bluuebunny/crossref_metadata_2025 huggingface dataset:
78-OR: Automated Glycemic Control with a Bionic Pancreas Configured for Use in the Critical Care Setting
Authors: SHERWOOD JORDAN , HILLARD MALLORY A. , GRENNAN KERRY B. , EL-KHATIB FIRAS , DAMIANO EDWARD , RUSSELL STEVEN J.
Published: June 2019

Tight glycemic control of hospitalized patients is difficult and labor intensive to achieve. We evaluated the feasibility of fully automated glycemic control with a version of the bionic pancreas (BP) designed for use in the critical-care setting. The fully automated BP controlled the intravenous delivery of insulin and 20% dextrose based on glucose values from the Abbott FreeStyle Navigator CGM. The same algorithm, initialized only with body mass, was used in all subjects. Adult subjects with type 1 (n=6) or type 2 (n=6) diabetes with a total daily dose (TDD) of insulin under usual care of 0.5-2.9 u/kg/day were under automated glucose control for an 8-hour period. Subjects started the study period fasted, later consumed an unrestricted meal of their choice, and still later took liquid nutrition nearly continuously for 2 hours before abruptly stopping, in order to simulate continuous enteral feeding and its interruption. Food intake was not announced to the BP. The primary outcome, mean plasma glucose (measured every 15 minutes), was 116±20 mg/dL. The % time within 70-180 mg/dL was 95±8% and the median (IQR) % of time <70 mg/dL was 0 (0, 2.3) and <54 mg/dl was 0 (0, 0). We concluded that the BP can achieve excellent glycemic control in volunteers with a wide range of insulin needs and in the face of realistic glycemic challenges. These results support feasibility testing of the critical care BP in the critical-care setting.

Disclosure

J. Sherwood: None. M.A. Hillard: None. K.B. Grennan: None. F. El-Khatib: Employee; Self; Beta Bionics. Stock/Shareholder; Self; Beta Bionics. E. Damiano: Advisory Panel; Self; Novo Nordisk A/S. Board Member; Self; Beta Bionics. Employee; Self; Beta Bionics. Stock/Shareholder; Self; Beta Bionics. Stock/Shareholder; Spouse/Partner; Beta Bionics. Other Relationship; Self; Ascensia Diabetes Care, Senseonics. S.J. Russell: Advisory Panel; Self; Companion Medical, Unomedical a/s. Consultant; Self; Flexion Therapeutics. Research Support; Self; Beta Bionics, MITRE Corporation, Novo Nordisk A/S, Zealand Pharma A/S. Other Relationship; Self; ADOCIA, Ascensia Diabetes Care, Ascensia Diabetes Care, Lilly Diabetes, Roche Diabetes Care, Senseonics.

Funding

Wallace H. Coulter Foundation
780-P: Effect of Partial Meal Replacement on Glycemic Variability in Patients with Type 2 Diabetes: A Randomized Clinical Trial
Authors: ZHOU JIAN , LU JINGYI , MA XIAOJING , PENG JIAHUI , YING LINGWEN , LU WEI , ZHU WEI , BAO YUQIAN
Published: June 2019

Background: Glycemic variability (GV) has been demonstrated to contribute to the development of diabetic complications. The current study sought to investigate the effect of partial meal replacement (PMR) on GV in type 2 diabetes.

Methods: 123 individuals with newly diagnosed and untreated type 2 diabetes were randomized to receive either lifestyle intervention (LI) together with breakfast replacement with a liquid formula (LI+PMR, n=62) or LI alone (n=61) for 4 weeks. All participants underwent continuous glucose monitoring (CGM) for 72 hours both before and after intervention. GV metrics obtained from CGM included the incremental area under the curve of postprandial blood glucose (AUCpp), standard deviation of blood glucose (SDBG), glucose coefficient of variation (CV), and mean amplitude of glycaemic excursions (MAGE).

Results: At the end of the study, patients in LI+PMR exhibited more pronounced improvements in systolic blood pressure (P=0.046) and time in range (P=0.033) than those in LI. More importantly, LI+PMR led to significantly greater improvements in all GV metrics including SDBG (P=0.005), CV (P=0.002), MAGE (P=0.016) and AUCpp (P<0.001) than did LI. In addition, multiple regression analysis revealed that LI+PMR (vs. LI) was independently associated with the improvements in GV after adjusting for covariates (all P<0.05).

Conclusion: Our study showed that LI+PMR resulted in significantly greater improvements in GV than did LI, suggesting that LI+PMR could be an effective treatment to alleviate glucose excursions.

Disclosure

J. Zhou: None. J. Lu: None. X. Ma: None. J. Peng: None. L. Ying: None. W. Lu: None. W. Zhu: None. Y. Bao: None.

Funding

Shanghai Municipal Education Commission; Gaofeng Clinical Medicine Grant (20161430)
785-P: Effects of Metformin and Behavioral Weight Loss on Serum Short-Chain Fatty Acids (SCFAs)
Authors: MUELLER NOEL T. , ZHANG MINGYU , JURASCHEK STEPHEN P. , MILLER EDGAR , MARUTHUR NISA M. , APPEL LAWRENCE J. , HSIN-CHIEH “JESSICA”
Published: June 2019

Background: Circulating SCFAs, produced by gut microbiota, have been associated with lower cardiometabolic disease risk factors. Evidence suggests metformin and behavioral weight loss alter gut microbiota, but no trials have examined their effects on circulating SCFAs.

Objective: To determine the effects of metformin and behavioral weight loss on serum SCFAs.

Methods: We conducted a parallel-arm, randomized trial, called SPIRIT. We enrolled overweight/obese adults who were previously treated for malignant tumors, but had no ongoing cancer treatment. We randomized 121 participants to 12 months of: 1) coach-directed behavioral weight loss, 2) metformin, or 3) self-directed weight loss (control). Targeted SCFAs were measured in serum by LC-MS/MS. We used ANCOVA to compare group differences in SCFA change from baseline to 6 months and 12 months.

Results: Groups did not differ by sex (79% female), race (45% black) or age (mean 60 years). At 6 months, mean weight loss was 3.9%, 2.7%, and 0.9% in coach-directed, metformin, and self-directed, respectively (both Ps<0.05 compared to self-directed). Compared to self-directed, metformin and coach-directed interventions increased acetate at 6 months (not 12 months); metformin increased butyrate and valerate at 6 months (not 12 months); and coach-directed decreased methylbutyrate at 12 months (Figure).

Conclusion: Metformin and behavioral weight loss affect serum SCFAs.

Disclosure

N.T. Mueller: None. M. Zhang: None. S.P. Juraschek: None. E. Miller: None. N.M. Maruthur: Other Relationship; Self; Johns Hopkins HealthCare Solutions. L.J. Appel: None.

Funding

Maryland Department of Health and Mental Hygiene; National Institutes of Health (to N.T.M.)
8-LB: Outcomes of Type 2 Diabetes (T2D) Clustering Replicated in the DEVOTE Trial
Authors: KAHKOSKA ANNA R. , HACHMANN-NIELSEN ELISE , KLEIN KLARA , KONGSBAK KRISTINE G. , KVIST KAJSA , BUSE JOHN B.
Published: June 2019

T2D is a heterogeneous disease. Individuals in the Swedish All New Diabetics in Scania (ANDIS) cohort with newly diagnosed T2D were grouped by 6 demographic and clinical variables to show 4 distinct T2D subtypes with differential risk for nephropathy and retinopathy. We tested the predictive validity of this clustering system for patients with advanced T2D in DEVOTE (a large, global, randomized, double-blind, cardiovascular outcomes trial; median observation time: 1.99 years) for major adverse cardiovascular event (MACE)-free survival, severe hypoglycemia (SH)-free survival, and overall survival rates. Subjects (N=7637, mean age=65.0 years, mean T2D duration=16.4 years, mean glycated hemoglobin [A1C]=8.43%) were assigned to a cluster for which they had the smallest Euclidean distance to the cluster center based on available baseline variables: A1C, BMI, age, age at diagnosis. Insulin resistance and sensitivity measures were not available. The 4 DEVOTE clusters showed baseline characteristics consistent with the original ANDIS clusters, with significant differences in MACE-incidence and SH-incidence (Table). The results were confirmed using data from the LEADER trial (data not shown). The study suggests that clusters derived from early T2D can be replicated in long-standing T2D. Future work should characterize differences in treatment response across clusters to improve outcomes across the heterogeneous T2D population.

Disclosure

A.R. Kahkoska: None. E. Hachmann-Nielsen: Employee; Self; Novo Nordisk A/S. K. Klein: None. K.G. Kongsbak: Employee; Self; Novo Nordisk A/S. Stock/Shareholder; Self; Novo Nordisk A/S. K. Kvist: Employee; Self; Novo Nordisk A/S. Stock/Shareholder; Self; Novo Nordisk A/S. J.B. Buse: Consultant; Self; Neurimmune AG. Research Support; Self; AstraZeneca, National Center for Advancing Translational Sciences, National Institute of Diabetes and Digestive and Kidney Diseases, Novo Nordisk A/S, Sanofi, vTv Therapeutics. Stock/Shareholder; Self; Mellitus Health, PhaseBio Pharmaceuticals, Inc., Stability Health. Other Relationship; Self; ADOCIA, AstraZeneca, Dance Biopharm Holdings Inc., Eli Lilly and Company, MannKind Corporation, NovaTarg, Novo Nordisk A/S, Senseonics, vTv Therapeutics, Zafgen, Inc.

Funding

Novo Nordisk
806-P: Quantifying Carbohydrate Intake: A Reliable, Valid, Sensitive Alternative to 24-Hour Dietary Recall
Authors: COX DANIEL , MONCRIEF MATTHEW A. , BANTON TOM , NGO VICTORIA M. , SINGH HARSIMRAN , DIAMOND ANNE M. , MCCALL ANTHONY L.
Published: June 2019

Carbohydrate (carb) ingestion strongly influences postprandial glucose (PPG). With recent interest in the role PPG plays in A1c and diabetic complications, there are research and clinical needs to quantify routine carb consumption. The 24-hour dietary recall is the gold standard for estimating carbs eaten, but it is tedious and narrowly focused. We developed a simple self-report to measure carbs routinely consumed (CRC). We hypothesized that the CRC would: 1) be reliable, 2) correlate with the 24-hour dietary recall, 3) be sensitive to a PPG-lowering intervention, and 4) reflect changes in A1c. Adults with type 2 diabetes (n = 116; mean age: 56 ± 11.6 years; mean disease duration: 5.3 ± 3 years; mean A1c: 8.2 ± 1.0) participated in a clinical trial comparing weight reduction to PPG reduction. At baseline and 3-month follow-up, participants completed the CRC, 3 days of ASA24 dietary recall, and A1c. The CRC score was the sum of the number of servings of 16 different high-carb food classes eaten (e.g., dried fruits) in an average week. The CRC mean was 35.9 ± 16.1. One-week test-retest reliability (r) was .96 (p = .02). Validity: At baseline, carbs eaten by CRC and ASA24 dietary recall were correlated (r = .43, p < .001). Change in CRC from baseline to follow-up was significantly lower for the PPG group (36.8 to 20.3, p <.001) but not for the weight-lowering group (33.0 to 34.4, p = .7). Correlation of pre-post change in A1c with CRC and ASA24 were r = .39 (p = .002) and r = -.03 (p = .8) respectively. Regression analysis indicated only the change in CRC predicted change in A1c. These data indicate the CRC is reliable and shows concurrent, discriminant and predictive validity - only changes in CRC reflected changes in A1c. The CRC may be useful to researchers in evaluating programs designed to lower carb intake. Clinicians might use it to evaluate a patient’s routine consumption of carbs and responsiveness to lifestyle interventions. Limitation: the CRC is not a comprehensive nutritional analysis.

Disclosure

D. Cox: None. M.A. Moncrief: None. T. Banton: None. V.M. Ngo: None. H. Singh: None. A.M. Diamond: None. A.L. McCall: None.

Funding

National Institutes of Health (R01DK108957); Dexcom, Inc. (IIS-2016-047)
81-LB: Patient Perspectives on the Impact of Diet on Glycemia in GCK-MODY
Authors: LETOURNEAU LISA R. , CHAN KAREN , SALGUERO BERMONTH MARIA V. , NAYLOR ROCHELLE N.
Published: June 2019

GCK-MODY is characterized by stable, mildly elevated glycemia. Microvascular complications are exceedingly rare and treatment is not recommended outside of pregnancy. Diet alteration is not expected to have significant impact on glycemia as glucose homeostasis is preserved. Yet, some subjects with GCK-MODY in the University of Chicago National Monogenic Diabetes Registry report decreased freedom to eat scores on quality of life questionnaires. The purpose of this study was to understand the perceptions of those with GCK-MODY on the impact of diet on glycemia through thematic analysis of Registry discussion groups transcripts. Participants were 56 individuals, ages 23-75 years, and 80% female. Emergent themes revealed division in views commonly held by respondents. One group was characterized as seeing the diagnosis of GCK-MODY liberating their choices and perceptions about food, often accompanied by personal examples of ineffectiveness of diet on changing glycemia. Conversely, a theme of restriction and rigidity was seen in others, with some respondents following strict, regimented diets, and practicing frequent self-monitoring of blood glucose. Fear of complications or health symptoms attributed to GCK-MODY were common motivators for dietary choices. Emotional distress was also frequently encountered. This qualitative study demonstrates dichotomous views held by respondents in regard to the impact of diet on glycemia in GCK-MODY with associated psychological impact. The themes seen in this discussion group are not necessarily generalizable to all individuals with GCK-MODY. Of 388 eligible participants, only 56 people have joined the GCK-MODY discussion group. It may be that those with high convictions in their beliefs about diet are overrepresented in this group. Nevertheless, the significant division in perceptions, focus on diets, and frequency of restrictive diets highlights the need for additional studies into the efficacy of diet on glycemia in this unique subset of hyperglycemia.

Disclosure

L.R. Letourneau: None. K. Chan: None. M.V. Salguero Bermonth: None. R.N. Naylor: None.

Funding

National Institute of Diabetes and Digestive and Kidney Diseases (R01DK104942, P30D70, DK020595, K23DK114564)
81-OR: Depressive Symptomatology Is a Major Predictor of Incident Disability in a Cohort of Childhood-Onset Type 1 Diabetes
Authors: COSTACOU TINA , ORCHARD TREVOR J.
Published: June 2019

Type 1 diabetes (T1D) is associated with numerous complications, which may in turn cause significant disability. However, little evidence is available on the proportion of T1D patients affected by disability in the U.S. We thus assessed incidence and predictors of disability in a childhood onset T1D cohort (n=658, mean baseline age, 28 and diabetes duration, 19 years) during a 25 year follow-up. Disability was assessed via self-report in response to the question: “Do you have any disabilities that limit the type or amount of work you can do at home, school or on the job?” Of 509 free of disabilities at baseline, 49.7% (n=253) reported a disability during follow-up. Incident cases were more likely to be older at baseline, with longer diabetes duration, higher HbA1c, non-HDLC, triglycerides, and albumin excretion rate (AER). They were also more likely to be women, current smokers, have hypertension, depressive symptoms (Beck Depression Inventory), and prevalent complications (i.e., cardiac autonomic neuropathy, proliferative retinopathy (PR), distal symmetric neuropathy (DSP), lower extremity arterial disease, and increased albuminuria). In multivariable Cox models, independent predictors of disability incidence comprised diabetes duration (HR=1.05, 95% CI: 1.02-1.07), female sex (1.99, 1.46-2.72), current smoking (1.40, 0.99-1.97), HbA1c (1.24, 1.12-1.38), non-HDLC (1.007, 1.003-1.011), log AER (1.12, 1.03-1.23), DSP (1.59, 1.10-2.29), coronary artery disease (1.84, 1.00-3.38) and depressive symptoms (mild/moderate HR=1.38 (0.98-1.94); moderate/severe HR=2.25 (1.24-4.09)). The addition of depressive symptoms to models including traditional risk factors and complication status significantly enhanced the prediction of incident disability (Uno’s concordance statistic p=0.02).

In conclusion, modifiable risk factors, depressive symptoms and diabetes complications predicted disability incidence, which affected almost half of this T1D cohort.

Disclosure

T. Costacou: None. T.J. Orchard: Consultant; Self; Boehringer Ingelheim International GmbH.

Funding

National Institutes of Health (DK34818); Rossi Memorial Fund
814-P: Determinants of Diabetes Self-Care in Two Populations of Arabs with Type 2 Diabetes Living in Their Country of Origin or in the United States: A Comparative Analysis
Authors: SUKKARIEH-HARATY OLA ALI , JABER LINDA , KHARMA JOELLE ABI , FARRAN NATALI , BASSIL MAYA
Published: June 2019

Optimal diabetes management requires daily activities of self-care. Thus, understanding the sociodemographic determinants of diabetes self-care is crucial to improve diabetes control.

The aim of this study is to compare diabetes self-care activities and their determinants in 2 populations of Arabs with type 2 diabetes (T2DM) living in their country of origin (Lebanon) or in the United States (U.S.). A total of 334 patients (59 ± 13 years; 52.1% M) living in Lebanon and 181 patients (62 ± 12 years; 52.5% M) living in the U.S. were recruited. Diabetes self-care activities were assessed using Summary of Diabetes Self-Care Activities Assessment (SDSCA); dimensions of diabetes distress were measured with the Diabetes Distress Scale (T1-DDS). Half of the population in Lebanon were employed, 61.6% had health insurance and 42.3% were smokers; while among those living in the U.S., 23.7% were employed, 96.1% had health insurance and 26.5% were smokers. There were no significant group differences for gender, marital status and education. Compared to those in Lebanon, patients living in the U.S. had significantly higher mean scores on various SDSCA subscales, including general diet (t = 5.24, p < 0.001), exercise (t = 3.31, p = 0.001), blood glucose testing (t = 4.41, p < 0.001), and foot care (t = 8.84, p < 0.001) indicating better diabetes self-care. Multiple regression analyses showed that total SDSCA scores correlated significantly with age (β= 0.06, p = 0.015) and education (β= 3.02, p=0.006) in patients living in Lebanon; whereas predictors of total SDSCA scores among participants living in the U.S. were education (β= 8.46, p = 0.005) and management distress subscale of T1-DDS (β= - 2.92, p < 0.001).

In conclusion, Arab patients with T2DM living in the U.S. showed better diabetes self-care activities compared to those living in their country of origin. Predictors of self-care varied between the 2 populations. Further exploring other determinants is warranted.

Disclosure

O.A. Sukkarieh-Haraty: None. L. Jaber: None. J. Abi Kharma: None. N. Farran: None. M. Bassil: None.
824-P: Ecological Momentary Assessment of Diabetes Self-Management: A Systematic Review of Methods and Procedures
Authors: NAM SOOHYUN , WHITTEMORE ROBIN , VLAHOV DAVID , DUNTON GENEVIEVE
Published: June 2019

Ecological momentary assessment (EMA) is a mHealth method of real-time data collection in which people report on behavior and the context of the behavior at multiple time points in their natural environment. It is an innovative counterpart to traditional research methods that have relied on retrospective measures. The aim of this systematic review is to describe EMA methodology that has been used in studies of diabetes self-management. PubMed, CINAHL, PsycINFO, and EMBASE were searched for studies published between January 2000 and December 2018. We identified six studies that met the inclusion criteria. We evaluated the following areas of EMA methodology: 1) sampling and study design, 2) primary measures, 3) delivery technology, 4) EMA schedule and prompting strategy, and 5) EMA compliances. Five out of six studies were conducted in the U.S. with adolescents with type 1 diabetes. One study was conducted in Japan with adults with type 2 diabetes. Four studies used a prospective observational study design with a monitoring period ranging from 3 to 14 days (a total 1,000 to 2,128 observations:). Two studies were integrated with ecological momentary interventions (30 days and 6 months) with real-time biobehavioral feedbacks. All studies assessed diabetes self-management behaviors via EMA surveys. Most studies (78%) reported the relationship among psychosocial contexts, mood, affect, eating, and glucose monitoring. Three studies used handheld computers; two used automated telephone response systems; and one used a smartphone app. The prompt frequency ranged from twice a day to 1-2 times per hour using interval-contingent prompting strategy. Most studies failed to report EMA compliance rates. For those who reported, compliance rates ranged 59-96%. There has been limited research using EMA methodology to assess diabetes self-management and contextual factors. More research with standardized EMA reporting may help to develop personalized diabetes intervention.

Disclosure

S. Nam: None. R. Whittemore: None. D. Vlahov: None. G. Dunton: None.
831-P: Comparing Experience and Satisfaction of Adults with Type 1 Diabetes Participating in Interventions to Reduce Diabetes Distress
Authors: BOWYER VICKY , FISHER LAWRENCE , HESSLER DANIELLE M. , POLONSKY WILLIAM , MASHARANI UMESH , PARRA JOSÉ , DEDHIA MANSI
Published: June 2019

Diabetes distress (DD) refers to the emotional burdens that arise from living with a demanding chronic disease like diabetes. T1REDEEM was a randomized-controlled trial comparing two group interventions to reduce DD among adults with type 1 diabetes (T1D): KnowIt (KI), a comprehensive education program, and OnTrack (OT), a program focused on identifying and addressing diabetes-related emotions. Both programs included a group workshop and 4 online group meetings over 3 months. Both programs were equally effective in reducing high DD. The aim of this report is to compare participant satisfaction between programs, and to identify key themes related to participation. 267 of 293 (91.1%) participants completed surveys following the 3-month intervention program to rate satisfaction and experience. T-tests compared group mean scores. A thematic analysis of open-ended survey questions identified overarching experiential themes. Participants in OT were significantly more satisfied than those in KI on multiple measures: they rated OT as more helpful (3.62 (1.1) vs. 3.13 (1.1)), had a more positive group workshop experience (4.22 (.9) vs. 3.68 (1.1)), and reported profiting more from group discussion (3.98 (1.0) vs. 3.58 (1.1)) and group support (3.72 (1.2) vs. 3.19 (1.3), all p<.05). Main themes related to satisfaction and experience differed by group. KI participants reported higher levels of disappointment, especially concerning lack of novelty of program content. OT participants reported greater exploration of new health behaviors, gaining a new perspective on their diabetes, and finding the experience of meeting other adults with T1D to be more assuring. Feeling support from and connection with other group participants was a more common theme in OT than KI. Findings suggest that high DD T1D adults participating in an emotion-focused intervention were more satisfied than those attending an education-focused program to address high DD.

Disclosure

V. Bowyer: None. L. Fisher: Consultant; Self; Abbott, Eli Lilly and Company. D.M. Hessler: Consultant; Self; Eli Lilly and Company. W. Polonsky: Consultant; Self; Abbott, Bigfoot Biomedical, Dexcom, Inc., Eli Lilly and Company, Insulet Corporation, Johnson & Johnson Diabetes Institute, Merck & Co., Inc., Novo Nordisk Inc., Sanofi, Servier. U. Masharani: Research Support; Self; Clementia Pharmaceuticals. J. Parra: Employee; Self; Behavioral Diabetes Institute. M. Dedhia: None.

Funding

National Institutes of Health
841-P: Clinically Elevated T1D Distress and Depression in Parents of Kids with New-Onset Type 1 Diabetes (T1D)
Authors: NOSER AMY E. , CLEMENTS MARK A. , MONZON ALEXANDRA , MAJIDI SHIDEH , PATTON SUSANA R.
Published: June 2019

We applied existing clinical cut-points for T1D distress to examine cross-sectional and prospective relations between distress and depression in 127 parents of 5-9-year-olds with new-onset T1D. Parents completed the Problem Areas in Diabetes Survey- Parent Revised (PAID-PR) and the Center for Epidemiologic Studies-Depression Scale-Revised (CESD-R) at baseline, 6, 12, 18, and 24 months post-baseline. We used clinical cut-points >3.11 (item mean) and >16 (total score) for the PAID-PR and CESD-R, respectively, to identify parents with elevated scores. We used unadjusted odds ratios to explore cross-sectional and prospective relations between parents’ scores. At baseline, kids were 7.5±1.3 years-old and 4.7±3.2 months from diagnosis. 68% of parents had PAID-PR scores >3.11 at baseline, dropping to 25-38% of parents later. 21-28% of parents had CESD-R scores >16 across all visits. Compared to parents without elevated PAID-PR scores at 6 months, parents with elevated PAID-PR scores were more likely to have elevated CESD-R scores at 6, 12, 18, and 24 months (ORs: 3.5-7.8, p’s ≤ .05) and these relations persisted. While elevated T1D distress may be common for parents shortly after their child’s diagnosis, our data suggest persistent elevated T1D distress is a risk factor for current and subsequent parental depression. Thus, we need interventions to treat T1D distress in parents of kids with new-onset T1D.

Disclosure

A.E. Noser: None. M.A. Clements: Advisory Panel; Self; Glooko, Inc. Consultant; Self; Eli Lilly and Company. Speaker's Bureau; Self; Medtronic. A. Monzon: None. S. Majidi: None. S.R. Patton: None.

Funding

National Institutes of Health
849-P: Comparative Effectiveness of In-Person and Conference Call Group Lifestyle Interventions in Primary Care—The Real Health Diabetes Randomized Clinical Trial (RCT)
Authors: DELAHANTY LINDA M. , CHANG YUCHIAO , PORNEALA BIANCA C. , MCCARTHY JEANNA , GOLDMAN VALERIE M. , LEVY DOUGLAS E. , WEXLER DEBORAH J.
Published: June 2019

Background: Lifestyle interventions (LI) to treat obesity and type 2 diabetes improve medical outcomes but are not currently available in usual care.

Objective: To compare the effectiveness of 2 LI programs: in-person group (IP) and telephone conference call (TCC) to medical nutrition therapy (MNT), on weight loss at 1 year in a practice-based RCT. The LI programs are adapted from Look AHEAD’s LI program and delivered in 3 community health centers and one hospital-based practice.

Methods: Patients with type 2 diabetes, HbA1c 6.5-11.5, BMI > 25 (> 23 in Asians) kg/m2 (n=211) were randomly assigned to IP (n=70), TCC (n=72), or MNT (n=69). Trained registered dietitians delivered 25 lifestyle sessions in the first year. MNT participants had facilitated referral for outpatient dietitian visits (usual care).

Results: Participants were 62 ± 10 years, 45% male, 77% white, with BMI 35 ± 6 kg/m2, diabetes duration 10 ± 8 years and HbA1c 7.7 ± 1.2%; 66% of IP and 72% of TCC attended >18/25 sessions. Mean percent weight change at 6 and 12 months was -5.6 ± 4.9 and -4.6 ± 6.1 in IP, -4.6 ± 5.8 and -4.8 ± 6.1 in TCC, and -1.1 ± 3.7 and -2.0 ± 4.1 in MNT, with statistically significant differences between both LI arms and MNT (P<0.01 at both timepoints), but not between the two LI arms at 6 and 12 months. HbA1c improved in all participants with no statistically significant differences among study arms. At 6 and 12 months, 42 and 45% of IP participants had stopped or reduced a glucose-lowering medication, compared to 23% of MNT participants at both timepoints (P=0.03 and 0.01, respectively). No significant difference in medication reduction was observed between TCC participants (33 and 36% at 6 and 12 months) and the other two groups.

Conclusions: IP and TCC lifestyle interventions can achieve equivalent outcomes in terms of clinically significant weight loss, improvement in glycemic control, and participant engagement. The TCC delivery format may extend program reach.

Disclosure

L.M. Delahanty: Advisory Panel; Self; Jana Care Inc., Omada Health, Inc., Weight Watchers International, Inc. Y. Chang: None. B.C. Porneala: None. J. McCarthy: None. V.M. Goldman: None. D.E. Levy: None. D.J. Wexler: Other Relationship; Spouse/Partner; APOLO1BIO.

Funding

National Institute of Diabetes and Digestive and Kidney Diseases
862-P: Association of Parent Executive Function and Child Glycemic Control in Type 1 Diabetes
Authors: TULLY CARRIE , BENTO SAMANTHA P. , HAMBURGER SAMANTHA , ROSE MEREDITH , STREISAND RANDI
Published: June 2019

Executive functions (EF) are a collection of effortful self-regulation abilities that control intentional behavior and promote regulation of thoughts and emotion. Parents of children with type 1 diabetes (T1D) are charged with organizing management of child behavior while simultaneously engaging in beneficial health behaviors, all of which involve key EF tasks (e.g., attention, self-regulation, working memory, and problem solving). As such, individual parent EF abilities likely play a significant role in children’s diabetes management and health outcomes. This study examined the relation between parent EF and glycemic control in children with T1D. Fifty-two parents of children age 2-10 (M parent age = 37.4 years, 53.8% African American, M child age = 8.0, M diabetes duration = 3.7 years) with T1D were enrolled in the cross-sectional study at a pediatric diabetes clinic. Parents completed the Working Memory Index (Arithmetic and Digit Span) of the Wechsler Adult Intellectual Scale - Fourth Edition, Behavior Rating Inventory of Executive Function, Self-Care Inventory-Parent, Center for Epidemiologic Scale - Depression and medical, psychiatric, and demographic history. Medical chart reviews were conducted to extract child glycemic control, diabetes health, and complications. Results from objective measures of EF demonstrated a positive association between Digit Span and A1C (r=-.25, p =.03), though not for Arithmetic and A1c (r = -0.14, p = 0.34). Linear regression was calculated to examine the relation between self-reported EF and adherence. Controlling for parent depressive symptoms, higher overall executive functioning was associated with higher adherence F(1, 51) = 7.78, p = .008, R2 = 0.13). There is an association between parent executive function and child glycemic control, which may be explained through differences in adherence behaviors. Future research should focus on parent EF screening in pediatric diabetes clinics and adapting cognitive interventions for this population.

Disclosure

C. Tully: None. S.P. Bento: None. S. Hamburger: None. M. Rose: None. R. Streisand: None.
866-P: Lifestyle Change Program Session Completion and Cardiometabolic Outcomes in Real-World Clinical Practice
Authors: HUANG HISAO-CHING , AZAR KRISTEN M. , SUDAT SYLVIA , PRESSMAN ALICE , ROMANELLI ROBERT
Published: June 2019

Background: Translational diabetes prevention lifestyle change programs can promote weight loss and reduce cardiometabolic risk factors in those at high risk for diabetes. Few studies have examined completion of such programs in the real world or the relationship between program completion and cardiometabolic outcomes.

Methods: In this retrospective study, we identified program participants, ≥18 years of age, in the electronic health records (2010-2017) of a large, community-based healthcare system. We examined the number of classes completed during the 12-week intensive core phase of the program (12 sessions max) and the total number of sessions completed during the full 12-month curriculum (26 session max). We further examined the relationship between total session completion and changes in weight, systolic/diastolic blood pressure (SBP/DBP), and total cholesterol (TC) at 12 months (±3 months) follow-up, using linear regression with adjustment for baseline characteristics.

Results: We identified 1,116 program participants meeting eligibility criteria. At baseline, mean weight = 99 kg, SBP/DBP = 126/76 mmHg, and TC = 192 mg/dL. Participants attended a mean of 9 of 12 sessions (median=11) during the intensive core phase, and 60% completed ≥10 sessions. Participants attended a mean of 14 sessions (median=15) over the full 12-month program. Each session completed was statistically significantly associated with, on average, a -0.39 kg change in weight (P<0.001) and a -0.13 mmHg change in DBP (P=0.01). There was a non-significant trend for each session completed and mean change in SBP (-0.13 mmHg; P=0.196) and TC (-0.11 mg/dL P=0.390).

Conclusion: In real-world clinical practice, lifestyle change program completion is suboptimal, yet evidence suggests that greater class attendance is associated with better outcomes. Strategies to promote program retention can have an important impact on cardiometabolic risk reduction.

Disclosure

H. Huang: None. K.M. Azar: None. S. Sudat: None. A. Pressman: None. R. Romanelli: None.

Funding

National Institute of Diabetes and Digestive and Kidney Diseases
867-P: The Impact of Diabetes on Daily Life: Highlights from People with T1D and Their Caregivers
Authors: BISPHAM JEOFFREY , HUGHES ALLYSON , PEREZ-NIEVES MAGALY , FAN LUDI , MCAULIFFE-FOGARTY ALICIA
Published: June 2019

People with type 1 diabetes (T1D) and caregivers of minors with T1D experience significant impact to many aspects of daily life. The impact of diabetes is not limited to monetary costs assessed by healthcare and economic data, but also includes the “cost” of sacrifices, such as sleep disruption and time lost. Limited research exists regarding daily disruptions and missed opportunities due to T1D. This study aimed to identify other aspects that are impacted by T1D in patients and caregivers living in the U.S. Six focus groups were conducted based on previously identified themes regarding finances, missed opportunities, and disruptions in daily activities from patients, caregivers and health care provider interviews. The current study conducted focus groups with people with T1D, ages 23-72 (n=17) and caregivers ages 34-55 (n=14), of minors with T1D. Five focus groups were conducted online and one was conducted in-person (San Diego, CA) with a total of 31 participants. All participants were recruited from T1D Exchange Glu (www.myglu.org), an online community for individuals living with T1D. Focus groups were audio-recorded, transcribed, and thematically analyzed. Participants reported issues with sleep, finance, health insurance (including obtaining supplies), and disruptions in work and school as most impacted by T1D. Overall, the majority of participants reported that their sleep was most impacted. Patients and caregivers experienced substantial amounts of sleep loss due to device alarms and night time blood glucose excursions as well as taking preventative actions to avoid excursions. People with T1D reported time dedicated to managing diabetes had a greater impact on life, while caregivers reported financial and employment sacrifices had the most impact. This study provides insight into the real-world impact of diabetes beyond the more commonly studied healthcare costs.

Disclosure

J. Bispham: None. A. Hughes: None. M. Perez-Nieves: Employee; Self; Eli Lilly and Company. Stock/Shareholder; Self; Eli Lilly and Company. L. Fan: Employee; Self; Lilly Diabetes. Stock/Shareholder; Self; Lilly Diabetes. A. McAuliffe-Fogarty: None.
872-P: Impact of Psychosocial Factors and Nutrition Using a 12-Week Course on Diabetes Management for Veterans
Authors: FARRELL NANCY
Published: June 2019

U.S veterans are at considerable risk for complications from diabetes. It affects nearly 25 percent of VA's population. Many veterans report suffering from psychosocial complications particularly lack of management success and symptoms of depression. The Diabetes Empowerment Group (DEG), a 12-week interdisciplinary group for diabetes management. Curriculum includes values assessment, goal setting, biofeedback, problem solving, mindful eating, and other management skills. A registered dietician provides nutritional education and coaching each session. Based on feedback, program changes are implemented to each new group cycle for quality improvement (QI) purposes.

Methods: Hemoglobin A1c levels for veterans were measured via on-site laboratory services. They completed Diabetes Empowerment Scale - Short Form and Patient Health Questionnaires-9 at the beginning and end of their respective group session cycles. Scores were used to determine whether group content impacted veterans' HbA1c, depressive symptoms and empowerment in managing their diabetes. Paired sample t-tests were utilized to compare pre- and post-session cycle values. Fifty-nine veterans completed lab work and QI measures. Mean HbA1c levels (t(58) = 2.55, p<0.01) and depressive symptoms scores (t(54) = 3.11, p<0.001) decreased from the beginning (M = 8.11, SD = 3.60; M = 11.31, SD = 43.55) of the group to the end (M = 7.74, SD = 1.97; M = 9.22, SD = 38.77). Mean empowerment scores increased (t(55) = -3.08, p<0.001 from the beginning (M = 3.56, SD = 0.58) of the group to the end (M = 4.02, SD = 1.24). These findings demonstrate the efficacy of DEG in helping veterans manage diabetes. We expect successive improvements toward a more integrative, standardized curriculum will result in increased empowerment and reduced HbA1c levels and depressive symptomatology. Future directions for QI include increasing access to care by initiating access by starting a new cycle of DEG every six weeks.

Disclosure

N. Farrell: None.
879-P: Using Telehealth to Enhance Engagement and Reduce Patient Burden in the Management of Gestational Diabetes: A Randomized Trial in a Diverse Community Setting
Authors: SINGH HARSIMRAN , SENDEJAS MICHELLE , PALLIVATHUCAL LIA B. , GONZALEZ MEGHAN , DECKER STEPHANIE , PIMENTEL ANA R. , MILLS MARLIN D. , AHN DAVID T. , BILLIMEK JOHN
Published: June 2019

Optimal management of gestational diabetes (GDM) is critical to ensure successful maternal and fetal birth outcomes, yet various factors limit uptake of GDM management education interventions. We developed a psychoeducational intervention for GDM management using a video telehealth platform (TH) as an alternative to routine in-person (RC) sessions to improve patient access and engagement. Both groups were guided by the same providers and received similar educational materials. However, all RC visits were held in-person while all TC visits (except for pre and post assessment) were held virtually. Clinical and psychosocial indicators including out of range blood glucose (BG), birth outcomes, BG monitoring behavior, and patient satisfaction were assessed. Between group comparisons were performed using independent samples t-tests and Fisher’s exact test. Sixty ethnically diverse women with GDM were randomized to TH (n=30) or to RC (n=30). At post assessment, GDM knowledge improved significantly and similarly in both groups (p=0.009), but no group differences were observed on the clinical (including out of range BGs) and psychosocial variables assessed. In late pregnancy, BG monitoring was significantly better in TH (84%) vs. RC (68.4%) (p<0.05). Similarly, attendance at all intervention visits was higher in TH (63.3%) vs. RC (36.7%). Total interaction time for participants completing all intervention visits was significantly shorter in TC (202 min) than in RC (255 min, p<0.001). Although, satisfaction was high in both groups, all but one participant indicated preference for TH for future GDM education. The impact of TH was found to be equivalent to RC on various clinical and psychosocial indicators, but superior in terms of patient engagement, BG monitoring adherence, and patient burden.

Disclosure

H. Singh: None. M. Sendejas: None. L.B. Pallivathucal: None. M. Gonzalez: None. S. Decker: Advisory Panel; Self; Sanofi-Aventis. A.R. Pimentel: None. M.D. Mills: None. D.T. Ahn: Advisory Panel; Self; Ascensia Diabetes Care, MannKind Corporation. J. Billimek: None.

Funding

Hoag Hospital Foundation
886-P: Smoking and Cessation Patterns of People with Diabetes
Authors: OZCAN SEYDA , GORURGOZ FERIDE , CARKOGLU ASLı , AKBULUT ZELIHA , NICHTER MIMI , NICHTER MARK
Published: June 2019

Turkey has the highest prevalence of diabetes and smoking in Europe (diabetes 13.7%; smoking 44% of men and 18% of women). Smokers with diabetes have a heightened risk of morbidity and mortality. The routine assessment of tobacco use as an essential to prevent smoking or encourage cessation.(ADA,2018) At present, little is known about the cessation services provided by diabetes professionals to their patients in Turkey. A nationwide survey was conducted to gather data on this topic. Utilizing a point prevalence methodology, data was collected from 24 provinces around Turkey. Diabetes nurses from 172 diabetes centers were invited to complete a survey (response rate 28.4%). The survey included 11 questions; patient demographics, type and duration of diabetes, patient smoking status, smoking and cessation behaviors after diabetes diagnosis, cessation recommendation from HCP. The survey with instruction + video about how to complete the survey were sent via e-mail and phone messages to the nurses. Surveys were completed on one clinic day between December 3-7,2018 to all diabetes patients. (Ethics 2018.229.IRB3.162) of patients (n=779), 59,4% is women; 86,3% has type 2 diabetes. Mean duration of diabetes 10,39 years; mean age is 54,97 years. Smoking prevalence is 26,8%. The highest smoking prevalence is 40,4% in men, while 19,0% in women. Of patients,19,3% smokes 10 cigarettes or more in a day; 26,2% is quitter while 10,7% of them quit after diabetes diagnosis; 80,1% believes any amount of smoking is harmful. As opposed to, 7.4% of patients believes 1-2 cigarettes in a day is not harmful, 6,0% believes that there is no relation between smoking and diabetes. Only 11,8% of smokers has quitting advice from HCP relating the risk of smoking for diabetes control. This nation-wide survey reveals the first data on smoking and cessation in Turkish people with diabetes. Findings shows that patients are not aware of the harm of tobacco. Behavior-based smoking cessation trainings will be applied for diabetes professionals in the light of these early data.

Disclosure

S. Ozcan: None. F. Gorurgoz: None. A. Carkoglu: None. Z. Akbulut: None. M. Nichter: None. M. Nichter: None.
89-OR: Type 1 Interferons Inhibition of Interleukin-10 Signaling in T Cells in Type 1 Diabetes Development
Authors: LOZANO MARCOS IGLESIAS , CHICCO MARIA , BIBICHEFF DARREL A. , BRANDACHER GERALD , RAIMONDI GIORGIO
Published: June 2019

Type 1 diabetes (T1D) is an autoimmune disease caused by T cell-mediated destruction of insulin-producing beta cells of the pancreas. The “fertile field” hypothesis of T1D proposes that, in a genetically predisposed individual, an inflamed environment prompts the organ towards autoimmunity. In this context, the protective role of the regulatory cytokine IL-10 remains unclear and somewhat controversial. In this study, we tested whether chronic and localized accumulation of type-I interferons (TI-IFNs) creates a “fertile field” that releases diabetogenic T cells from IL-10 mediated regulation and prompts T1D development. In vitro incubation of mouse T cells with IFN-β induces a dramatic defect in the production of phospho-STAT3 in response to IL-10 (but not in response to IL-6, that shares the same signaling pathway). This resulted in prevention of upregulation of IL-10 induced genes. This altered signaling was NOT caused by reduction of IL-10 receptor expression, nor by induction of SOCS-1 or 3. Instead, microarray analysis suggested a novel role for the transcription factor STAT1. IFN-β increases STAT1 levels causing a reversal of the STAT1/STAT3 protein ratio in T cells, ultimately favoring a competitive role of STAT1. In agreement, STAT1-KO T cells exposed to IFN-β did not show any defect in IL-10 signaling. In diabetes-prone NOD mice we discovered a persistent reduction of IL-10 signaling in T cells of pancreatic and mesenteric lymph nodes (but not in T cells of other lymphoid tissues), correlating with the reported aberrant and localized accumulation of TI-IFNs in these mice. Early treatment of NOD mice with an IFNRA blocking antibody (that delays the onset and reduces the incidence of T1D) showed a clear restoration of IL-10 signaling. Overall, these data reveal a previously unknown molecular interplay between IL-10 and TI-IFNs that, if thoroughly elucidated, could reveal a novel target of intervention to enhance the efficacy of T1D immunotherapies.

Disclosure

M. Iglesias Lozano: None. M. Chicco: None. D.A. Bibicheff: None. G. Brandacher: None. G. Raimondi: None.
893-P: A Smartphone App-Based Lifestyle Intervention for Weight Loss, Improvement of Hemoglobin A1c (A1c), and Prediabetes
Authors: VAZ CHERIE LISA , CARNES NICHOLAS , ZHAO HUAQING , WILLIAMS KEVIN JON
Published: June 2019

We previously reported the successful RCT of our smartphone app-based lifestyle intervention in overweight or obese subjects (ClinicalTrials.gov NCT02742662). Our intervention met the prespecified primary outcome of clinically meaningful, statistically significant weight loss at 6 months over standard of care in wait-listed controls (ADA 2018). Here we report effects of the intervention on glycemia and risk of diabetes as assessed by A1c, a prespecified secondary endpoint. The app downloads daily weights from smartscales and physical activity from 3-axis accelerometers. The technology allows peer social networking and remote coaching. Subjects chose diets from a selection of low glycemic index, low fat, low carb or Mediterranean. We performed comparisons using the t test. Intervention group (I) N=13, no dropouts, 84.62% F, age 40.2 ± 3.73 y (means ± SE), initial weight 94.2 ± 3.41 kg, BMI 34.5 ± 1.25 kg/m2. Wait-listed Control group (C) n=15, 86.67% F, age 45.9 ± 3.29 y, initial weight 92.3 ± 4.37 kg, BMI 34.4 ± 1.48 kg/m2. N=14 began the study and received in-person weight management visits at 0, 3, and 6 months. N=10 completed the 6-12 month phase during which they received the app-based lifestyle intervention. The intervention significantly improved A1c at 6 months -0.251 ± 0.0894 (95% CI -0.4419 to -0.0609) p=0.013 (I over C, per protocol analysis). At 6 months (I) change in A1c (n=9) -0.189 ± 0.0389 (95% CI -0.2786 to -0.0992) p= 0.0013, (C) change in A1c (n=8) +0.0625 ± 0.0844 (95% CI -0.1370 to 0.2620) p=0.48. After receiving the intervention from 6-12 months (C) group (n=10) improved A1c by -0.26 ± 0.0718 (95% -0.4224 to -0.0976) p=0.0056. All (C) subjects with prediabetes (n=4 of 10) who received the intervention resolved prediabetes at 12 months. Thus, the intervention produced clinically and statistically significant improvements in A1c. Our smartphone app-based lifestyle intervention may be a useful tool to treat prediabetes and prevent diabetes.

Disclosure

C. Vaz: None. N. Carnes: None. H. Zhao: None. K. Williams: Advisory Panel; Self; Gemphire Therapeutics Inc. Stock/Shareholder; Self; Gemphire Therapeutics Inc., Hygieia.

Funding

Temple University; Obesity Treatment Foundation