bluuebunny/crossref_metadata_2025_split huggingface dataset:
758-P: Medical Food (MF) with Butyrate Producing (BP)+Mucin Regulating (MR) Microbes Improves Glucose Control (GC) in T2D
Authors: KOLTERMAN ORVILLE G. , PERRAUDEAU FANNY , IYER MOHAN S. , EID JOHN S. , BULLARD JAMES , SCHICKLBERGER MARCUS F. , CHENG ANDREW , JUSTICE NICHOLAS , MCMURDIE PAUL , STONEBURNER BRENDON , GINES JESSICA , TYAGI SURABHI , CUTCLIFFE COLLEEN 
Published: June 2019

Studies show that BP+MR are decreased inT2D; the impact of administering specific strains has not been reported. A 12-week, double blind, placebo-controlled study of 2 MFs prepared GMP using only GRAS constituents (MF-1: BP; MF-2: BP + MR) in T2D (drug naive + metformin ± SFU, n=76), showed improved GC. See Table for demographics and key results. The primary endpoint was change from baseline (∆) in total glucose AUC0-180 min during a Boost Plus™ (720 cal) MTT. At 12 weeks, MF-2 yielded significant ∆s in both total (T) and incremental (I) glucose AUC0-180 min, (p=0.05 and 0.007 respectively). MF-1 improved only I glucose AUC0-180 min (p=0.05). Neither MF-1 or MF-2 impacted fasting glucose, T or I insulin AUC0-180 min, weight, BMI, HOMA-IR, lipids, or c-reactive protein. No safety or tolerability concerns were observed. Pre and post fecal microbial analyses are pending. Post hoc analyses revealed 2 interesting results. 1) SFU subjects across both study groups showed minimal response while subjects not using SFUs had greater ∆s in both T glucose AUC0-180 min (-24.4%) and placebo-corrected ∆ A1c (-0.7%). 2) MF-2 showed significant reductions in ALT consistent with improved liver health.
In conclusion, 1) Interventions directed at increasing BP+MR may be of benefit in T2D. 2) MF-2 appears to be a safe and effective non-pharmacologic intervention for T2D which merits further investigation.

Disclosure
O.G. Kolterman: Advisory Panel; Spouse/Partner; Intarcia Therapeutics, Inc. Advisory Panel; Self; Zafgen, Inc. Board Member; Self; American Diabetes Association, GlySens Incorporated, Viacyte, Inc. Consultant; Self; ADOCIA, Cirius Therapeutics Inc, DiaVacs Inc, JDRF, Nanoprecisionmedical, NuSirt Biopharma, Inc., Renova Therapeutics, Sensulin, LLC. Employee; Self; Whole Biome Inc. Stock/Shareholder; Self; Corcept Therapeutics, GI Therapeutics, Xeris Pharmaceuticals, Inc. Other Relationship; Spouse/Partner; American Diabetes Association. F. Perraudeau: Employee; Self; Whole Biome. M.S. Iyer: Employee; Self; Whole Biome Inc. J.S. Eid: Board Member; Self; Whole Biome Inc. J. Bullard: Employee; Self; Whole Biome Inc. Stock/Shareholder; Self; Whole Biome Inc. M.F. Schicklberger: Employee; Self; Whole Biome Inc. A. Cheng: None. N. Justice: Employee; Self; Whole Biome. P. McMurdie: Employee; Self; Whole Biome, Inc. B. Stoneburner: None. J. Gines: Employee; Self; Whole Biome Inc. S. Tyagi: None. C. Cutcliffe: Employee; Self; Whole Biome Inc.
76-OR: In-Depth Review of Glycemic Control and Glycemic Variability in People with Type 1 Diabetes Using Open Source Artificial Pancreas Systems
Authors: MELMER ANDREAS , ZÜGER THOMAS , LEWIS DANA M. , LEIBRAND SCOTT M. , LAIMER MARKUS 
Published: June 2019

Background: Thousands with type 1 diabetes are estimated to be using open source Artificial Pancreas Systems (APS) with commercially available insulin pumps, continuous glucose monitors (CGM), and an open source control algorithm to process glucose readings and adjust insulin delivery. OpenAPS and similar do-it-yourself (DIY) closed loop systems gained considerable interest in the online diabetes community. Many using DIY closed loop systems have chosen to donate their data to a shared, anonymized data repository called the “OpenAPS Data Commons.” The present study evaluated glycemic control and glycemic variability of CGM readings of 80 DIY closed loop users.
Methods: We analyzed 19251 days (53 years) of CGM readings with a mean duration of 134 days per patient (min. 3 days, max. 917 days) after the patient started looping.
Results: Mean glucose was 137 ± 20mg/dl and estimated glycated hemogloblin A1c (eA1c) was 6.40 ± 0.70%. Time in target range (70-180mg/dL) was 77.5 ± 10.5%, 4.3% of CGM readings were below 70mg/dL, 1.3% were below 54mg/dL, 18.2% were above 180mg/dL, and 4.1% of CGM readings were above 250mg/dL, respectively. A total of 6474 hypoglycemic events (CGM reading &lt; 54mg/dL) was observed (daytime: 5004 [73.9%]; nighttime: 1765 [26.1%]), which corresponds to 0.34 hypoglycemic events per day. The mean duration of each hypoglycemia event was 65.4 ± 41.4 minutes, and 1484 events were prolonged (duration &gt; 120 minutes; daytime: 1043 [76.30%]; nighttime: 324 [23.7%]). Coefficient of variation (CV) was 35.5 ± 5.9% (daytime: 35.4%; nighttime: 33.9%) and mean of daily differences (MODD) was 50.1 ± 13.5 mg/dL.
Conclusion: Open source AP systems show potential to support stable glycemic control in people with T1D. This is the largest descriptive analysis of open source APS data to date. The results are promising, but open source APS should be investigated in additional detail before a conclusion about their safety and efficacy can be drawn.

Disclosure
A. Melmer: None. T. Züger: None. D.M. Lewis: Consultant; Self; Diabeloop SA, Roche Diabetes Care. S.M. Leibrand: Consultant; Self; Diabeloop SA, Roche Diabetes Care. M. Laimer: None.
773-P: The Study of Metabolic Improvement by Nutritional Intervention Controlling Endogenous GIP (Mini Egg Study): A Randomized, Double-Blinded, Crossover Study
Authors: SAKANE NAOKI , TAKASE HIDETO , SUZUKI JUNKO , SUZUKAMO CHIKA , NIRENGI SHINSUKE , SUGANUMA AKIKO , OSAKI NORIKO 
Published: June 2019

Objective: Given the major role of glucose-dependent insulinotropic polypeptide (GIP) in the regulation of adiposity, this study examined the effects induced by a diet based on the Japanese tradition (SMART WASHOKU) on the visceral fat area (VFA) and GIP secretions.
Research Design and Methods: Overweight/obese men (n=21; mean age: 41 ± 9 y; mean BMI: 25.2 ± 2.0 kg/m2) without diabetes were placed on either a SMART WASHOKU (protein/fat=1.0, fiber/carb ratio≥0.063, and omega-3 PUFA/fat ratio ≥0.054) or isocaloric control meal for two weeks, in a randomized, double-blind, cross-over setup with a four-week washout period. For the meal tolerance test, blood samples were collected at 0, 30, 60, 120, 180, and 240 minutes post-meal, followed by measuring blood glucose, insulin, GIP, and glucagon-like peptide-1 (GLP-1) levels.
Results: Relative to a control meal, SMART WASHOKU meal yielded significantly lower plasma postprandial GIP concentrations (AUC: 700.0 ± 208.0 vs. 1117.0 ± 351.4, P &lt; 0.05); however, between meals, there was no significant difference in the levels of GLP-1, PYY, and ghrelin. Relative to control meal, a SMART WASHOKU intervention produced a modest but significant reduction of VFA in our participants (-3.4 ± 12.3 vs. -13.0 ± 9.3 cm2, P &lt; 0.05). Compared with the control meal, SMART WASHOKU meal did not modify the concentrations of AST, ALT, GGT, and hs-CRP; however, we did observe a significantly reduced in the levels of LDL-cholesterol, triglyceride, and HbA1c.
Conclusions: Based on our findings, we conclude that in overweight/obese men, a SMART WASHOKU meal would be helpful in decreasing VFA and improving metabolic parameters, possibly via suppressing GIP secretion.

Disclosure
N. Sakane: Board Member; Spouse/Partner; Kao Corporation. H. Takase: Employee; Self; Kao Corporation. J. Suzuki: Employee; Self; Kao Corporation. C. Suzukamo: Employee; Self; Kao Corporation. S. Nirengi: None. A. Suganuma: None. N. Osaki: Employee; Self; Kao Corporation.

Funding
Kao Corporation; Japan Society for the Promotion of Science (18K01988); Strategic Innovation Project of Japan (14533567); Bio-oriented Technology Research Advancement Institution, NARO
782-P: Personalized, Machine Learning-Based Nutrition Reduces Diabetes Markers in Type 2 Diabetic Patients
Authors: SHLOMO YATIR BEN , AZULAY SHAHAR , RAVEH-SADKA TALI , COHEN YOSSI , HANEMANN ARIEL 
Published: June 2019

HbA1c% is the most commonly used metric for assessing glycemic status, but only represents an averaged, indirect measure. Continuous Glucose Monitors (CGM) provides additional, elaborated assessment metrics. A recent study, [Zeevi et al., 2015, Cell ] showed that glycemic responses to foods vary across individuals and can be predicted using a machine learning framework. Moreover, it showed that personally tailored diets based on this framework improves Postprandial Glycemic Response (PPGR) in one-week interventions. Here, we tested the ability of such framework to improve longer term measures of glycemic control. A cohort of 28 diabetic individuals, not using short term insulin, were tracked. Each participant was tested for initial HbA1c, and connected to a CGM for a period of 14 days. Then, participant's anthropometrics, lifestyle, clinical parameters, and gut microbiome composition, were fed into a machine learning algorithm built into a personalized mobile application. Using the application, participants could define meals by combining foods, and obtain instant scores indicating the predicted PPGR for each meal. Participants were instructed to limit consumption to highly scoring meals. After 4-20 months of using the application, participants were re-connected to CGM, and HbA1c% levels were measured again.
Results: Significant improvements in multiple endpoints: Average HbA1c% dropped from 7.2% to 6.5% (p-value: 1.2e-8). Average %time-in-range [70,140] mg/dl increased from 69.1% to 79.6% (p-value: 0.005). Average %time-in-range [70,180] mg/dl increased from 89.6% to 94.2% (p-value: 0.002). Mean glucose levels decreased from 125.6 mg/dl to 114.6 mg/dl (p-value: 0.0002). These observations, coupled with the short-term benefits shown in recent work, imply that drugless, personalized, nutrition-based interventions, may be key to achieving significant improvements in glycemic control of type 2 diabetic patients.

Disclosure
Y. Ben Shlomo: Employee; Self; DayTwo. S. Azulay: Employee; Self; DayTwo. T. Raveh-Sadka: Employee; Self; DayTwo. Y. Cohen: Employee; Self; DayTwo. A. Hanemann: Employee; Self; DayTwo.
792-P: Effect of Oral Anserine Supplementation on Type 2 Diabetes and Diabetic Nephropathy in BTBR ob/ob Mice
Authors: EVERAERT INGE , HANSSENS MAXIME , BAELDE HANS J. , DERAVE WIM 
Published: June 2019

Carnosine, a naturally occurring dipeptide present in an omnivorous diet, has been shown to ameliorate the development of metabolic syndrome, type 2 diabetes and early- and advanced-stage diabetic nephropathy (Albrecht et al. 2017) in different rodent models. The physiological mechanisms of the protection by carnosine is presumably related to its anti-lipidemic, anti-hyperglycemic and anti-glycation actions. As anserine, its methylated analogue, is more bio-available in humans upon supplementation (Everaert et al. 2018) without affecting its functionality, it was now aimed to investigate the effect of oral supplementation with anserine on the development of severe diabetes and advanced diabetic nephropathy in BTBR ob/ob mice. Male and female BTBR ob/ob mice were either supplemented with 4mM carnosine or anserine in drinking water for 18 weeks and compared with non-supplemented BTBR ob/ob and wt/wt mice. Tissue carnosine and anserine levels were determined with HPLC and metabolic markers were determined in clinical lab of University Hospital UZ Ghent. Gastrocnemius carnosine and anserine levels were lower in male ob/ob vs. wt/wt mice, but were not affected by supplementation. Kidney carnosine and anserine levels were not different between ob/ob and wt/wt mice, but anserine levels were significantly higher in anserine-treated mice compared to non-treated ob/ob mice. The evolution of fasting blood glucose, fructosamine, triglycerides and cholesterol was not affected by the supplementation regimen. The area of the glomerular tuft and whole glomerulus was bigger in ob/ob vs. wt/wt mice, but not affected by supplementation. Based on the currently measured markers, it is suggested that chronic oral anserine supplementation is not able to attenuate the development of diabetes or diabetic nephropathy in the severe model of BTBR ob/ob mice. Further research will have to elucidate whether anserine can attenuate milder forms of metabolic syndrome or type 2 diabetes.

Disclosure
I. Everaert: None. M. Hanssens: None. H.J. Baelde: None. W. Derave: None.

Funding
Research Foundation - Flanders
793-P: Serum Vitamin C Level Is Associated with Low Mortality Dependent on Metabolic Syndrome and Periodontitis Status
Authors: TSOU PEILING , WU CHANG-JIUN 
Published: June 2019

Background: Both metabolic syndrome and severe periodontitis have been linked to higher all-cause mortality. Additionally, a bidirectional relationship exists between metabolic syndrome and periodontitis. Vitamin C is a potent antioxidant radical scavenger and serum vitamin C level may have modifying effects on mortality rate.
Methods: We analyzed subjects from the NHANES III cohort, aged &gt;= 40 years old who have received oral examination (n=10165). The NHANES III periodontal measurements included periodontal probing depth (PPD), gingival recession and bleeding on probing (BOP). Clinical attachment loss (CAL) was calculated as the sum of the recession and PPD. We used the linked mortality-follow-up data through December 31, 2015 for these NHANES III participants and identified 5320 deaths. Leading causes of death were stratified by metabolic syndrome and mean CAL status.
Results: Subjects with metabolic syndrome (MS) and periodontitis (PD) are associated with higher mortality rates in this cohort (Table 1, Chi-square P values &lt; 1e-10). High serum Vitamin C level is associated with low mortality rate in mid-risk population including subjects with MS but no PD and subjects with PD but no MS (Table 2). In contrast, the association is not observed in either high-risk (with both MS and PD) nor low-risk subjects (no MS no PD).

Disclosure
P. Tsou: None. C. Wu: None.
794-P: Effect of Intermittent Very-Low-Calorie Diet on Glycemic Control and Cardiovascular Risk Factors in Obese Patients with Type 2 Diabetes Mellitus
Authors: UMPHONSATHIEN MONGKONTIDA , RATTANASIAN PREEDAPORN , SUANSAWANG WANLAPA , LOKATTACHARIYA SIRIPORN , KHOVIDHUNKIT WEERAPAN 
Published: June 2019

Aim: Intermittent very-low-calorie diet (VLCD) provides more flexibility than continuous VLCD to optimize individual results. This study was designed to determine the effects of Intermittent VLCD (2 or 4 days/week) on glycemic control, metabolic parameters and quality of life (QoL) in patients with type 2 diabetes and obesity.
Method: 40 participants (mean age 49.6 ± 7.9 years, BMI 30.1 ± 5.9 kg/m2, mean diabetes duration 4.7 ± 3.1 years, mean HbA1C 7.4 ± 1.2%) were enrolled. Participants were randomly assigned 1:1:1 into 3 groups [control (n=12), 2 days/week VLCD (n=14), or 4 days/week VLCD (n=14)]. In the Intermittent VLCD groups, participants received 600 kcal/day in restricted days (2 and 4 non-consecutive days/week) and ad libitum food consumption on non-restricted days for 20 weeks. Metabolic parameters and QoL were evaluated at baseline, 2nd, 10th and 20th week.
Results: There was improvement in glycemic control in both intermittent VLCD groups throughout the study period. At the end of study, an intention-to-treat analysis showed that the mean reduction (± SEM) of FPG level was 7.9 (± 13.5), 25.1 (± 12.5) and 39.7 (± 12.5) mg/dl, and HbA1C level was 0.1(± 1.3), 0.7 (± 0.3) and 1.2 (± 0.3) % in the control group, the 2 days/week VLCD group and the 4 days/week VLCD group, respectively. There were no significant differences in the reduction in FPG or HbA1c between the 2 days/week and 4 days/week VLCD groups. The mean difference (± SEM) of FPG level between both groups was 11 mg/dl (95% CI, -17.5 - 39.5 mg/dl) and the mean difference (± SEM) of HbA1C level between both groups was 0.39% (95% CI, -3.3 - 1.1%). Intermittent VLCD was associated with marked improvement in insulin sensitivity and beta-cell function, as reflected in HOMA-IR, Matsuda, Disposition, and Insulinogenic indices. QoL was significantly increased in all groups.
Conclusion: Intermittent VLCD, 2 days/week or 4 days/week, was equally comparable and effective in achieving glycemic control.

Disclosure
M. Umphonsathien: None. P. Rattanasian: None. W. Suansawang: None. S. Lokattachariya: None. W. Khovidhunkit: None.

Funding
National Research Council of Thailand; Health Systems Research Institute
796-P: A Systematic Review of Diabetes-Related Outcomes in Food Provision Studies
Authors: MARTINEZ JOSEPH B. , DRAIME JUANITA A. , GARDNER JULIA , BERMAN SARAH E. , CHEN ALEDA M.H. 
Published: June 2019

In 2017, U.S. diabetes direct and productivity-related costs were $327 billion and accounted for 4 million deaths, yet much of this could be prevented by adhering to dietary guidelines. The objective was to perform a systematic review of the nutritional intervention literature where meals were provided to determine their clinical and cost impact in diabetes therapy. CINAHL, Cochrane, Health Source, and MEDLINE/PubMed were searched for food-provision articles published between January 1, 2013-May 1, 2018. Two researchers independently performed critical appraisal. Of 351 articles, appraisal was completed for 33 articles (N=14,258) that consisted of diets related to low caloric/carbohydrate intake or specific nutrients. Low calorie/carbohydrate diets consistently and significantly (p&lt;0.017) reduced weight (&gt;5% weight loss: 97.6%-100%; body-mass index loss: 2.3-5.4 kg/m2), waist circumference reduction (4.8-12cm), and improved markers of diabetes (A1c: 0.9-1.5% reduction) in short time frames (3 weeks-1 year). Patients reported higher dietary satisfaction (up to 93%) while achieving adequacy or 100% compliance. Large-scale education-based dietary interventions have challenges with patient adherence, yet resulted in 31.4% of patients moving from diabetes to prediabetes and 16.1% from prediabetes to none in 3 months. Other large-scale non-food provision studies (N=96,553) observed when patients improved A1c control (from 13.2% &gt;9%A1c to 9.2% &gt;9%A1c; p=0.01), hospitalization days were reduced by 2% annually (800,000 days) and $1.8 billion saved annually in the U.S. In this systematic review, A1c was significantly reduced by 0.9-1.5% (p&lt;0.05) within weeks to months. Providing guideline-based culinary medicine prescriptions for medically tailored, goal-based meals may reduce healthcare costs by improving patient adherence and clinical outcomes; resulting in significant cost savings to the U.S. healthcare system, in reduced hospitalizations and/or overall direct costs.

Disclosure
J.B. Martinez: Board Member; Self; Healthy Meals Supreme, LLC. J.A. Draime: Consultant; Self; Healthy Meals. J. Gardner: None. S.E. Berman: None. A.M.H. Chen: None.

Funding
Healthy Meals Supreme, LLC
80-LB: Effect of a Behavioral Economics Intervention on Adherence and Glycemic Outcomes in Youth with T1D
Authors: NALLY LAURA M. , WAGNER JULIE , VAN NAME MICHELLE A. , SHERR JENNIFER , ZAJAC KRISTYN , FINNEGAN JENNIFER L. , TAMBORLANE WILLIAM V. 
Published: June 2019

Despite the availability of the first automated hybrid closed-loop (HCL) system for type 1 diabetes (T1D), many youth do not use the automated feature. This 18-week prospective pilot study evaluates the impact of behavioral economic principles on 670G HCL system use in adolescents and young adults with T1D. Small monetary rewards were given for wearing/calibrating the CGM and using “auto mode.” For each of these tasks, participants received $1/day with a $3/week bonus for sustained use, with the bonus increasing by $5/week for every consecutive week the CGM is worn, up to $13/week. Participants were also rewarded for giving at least 3 meal boluses/day ($1/day), and uploading glycemic data ($5/week). However, if participants failed to perform diabetes tasks, rewards decreased to their original values. Data from 16 participants (16.2±2.5 years, 56% F) were collected at baseline, 6, 12, and 18 weeks. Of those not wearing a CGM at enrollment (88%), 86% had used a CGM previously and chose to discontinue its use. Participants used the CGM on most days, and gave at least 4 meal boluses/day consistently. HbA1c decreased by 0.5% from baseline to 6 weeks and was maintained at 12-18 weeks (p&lt;0.05). In this pilot study of youth starting the 670G HCL system, compensation for diabetes tasks was associated with bolus adherence and improved HbA1c. Though most youth had failed CGM use in the past, CGM wear occurred &gt;70% of time during reinforcement.

Disclosure
L.M. Nally: None. J. Wagner: None. M.A. Van Name: Research Support; Self; Novo Nordisk Inc. J. Sherr: Advisory Panel; Self; Bigfoot Biomedical, Eli Lilly and Company, Insulet Corporation. Consultant; Self; Lexicon Pharmaceuticals, Inc., Medtronic, Sanofi. Research Support; Self; Dexcom, Inc., Insulet Corporation. K. Zajac: None. J.L. Finnegan: None. W.V. Tamborlane: Consultant; Self; AstraZeneca, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Medtronic MiniMed, Inc., Novo Nordisk Inc., Sanofi, Takeda Pharmaceutical Company Limited.

Funding
National Institutes of Health (1DP3DK097705-01)
800-P: A Comparative Effectiveness Trial for Youth with Type 1 Diabetes to Reduce Alcohol Use in College
Authors: WISK LAUREN E. , NELSON ELIZA , MAGANE KARA M. , WEITZMAN ELISSA R. 
Published: June 2019

Youth with type 1 diabetes (T1D) use alcohol similar to their healthy peers; prevention is needed. We sought to develop and test competing versions of an intervention targeting alcohol avoidance for youth with T1D in a comparative effectiveness pilot trial. We recruited 138 college students (ages 17-25) with T1D via social media and delivered a brief electronic intervention, with participants randomly assigned to receive identical content narrated either by a peer or provider and evaluated effects on behavior at 2-weeks post-intervention. Of 138 enrolled, 122 completed follow-up; youth were 20.5 years, 80.3% female, 82.8% used a pump, 60.7% a CGM, mean last HbA1c of 7.7, with 85.2% lifetime alcohol use. Both arms saw gains in knowledge, attitudes, and concerns at follow-up (see Table) but those delivered the provider intervention rated their spokesperson as more knowledgeable and trustworthy. All youth reported decreases in binge drinking post intervention (21.3%) compared to prior (35.2%, OR 0.49, 95% CI 0.33-0.73). Changes in binge drinking were partially mediated by concerns about alcohol and T1D. This scalable intervention was successful at affecting knowledge, attitudes/concerns, and binge drinking and could be implemented broadly.

Disclosure
L.E. Wisk: None. E. Nelson: None. K.M. Magane: None. E.R. Weitzman: None.

Funding
Boston Children’s Hospital (FP01017994 to L.E.W., E.R.W.); Agency for Healthcare Research and Quality (K12HS022986); Conrad N. Hilton Foundation (20140273 to E.R.W.)