bluuebunny/crossref_metadata_2025_split huggingface dataset:
Early Hospitalization for Diabetes Care Improves Glycemic Control in Patients with Type 2 Diabetes Reserved Insulin Secretion
Authors: IKEDA DAISUKE 
Published: June 2018

Background and Aims: In Japan, early hospitalization for diabetes care is widely diffused, and keeps glycemic control good for the long term through intensive diabetes education in the short term. In recent years, new classes of antidiabetes medicine have been launched. Glycemic control in patients with type 2 diabetes, especially reserved insulin secretion, becomes easier. We aimed to know whether recent early diabetes hospitalization is still work for glycemic control of type 2 diabetes patients reserved insulin secretion.
Methods: Japanese type 2 diabetes patients ware without medication, with HbA1c &gt;8.0 in their first visit and with good insulin secretion (δCPR &gt;2.0 in glucagon stimulation test) within 3 months. Their first visits ware from April 2012 to Oct 2017 We retrospectively compared between 36 patients with early hospitalization and 35 patients without hospitalization. In our diabetes hospitalization, patients get a diabetes education. Most patients are canceled glucose toxicity by insulin and then changed any other applicable antidiabetic medicines without insulin possible.
Results: At baseline, HbA1c of patients in early hospitalization group was higher than no hospitalization group (11.6±1.9%, 10.3±1.4%, p=0.002). δCPR was no significant difference. HbA1c of early hospitalization group was lower than no hospitalization group over 3years(1y: 6.4±0.8%, 7.4±1.1%, p&lt;0.001, 2y: 6.5±0.8%, 7.3±0.9%, p=0.008, 3y: 6.2±0.6%, 7.5±0.8%, p&lt;0.001). Numbers of diabetic medicine classes in early hospitalization group ware smaller than no hospitalization group after 2 years (1.8±0.8, 2.5±0.9, p=0.010). Two patient in early hospitalization group interrupted to visit our hospital, although 9 patients in no hospitalization group.
Conclusion: Diabetes hospitalization is still one of very effective therapeutic method today. Education and earlier glycemic control may contribute to keep glycemic control good over a long lifetime.

Disclosure
D. Ikeda: None.
Comparison of Disparities between FGM/CGM Sensor Glucose Values and Blood Glucose Values in Type 2 Diabetic Patients Admitted for Glycemic Control
Authors: TANIZAWA MIKA , TAKAHASHI HIROSHI , MORI YUTAKA , UTSUNOMIYA KAZUNORI 
Published: June 2018

Objective: The disparities were compared between flash glucose monitoring (FGM) sensor glucose (SG) values and SMBG blood glucose (BG) values vs. between continuous glucose monitoring (CGM) SG values and BG values to establish the accuracy of FGM SG values.
Methods: CGM (CGMS-Gold, Medtronic Minimed) and FGM (FreeStyle Libre Pro; Abbott Japan) were simultaneously put in place in 16 type 2 diabetic patients admitted for glycemic control (BMI, 28.7 ± 5.2 kg/m2; HbA1c, 9.8 ± 2.1%). SMBG BG values at 500 time points registered on CGMS-Gold for calibration purpose and CGM/FGM SG values at the same time points, were selected to examine the accuracy of FGM SG values. Both these devices were evaluated for accuracy in terms of 1) simple correlation coefficients between CGM/FGM SG values and BG values; and 2) mean absolute relative differences (MARD) in SG values of CGM/FGM relative to BG values as reference.
Results: 1) A strong positive correlations were found between the SMBG BG values and CGM/FGM SG values (r = 0.9462, p &lt; 0.001 / r = 0.8797, p &lt; 0.001). 2) The MARD in CGM/FGM SG values were 6.53 ± 6.35% (0-47.3%) / 10.35 ± 9.64% (0-65.5%), and the frequency of MARD showing 10% or less accounted for 79.0% of all CGM SG values, and 58.2% of all FGM SG values. The relationship between the MARD in CGM/FGM SG values and the durations of CGM/FGM put in place showed that while the MARD in CGM SG values was nearly constant, the MARD in FGM SG values varied from day to day. Again, the relationship between MARD in CGM/FGM SG values and BG value showed that while the MARD in CGM SG values remained constant, irrespective of BG values, the MARD in FGM SG values tended to increase with decreasing BG values. Additionally, the disparity between the FGM SG values and the BG values varied greatly depending on the individual patient.
Conclusions: Despite being an innovative device for glucose monitoring, FGM may be appropriately positioned as an adjunct, but not an alternative, to SMBG.

Disclosure
M. Tanizawa: None. H. Takahashi: None. Y. Mori: None. K. Utsunomiya: None.
Controlled Release of Insulin Granules from PLGA Microparticles for Glucose Modulation in Diabetes
Authors: PRIMAVERA ROSITA , MAGNONE MIRKO , MASCOLO DANIELE DI , ZOCCHI ELENA , PASCALE ANGELO DE , DECUZZI PAOLO 
Published: June 2018

Diabetes is a chronic disease deriving from the insufficient production or utilization of insulin. So far, the treatment of diabetes relies on the daily subcutaneous injection of insulin. However, this approach suffers of poor patient compliance and fluctuations in blood glucose levels that increases the risk of hypoglycemia, cardiovascular disease, non-healing wounds and other comorbidities. In this work, a delivery system is proposed for the controlled release of insulin and regulation of glycaemia. Nanoscale granules of insulin were synthesized and encapsulated within the porous matrix of PLGA microparticles (i-μPLs). The granules were obtained with an accurate crystallization process returning spherical nanoparticles with a diameter of 209.9±15.8 nm. μPLs were prepared via a top-down approach resulting in 20 x 5 μm square microparticles, made out of a biodegradable polymer - poly(lactic-co-glycolic acid) (PLGA) - which is already used in clinical applications. In vitro studies were conducted on different cells, including macrophages, fibroblasts and endothelial cells, and confirmed the safety and biological activity of i-μPLs. After insulin stimulation, phosphorylated AKT at Ser473 was assessed in cell lysate using a commercial kit (In-Cell ELISA): i-μPL activity was comparable to that of free, commercial insulin. As preliminary in vivo studies, i-μPLs (0.25 U) or empty μPLs (control) were implanted in the spleen of mice. Twenty-four hours post implantation, fasted mice underwent an oral glucose tolerance test (1 g glucose/Kg body weight). In i-μPL treated mice, the mean blood glucose level was lower as compared to controls at time zero (before gavage) and at 15, 30, 60 and 120 min. Consequently, the glycaemia AUC was reduced in i-μPLs-treated vs. control mice (17828±1527 vs. 20543±413, p=0.06). This preliminary data would suggest that i-μPLs could be effectively used to modulate glucose content in diabetes.

Disclosure
R. Primavera: None. M. Magnone: None. D. Di Mascolo: None. E. Zocchi: None. A. De Pascale: None. P. Decuzzi: None.
Effects of Linagliptin on Endothelial Function and Global Arginine Bioavailability Ratio in Coronary Artery Disease Patients with Early Diabetes
Authors: ABERER FELIX , TRIPOLT NORBERT J. , URL JASMIN , HÖDL RONALD , DIMSITY GUDRUN , AZIZ FAISAL , RIEDL REGINA , HAFNER FRANZ , STRUNK DIRK , STOJAKOVIC TATJANA , BRODMANN MARIANNE , SOURIJ HARALD 
Published: June 2018

Aims: To investigate the effects of the DPP-4 inhibitor Linagliptin in subjects with coronary artery disease (CAD) and early type 2 diabetes mellitus (T2DM) on a set of cardiovascular surrogate measurements.
Materials and Methods: In this randomized, placebo-controlled, double-blind, single-center study, we included subjects with early diabetes (postchallenge diabetes (2h glucose &gt;200mg/dl) or T2DM treated with diet only or on a stable dose of metformin monotherapy, HbA1c&lt;75mmol/mol) and established CAD. Participants were randomized to receive either Linagliptin (5mg) once daily orally or placebo for 12 weeks. The primary outcome was the change in flow mediated dilatation (FMD).
Results: We investigated 43 patients with a mean age of 6±8 years. FMD at baseline was 3.5±3.1% in the Linagliptin group vs. 4.0±2.9% in the placebo group. The change in mean FMD in the Linagliptin group (0.4±4.8%) was not significantly different compared to the change in the placebo group (-0.45±3.01%; p=0.486). No significant improvements were seen in the arginine bioavailability ratios (GABR); p=0.6and AOR; p=0.549), body weight, blood pressure and lipid parameters. Of note, HbA1c was significantly reduced in the linagliptin group (-1.5 vs. -0.4; p=0.026).
Conclusion: Linagliptin treatment in subjects with CAD and early T2DM did not improve endothelial function or GABR.

Disclosure
F. Aberer: None. N.J. Tripolt: None. J. Url: None. R. Hödl: None. G. Dimsity: None. F. Aziz: None. R. Riedl: None. F. Hafner: None. D. Strunk: None. T. Stojakovic: None. M. Brodmann: None. H. Sourij: Speaker's Bureau; Self; Boehringer Ingelheim GmbH, Novo Nordisk A/S, Amgen Inc., Sanofi, MSD K.K.. Research Support; Self; AstraZeneca, Boehringer Ingelheim GmbH, MSD K.K., GI Dynamics Inc..
Trends in Insulin Therapy—A1C and Age at the Time of Insulin Initiation in the Real-World Setting
Authors: KOVIL RAJIV , CHAWLA MANOJ S. , CHAWLA PURVI M. , KOTHARI MIKHIL C. , SHAIKH AMBARI F. 
Published: June 2018

Majority of T2DM patients will eventually require insulin; yet not much is known about the trends and type of insulin choice for initiation in different geographies. We analyzed databases at two specialized diabetes care centers in urban India and identified patients initiated on insulin. A total of 673 eligible patients [males (N= 342), females (N=331)]initiated on insulin during the period of Jan to Dec 2017, were analyzed. Among trends observed, there was a predominant usage of premix insulin for initiation as compared to basal insulin (4.96:1),indicating the physician preference.
Results are presented in the Table. Patients in two groups, receiving basal insulin and premix insulin were further divided on the basis of age into sub-groups of less than 60 years and more than 60 years. In the premix insulin group, a statistically significant difference in the A1C levels at initiation was observed in between the age groups defined earlier [Mean A1C in &lt; 60-year group was 9.5% vs. 9.2% in &gt; 60-year group, p = 0.03.] High A1C at initiation reflects the physician-patient inertia in insulin initiation, despite several guidelines recommending early insulinization. Although our study has the limitation of being a two-center evaluation, the utilization pattern reflects a delay in insulin initiation and predominant premix insulin usage in the Indian population, in view of the high carbohydrate content of the Indian diet.
Mean Age and A1C at Insulin Initiation in Different GroupsMean ± SD95% CIMin, MaxAge (years) at Premix Initiation (N=560)57 ± 1356-5817, 86Age (years) at Basal Initiation (N=113)57 ± 1454-5918, 82Mean Age at Initiation (N=673)57 ± 1356-5817, 86HbA1c (%) at Premix Initiation (N=560)9.4 ± 1.89.2-9.54.1, 16HbA1c (%) at Basal Initiation (N=113)9.8 ± 1.89.5-106.4, 15Mean A1C at Initiation (N=673)9.5 ± 1.89.3-9.64.1, 16

Disclosure
R. Kovil: Speaker's Bureau; Self; Eli Lilly and Company, Novo Nordisk A/S, Sanofi, Boehringer Ingelheim Pharmaceuticals, Inc., AstraZeneca, Janssen Pharmaceuticals, Inc., MSD Pharmaceuticals Pvt. Ltd. M.S. Chawla: Speaker's Bureau; Self; IPCA Laboratories, Eli Lilly and Company, Novo Nordisk A/S, MSD Pharmaceutical Pvt. Ltd., Boehringer Ingelheim Pharmaceuticals, Inc., AstraZeneca. Speaker's Bureau; Spouse/Partner; Sanofi. P.M. Chawla: Speaker's Bureau; Self; Sanofi. Speaker's Bureau; Spouse/Partner; Eli Lilly and Company, IPCA LABORATORIES, Novo Nordisk A/S, MSD PHARMACEUTICALS PVT. LTD., Boehringer Ingelheim Pharmaceuticals, Inc., AstraZeneca. M.C. Kothari: None. A.F. Shaikh: None.
Refractory Nighttime Hypoglycemia in a Toddler—What Happens When Long-Acting Insulin Is Accidentally Used in a Pump?
Authors: BENITEZ SARA G. , MERJANEH LINA 
Published: June 2018

Background: Hypoglycemia is the most common complication of type 1 diabetes (T1D) in children. Hypoglycemia prevents optimal glycemic control and can have deleterious effects on the developing brain.
Clinical Case: A 2-year-old female was diagnosed with T1D and started on an insulin regimen of detemir and lispro. At age 3, she was transitioned to a Medtronic 530 G insulin pump and Enlite continuous glucose monitor. For 7 months, she had stable insulin requirement without significant issues. Thereafter, the family started reporting severe nighttime hypoglycemia and daytime hyperglycemia. Overnight basal rates were decreased gradually to zero with persistence of hypoglycemia despite being fed continuously at night. Daytime insulin doses were increased with dose exceeding 0.9 u/kg/day with persistence of hyperglycemia and worsening of Hba1c. After one year, it was determined that the abnormal patterns were due to using detemir instead of lispro in the pump. This explains why the high doses given during the day did not lower the blood sugars but their effects were seen hours later causing refractory hypoglycemia at night.
Conclusion: We report refractory nighttime hypoglycemia in a toddler with T1D that is due to using long acting insulin in the pump. Clinicians should be aware of this possibility. Using only short acting insulin in the pump should be emphasized to patients and their families.

Disclosure
S.G. Benitez: None. L. Merjaneh: None.
Change in Glucose Levels during Pregnancy and Parturition in Normoglycemic Women Indicated by Flash Glucose Monitoring System
Authors: NISHIMURA AKIKO , FURUTA MARIE , CHIGUSA YOSHITSUGU , MAENO MIKA , FUKAMI MADOKA , HARASHIMA SHINICHI 
Published: June 2018

Accurate knowledge of changes in plasma glucose levels during pregnancy and parturition in normoglycemic women is important for safe management of hyperglycemic disorders in pregnancy. However, there are few reports showing long-term changes in glucose levels over the entire pregnancy period. Flash glucose monitoring (FGM) is a new sensor technology that enables us to ascertain these glucose levels. This is the first study in Japan to monitor glucose levels during this period in normoglycemic, pregnant women by using FGM, which was performed once in non-pregnant women and up to 5 times (first trimester, second trimester, third trimester, parturition, and 3-month postpartum) in pregnant women. Twenty-one non-pregnant women and 9 pregnant women participated in the study. In non-pregnant women, the average age and BMI were 34.4±9.1 years and 20.4±1.5 kg/m2, respectively; the average glucose level was 101.9±20.8 mg/dL, with no difference in age groups. In pregnant women, the average age and BMI were 33.0±2.7 years and 19.0±1.4 kg/m2, respectively. The average glucose levels were 99.8±5.0 mg/dL at first trimester, 85.1±13.0 mg/dL at second trimester, 92.0±7.6 mg/dL at third trimester, 107.3±8.1 mg/dL during parturition, and 95.7±10.0 mg/dL at 3-month postpartum. Compared to glucose levels of non-pregnant women, those of pregnant women were significantly lower at second and third trimester, and returned to the same level at 3-month postpartum. The glucose level during parturition was significantly highest; the proportion of time to achieve optimal target glucose level of 80-110 mg/dL was 62.3±19.9% and the highest value was 244 mg/dL. Maternal and neonatal clinical courses were uneventful in all pregnant cases. It is thus necessary to evaluate to what extent peak value and duration of hyperglycemia affects birth outcome.

Disclosure
A. Nishimura: None. M. Furuta: None. Y. Chigusa: None. M. Maeno: None. M. Fukami: None. S. Harashima: Advisory Panel; Self; Novo Nordisk Inc.. Speaker's Bureau; Self; Novo Nordisk Inc.. Research Support; Self; AstraZeneca. Speaker's Bureau; Self; Sanofi K.K.. Research Support; Self; Sanofi K.K.. Speaker's Bureau; Self; Tanabe Mitsubishi KK. Advisory Panel; Self; Tanabe Mitsubishi KK. Speaker's Bureau; Self; Novartis Pharma K.K., Eli Lilly and Company, Ono Pharmaceutical Co., Ltd..
Evaluation of 24-Hour Blood Pressure and Arrhythmias through Simultaneous Ambulatory Blood Pressure Monitoring and Holter Monitoring in Type 2 Diabetes Mellitus Patients with Hypertension
Authors: REDKAR VIVEK , REDKAR SAGAR , REDKAR SUPRIYA , INAMDAR ANIKET , INAMDAR MANOHAR , RANE SHRADDHA , KHANOLKAR DARSHAN , JAGTAP MOHAN , YERALKAR DISHA , WADHWA NAVNEET 
Published: June 2018

We studied 1200 (Males=868, Females =332) hypertensive, T2DM hospitalised for 24 hours to analyse the association of hypertension and arrhythmias simultaneously for three years (January 2015-December 2017), as part of the PREDICT protocol, a mixed methods approach, developed as a standard care of management at three tertiary care hospitals. We used Trillium 3000 Holter recorder (Forest Medical) and DynaPulse 5000A Ambulatory Blood Pressure monitoring (ABPM) and the Trillium Gold software, respectively for the recording and the data analysis. ANOVA, Graphpad was used for statistical analysis. The mean age was 51.2 ± 7.9 years (range 41-82 years). The tertile in the triad of age &gt; 60 years, duration of diabetes &gt; 20 years and HbA1c &gt; 11% had the highest incidence of arrhythmias (p&lt;0.0001). The socioeconomic status was high in 401 patients (43%), middle income in 436 (36.3%) and low income in 363 cases (30%). The commonest risk factors were sedentary lifestyle (64%), obesity (56%), dyslipidemia (37%), smoking (23%), sleep apnea (21%). The mean 24-hour BP was 143 ± 12 mmHg for the SBP and 92.6 ± 12.2 mmHg for DBP. The awake and asleep BP mean were respectively 147 ± 11 mmHg and 137 ± 13.7 mmHg for SBP, 89.5 ± 10.2 and 83.1 ± 8.9 mmHg for DBP. Arterial pressure variability and bradyarrhythmia were significantly associated with sleep apnea (p&lt;0.0001). Patients with ST-T wave depression &gt; 1 mm (26%) and tachycardia (31%) as a sub-group were significantly associated with both the reverse dippers and non-dippers. (p&lt;0.0001). Chronotherapy in concurrence with the circadian rhythm to reduce the side effects, optimise the dosage, reduce the pill burden would be a suitable option to achieve a better BP control in T2DM. Nocturnal anti-hypertensive dosing to target the nocturnal hypertension would be an appropriate management approach.

Disclosure
V. Redkar: None. S. Redkar: None. S. Redkar: None. A. Inamdar: None. M. Inamdar: None. S. Rane: None. D. Khanolkar: None. M. Jagtap: None. D. Yeralkar: None. N. Wadhwa: None.
Timing of CGM Initiation in Pediatric Diabetes—The CGM TIME Trial
Authors: LAWSON MARGARET L. , COURTNEY JENNILEA , BRADLEY BRENDA J. , MCASSEY KAREN , CLARSON CHERIL , KIRSCH SUSAN E. , CURTIS JACQUELINE , MAHMUD FARID H. , RICHARDSON CHRISTINE , COOPER TAMMY , TANG KEN ,   THE CGM TIME TRIAL STUDY GROUP, JDRF CANADIAN CLINICAL TRIAL NETWORK CCTN1101
Published: June 2018

Background: The impact of timing of CGM initiation in pump naïve pediatric patients on CGM adherence and hemoglobin A1C remains unclear.
Methods: A 5-site RCT of pump naïve subjects (aged 5-18 years) with type 1 diabetes (T1D) &gt; 1 year was conducted to compare simultaneous pump and CGM (“SIM” group) vs. standard pump therapy with CGM initiation delayed for 6 months (“DEL” group). A step-wise approach to CGM settings was used. Primary outcome was CGM adherence (hours per 28 days (MiniMed™ Veo™ system and CareLink Professional use)) assessed over six months after CGM initiation. The main secondary outcome, A1Cs, was measured centrally at baseline and every 6 months. Linear mixed-models and ordinary least squares models were fitted to further estimate the effect of intervention, and covariates of baseline age, T1D duration, and A1C, as well as gender and clinical site.
Results: We randomized 144 of 152 (95%) eligible subjects into the SIM or DEL intervention. Five (3 SIM, 2 DEL) withdrew before visit 1 and 1 (DEL) a week after pump start, with 70 SIM, 68 DEL eligible for analysis. Baseline mean age was 11.5±3.3(SD) years, T1D duration 3.4±3.1 years, and A1C 7.9±0.9% (range 5.5-11.2%). During the 6th month, median CGM adherence was 485.6 hours (95% CI: 229.5, 585.7) in SIM vs. 408.2 (95% CI: 134.9, 572.8) in DEL, with this difference in adherence translating into an additional 2.8 hours of CGM per day. Median 6-month A1C was 7.9 [IQR: 7.5, 8.4] for SIM vs. 7.8 [IQR: 7.4, 8.4] for DEL. Fitted models suggest those randomized to SIM had better CGM adherence (main effect = 74.4 [95% CI: 26.8, 121.9], p=0.002), with higher adherence among females (p=0.03). Overall, there was no difference in A1C 6 months after CGM initiation (-0.20 [95% CI: -0.45, 0.06], p=0.13).
Conclusion: CGM adherence was higher when initiated at the same time as pump therapy however there was no significant effect on A1C. More research is required to understand why CGM did not have an effect on A1C and examine how CGM may affect other measures of glycemic control.

Disclosure
M.L. Lawson: None. J. Courtney: None. B.J. Bradley: None. K. McAssey: None. C. Clarson: None. S.E. Kirsch: None. J. Curtis: None. F.H. Mahmud: None. C. Richardson: Advisory Panel; Self; Dexcom, Inc.. T. Cooper: None. K. Tang: None.
Diabetes Risk in Women Employees (DRIWE)—An Institution-Based Screening Model Detects High Prevalence of Women Employees at Risk of Type 2 Diabetes
Authors: SANKAR PRASANTH , SASIKUMAR PRIYANKA , MEDAYIL RITUNA , JACOB RITTIN , SASIDHARAN SARANYA 
Published: June 2018

Background: Office employed women are exposed to unhealthy lifestyle. Indian Diabetes Risk Score (MDRF-IDRS) is a well validated method for detection of undiagnosed diabetes in the community.
Aim: To assess prevalence of diabetes risk among women employees, using MDRF-IDRS.
Methodology: A cross sectional study was done among 326 women employees in a semi urban hospital in South India to screen for risk factors for diabetes including age, waist circumference (WC), family history of diabetes (FH) physical activity (PA), gestational diabetes (GDM) and menopausal status. Those with high risk score (IDRS≥60) underwent testing for venous fasting plasma glucose (FPG). Statistical analysis was done using Chi-square test and Logistic regression.
Results: IDRS score ≥ 60 was present in 48.7%. Mean age of participants was 33.1±8.15. Preexisting diabetes and GDM was present in 3.4% and 4% respectively, while 7.1% were post-menopausal. Majority (64.1%) were younger than 35 years. WC &lt;80cm, 80-89cm and &gt;90cm was noted in 13.5%, 36.5% and 50%. Vast majority (87.4%) had sedentary lifestyle. Positive FH was present in 45.4%. There was significant association of score ≥ 60 with GDM and post-menopausal status (p&lt;0.001). Association of increasing age with PA (p&lt;0.001), suggesting that physical inactivity in younger women. Among those with score ≥ 60, FPG was ≥ 100mg/dl in 26.42%. Significant association of FPG ≥ 100mg/dl was noted with total IDRS score (p&lt;0.001), positive FH (p=0.004), increasing age (p=0.018), history of GDM (p=0.034), and post-menopausal status (p=0.031), but not with PA or WC.
Discussion: Institution based screening is a novel strategy employed in DRIWE study. Results show high prevalence of diabetes risk among employed women. Physical inactivity in a vast majority is also noted. Screening women employees with help of a simple cost effective IDRS tool can help encourage those identified at-risk to adopt lifestyle changes to prevent diabetes.

Disclosure
P. Sankar: None. P. Sasikumar: None. R. Medayil: None. R. Jacob: None. S. Sasidharan: None.