bluuebunny/crossref_metadata_2025_split huggingface dataset:
Effect of Resistant Starch on Postprandial Glucose Levels in Sedentary, Abdominally Obese Persons
Authors: MA TONGYU , LEE CHONG-DO 
Published: June 2018

Background: Although the resistant starch (RS) supplementation has shown promise in lowering postprandial glucose in healthy non-obese persons, little is known about the effect of RS on postprandial glucose levels in abdominally obese persons.
Objective: This study examined the effect of RS-supplemented muffins on postprandial glucose levels in sedentary, abdominally obese individuals as compared with digestible carbohydrates-matched oral glucose solution.
Method: A total of 8 sedentary, abdominally obese participants were randomly assigned to two sequences of treatments (AB, BA) using a 2 x 2 randomized cross-over design. The treatment effect tested with a muffin that contained 75 g of digestible carbohydrates and 30 g of RS (TRT), while the control tested using a 75-g oral glucose solution as a control condition (CON). Linear mixed models were used to test the treatment effect (TRT vs. CON) on glucose values and area under the curve (AUC).
Results: The 2-h postprandial glucose AUC was significantly lower in the TRT than in the CON (12.5±1.6 mmol/L·h vs. 15.6±3 mmol/L·h, P=0.002). The glucose levels were also significantly lower in the TRT than in the CON at 30 minutes (6.6±0.8 vs. 8.3±1.3 mmol/L, P=0.001), 60 minutes (6.6 ± 1.1 vs. 8.5 ± 2.1 mmol/L, P=0.004), and 90 minutes (6.3±1.1 vs. 8.1±1.8 mmol/L, P=0.003). The 2-h postprandial insulin AUC was also significantly lower in the TRT than in the CON (1354.5±6vs. 1788.9±522.8 pmol/L·h, P&lt;0.001). Based on the 2-h glucose incremental AUC values, the calculated glycemic index of the RS-supplemented muffins was 48 (glucose=100).
Conclusion: The RS muffins supplemented with 30 g of RS could reduce postprandial glucose and insulin responses in abdominally obese adults.

Disclosure
T. Ma: None. C. Lee: None.
Clinical Relevance of the Behavioral Stages of Change with the Efficacy of Multifaceted Interventions on the Drop-Out from Regular Medical Care in Patients with Diabetes—The Japan Diabetes Outcome Intervention Trial-2 (J-DOIT2)
Authors: BOUCHI RYOTARO , NODA MITSUHIKO , HAYASHINO YASUAKI , YAMAZAKI KATSUYA , SUZUKI HIKARI , GOTO ATSUSHI , FURUKAWA TOSHI A. , IZUMI KAZUO , KOBAYASHI MASASHI ,   J-DOIT2 STUDY GROUP
Published: June 2018

Background: To examine the impact of lifestyle intervention by telephone (TSC) and face-to-face (FFA) according to the stages of lifestyle change (SLC) on the drop-out from regular medical care of diabetes
Methods: Secondary analysis was performed on data from the Japan Diabetes Outcome Intervention Trial-2 large trial (J-DOIT2-LT), which was a 1-year, prospective, cluster randomized, intervention trial. 11 district medical associations were divided into two subregions (clusters), in which patients were registered, and then were randomized to an intervention group (TSC or FFA) or control group (CG). Lifestyle advisors reminded patients of medical visits to the primary care physician (PCP) and gave lifestyle advice by TSC or FFA. The CG received usual medical care. The outcome of this analysis was the drop-out rate from regular medical care. We estimated the HR and 95% CI of either TSC or FFA relative to CG according to the SLC (stage 1/2/3/4/5: pre-contemplation/contemplation/preparation/action/maintenance).
Results: A total of 2,071 participants (mean age: 57 ± 6 years; 38% female) were studied. 1170, 616, and 285 patients were divided into CG, TSC, and FFA. In the stage 1-3 of diet, TSC (HR:0.47; 95% CI:0.27-0.82) and FFA (HR:0.20; 95% CI:0.07-0.55) were significantly associated with a low risk of the drop-out after adjusting for covariates. The similar association was observed in the stage 1-3 of exercise. In contrast, neither TSC nor FFA reduced the risk for drop-out in the stage 4-5 of diet. TSC (HR:0.12; 95% CI:0.02-0.95) but not FFA (HR:0.37; 95% CI:0.09-1.62) was associated with a low risk for the drop-out in the stage 4-5 of exercise.
Conclusions: FFA could be more effective than TSC to reduce the risk for drop-out from regular medical care of diabetes at the stage 1-3. In contrast, TSC may be enough to reduce the risk for the drop-out in the stage 4-5.

Disclosure
R. Bouchi: None. M. Noda: None. Y. Hayashino: None. K. Yamazaki: None. H. Suzuki: None. A. Goto: None. T.A. Furukawa: None. K. Izumi: None. M. Kobayashi: None.
Patient-Reported Outcomes in T2D Patients Inadequately Controlled by Metformin Are More Favorable for Dapagliflozin plus Saxagliptin vs. Insulin Glargine
Authors: TESTA MARCIA A. , SIMONSON DONALD C. , EKHOLM ELLA , MAXWELL SU , JOHNSSON EVA K. 
Published: June 2018

Patients with T2D inadequately controlled by metformin require additional oral antidiabetes agent(s), injected GLP-1 or basal insulin. Although insulin has greater effect on A1C than a DPP-4 or SGLT2 inhibitor, its higher rates of hypoglycemia, weight gain and regimen burden might decrease satisfaction and quality of life. We analyzed patient-reported outcomes (PRO) from patients with T2D inadequately controlled by metformin ± sulfonylurea during an international, randomized, 24-week, open-label, non-inferiority trial (NCT02551874) of dapagliflozin plus saxagliptin add-on (DAPA + SAXA, n = 324) compared to titrated insulin glargine add-on (INS, n = 319). A1C and PRO questionnaires were obtained at baseline and weeks 12 and 24. Baseline data were: 54.0% male; 80.4% white; 60.7% working ≥3 days/week; age 55.5 ± 9.6 years; A1C 9.0 ± 1.0%; BMI 32.2 ± 5.3 kg/m2; diabetes duration 9.4 ± 6.3 years. Overall Satisfaction, Regimen Acceptance and its eight subscales, Net Benefit and Preference subscale, and Weight Concern all favored DAPA + SAXA at week 24 (Table). Quality of life scales favored DAPA + SAXA at week 12, but were not different at week 24. Compared to INS, DAPA + SAXA had greater treatment satisfaction and acceptance, better short-term quality of life, and less burden and concern about weight gain, hypoglycemia and pain despite comparable A1C.
Change from baseline in HbA1c and PRO at Wk 24 [LS Mean (SE)]: Higher value denotes better outcomeWk-24 EndpointDAPA + SAXA + MetforminINS + MetforminP-valueWk-24 EndpointDAPA + SAXA + MetforminINS + MetforminP-valueHbA1c (%)−1.67 (0.06)−1.54 (0.06)0.118-- Interference6.45 (0.98)2.75 (1.00)0.009Overall Satisfaction10.14 (0.63)6.19 (0.64)&lt;0.0001-- Social4.32 (0.83)0.62 (0.85)0.002- Regimen Acceptance7.00 (0.72)2.28 (0.73)&lt;0.0001-- Pain4.41 (0.94)−1.93 (0.96)&lt;0.0001-- Burden7.70 (0.85)2.48 (0.86)&lt;0.0001-- Side Effects6.(0.99)0.17 (1.00)&lt;0.0001-- Convenience8.01 (0.89)2.95 (0.91)&lt;0.0001- Net Benefit17.36 (0.67)15.34 (0.68)0.035-- Flexibility9.91 (1.01)4.69 (1.02)&lt;0.001-- Preference30.69 (1.24)26.26 (1.26)0.012-- Hassle5.92 (0.94)1.83 (0.95)0.002Weight Concern17.68 (2.46)10.38 (2.50)0.038

Disclosure
M.A. Testa: Stock/Shareholder; Spouse/Partner; GI Windows, Inc.. Stock/Shareholder; Self; Phase V Technologies, Inc. D.C. Simonson: Advisory Panel; Self; GI Windows, Inc.. Stock/Shareholder; Self; GI Windows, Inc.. Stock/Shareholder; Spouse/Partner; Phase V Technologies, Inc. E. Ekholm: None. M. Su: None. E.K. Johnsson: Employee; Self; AstraZeneca.
Acceptability of a Self-Regulation Theory-Based mHealth Behavior Intervention for Older Adults with Type 2 Diabetes and Obesity
Authors: ZHENG YAGUANG , WEINGER KATIE , GREGAS MATT C. , GREENBERG JORDAN , LI ZHUOXIN , BURKE LORA E. , QI CHENFANG , SLYNE CHRISTINE , GREAVES TORI , MUNSHI MEDHA 
Published: June 2018

Background: The successful use of mobile health (mHealth) in lifestyle changes for older adults with type 2 diabetes is unknown. We report here acceptability of a mHealth intervention for older adults.
Method: We used a one-group pre-posttest design. Participants received an 8-week theory-based mHealth intervention, using the Lose It! App for daily self-monitoring of food intake, a Fitbit, and Bluetooth-enabled glucometers and weighing scales. Linear mixed models were used for analysis.
Results: The sample (N=9) was white (88.9%), female (44.4%), with a mean age of 76.4±6.0 years (range: 69-89), 15.7±2.0 years of education, BMI of 33.3±3.1 kg/m2 and HbA1c 7.4%±0.8. The Montreal Cognitive Assessment score was 24.6±2.7, indicating no severe cognitive impairment. Over 56 days, the % days of using the Lose It!, Fitbit, glucometer, and scales were 92.7±7.9, 93.7±10.6, 76.4±23.5, 52.4±37.8, respectively. The data showed a significant % weight loss (b=-0.04, p&lt;.001), decreased calorie intake (b=-4.6, p=.0004) and increased steps (b1=34.0, b2=-1.0, p=.02) over time. The mean % weight loss from baseline was 4.44%±3.19. The dose of oral hypoglycemic agents or insulin was reduced among 4 participants.
Conclusion: Older adults are able to use mHealth to improve outcomes. The additional 3-month follow-up is ongoing to provide insight into long-term feasibility and acceptability.

Disclosure
Y. Zheng: None. K. Weinger: None. M.C. Gregas: None. J. Greenberg: None. Z. Li: None. L.E. Burke: None. C. Qi: None. C. Slyne: None. T. Greaves: None. M. Munshi: Consultant; Self; Sanofi.
The Effects of a Sleep Extension Intervention on Glucose Control in Youth with Type 1 Diabetes
Authors: PERFECT MICHELLE , FRYE SARA , BLUEZ GRAI P. 
Published: June 2018

Although the 2017 Standard of Diabetes Care introduced recommendations to assess sleep patterns in individuals with type 2 diabetes, they do not contain such recommendations for individuals with type 1 diabetes (T1DM). We conducted a randomized clinical trial (RCT) to examine whether increasing sleep duration over a one-week period in youth’s natural environment improved glucose control and neurobehavioral performance. The primary outcomes of glycemic control (percent time in target range and average glucose levels) were assessed via a continuous glucose monitor (CGM) before and after being randomized to a sleep extension condition or a fixed sleep duration condition. Participants between the ages of 10 and 16 were 111 youth with almost half female; 35% were Latino/a, 51% Caucasian, and 14% mixed raced. The majority (80%) increased their sleep by more than 15 minutes; one-third achieved an increase of one hour of additional of sleep. Using actigraphy (wrist-like device that measures movement to estimate sleep) and a sleep diary, the average increase in sleep duration is 43.0 minutes vs. .30 minutes. Comparatively, research has noted that medications are considered to have a benefit to improve sleep if the individual increases sleep by 15 or more minutes. Controlling for baseline, extension participants differed from the fixed sleep duration group by 17mg/dl points, F(1, 102) = 9.55, p = .003, η2 = .39. During the Sleep Modification week, those in the Sleep Extension condition showed a 7.4% improvement in glucose levels, accounting for 11 hours more in the target range than those in the Fixed Sleep condition. These data will contribute to the long-term goal of establishing research evidence that sleep contributes to diabetes clinical care.

Disclosure
M. Perfect: None. S. Frye: None. G.P. Bluez: None.
Adults with T1D Report Half-Unit Pen Prevents Hyperglycemia and Hypoglycemia with Less Worry and Anxiety
Authors: DE OLIVEIRA CAROLINA PIRAS , MITCHELL BETH , FAN LUDI , GAREY COLLEEN , LIAO BIRONG , BISPHAM JEOFFREY , VINT NAN , PEREZ-NIEVES MAGALY , MCAULIFFE-FOGARTY ALICIA H. 
Published: June 2018

People with type 1 diabetes (PWD) that strive for lower glucose targets are in need of more precise dosing and may require smaller insulin dose adjustments. Most currently available pens deliver insulin in one unit (U) increments, and few deliver half (0.5) U. There is a need to better understand who is using half unit pens (HUP) and their potential benefit for patients in the real world. This study aims to characterize PWD who have used (current/former=EVER users) HUP vs. those PWD that have never used HUP (NEVER users). This research also identified the main factors driving benefit from PWD perspective. An observational, cross-sectional survey was completed through T1D Exchange’s online patient community, myGlu.org. Chi square test, Fisher’s exact test, and t-tests were used for analyses. A total of 278 PWD (156 EVER, 122 NEVER users) over the age of 18 were recruited for the study (mean age: 42±13 years old, gender: 55% male, mean BMI (kg/m2): 26.0 ±3.8, and mean A1c (%): 6.3± 0.9), EVER users had diabetes a shorter duration (p&lt;.001). NEVER users were more likely to use an insulin pump (p&lt;.001). EVER users self-reported a significantly lower upper fasting glucose target compared to NEVER users (p&lt;.001), and a lower overall post-prandial glucose target (p&lt;.001). NEVER users were more likely to start to treat low blood sugar at lower readings (p&lt;.001), and they were more confident in avoiding severe hypoglycemia (p&lt;.001). Based on PWD experience, the greatest benefits of using HUP were prevention of hypo and hyperglycemia events and less worry and anxiety. HUP is an option for PWD that wish to maintain tighter management of their diabetes, avoiding hypo and hyperglycemic events while decreasing their level of worry and anxiety about their disease. It is important for PWD and health care providers to understand the benefits of this insulin delivery device to appreciate options for making diabetes management easier.

Disclosure
C. Piras de Oliveira: Employee; Self; Eli Lilly and Company. Stock/Shareholder; Self; Eli Lilly and Company. B. Mitchell: Stock/Shareholder; Spouse/Partner; Eli Lilly and Company. L. Fan: Employee; Self; Eli Lilly and Company. C. Garey: None. B. Liao: Employee; Self; Eli Lilly and Company. J. Bispham: None. N. Vint: Employee; Self; Eli Lilly and Company. M. Perez-Nieves: Employee; Self; Eli Lilly and Company. Stock/Shareholder; Self; Eli Lilly and Company. A.H. McAuliffe-Fogarty: Advisory Panel; Self; Novo Nordisk Inc..
Novel Small Molecule TXNIP Inhibitor Protects Against Diabetes
Authors: THIELEN LANCE , CHEN JUNQIN , XU GUANLAN , JING GU , GRAYSON TRUMAN , JO SEONGHO , SHALEV ANATH 
Published: June 2018

Loss of functional beta cell mass represents a major factor in the pathogenesis of diabetes. Currently, there are no therapies that halt this process; however, thioredoxin-interacting protein (TXNIP) has recently emerged as a promising therapeutic target. TXNIP was found to be the top glucose-induced gene in a human pancreatic islet microarray, is increased in diabetes, and TXNIP overexpression results in beta cell apoptosis. TXNIP reduction has shown favorable effects in vivo, where whole body TXNIP-deficient and beta cell-specific TXNIP knockout mice have decreased beta cell apoptosis, increased beta cell mass, elevated insulin levels, and are protected from diabetes. We have also shown that pharmacologic TXNIP inhibition, via the anti-hypertensive medication verapamil, was able to mimic the protective effects of genetic TXNIP deletion and reversed overt diabetes in mice. In addition, it has been established that TXNIP downregulation is beneficial in multiple tissues, making it unnecessary and even undesirable to have a beta cell-specific TXNIP inhibitor and suggesting that detrimental off target effects are unlikely. We have since undertaken a high-throughput screen of 300,000 small molecules that has yielded a novel compound, TI-37330, which is more effective than verapamil in inhibiting TXNIP expression. Moreover, TI-37330 protected primary human islets and INS-1 beta cells against glucose- and cytokine-induced TXNIP and beta cell apoptosis. TI-37330 has also shown in vivo potential as it was found to have good pharmacokinetic properties and was well tolerated in healthy mice. In the context of streptozotocin-induced diabetes, oral administration of TI-37330 promoted beta cell survival, prevented diabetes, and even significantly improved overt diabetes. Collectively, these data establish small molecule TXNIP inhibitors, especially TI-37330, as robust candidates for further development.

Disclosure
L. Thielen: None. J. Chen: None. G. Xu: None. G. Jing: None. T. Grayson: None. S. Jo: None. A. Shalev: None.
An Examination of the Presence of Mental Health Diagnoses in a Clinical Sample of Individuals with Type 1 Diabetes
Authors: STANEK KELLY R. , MAJIDI SHIDEH , YOUNGKIN ERIN M. , VOGELI JO M. , DRISCOLL KIMBERLY A. 
Published: June 2018

Objective: To examine demographic and mental health diagnostic characteristics for individuals with type 1 diabetes (T1D) and current mental health diagnoses.
Methods: The medical records of 397 individuals ages 10-25 with T1D (mean age = 15.3±3.1 years, mean T1D duration = 6.0±4.5 years) who were screened during routine T1D clinic visits for depressive symptoms using the Patient Health Questionnaire-9 (PHQ-9) were reviewed for current DSM-5 diagnoses, demographic information, and T1D management data.
Results: Of those screened, 29% had a mental health diagnosis; 56% had 1 diagnosis, 26% had 2, and 18% had 3+. The most common diagnoses were depression (16% of total screened), anxiety (15%), and attention-deficit/hyperactivity disorder (10%). Other diagnoses included mood, learning, and eating disorders. Those with a mental health diagnosis were slightly older and they had higher PHQ-9 scores and higher HbA1c (Table). Sex, race, insulin regimen, continuous glucose monitor use, T1D duration, and insurance were not significantly different.
Conclusions: Mental health diagnoses are common in adolescents and young adults with T1D. Those with mental health conditions may experience greater difficulties in T1D management, contributing to higher HbA1c. There is a need to develop tailored interventions to improve T1D management when specific mental health conditions are present.
Differences in Characteristics between T1D youth with and without a Mental Health Diagnosis.Mental Health Diagnosis (n=116)No Mental Health Diagnosis (n=281)p-valueAge (years)15.8±2.915.0±3.20.023PHQ-9 Score7.5±6.43.8±4.3&lt;0.001A1C9.88±2.59.17±2.10.004

Disclosure
K.R. Stanek: None. S. Majidi: None. E.M. Youngkin: None. J.M. Vogeli: None. K.A. Driscoll: None.
Diabetes Prevention within a Large Health Care System
Authors: AZAR KRISTEN M.J. , NASRALLAH CATHERINE , SZWERINSKI NINA , CHOPRA VIDITA , HALLEY MEGHAN , ROMANELLI ROBERT 
Published: June 2018

Background: The Group Lifestyle Balance™ (GLB) program is an adaption of the landmark Diabetes Prevention Program that has been recognized by the CDC as a model curriculum for diabetes prevention. The implementation of GLB at 8 predominantly autonomous and highly diverse clinics within a single, large multi-specialty healthcare organization provides a unique opportunity to evaluate the program in a real-world setting.
Methods: We conducted structured interviews with GLB facilitators at Sutter Health, a Healthcare Delivery System in Northern California, using snowball sampling. Interview questions were based on the RE-AIM framework to explore the reach, effectiveness, adoption, implementation and maintenance of the program between sites. We focused this analysis on a single regional affiliate of Sutter, with 8 clinic sites offering GLB to examine potential within-region variation.
Results: Ten GLB facilitators were interviewed, representing 8 clinical sites within the Sutter Health regional affiliate. All the facilitators were diabetes educators; 9 were registered dietitians and 1 was a registered nurse. Five sites began offering GLB in 2010, followed by two sites in 2013 and one in 2015. Eligibility criteria were the same across sites, and included all patients regardless of risk factors, except pregnant women. While all sites consistently offer 12 weekly “core” sessions over a 3-month period, the maintenance sessions are optional and are only offered at half of the sites. Almost all facilitators (n= 9) reported that they use a modified version of the curriculum developed by the University of Pittsburgh and all mentioned that they provide participants with additional information.
Conclusion: These preliminary data suggest that the GLB program has been implemented within a regional affiliate of a healthcare system, consistently, yet with some variation in the use of the post-core maintenance curriculum. Future work will examine the effectiveness of GLB based on the type of curriculum and duration of the program.

Disclosure
K.M.J. Azar: Research Support; Self; Janssen Scientific Affairs, LLC., Regeneron Pharmaceuticals, Inc..C. Nasrallah: None. N. Szwerinski: None. V. Chopra: None. M. Halley: None. R. Romanelli: Research Support; Self; Janssen Scientific Affairs, LLC., Regeneron Pharmaceuticals, Inc., Pfizer Inc..
Frequency of Flash Glucose Monitoring Scans and Hemoglobin A1c in Real Life
Authors: LAURENZI ANDREA , CARETTO AMELIA , BARRASSO MARILUCE , ANDREA MARIO BOLLA , MOLINARI CHIARA , ZANARDINI ANNA , DOZIO NICOLETTA C. , MENEGHINI ELENA , BOSI EMANUELE , SCAVINI MARINA 
Published: June 2018

Introduction: In patients with type 1 diabetes mellitus (T1D) the relationship between low number of self-monitoring of blood glucose (SMBG) measurements and elevated hemoglobin A1c (HbA1c) levels has been reported. However, the optimal frequency of SMBG has not been defined. Flash glucose monitoring (FGM) is an emerging technology allowing patient with diabetes to measure interstitial glucose concentrations in a non-invasive manner, with patients obtaining more measurements than with SMBG.
Materials and Methods: We collected data from 103 adult T1D patients using FGM technology in real life for at least 28 days. We recorded patients demographics, diabetes duration, type of treatment (CSII or MDI) and we downloaded FGM data to the Abbott Freestyle Libre software, which provides the number of daily FGM scans and estimates of HbA1c based on continuous glucose profile readings. The correlation between median FGM scan frequency over 28 days and the estimated HbA1c was analyzed using Spearman rho. We also computed HbA1c median levels for quintiles of scan frequency and compared them using Kruskal-Wallis test.
Results: A significant correlation was found between median scan Spearman rho was -0.48 (p&lt;0.0001). Moreover, median HbA1c level decreased significantly from the first (3-5) to the third (10-14) quintile of daily scan frequency [from 69 mmol/mol (IQR 62 to 78) to 54 mmol/mol (49 to 50), p#x003C0.0001] and remained unchanged thereafter, i.e., from the third to the fifth (24-50) quintile daily scan frequency [from 54 mmol/mol (49 to 50) to 53 mmol/mol (45 to 56), p=0.7638].
Conclusions: In T1D patients we confirmed that frequent measurements of interstitial glucose benefits glucose control in real life conditions. The maximum benefit in term of HbA1c decrease is obtained between 10 to 14 scans daily, a number of glucose measurements that would unlikely be sustainable with SMBG.

Disclosure
A. Laurenzi: Other Relationship; Self; Animas Corporation, LifeScan, Inc..A. Caretto: None.M. Barrasso: None. A. Bolla: Other Relationship; Self; Roche Diabetes Care Health and Digital Solutions. C. Molinari: Other Relationship; Self; Eli Lilly and Company, Sanofi. A. Zanardini: Other Relationship; Self; Roche Diagnostics Corporation.N.C. Dozio: None.E. Meneghini: None. E. Bosi: Consultant; Self; Abbott, AstraZeneca, Lexicon Pharmaceuticals, Inc., LifeScan, Inc.. Employee; Spouse/Partner; LifeScan, Inc.. Consultant; Self; Medtronic, Merck Sharp &Dohme Corp., Novartis AG, Roche Diabetes Care Health and Digital Solutions, Sanofi. M. Scavini: Consultant; Self; Sanofi, Roche Diabetes Care Health and Digital Solutions.