bluuebunny/crossref_metadata_2025 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 < 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 > 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 < 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 < 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 >= 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 < 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<0.017) reduced weight (>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% >9%A1c to 9.2% >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<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<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 >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.)
805-P: Barriers and Facilitators of Participation in Clinical Trials among Youth and Young Adults with Type 1 Diabetes and Their Caregivers
Authors: WESTEN SARAH C. , ANDERSON LINDSAY M. , BARRY SAMANTHA A. , LOOK SYDNEY , PINTO STEFANIA , ANASTASIA ALBANESE-O'NEILL , KEMP CYNTHIA A. , HALLER MICHAEL J. , PAPADAKIS JACLYN L. , SCHATZ DESMOND , OLSEN BRIAN T. , JANICKE DAVID M. , WEISSBERG-BENCHELL JILL , JOHNSON NICOLE
Published: June 2019

Objective: Despite long-standing participation of youth with T1D in research, clinical trials often fail to meet recruitment goals. The current study examined youth, young adult, and caregiver barriers and facilitators of participation in clinical research.

Methods: Participants were recruited online nationally and in-clinic from two diabetes clinics in the U.S. Self-report surveys of research participation, barriers, and interests were obtained; HbA1c was collected via chart review.

Results: Young adults (N=83; Mage=22.2±2.1; MA1c=7.6±1.5) and caregivers (N=81; Mage=45.3±7.8) via online surveys; and, adolescents (N=16; Mage=14.8±1.7; MA1c=9.1±2.2), young adults (N=10; Mage=20.9±2.2; MA1c=8.7±2.4), and caregivers (N=26; Mage=43.4±9.2) via routine diabetes clinic visits participated. Barriers to enrollment in included: missing school or work, potential unwanted side effects, location, time, and limited information. Over half of online participants (54%) reported lack of discussion with their physician about clinical trials, while 46.9% of in-clinic participants indicated their provider never or almost never discussed clinical research. Highest-rated research interests included: finding a cure, new technology, and closed-loop research. Among caregivers (online cohort), preference for the youth’s provider to discuss clinical trials during clinic visits was correlated with HbA1c% (r=0.302, p<.01); caregivers of youth with higher HbA1c indicated stronger desire to learn about research. This relationship was not significant among young adults (r=-0.06, ns).

Conclusions: Youth, young adults, and caregivers expressed interest in learning more about research, yet identified logistical barriers to participation. Education and outreach are needed. Tailored multi-modal recruitment strategies (e.g., online for young adults; via events/provider for caregivers) may help overcome barriers to participation.

Disclosure

S.C. Westen: None. L.M. Anderson: None. S.A. Barry: None. S. Look: None. S. Pinto: None. A. Albanese-O'Neill: None. C.A. Kemp: None. M.J. Haller: Advisory Panel; Self; Pancreum, SAB Biotherapeutics. J.L. Papadakis: None. D. Schatz: None. B.T. Olsen: None. D.M. Janicke: None. J. Weissberg-Benchell: Consultant; Self; Roche Diabetes Care. N. Johnson: None.

Funding

JDRF
811-P: Validation of Self-Administered Online Neurocognitive Assessment in Adults with Diabetes and CKD
Authors: CHAYTOR NAOMI , BARBOSA-LEIKER CELESTINA , GERMINE LAURA , MCPHERSON STERLING M. , TUTTLE KATHERINE R.
Published: June 2019

Cognition is often impaired in individuals with diabetes, and chronic kidney disease (CKD), a common microvascular complication, may further worsen cognitive function. However, logistical challenges associated with traditional neuropsychological assessment limit detection of cognitive impairment in research and clinical care. The goal of this project was to evaluate psychometric properties of self-administered online neurocognitive assessment (www.testmybrain.org) compared to traditional testing. We used a counterbalanced, within-subjects design comparing online neurocognitive performance to traditional in-person performance in a sample of adults with diabetes with and without CKD (type 1 diabetes N=14, type 2 diabetes N=35, CKD N=18). Associations between each online and analogous in-person test were adequate to good (rs = 0.49-0.66). The magnitude of correlations between divergent cognitive tests did not differ for online versus in-person tests. The amount of variance in age, education, HbA1c, and estimated glomerular filtration rate (eGFR) accounted for by the online versus in-person tests was similar (age R2=0.54 versus 0.23; education R2=0.37 versus 0.30; HbA1c R2=0.20 versus 0.12; eGFR R2 = 0.16 versus 0.18). The magnitude of variance accounted for in everyday functioning by the online versus in-person tests was also similar (Functional Activities Questionnaire R2=0.08 versus 0.07; Neuro-QoL Cognitive Function R2=0.14 versus 0.16; Diabetes Self-Management Questionnaire R2=0.19 versus 0.19).

In conclusion, this battery of self-administered online neurocognitive tests had adequate to good construct validity, with comparable discriminant, construct, and ecological validity to that of traditional testing. The self-administered online assessments used here have sufficient validity to increase the feasibility of cognitive testing in adults with diabetes, with and without CKD; high-risk groups for cognitive impairment.

Disclosure

N. Chaytor: Consultant; Self; Eli Lilly and Company. C. Barbosa-Leiker: None. L. Germine: None. S.M. McPherson: Consultant; Self; Consistent Care Company, Orthopedic Specialty Institute. Research Support; Self; Bristol-Myers Squibb Company, Managed Health Connections, LLC, Ringful Health, LLC. K.R. Tuttle: Consultant; Self; AstraZeneca, Boehringer Ingelheim International GmbH, Gilead Sciences, Inc., Goldfinch Bio. Research Support; Self; Eli Lilly and Company.

Funding

National Center For Advancing Translational Sciences (UL1TR002319)
834-P: Weight Change and Dementia Risk in Patients with New-Onset Type 2 Diabetes: A Nationwide Cohort Study
Authors: KWON HYUK-SANG , YOO SOON JIB , LEE MIN-KYUNG , NAM GA EUN
Published: June 2019

Objective: This study examined the association between baseline body mass index (BMI), percent weight change, and the risk of dementia in patients newly diagnosed with type 2 diabetes.

Research Design and Methods: Using the South Korean National Health Insurance Service-National Health Screening Cohort database, we identified 167,876 subjects aged ≥40 years diagnosed with new-onset type 2 diabetes between 2007 and 2012. Their weight changes were monitored for about 2 years after diagnosis, with follow-ups occurring for an average for 3.5 years. The hazard ratios (HRs) and 95% confidence intervals (CIs) of all-cause dementia, Alzheimer’s disease (AD), and vascular dementia (VD) were estimated using multivariable Cox proportional hazards regression models.

Results: We identified 2563 incident dementia cases during follow-up. Baseline BMI among patients with new-onset type 2 diabetes was inversely associated with the risk of all-cause dementia and AD, independent of confounding variables (P for trend <0.001). Percent weight change during the two years after a diagnosis of type 2 diabetes, showed significant U-shape associations with the risk of all-cause dementia (P <0.001) and AD (P = 0.018) development; the HRs of both diseases increased significantly when weight loss or gain was greater than 10%. Additionally, weight gain greater than 10% was associated with increased risk of VD.

Conclusions: A lower baseline BMI was associated with increased risks of all-cause dementia and AD in patients with new-onset type 2 diabetes. Weight loss or weight gain after diagnosis of diabetes was associated with increased risk of all-cause dementia and AD. Weight gain was associated with increased risk of VD.

Disclosure

H. Kwon: None. S. Yoo: None. M. Lee: None. G. Nam: None.
84-LB: Real-World Psychosocial Outcomes and Ease of Use Predict Trust in Automated Insulin Delivery (AID) Systems
Authors: MANNING MICHELLE L. , MCELWEE-MALLOY MOLLY , STONER KEATON C. , HABIF STEPHANIE
Published: June 2019

Background: Understanding qualities that make up trust in AID systems is imperative for successful development of systems built for long-term use. Previous research has demonstrated that trust is associated with: (a) better glycemic outcomes, (b) decreased self-management burdens, and (c) continued use of therapy.

Method: In December 2018, 5,037 individuals with diabetes responded to an online survey administered by dQ&A. We analyzed a subgroup of 386 survey participants who reported on their use of an AID system (The t:slim X2™ insulin pump with Basal-IQ® technology from Tandem Diabetes Care® = 116 ; The MiniMed 670G insulin pump system from Medtronic = 270).

Results: Hierarchical multiple regression analysis was used to ascertain the significance of ease of use (device level) and psychosocial (individual level) predictors of trust in AID systems. There were no issues with multicollinearity (all VIFs < 3). In Model 1, ease of use accounted for 45% of variance in trust, F (3,382) = 106.74, p < .001. After psychosocial predictors were added in Model 2, variance accounted for was 64%, explaining an additional 19% of unique variance in trust, F (3,379) = 65.46, p < .001.

Conclusion: These findings suggest that both ease of use and psychosocial outcomes are distinctly informative and instrumental in the development of trust in AID systems.

Disclosure

M.L. Manning: Employee; Self; Tandem Diabetes Care. M. McElwee-Malloy: Employee; Self; Tandem Diabetes Care. K.C. Stoner: Other Relationship; Self; Multiple companies and organizations in the diabetes field (greater than 10). S. Habif: Employee; Self; Tandem Diabetes Care.
84-OR: Index60 and 2-Hour Glucose Diagnostic Thresholds: Comparison of Type 1 Diabetes (T1D) Marker Profiles
Authors: REDONDO MARIA JOSE , NATHAN BRANDON M. , BOCCHINO LAURA E. , GEYER SUSAN , JACOBSEN LAURA M. , SIMS EMILY K. , PUGLIESE ALBERTO , SKYLER JAY S. , PALMER JERRY P. , SOSENKO JAY
Published: June 2019

Since T1D is increasingly recognized as a heterogeneous disorder, we sought to determine whether different diagnostic criteria could identify individuals with a distinct profile of markers typical for T1D.

We studied autoantibody positive (Ab+) TrialNet Pathway to Prevention participants. Markers that typically cluster in individuals diagnosed with T1D were compared between groups defined by oral glucose tolerance test (OGTT) 2-hour glucose ≥200 mg/dl (2hrglu≥200), which is an ADA standard diagnostic criterion, and Index60≥2.00 (Ind60≥2.00; based on fasting C-peptide [C-pep] and OGTT 60-minute C-pep and 60-minute glucose), which has previously shown potential utility as a diagnostic criterion for T1D. Three groups were compared: (A) 2hrglu≥200 Only (Ind60 <2.00), (B) Ind60≥2.00 Only (2hrglu <200), and (C) Both Ind60≥200 and 2hrglu≥2.00.

Participants in the Ind60≥2.00-Only or Ind60≥2.00 and 2hrglu≥200 groups were younger, had lower 30-0 minute C-pep and AUC C-pep, and had higher percentages of mIAA and multiple Ab+ compared with those in the 2-hrglu≥200 Only group (Table).

In sum, individuals with Ind60≥2.00 had more characteristic T1D features than those with 2-hrglu≥200 but Ind60 <2.00, who were atypical. It thus appears that the use of T1D-specific diagnostic measures, such as Ind60≥2.00, may help identify more homogeneous groups of individuals with T1D.

Disclosure

M.J. Redondo: None. B.M. Nathan: None. L.E. Bocchino: None. S. Geyer: None. L.M. Jacobsen: None. E.K. Sims: None. A. Pugliese: None. J.S. Skyler: Advisory Panel; Self; ADOCIA, Applied Therapeutics, Dance Biopharm Holdings Inc., Orgenesis Ltd., Tolerion, Inc., Viacyte, Inc. Board Member; Self; Dexcom, Inc., Intarcia Therapeutics, Inc., Moerae Matrix, Inc. Consultant; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Dalcor, Dialogics, Elcelyx Therapeutics, Inc., Esperion, GeNeuro Innovation, Ideal Life, Immunomolecular Therapeutics, Intrexon, Kamada, Nestlé, Sanofi, Valeritas, Inc., Zafgen, Inc. Stock/Shareholder; Self; Dexcom, Inc., Ideal Life, Intarcia Therapeutics, Inc., Intrexon, Moerae Matrix, Inc. J.P. Palmer: None. J. Sosenko: None.

Funding

National Institutes of Health
844-P: Tobacco Use Patterns and Clinical Outcomes in the T1D Exchange
Authors: RASH CARLA , WAGNER JULIE , ALESSI SHEILA M. , FOSTER NICOLE C. , TAMBORLANE WILLIAM V. , VAN NAME MICHELLE A.
Published: June 2019

Tobacco use confers unique risks to persons with type 1 diabetes (T1D). This study examined associations between tobacco use and diabetes outcomes using the Type 1 Diabetes Exchange Registry. Participants (N=933) were adults who completed an emailed set of standardized self-report instruments that included items on tobacco use. Participants were on average (SD) 38 (16) years of age, 61% female, and 90% non-Hispanic white. The majority had never used tobacco products (55%, n = 515); 18% (n = 166) were current users and 27% (n = 252) were former users. After controlling for relevant covariates, diabetes self-care scores and frequency of self-monitoring of blood glucose were lower among current users vs. never and former users, adjusted ps ≤ .01. Chart-extracted A1c values and participant-reported diabetes distress scores were higher among current users vs. never or former users, adjusted ps ≤ .001. BMI was lower among current smokers relative to never and former users, adjusted p = .04, but the odds of a nephropathy diagnosis or history of severe hypoglycemia or hospitalization for diabetic ketoacidosis did not differ by tobacco status. Among current users and relative to non-daily use, daily use was associated with significantly worse outcomes on diabetes self-care and diabetes distress scores and A1c values. These cross-sectional comparisons suggest that current tobacco use, particularly daily use, is associated with worse status on several clinical indicators outside BMI. Former users do not evidence these negative impacts on diabetes outcomes. Future research should assess whether better functional status on clinical indicators of diabetes management are causally related to successful smoking cessation. In this sample, smoking rates among individuals with T1D were higher than the national average, suggesting a need for evidence-based tobacco cessation strategies directed toward this high risk group.

Disclosure

C. Rash: None. J. Wagner: None. S.M. Alessi: None. N.C. Foster: 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. M.A. Van Name: Research Support; Self; Novo Nordisk Inc.
857-P: Relationship between Housing Insecurity and Diabetes Care and Self-Care Behaviors
Authors: MOSLEY-JOHNSON ELISE , WALKER REBEKAH J. , PRIGMORE HEATHER L. , EGEDE LEONARD E.
Published: June 2019

Background: The aim of this analysis was to examine the influence that housing insecurity has on diabetes care.

Methods: Using nationally representative data from 2014 and 2015 Behavioral Risk Factor Surveillance System (BRFSS), we investigated 16,091 individuals, representing over 7 million adults with diabetes in the U.S. Housing insecurity defined as how often in the past 12 months respondents reported being worried or stressed about having enough money to pay your rent/mortgage; responses of sometimes/often/always were categorized as housing insecure. Unadjusted logistic models for the relationship of housing insecurity on diabetes self-care and quality of care were followed by tests for interaction between housing insecurity and either race/ethnicity or employment. Stratified models were adjusted for age, gender, race/ethnicity, education, marital status, employment status, household income, insurance, and comorbidity count.

Results: 38.1% of adults with diabetes reported housing insecurity. Significant interactions existed between housing insecurity and employment on the relationship with seeing a doctor or checking A1c. Significant interactions existed between housing insecurity and race/ethnicity on having an eye exam in the past 12 months or completing physical activity in the past month. Individuals who were employed who reported housing insecurity had a lower likelihood of seeing a doctor in the past 12 months (0.58, 95% CI 0.37, 0.92) and having their A1c checked (0.45, 95% CI 0.26, 0.79). Non-Hispanic blacks who reported housing insecurity had a lower likelihood of having an eye exam (0.67, 95% CI 0.54, 0.83) or being physically active (0.81, 95% CI 0.69, 0.96).

Conclusion: Housing insecurity had an influence on diabetes care and self-care behaviors. For those who were employed, seeing a doctor and checking A1c was still negatively associated with housing insecurity. Diabetes care interventions should include a focus on housing insecurity as it has an impact on diabetes care.

Disclosure

E. Mosley-Johnson: None. R.J. Walker: None. H.L. Prigmore: None. L.E. Egede: Consultant; Self; Novo Nordisk Inc. Research Support; Self; National Institute of Diabetes and Digestive and Kidney Diseases.

Funding

National Institutes of Health
858-P: Assessing Sleep Characteristics in Young Children with Type 1 Diabetes
Authors: SINISTERRA MANUELA , HAMBURGER SAMANTHA , TULLY CARRIE , HERRERA NICOLE , HAMBURGER EMILY , JASER SARAH S. , STREISAND RANDI
Published: June 2019

Children and teens with type 1 diabetes (T1D) and their parents report shorter sleep duration and greater sleep disturbances related to diabetes management. Yet, few studies have specifically examined sleep in young children with T1D nor used both objective and self-report measures. The purpose of this study was to explore sleep characteristics of very young children with T1D and the feasibility of actigraph use to measure sleep in this high-risk population.

Four nights of child actigraphy data were collected at baseline for a subsample of 11 families with young children with T1D (age 2-5) participating in a diabetes-related behavioral intervention (M child age=4.7 years; M A1c=7.8; 100% continuous glucose monitor use; 27.3% insulin pump use; M parent age=39 years; 81.8% Caucasian). Additionally, parents completed a questionnaire on child sleep duration and disturbances related to blood glucose (BG) checks.

Actigraphy data indicated that children slept for about 9.8 hours/night (SD=50.08 minutes) and experienced an average of 8 awakenings throughout the night. Parent report of child sleep duration was longer than measured by actigraphy, averaging 10.4 hours/night (SD=43.2 minutes). A majority of parents (81%) reported checking their child’s BG once per night. Only 27% of parents reported that their child’s sleep was disrupted by BG checks, though 91% reported their own sleep was disrupted.

Our findings support the feasibility and acceptability of actigraph use to measure sleep in this population, as the devices were worn by all children for the allotted period and returned valid data. Average child sleep duration was in the lower range of suggested sleep length for young children (recommended 9-13 hours). Though most parents reported conducting nocturnal BG checks, actigraphy measures suggest minimal disruption for the child. Young children may not experience as much sleep disturbance as older children with T1D, reinforcing that the burden typically falls upon caregivers as has been described in the literature.

Disclosure

M. Sinisterra: None. S. Hamburger: None. C. Tully: None. N. Herrera: None. E. Hamburger: None. S.S. Jaser: None. R. Streisand: None.

Funding

National Institutes of Health (1DP3DK103998-01)
868-P: A Needs-Based Approach for Uncontrolled Hyperglycemia
Authors: MALKANI SAMIR , MACGREGOR KRISTIN L. , HAAS RICHARD A. , WONG DENISE H. , NOUNOU MOHAMED , REYNOLDS MORGAN
Published: June 2019

Study Plan: Chronic uncontrolled hyperglycemia (defined as HbA1c >9% persistently) is common, even at specialty diabetes clinics. We hypothesized this group might respond to a coordinated multidisciplinary approach to target medical, educational, and psychosocial factors impacting their diabetes control. We recruited 27 such individuals to participate in a single multidisciplinary clinic (MDC) where they were seen by an endocrinologist, psychologist and educator who formulated a joint treatment plan after a 360 assessment. The patients were also screened for depression, anxiety and diabetes distress. Two other comparator groups (n=27 each) with baseline A1c>9% were formed. One group had individuals with identified psychological problems who received regular follow-up by a psychologist, endocrinologist, and diabetes educator. The second group received standard care from an endocrinologist and educator. All groups were followed out for 1 year, with hemoglobin A1c readings every 3 months, though many patients got the A1c less frequently.

Results: All groups had an improvement in the A1c over a year of follow-up. Compared to baseline, those in the MDC group had a greatest average lowering of hemoglobin A1c (-1.62), followed by the group with regular behavioral therapy (-1.23), while the group receiving standard care had the smallest improvement (-1.16). Importantly, the presence of depression, anxiety and diabetes distress was relatively low in the group with resistant hyperglycemia, and the degree of glycemic improvement had no correlation to the presence or absence of psychological problems.

Conclusion: A single multidisciplinary clinic visit with treatment planning can lead to substantial improvements in A1c, for those with resistant hyperglycemia and no apparent psychological problems. On the other hand, those with uncontrolled hyperglycemia not deemed to be “resistant” did quite well with usual care. Patients with identified psychological problems benefited from regular counseling by a behavioral therapist.

Disclosure

S. Malkani: Other Relationship; Self; Theracos, Inc. K.L. MacGregor: None. R.A. Haas: None. D.H. Wong: None. M. Nounou: None. M. Reynolds: None.
876-P: Peer Support in Primary Care through the Shanghai Integration Model
Authors: TANG PATRICK Y. , LIU YUEXING , COUFAL MUCHIEH M. , QIAN YIQING , CAI CHUN , FISHER EDWIN B. , JIA WEIPING
Published: June 2019

Peer support (PS) is effective in promoting diabetes management, but needs pragmatic models for implementation. The Shanghai Integration Model links specialty/hospital care with primary care in Community Health Centers (CHCs), providing an organizational base for PS. This study reports formative evaluation, implementation and effectiveness of PS within the Shanghai model. The intervention emphasizes diet, physical activity, and insulin/medication use and addresses barriers to management and quality of life. Formative evaluation (3 focus groups, interviews with 15 CHC staff and patients, monthly consultation with CHC staff) led to emphases on group rather than individual PS with theme-based, interactive activities co-led with CHC staff. Peer leaders also follow-up with patients and organize neighborhood activities for physical activity, healthy diet, and comradery. In 9 CHCs, 74 volunteers trained as peer leaders reached 1284 adults (means: age = 68, years with diabetes = 11.8, HbA1c = 7.52%; % on insulin = 33.5%, oral medications = 76.2%). Counter to common difficulty reaching men, 43.1% are male. Two researchers familiar with each CHC rated implementation on 10 features (e.g., activities led by peer leaders) yielding low/medium/high PS implementation (3 CHCs each). Baseline to 12 months, levels of implementation differed on changes in HbA1c -- low: +0.07 points, medium: -0.17, high -0.18 (p < 0.001, controlling for initial HbA1c). For those with initial HbA1c > 8%, changes were more pronounced: -0.28, -1.01, and -0.86 points (p = 0.001, controlling initial HbA1c). Greater implementation was also associated with reductions in BMI (r = -.17) for those with baseline BMI over 26, and reductions in diabetes distress (r = -.20) and pain/negative emotion (r = -.14) among those elevated (top 33%) on these (ps ≤ 0.007). Peer support is feasible in CHCs. Extent of implementation is associated with improved glucose control, especially among those in poor control, as well as other clinical and quality-of-life indicators.

Disclosure

P.Y. Tang: None. Y. Liu: None. M.M. Coufal: None. Y. Qian: None. C. Cai: None. E.B. Fisher: Consultant; Self; Novo Nordisk Inc. Research Support; Self; Merck Foundation, Novo Nordisk Inc., Sanofi. W. Jia: None.

Funding

Merck & Co., Inc. Foundation; Sanofi China; National Institute of Diabetes and Digestive and Kidney Diseases (P30DK092926)