bluuebunny/crossref_metadata_2025_split huggingface dataset:
650-P: Safety and Effectiveness of Recombinant Human Insulin Insugen in Real-World Clinical Setting
Authors: RAJ PRAVEEN , J PRIYA , MATHEW DANO C. , BISWAS CAMELIA , NETHRA SABARRI 
Published: June 2020

Background: As the burden of diabetes is increasing dramatically, the demand of insulin is also on rise, affordable access to insulin remains a challenge, particularly in Low and Mid income countries. For that reason, recombinant human insulin (rHI) formulations are considered to be effective alternatives to insulin analogues in countries with limited healthcare systems and resources. Continuing patient education and support programmes with rHI are critical role players in improving the access and overall disease management.
Objective: This is a non-interventional study to observe the safety and effectiveness of Recombinant Human insulin in a real world population with type 2 (T2DM) diabetes mellitus from Indian perspective.
Methodology: Out of 10426 diabetes patients who were enrolled in patient support program i.e “Insulin Therapy Assistance Program (iTAP)”, 5691 patients were initiated with various formulations of rHI (Insugen R, N, 30/70 and 50/50). Insulin therapy was initiated in T2DM patients with A1C &gt; 7%. HbA1c, FPG and PPG values were recorded at baseline and follow up of 3, 6 and 9 months.
Results:
The Figure 1, 2, 3 depict the baseline and follow up of FBG, PPG and HbA1c respectively.
Figure 1. Change in FPG (*p&lt;0.05).
Figure 2. Change in PPG (*p&lt;0.05).
Figure 3. Change in HbA1c (*p&lt;0.05).
Conclusion: In the current study, various formulations of rHI were well tolerated and resulted in significant reduction of HbA1c, FPG and PPG when aided with patient support program. Considering the economic impact of diabetes patients in taking insulins, human insulin become an alternative option in comparison to analogues which are expensive. Early initiation of insulin therapy can prevent or delay diabetes complications. Access to affordable insulin therapy is the key success factor while considering Insulin Therapy.

Disclosure
P. Raj: Employee; Self; Biocon. P. J: None. D.C. Mathew: None. C. Biswas: None. S. Nethra: None.
662-P: Oral Health: Neglected Diabetes Intervention
Authors: ZIEMER DAVID C. , BARNES CATHERINE S. , RUPASINGHE RUPPAGE S.M. , KHARE SMRITI 
Published: June 2020

Oral health and diabetes can be mutually detrimental, Diabetes Education guidelines encourage good oral health practices: brushing, flossing and visiting dentist. We assessed the quality of patient outcomes and behaviors and provider support for oral health in a public hospital specialty diabetes (DM) clinic.
Patients (n=99) completed waiting room surveys on oral health history, practices, barriers and knowledge. For quality assessment, providers completed self-administered surveys on their visit discussions for oral health. Population was 54% male, had mean age 59 yr and mean DM duration 13 yr, 24% had completed &lt; 12th grade, 23% were current smokers, and 36% had some dental coverage.
While most patients knew good oral health practices, only a minority followed them. This was reflected in tooth loss and oral problems. Most patients knew DM causes dental problems (75%) and dental problems could worsen DM (60%). Most (93%) reported they should brush 2 or more times per day, only 51% did that; (74%) believed in at least once daily flossing but only 31% did so; 82% said they should visit a dentist 2 or more times a year, only 17% did so. Access to dental care was a major issue: 66% reported cost and 11% time as barriers to dental visits. Brushing barriers included: time – 23%, forget – 11%, “don’t know”/”lazy” – 11% and tired – 7%. Good oral health practices decreased with age and tooth loss but increased with higher education. Only 17% utilized charity or sliding scale clinics. They had lost median of 7 teeth and 13% were completely edentulous. In past year 40%, had tooth ache, 30% bleeding gums, 20% loose teeth, and 28% decayed teeth.
Provider support was low. Per the provider survey a minority (&lt;30%) discussed the 3 oral health practices with half or more of patients.
Patient oral health outcomes and practices are poor. Knowledge is not a major barrier. Oral health is associated with better DM control and quality of life, but intervention and support may be neglected by providers. DM Clinics must assess and improve oral health practices and education.

Disclosure
D.C. Ziemer: None. C.S. Barnes: None. R.S.M. Rupasinghe: None. S. Khare: None.
665-P: An Online Insulin Pump and CGM Curriculum for Parents of Children with T1D: TeKnO T1D
Authors: MARKS BRYNN E. , WOLFSDORF JOSEPH I. , RICHARDSON ALEXIS M. , SLAATS JULIE , MONAGHAN MAUREEN , STREISAND RANDI , GARVEY KATHARINE 
Published: June 2020

Background: With increasing use of insulin pumps and CGM, parents of children with T1D may benefit from educational opportunities to optimize device use.
Objectives: We assessed parents’ satisfaction with an online educational curriculum- Technology Knowledge Optimization in T1D (TeKnO T1D)- originally developed to improve clinicians’ knowledge of T1D technology.
Methods: Parents (n=29) of children (M age 10.4 ± 2.2 yrs) with well-controlled T1D (M A1c 6.8 ± 0.5%) managed with a pump and CGM piloted the TeKnO T1D curricula. Parents were randomized to begin with the pump or CGM content and completed surveys containing Likert-scale and free-text items before accessing the second curriculum. Iterative, qualitative thematic analysis was conducted by 3 team members.
Results: Table 1 shows percentages of parents who agreed or strongly agreed with statements in the evaluations. Qualitative analyses showed positive reactions to the curricula. Parents desired device and age-specific curricula with additional focus on interpretation of glycemic data and management of specific scenarios (exercise, sick days) including the use of temporary basal rates and extended boluses.
Conclusion: TeKnO T1D is a feasible, enjoyable educational approach for parents. Results will guide future development of device and age-specific curricula so that its impact on knowledge and glycemic control can be evaluated in a more diverse sample.

Disclosure
B.E. Marks: None. J.I. Wolfsdorf: Other Relationship; Self; Ultragenyx Pharmaceutical, UpToDate, Xeris Pharmaceuticals, Inc. A.M. Richardson: None. J. Slaats: Other Relationship; Self; Tandem Diabetes Care. M. Monaghan: Research Support; Self; American Diabetes Association. R. Streisand: None. K. Garvey: None.

Funding
National Institutes of Health (T32DK007699); Pediatric Endocrine Society; Boston Children’s Hospital
669-P: Serial Online Education Helps Break Down Primary Care Practitioner Barriers to Insulin Therapy for T2DM Management
Authors: TURELL WENDY , DREXEL CAROLE , BEASER RICHARD S. 
Published: June 2020

Introduction: Clinicians in primary care settings play key roles in T2DM care, yet data and past educational outcomes suggest they’re ill-prepared in insulin replacement therapy delivery, including recognition of need, and its optimization.
Methods: An online interactive CME series for health care providers (HCPs) launched live-online in June 2019 and remained online for 6 months. “Insulin Replacement Therapy: Evolving Treatments and their Clinical Implications” included three 1-hour sessions focusing on: 1) insulin treatment options; 2) indications for initiation/advancement of insulin; and, 3) individualization/optimization. Sessions included polling and live Q and A segments. Faculty included physicians and a clinical pharmacist who specialize in diabetes and endocrinology. Evaluation included pre/post/2-mos. post surveys measuring knowledge, competence and self-reported clinical impact. In total, 2,230 learners participated in the series, including 819 physicians, 397 NPs/PAs, and 169 pharmacists. Primary care, internal medicine and diabetes specialists totaled 1,318.
Results: Follow-up results indicated that 76% of learners reported positive educational impact on clinical practice and 128 examples were shared of specific clinical improvements, many relative to insulin use for T2DM. Additionally, 76% of respondents reported positive impact on patient outcomes and/or satisfaction, with 106 specific impact examples shared. Knowledge and competence questions that aligned with learning objectives consistently yielded improvements, all of which (12 questions) demonstrated statistically significant pre to post change.
Conclusion: CME on diabetes management and insulin use leads to increased clinical confidence among HCPs, ultimately improving the quality of care of T2DM people who are in need of insulin replacement therapy. Data continue to confirm previous results about the positive impact of continuing education for clinicians.

Disclosure
W. Turell: None. C. Drexel: None. R.S. Beaser: None.

Funding
Eli Lilly and Company; Novo Nordisk; Medtronic; MannKind Corporation
691-P: Exercise Effect on Endogenous Glucose Production in Type 1 Diabetes: A Modeling Analysis
Authors: ROMERES DAVIDE , SCHIAVON MICHELE , VISENTIN ROBERTO , BASU ANANDA , COBELLI CLAUDIO , BASU RITA , CHIARA DALLA MAN 
Published: June 2020

Quantifying the exercise effect (EE) on glucose turnover is fundamental for type 1 diabetes (T1D) management. We recently proposed a model describing EE on insulin-dependent and -independent glucose utilization in subjects with and without T1D (ND). However, to date, a model of EE on endogenous glucose production (EGP) is still lacking. To do so, we analysed existing data on 6 T1D (age 29±3 yrs, BMI 28.3±2.0 kg/m2, VO2 max 28.7±2.9 ml/kg/min, mean±SE) and 6 ND (age=28.2±4.2 yr, BMI=23.6 ±1.0 kg/m2, VO2 max 36.6±2.9 ml/kg/min) subjects studied with a glucose clamp, during, before and after a 60 min aerobic exercise session at 65% VO2max on three visits: euglycemia-low insulin (V1); euglycemia-high insulin (V2) and hyperglycemia-low insulin (V3) in random order. EGP was measured with the isotope dilution technique using [6,6-2H2]glucose. A battery of models was tested against data to assess if EE on EGP is mediated by insulin, glucose or both. The best model (Fig 1) provided a good description of the data in both groups. Results show that EE on EGP is delayed and insulin mediated. Further studies are needed to validate the model in real life conditions thus making it usable for optimization of insulin therapy.

Disclosure
D. Romeres: None. M. Schiavon: None. R. Visentin: None. A. Basu: Consultant; Spouse/Partner; GENFIT. Research Support; Spouse/Partner; AstraZeneca. C. Cobelli: None. R. Basu: Consultant; Self; GENFIT. Research Support; Self; AstraZeneca. C. Dalla Man: Research Support; Self; Sanofi-Aventis Deutschland GmbH.

Funding
Italian Ministry of Education (232/2016); National Institute of Diabetes and Digestive and Kidney Diseases (DK029953 to R.B.), (DK085516 to A.B.)
70-LB: Noninvasive Blood Glucose Measurement Techniques Based on Nonequilibrium Metabolic Heat Conformation Method
Authors: TAN HOCK S. , HE ZONGYAN 
Published: June 2020

Traditional metabolic heat conformation (MHC) method can be used for non-invasive blood glucose measurements when the body is in thermal equilibrium state. But in non-thermal equilibrium state, such as after meals, the traditional method may result in a poor accuracy. We propose a new method by extending the MHC principle to cover non-equilibrium state and develop a new measurement standard and calculation algorithm. The blood glucose measurement for the new algorithm is the sum of the blood glucose in equilibrium state and the blood glucose increase in non-equilibrium state. Results from clinical trials using this new method show significant improvement in accuracy of blood glucose measurements. Compared with the traditional MHC method, measurements using the new method results in improvement in correlation coefficients with intravenous blood-draw glucose concentration from 0.71 to 0.93 (for fasting measurements), from 0.61 to 0.93 (for measurements of 2 hours after a meal) and from 0.63 to 0.89 (for measurements of 3.5 hours after a meal). Applying Parkes Error Standard analysis, in the traditional MHC method, Range A (relative error does not exceed ±20%) accounts only for 54.3%, Range B (relative error does not exceed ±50%) accounts for 39.6%. In the new method, Range A accounts for 81.1%, and Range B accounts for 16.2%.

Disclosure
H.S. Tan: None. Z. He: None.
708-P: Medical Prescriptions of Fresh Vegetables Improve Clinical and Psychosocial Outcomes for Adults with or at Risk of Type 2 Diabetes (T2D)
Authors: KUJAN MARY A. , GLANTZ NAMINO M. , CONNEELY CASEY , CHEN VINCENT , KERR DAVID 
Published: June 2020

For adults with T2D, food insecurity and low socio-economic status are major barriers to accessing nutritious food, leading to compensatory consumption of foods harmful to health. In particular, consumption of fresh vegetables is well below recommended levels in the United States. The aim of this project was to examine the health impact of improving access to fresh vegetables through the use of medical prescriptions for organic vegetables for adults with or at risk of T2D (ADA Risk Calculator).
Over 12 weeks (and after obtaining informed consent), participants provided baseline clinical information and then received weekly medical prescriptions of 21 servings of locally sourced organic vegetables at three community based distribution centers in Santa Barbara, CA, after which baseline measurements were repeated. No additional structured nutrition education was provided.
Overall, 145 adults (74% Hispanic/Latino, aged 53 [42-62] years (median [IQ range]), 78% female, with (31%) or at risk of T2D have been enrolled. At entry, 62% were food insecure which reduced to 37% after 12 weeks (p&lt;0.0001) associated with lowering of systolic blood pressure (SBP) (-2.5 [95%CI: -4.8 to -0.2] mmHg, p=0.035) which was greater for those with an initial SBP &gt;130 mmHg (-6.8 [95%CI: -11.7, -1.9] mmHg, p=0.005), and a reduction in waist circumference (0.9 [95%CI -1.6 to -0.2] cm, p=0.002). The change in waist circumference was also significant with baseline high-risk values of &gt;88 cm (p=0.02) for women and &gt;102 cm (p=0.02) for men. Median weight also fell slightly (-0.45 kg, p=0.04). For participants with a baseline HbA1c &gt;7.0%, this reduced significantly (-0.6 [95% CI -1.2 to -0.05] %, p=0.01). Overall self-reported sleep quality, mood and pain (100 mm visual analogue scales) also improved (all p&lt;0.001).
Medical prescriptions of organic vegetables are associated with measurable clinical and psychosocial benefits for adults with or at risk of T2D.

Disclosure
M.A. Kujan: None. N.M. Glantz: Research Support; Self; Abbott, Eli Lilly and Company. C. Conneely: None. V. Chen: None. D. Kerr: Advisory Panel; Self; Novo Nordisk A/S, Sanofi-Aventis. Research Support; Self; Eli Lilly and Company. Stock/Shareholder; Self; Glooko, Inc.

Funding
U.S. Department of Agriculture (2018-01793)
709-P: Long-Term Adherence to Carbohydrate Restriction Confers Added Benefits for Adults with T2D
Authors: ADAMS REBECCA N. , ATHINARAYANAN SHAMINIE J. , PHINNEY STEPHEN , MCKENZIE AMY 
Published: June 2020

Background: We previously observed that adherence to carbohydrate restriction (CR) nutrition therapy during the first 3 months of a continuous remote care intervention predicted 1-yr improvements in weight and HbA1c in adults with T2D. However, the extent to which ongoing CR is needed to sustain health improvements is unknown.
Methods: 262 adults with T2D counseled on CR reported adherence measured by blood beta-hydroxybutyrate (BHB) regularly via a mobile app. Patients enrolled 1-yr with mean BHB ≥0.3 mM in the first 3 months (n=174) were split into quartiles based on the percent of BHB logs ≥ 0.3 and 0.5 mM during months 4 through 12. We conducted ANOVAs to compare the groups’ percent change in weight and HbA1c from baseline to 1-yr.
Results: All groups had clinically significant improvements on average in weight and HbA1c, but the percent change statistically differed by group (Ps&lt;0.01). Participants who reported CR more often had greater benefit at 1-yr (Table 1). Using a 0.3 mM BHB cut-off, very consistent restriction (≥95% of the time) yielded significantly greater benefit. A 0.5 mM cut-off demonstrated greater benefit with lower frequencies of reporting (≥38% for weight and ≥66% for HbA1c).
Discussion: More frequent CR over the remainder of the year conferred greater benefit on health outcomes. Future analyses should carefully examine whether the pattern of BHB values over time influences outcomes.

Disclosure
R.N. Adams: Employee; Self; Virta Health Corp. S.J. Athinarayanan: Employee; Self; Virta Health Corp. S. Phinney: Advisory Panel; Self; Atkins Nutritionals, Inc. Stock/Shareholder; Self; Beyond Obesity LLC (publishing), Virta Health Corp. A. McKenzie: Employee; Self; Virta Health Corp. Stock/Shareholder; Self; Virta Health Corp.
710-P: Serum DPP-4 Protein Is Decreased upon Consuming an Isocaloric High Saturated Fat Diet and Genetically Determined in Healthy Human Twins
Authors: KRUSE MICHAEL , OST ANNE-CATHRIN , HORNEMANN SILKE , HOFFMANN DANIELA , FRAHNOW TURID , BUSJAHN ANDREAS , PFEIFFER ANDREAS F. 
Published: June 2020

Obesity is associated with increased levels of soluble Dipeptidyl Peptidase-4 (DPP-4) in serum leading to adipose tissue inflammation and insulin resistance. Animal studies, however, have shown that a high fat diet acutely decreases serum DDP-4 levels. This study investigated the response of serum DDP-4 to a sudden switch from a healthy isocaloric low fat diet to an isocaloric high fat diet (HFD) in healthy human twins. 35 monzyogotic and 11 dizygotic healthy pairs of twins (women and men, age 18 - 70) were investigated for 12 weeks. An isocaloric diet rich in carbohydrates (55% carbohydrates, 30% fat, 15% protein, LF) was applied for 6 weeks, followed by an isocaloric diet rich in saturated fat (40% carbohydrates, 45% fat, 15% protein, HF) for another 6 weeks. Body weight (BW) and serum concentrations of DPP-4, tumor necrosis factor α (TNFα) and insulin were analyzed after the LF period, after one week (HF1w) and at the end (HF6w) of the HF period. Total body fat and lean mass were determined by DEXA-Scan at LF and HF6w. BW was constant over the time of intervention. Serum DPP-4 protein was decreased by 15% at HF1w and by 18% at HF6w, respectively, compared to LF (both P&lt;0.001). At HF1w DPP-4 and TNFα serum levels were positively correlated (r=0.299, P=0.004) however, this correlation was lost at HF6w. Serum DPP-4 was positively correlated with lean mass at LF (r=0.357, P&lt;0.001) and HF6w (r=0.218, P&lt;0.05), however not with body fat content. DPP-4 serum protein was strongly positively correlated within monzogotic twins at LF, HF1w and HF6w (for all P&lt;0.01), but not within dizygotic twins. Insulin was increased 1.20-fold and 1.12-fold at HF1w and HF6w, respectively, compared to LF (both P&lt;0.001). These data indicate that serum DPP-4 protein responds to nutritional stimuli and is decreased upon consuming a HFD under isocaloric conditions in healthy human subjects which is in contrast to overt adiposity. Moreover, expression of serum DPP-4 protein is genetically determined.

Disclosure
M. Kruse: None. A. Ost: None. S. Hornemann: None. D. Hoffmann: None. T. Frahnow: None. A. Busjahn: None. A.F. Pfeiffer: None.

Funding
German Federal Ministry of Education and Research (0315424)
73-OR: Gut–Brain Signals That Regulate Hunger
Authors: KNIGHT ZACHARY 
Published: June 2020

Body weight is regulated by interoceptive neural circuits that track energy need, but how the activity of these circuits is altered in obesity remains poorly understood. Here we describe the in vivo dynamics of hunger-promoting AgRP neurons during the development of diet-induced obesity in mice. We show that high-fat diet attenuates the response of AgRP neurons to an array of stimuli including food cues, intragastric nutrients, and the hormones cholecystokinin and ghrelin. These alterations are nutrient-specific, with AgRP neurons becoming desensitized to dietary fat but not carbohydrate or protein. Subsequent weight loss restores the responsiveness of AgRP neurons to exterosensory cues but fails to rescue their sensitivity to gastrointestinal hormones or nutrients. These findings reveal that obesity triggers broad dysregulation of hypothalamic hunger neurons that is incompletely reversed by weight loss and may contribute to the difficulty of maintaining a reduced weight.

Disclosure
Z. Knight: None.

Funding
American Diabetes Association/Pathway to Stop Diabetes (1-16-ACE-29)
733-P: Postprandial Glucose Variability in People with Type 1 Diabetes Is Individual and Impacted by Physiological and Clinical Parameters
Authors: DINGENA CASSY F.B. , MARSH AILSA , AJJAN RAMZI , CAMPBELL MATTHEW 
Published: June 2020

Aim: To assess whether postprandial glucose responses (PPGRs) are individual in people with type 1 diabetes (T1DM) and influenced by personal physiological and clinical parameters.
Methods: We assessed physiological and clinical parameters of one-hundred and twenty individuals with type 1 diabetes (mean±SD: Age 31±7years, BMI 26.9±2.3kg.m2, HbA1c 7.6±0.8% [55.8±8.2mmol/moL]) and captured postprandial interstitial glucose responses via continuous glucose monitoring (CGM) in response to two carbohydrate-based standardised meals (shredded wheat [SW] or millet oat-porridge [OP]), twice, on four separate occasions. Each meal was matched for energy, fibre, and macronutrient composition, glycaemic index (GI), and insulin administration.
Results: Despite identical energy, fibre, and macronutrient content, GI, and prandial insulin administration, the average PPGR differed significantly between OP and SW, respectively (IG AUC: 1807±588 vs. 1678±533 mmol.L.min-1; p=0.05). PPGRs to each meal type showed a high degree of reproducibility within individuals (OP r=0.994, p&lt;0.001 vs. SW r=0.987 p&lt;0.001), but large interpersonal variation within each meal type (CV%: OP 32.5% vs. SW 31.7%). Higher PPGR was positively associated with PPGR variability (r=0.698, p&lt;0.001), HbA1c (r=0.223, p=0.014), BMI (r=0.316, p&lt;0.001), and age (r=0.277, p&lt;0.001).
Conclusions: Using a total of 19,200 glucose measurements, we show that PPGR in individuals with type 1 diabetes is interpersonal and influenced by BMI, age, and HbA1c. We show that identification of personal characteristics is a promising means for designing effective nutritional interventions to predict and control glycaemic responses to food in this population.

Disclosure
C.F.B. Dingena: None. A. Marsh: None. R. Ajjan: Advisory Panel; Self; Eli Lilly and Company, Merck Sharp & Dohme Corp., Novo Nordisk Inc., Takeda Pharmaceutical Company Limited. Other Relationship; Self; Abbott. M. Campbell: None.