAMA 
Published: June 2018

Self-monitoring of blood glucose (SMBG) is known to be valuable for proper diabetes management. However, the optimal frequency of SMBG has been debated. The aim of this study is to evaluate the relationship between frequency of SMBG and the degree of glycemic control and the magnitude of weight reduction in patients with type 2 diabetes (T2D) and obesity enrolled in an intensive lifestyle intervention (ILI).
We evaluated 36 patients with T2D and obesity (mean age 56±9 years, 56% female) enrolled in the Weight Achievement and Intensive Treatment (Why WAIT) program, a 12-week multidisciplinary ILI clinical program between May 2016 and December 2017. Participants were asked to test their blood glucose before each meal, at bed time, before and after exercise, occasionally postprandial and when needed. At baseline, average body weight was 105.7±20.9 kg, BMI 36±6 kg/m2, HbA1c 7.8±1.3%, and 41% of participants were treated with insulin. Based on their actual frequency of SMBG per day, participants were divided into tertiles. The lowest tertile tested on average 2.3±0.6 times/day (range: 1.1-2.9 times). The middle tertile tested on average 3.3±0.3 times/day (range: 3.0-3.9 times). The highest tertile tested on average 5.2±1 times/day (range: 4.0-7.7 times). HbA1c and body weight did not differ between tertiles at baseline.
At 12 weeks, HbA1c changed by -0.9±0.3% (p=0.01), -1.2±0.4% (p&lt;0.01) and -1.7±0.5% (p=0.001) respectively from baseline. Body weight changed by -7.6±3.2 kg (-7.13%), -9.2±6.4 kg (-8.7%), and -10.6±4.1 kg (-9.9%) respectively from baseline (p&lt;0.01 for all). The reduction in HbA1c and body weight was significantly better in the highest tertile of SMBG in comparison to the lowest tertile (p&lt;0.for both).
In conclusion, patients with T2D and obesity who test their blood glucose more often during ILI achieve significantly better HbA1c reduction and significantly higher percentage of weight loss.

Disclosure
S. Tomah: None. N. Mahmoud: None. A. Mottalib: None. K. Alsibai: None. S. Ashrafzadeh: None. T. Elseaidy: None. O. Hamdy: Research Support; Self; Abbott. Advisory Panel; Self; AstraZeneca. Consultant; Self; Merck & Co., Inc.. Research Support; Self; Novo Nordisk A/S. Stock/Shareholder; Self; Healthimation, LLC.. Consultant; Self; Sanofi-Aventis.
Glycemic Parameters for Clinical Shifting to Glargine 300 U/mL (Gla-300) Basal-Plus/Basal-Bolus Insulin Therapies in Asian Patients with Poorly Controlled T2DM
Authors: LIN CHIA-HUNG 
Published: June 2018

Aim: T2DM patients are shifted to long-acting insulin analogs when premixed insulin therapy becomes insufficient for individuals to achieve glycemic control. The objective of this study was to investigate glucose patterns from continuous glucose monitoring (CGM) for the clinical assignment of Asian T2DM patients with poor glucose control to Gla-300 basal-plus or Gla-300 basal-bolus therapy.
Method: 20 T2DM premixed insulin outpatients requiring therapy change were enrolled in the study. Based on clinical judgment during routine follow-up, patients were switched to Gla-300 basal-plus or Gla-300 basal-bolus therapy by clinicians. Adjustments were not made to patients’ diet or daily routines. Non-real time CGM was prospectively applied at baseline and one month after switching insulin therapy regimens. Mean fasting and postprandial glucose levels, glucose excursion markers, including mean amplitude of glucose excursion (MAGE) and standard deviation of plasma glucose (SDPG), estimated A1C from CGM and frequency of hypoglycemia were recorded for computer-assisted analysis.
Result: Baseline CGM data indicated that pre-meal (dinner) glucose levels (129 ± 33 vs. 204 ± 92 mg/dL, p=0.046), SDPG (52 ± 11 vs. 72 ± 21 mg/dL, p=0.029) and MAGE (119 ± 26 vs. 174 ± 32 mg/dL, p=0.038) were statistically lower in patients shifted to basal-plus therapy than those shifted to basal-bolus therapy. One month after initiating Gla-300-based insulin therapies, glucose excursion manifestations, estimated A1C levels and hypoglycemia occurrences were shown to decrease in both treatment groups; though without statistical significance between groups.
Conclusion: The baseline glucose excursion markers (i.e., SDPG and MAGE) as well as pre-dinner glucose levels are significant glycemic parameters that can be assessed for the clinical shifting of T2DM Asian patients from premixed insulin to Gla-300 based basal-plus or basal-bolus therapies.

Disclosure
C. Lin: None.
The Effect of Flash Glucose Monitoring on Glycemic Control in Patients with Type 1 Diabetes
Authors: DØRFLINGER GRY H. , ØSTERGAARD JAKOB A. , FISKER SANNE , KNUDSEN SOREN T. , HANSEN TROELS K. 
Published: June 2018

Introduction: Freestyle Libre Flash glucose monitoring system is a new approach to self-monitoring of glucose. We investigated the effect on glycaemic control of applying this system in patients with type 1 diabetes in a real world clinical setting.
Materials and Methods: A total of 210 consecutive patients with type 1 diabetes were included in an observational study investigating the change in glycaemic control upon introducing Freestyle Libre Flash Glucose monitoring (FGM) system (Abbott Diabetes Care Ltd, Range Road Witney, Oxon OX29 OYL; UK). Hba1c was monitored prior to the application of FGM and every 3-4 months during a follow-up of between 3 and 15 months.
Results: HbA1C decreased significantly by 5 mmol/mol (IQR 10, P &lt;0.0001) after 3 months as compared with baseline, where after HbA1c stabilized.
When subdividing patients according to baseline glycemic control (Hba1c &lt;53 mmol/mol, 54-70 mmol/mol, &gt;70 mmol/mol) at inclusion in the study, we found a significant decrease in Hba1c in two groups (54-70: 4 mmol/mol, P&lt;0.0001, &gt;70: 7 mmol/mol, P&lt;0.0001) from baseline to 3 months.
Conclusion: In this observational study, we found a significant decrease in Hba1c- levels after the introduction of flash glucose monitoring in subjects with type 1 diabetes; this decrease was maintained throughout the 12-month study period.

Disclosure
G.H. Dørflinger: None. J.A. Østergaard: None. S. Fisker: Other Relationship; Self; Novo Nordisk A/S. S.T. Knudsen: Advisory Panel; Self; Novo Nordisk A/S, Merck & Co., Inc., Sanofi-Aventis, Eli Lilly and Company, Boehringer Ingelheim GmbH, AstraZeneca. Speaker's Bureau; Self; Merck & Co., Inc., Boehringer Ingelheim GmbH, AstraZeneca. T.K. Hansen: Advisory Panel; Self; Abbott, AstraZeneca, Novo Nordisk A/S. Research Support; Self; Novo Nordisk Foundation. Advisory Panel; Self; Merck Sharp & Dohme Corp..
Assessing Glucose Trend Accuracy with a Novel Continuous Glucose Monitoring System
Authors: JOHNSON TERRI , ZHANG XIAOHE , BALO ANDREW 
Published: June 2018

In addition to point accuracy, continuous glucose monitoring (CGM) devices should be evaluated on trend accuracy to determine whether they provide accurate and timely tracking of glucose fluctuations. We evaluated trend accuracy in a study of the investigational G6 Factory-Calibrated System ("G6 FC", Dexcom), which provides real-time glucose measurements and trend indicators. A total of 76 subjects enrolled (49 children ages 6-17 years and 27 adults) at four U.S. clinical sites. 73 had type 1 diabetes. Participants attended 1 or 2 clinic sessions during which CGM readings were compared to reference venous YSI glucose obtained every 15 minutes. Trend accuracy was assessed using R-deviation, which computes the difference between “instantaneous” rates of glucose change for the CGM and the reference rate of glucose change. Approximately 94% of data had less than ±1 mg/dL/min difference from the reference rate of change (95% for adults vs. 93% for children). When YSI glucose values were falling rapidly (&lt;-2 mg/dL/min), the G6 FC showed that glucose values were falling moderately to rapidly 83% of the time; when the glucose values were rising rapidly (&gt;2 mg/dL/min), the G6 FC showed that glucose values were rising moderately to rapidly 91% of the time (Table). Accurate tracking of glucose trends with the novel G6 FC CGM system will provide additional assurance to the patients relying on these data for diabetes management decisions.G6 FC System's Concurrence on Rate of ChangeCGM Rate of Change (mg/dL/min)YSI Rate of Change (mg/dL/min)Matched Pairs (N)&lt; -2[-2, -1)[-1, 0)[0, 1)[1, 2]&gt;2&lt; -245.0%37.5%17.5%0.0%0.0%0.0%40[-2, -1)3.6%59.5%33.6%2.9%0.4%0.0%274[-1, 1)0.2%3.9%57.2%34.8%3.6%0.3%2707[1, 2]0.0%0.8%1.6%36.2%50.2%11.3%257&gt; 20.0%0.0%2.4%6.6%27.7%63.3%166Matched Pairs (N)33285165610542741423444

Disclosure
T. Johnson: Employee; Self; Dexcom, Inc. X. Zhang: Employee; Self; Dexcom, Inc. A. Balo: Employee; Self; Dexcom, Inc..
Beneficial Effect of Flash Glucose Monitoring Persists in a Two-Year Perspective—A Clinical Follow-Up Study of 334 Individuals with Type 1 Diabetes
Authors: LONDAHL MAGNUS , FAGHER KATARINA , KATZMAN PER , FILIPSSON KARIN 
Published: June 2018

Short term follow-up studies indicate that use of Flash glucose monitoring (FGM) improves metabolic control in people with type 1 diabetes. Whether this effect persists is unknown.
The aim of this study was to evaluate long-term effects on HbA1c and treatment satisfaction in people with type 1 diabetes after introduction of FGM in a university hospital diabetes clinic. Treatment satisfaction was measured using DTSQs questionnaires at the one year follow-up. Of the first 334 patients who were introduced to FGM 80.5% were still users after 2 years, 8.7% changed to a CGM-system, 6.6% stopped due to skin reactions, 3.4% did not want to continue and 1.3% had died. Baseline HbA1c among continuers were 71.8±16.6 mmol/mol (8.7%). Compared to baseline, HbA1c was -8.3±9.8 mmol/mol after 1 year and 9.0±11.8 mmol/mol lower after 2 years. Self-estimated treatment satisfaction after 1 year was 2.44±0.74 (+3 to -3) and rating for continued FGM use was 2.87±0.33. Unacceptable high blood glucose was less often present (-0.6) as were unacceptable low blood glucose levels (-0.3).
Conclusions: Use of FGM adds clinical significant advantage to individuals with 1 diabetes in terms of HbA1c reduction and improved self-estimated treatment satisfaction also in a 2-year perspective.

Disclosure
M. Londahl: Speaker's Bureau; Self; Abbott, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company. Advisory Panel; Self; Amgen Inc.. Speaker's Bureau; Self; AstraZeneca, Novo Nordisk A/S. Research Support; Self; Sanofi. Speaker's Bureau; Self; Sanofi. Research Support; Self; ReApplix AS. K. Fagher: Speaker's Bureau; Self; AstraZeneca, Sanofi, Novo Nordisk A/S, Merck Sharp & Dohme Corp.. P. Katzman: None. K. Filipsson: Speaker's Bureau; Self; Boehringer Ingelheim GmbH, Eli Lilly and Company. Consultant; Self; Eli Lilly and Company. Advisory Panel; Self; MSD K.K.. Speaker's Bureau; Self; Novo Nordisk A/S, Sanofi.
Hypoglycemia with Mealtime Fast-Acting Insulin Aspart vs. Insulin Aspart Across Two Large Type 1 Diabetes Trials
Authors: BLOCK CHRISTOPHE DE , CARLSON ANDERS , ROSE LUDGER , GONDOLF THEIS , GORST-RASMUSSEN ANDERS , LANE WENDY 
Published: June 2018

Hypoglycemia is a ubiquitous challenge with insulin treatment in type 1 diabetes (T1D), with nocturnal episodes of particular concern. Severe (as defined by the ADA) or blood glucose-confirmed (&lt;56 mg/dL [3.1 mmol/L]) hypoglycemia was investigated across two double-blind, treat-to-target, randomized trials assessing the efficacy and safety of mealtime fast-acting insulin aspart (FA) vs. insulin aspart (IAsp) by multiple daily injections in adults with T1D: a 52-week trial in combination with insulin detemir (onset 1; n=761), and a 26-week trial in combination with insulin degludec (onset 8; n=684). FA was confirmed to be non-inferior to IAsp regarding change from baseline in A1C in both trials, with a statistically significantly greater A1C reduction with FA in onset 1. Importantly, nocturnal hypoglycemia rates were consistently lower with FA vs. IAsp in both trials (pooled estimated treatment rate ratio [ETR] 0.84 [95% CI 0.72;0.98]; p=0.02) (Figure), while no significant difference was observed for overall (pooled ETR 0.94 [95% CI: 0.85;1.05]) and diurnal hypoglycemia (pooled ETR 0.96 [95% 0.86;1.07])(Figure) with some heterogeneity across trials.
In summary, analysis across two large trials supports the safety of mealtime FA, with lower rates of nocturnal hypoglycemia with FA vs. IAsp.
ClinicalTrials.gov: NCT01831765; NCT02500706.

Disclosure
C. De Block: None. A. Carlson: Advisory Panel; Self; Sanofi, Insulet Corporation. Consultant; Self; Merck & Co., Inc.. Research Support; Self; Medtronic, Novo Nordisk A/S. L. Rose: Advisory Panel; Self; Novo Nordisk A/S. Consultant; Self; Member of Association of Statutory Health Insurance Physicians. T. Gondolf: Employee; Self; Novo Nordisk A/S. Employee; Spouse/Partner; Chr. Hansen A/S. A. Gorst-Rasmussen: Employee; Self; Novo Nordisk A/S. W. Lane: Advisory Panel; Self; Novo Nordisk A/S, Insulet Corporation, Intarcia Therapeutics, Inc., Sanofi. Research Support; Self; Novo Nordisk A/S, Eli Lilly and Company, Lexicon Pharmaceuticals, Inc., Sanofi, Dexcom, Inc.. Speaker's Bureau; Self; Novo Nordisk A/S, Insulet Corporation.
Patient Reported Outcomes (PRO) in a Study of Human Regular U-500 Insulin (U-500R) Delivered by Continuous Subcutaneous Insulin Infusion (CSII) or Multiple Daily Injections (MDI) in Patients with T2D
Authors: PENG XIAOMEI , CHEN JIELING , FAN LUDI , ILAG LIZA , LY TRANG T. , JOHNSON JENNAL 
Published: June 2018

Persons with T2D treated with U-500R have shown improved glycemic control. This prospective analysis evaluated the impact on PRO of U-500R delivered by CSII (using an investigational Omnipod U-500TM Insulin Management System) or MDI (using a U-100 syringe). In this 26-week (week), open-label, parallel trial, 420 patients treated with &gt;200 units/day of insulin for T2D were randomized to CSII (n=209) or MDI (n=211) treatment groups. The Treatment-Related Impact Measure for Diabetes (TRIM-D) and Diabetes Device (TRIM-DD) questionnaires were assessed at baseline, week 14, and week 26. Results are shown in Table 1. TRIM-D scores (overall score and all 5 domain scores) and TRIM-DD overall score in both groups improved significantly from baseline to week 26 (p&lt;0.05). At week 26, change in baseline score for the CSII group was significantly higher than the MDI group in all TRIM-D measures (p&lt;0.05). At week 26, there were no significant differences in the change from baseline score between the CSII and MDI groups in TRIM-DD overall or its domains.
In summary, the U-500R CSII device scored significantly better than MDI in the perceived impact on diabetes treatment (TRIM-D) but not for diabetes device (TRIM-DD). PROs for diabetes treatment improved significantly from baseline to week 26 in patients treated with U-500R by either CSII or MDI.

Disclosure
X. Peng: Employee; Self; Eli Lilly and Company. J. Chen: None. L. Fan: Employee; Self; Eli Lilly and Company. L. Ilag: Employee; Self; Eli Lilly and Company. Stock/Shareholder; Self; Eli Lilly and Company. T.T. Ly: Employee; Self; Insulet Corporation. J. Johnson: Employee; Self; Eli Lilly and Company.
Postprandial Response in Children Using the MiniMed™ 670G System
Authors: GROSMAN BENYAMIN , ROY ANIRBAN , WU DI , PARIKH NEHA , LEE SCOTT W. , KAUFMAN FRANCINE R. 
Published: June 2018

The Medtronic MiniMed™ 670G hybrid closed-loop (HCL) system was investigated in a multi-center pivotal trial conducted in 1T1D children aged 7-13 years. A 3-month at-home study phase with Auto Mode enabled followed the 2 week run-in phase in Manual Mode. The system improved overall glycemic control and minimized the percentage of time in hypoglycemia (≤70mg/dL, 3.9mmol/L). Several aspects of the postprandial response and sensor glucose (SG) values, during the run-in and study were compared. The maximum increase in SG (mg/dL) per 50 grams of carbohydrate (carb) in postprandial responses &gt;3h; settling time, defined as the minutes for the postprandial response to settle back to &lt;10mg/dL of the glycemic value at meal start; and the 3-h postprandial distribution of SG values were analyzed. Analyses were separated into 4-11am, 11am-4pm, and 4pm-4am periods. The median (IQR) for the postprandial maximum SG increase 4-11am was 91 (139) and 96 (136) mg/dL, p=0.34; for 11am-4pm was 86 (152) and 82 (141) mg/dL, p=0.66; and for 4pm-4am was 102(182) and 87.5 (166), p&lt;0.001, for run-in and study, respectively. That for settling time for 4-11am was 192 (176) and 189 (158) min, p&lt;0.001; for 11am-4am was 195.5 (213) and 191 (217) min, p=0.24; and for 4pm-4am was 295 (555) and 221 (447) min, p&lt;0.001, respectively. That for 3-h postprandial SG values for 4-11am was 154 (106) and 150.5 (88) mg/dL, p=0.004; for 11am-4pm was 159.5 (104) and 153 (93) mg/dL, p&lt;0.001; and for 4pm-4am was 163 (106) and 158 (89) mg/dL, p=0.001, respectively. The postprandial response in most of the tested outcomes between the study and run-in phase was significantly improved when the MiniMed™ 670G Auto Mode feature was enabled. For meals consumed between 4pm-4am, a reduction of 14.5 mg/dL was observed in the median maximum SG per 50 grams of carb. Furthermore, for meals consumed between 4pm-4am, settling time was reduced by 74 minutes. Overall, the HCL system reduced postprandial excursions and settling times throughout the day, while showing significant improvements 4pm-4am.

Disclosure
B. Grosman: Employee; Self; Medtronic. A. Roy: Employee; Self; Medtronic MiniMed, Inc.. D. Wu: None. N. Parikh: Employee; Self; Medtronic. S.W. Lee: Employee; Self; Medtronic. F.R. Kaufman: Employee; Self; Medtronic.
Real-World Use of Hybrid Closed-Loop Therapy in Pediatric Patients with Type 1 Diabetes
Authors: BERGET CARI , MESSER LAUREL H. , PYLE LAURA , WESTFALL EMILY , FORLENZA GREGORY P. , DRISCOLL KIMBERLY A. 
Published: June 2018

Objective: To describe the real world impact of the 670G Hybrid Closed Loop (HCL) system on glucose control in pediatric patients with type 1 diabetes (T1D).
Methods: Patients starting the 670G were recruited to participate in a 12-month observational study. Data on 670G use and glycemic outcomes were obtained from pump downloads and chart review as part of routine clinical care. Descriptive statistics are reported as medians (25th%ile, 75th%ile).
Results: Nineteen pediatric patients (14 y (11.7, 17.4); 53% F) with 32 days (26, 44) of 670G data were included. T1D duration was 7 years (3, 9) and HbA1C was 8.5% (7.9, 9.6). Patients spent 70% (35, 85) of each week in HCL. System exits from HCL mode (auto mode) to standard pump mode (manual mode) occurred 0.64 times/day (0.5, 1.05), primarily due to hyperglycemia. Sensor glucose time in target range (70-180 mg/dl) was 60% (50, 64) with 1% of sensor glucose values ≤70 mg/dl. Increased time spent in HCL was correlated with reduced mean sensor glucose and standard deviation of glucose, and increased time in target range (Table).
Conclusions: Youth using the 670G in clinical care were able to stay in HCL most of the time in the initial weeks of system use. HCL use may improve glucose control for pediatric patients with T1D. Data collection is ongoing and will elucidate the impact of the 670G on glycemic control longitudinally and describe patient use of the system in real-world conditions. Correlation of % time in HCL 'auto mode' with glucose variablesVariableSpearman Correlation Coefficientp-value% time sensor values 70-180 mg/dl0.670.002Mean sensor glucose value-0.600.007% time sensor &lt;54 mg/dl-0.0490.84% time sensor values 54-69 mg/dl0.170.50% time sensor values &gt;250 mg/dl-0.670.002Standard deviation of sensor glucose values-0.540.02

Disclosure
C. Berget: None. L.H. Messer: Other Relationship; Self; Medtronic MiniMed, Inc.. L. Pyle: None. E. Westfall: None. G.P. Forlenza: Advisory Panel; Self; Dexcom, Inc.. Research Support; Self; Medtronic, Tandem Diabetes Care, Inc., Insulet Corporation, Dexcom, Inc., Novo Nordisk Inc., Bigfoot Biomedical. K.A. Driscoll: None.