bluuebunny/crossref_metadata_2025_split huggingface dataset:
690-P: Relationship of Diabetes Distress and Symptoms of Autonomic Nervous System Dysregulation in Type 1 Diabetes Adults
Authors: DE GROOT MARY , MYERS BARBARA A. , STUMP TIMOTHY , DANA DEBORAH , KOLACZ JACEK , PORGES STEPHEN W. 
Published: June 2024

Purpose: To test the association of autonomic nervous system (ANS) dysregulation symptoms and diabetes distress (DD) in type 1 diabetes (T1D) adults. 556 US adults with self-identified T1D completed a web-based survey in May 2023, including demographics, ANS reactivity symptoms (Body Perception Questionnaire; BPQ, validated against physiologic measures), diabetes-related distress (Diabetes Distress Scale-28 T1D; DDS), depressive symptoms (PHQ-8) and anxiety (GAD-7). Mean age was 45.1 years (S.D. = 15.7), 73.2% female, 95.3% White, with a median annual household income of $60,000-100,000. Mean self-reported A1c was 6.7% (S.D. 1.0%). 72.5% reported using an insulin pump. Mean hypoglycemic episodes per week was 5.7 (9.9). Mean age at diabetes diagnosis was 20.6 years (S.D. 14.7) and mean duration of diabetes was 25.4 (S.D. 17.6) years. The sample reported high levels of comorbid hypertension (33.0%), dyslipidemia (28.6%), thyroid disorder (34.5%) and depression (28.8%). Mean total item DDS score was 2.3 (S.D. 0.8; moderate severity). The highest scores were observed in the powerlessness (mean = 3.2; S.D. 1.3), hypoglycemia distress (mean = 2.7, S.D. 1.3) and physician distress (mean = 2.4; S.D. 1.2) subscales. Mean PHQ-8 score was 6.8 (S.D. = 5.5; mild) and the mean GAD-7 score was 5.9 (S.D. 5.3, mild). BPQ mean T scores were 48.9 (S.D. 8.4) for Supradiaphragmatic and 50.6 (S.D. 8.9) for Subdiaphragmatic Reactivity subscales. Controlling for covariates, clinical categories of the DDS predicted significant differences in BPQ subscale T scores. Greatest differences in BPQ scores were observed between ‘no/little/low’ and ‘high’ distress DDS categories on all subscales (p’s &lt;= 0.001), with ‘high’ DDS having the highest BPQ scores. Findings confirm a relationship between ANS reactivity symptoms and diabetes-related distress in adults with T1D, consistent with the Polyvagal Theory. Development of interventions that target ANS regulation to treat DD for T1D adults are needed.

Disclosure
M. de Groot: None. B.A. Myers: None. T. Stump: None. D. Dana: None. J. Kolacz: None. S.W. Porges: None.

Funding
Indiana University School of Medicine
705-P: Health Literacy on Self-Management in Older Adults with Type 2 DM—Mediating Role of Self-Efficacy
Authors: KIM MINJIN , CHOEL LEE SANG , SUCK GOO YOUNG , PARK SUNHEE 
Published: June 2024

Background & Aims: In this digital era, eHealth literacy serves as a key factor influencing diabetic self-management; hence, further investigation into the psychological mechanisms underlying this relationship is necessary. This study aimed to determine if self-efficacy mediates the relationship between eHealth literacy and diabetes self-management in older adults with Type 2 diabetes (T2DM).
Methods: A cross-sectional study was undertaken, encompassing 105 Korean older adults with T2DM drawn from two outpatient clinics. Data on eHealth literacy, diabetes self-management, and self-efficacy were collected with structured self-report questionnaire. The data were analyzed using SPSS PROCESS Macro 4.0.
Results: We found that self-efficacy mediated the relationship between eHealth literacy and self-management. eHealth literacy and self-efficacy promote diabetes self-management, and higher eHealth literacy among older adults with T2DM can positively influence their diabetes self-management.
Conclusion: This study evaluated eHealth literacy and self-efficacy in diabetes self-management tasks among older adults with T2DM, which may help health care providers in tailoring individualized diabetes self-management care. Furthermore, strategies to enhance their access to internet-based information on diabetes health may contribute to improved diabetes self-management.

Disclosure
M. Kim: None. S. Lee: None. Y. Goo: None. S. Park: None.
709-P: Status and Influencing Factors of Resilience in Middle-Old Age Adults with Type 2 Diabetes on Insulin Therapy at Home
Authors: YANG QIAOLING , HE QIANYU , CHENG LI 
Published: June 2024

Introduction &Objective: Middle-old age adults with type 2 diabetes on insulin therapy at home often have a range of psychological issues because of the illness, which significantly affects both their physical and mental well-being and the therapeutic outcome. The aim of this study was to examine the status of resilience in this population and explore its influencing factors.
Methods: From September 2019 to January 2021, a total of 168 middle-old age adults with type 2 diabetes on insulin therapy were investigated by self-designed general and disease data questionnaire, Connor Davidson Resilience Scale (CD-RISC), Diabetes Management Self-efficacy Scale (DMSES), Social Support Rating Scale (SSRS) and Medical Coping Modes Questionnaire (MCMQ). Statistic methods including t-test, analysis of variance and multiple linear regression analysis were adopted to the data analysis.
Results: The CD-RISC score was (58.20±14.26), and the average score of optimism dimension is the highest(2.61±0.93). Multiple linear regression analysis showed that self-efficacy, social support and the coping style of facing and avoiding were the protective factors for resilience, and the coping style of yielding is the risk factor for resilience(all P&lt;0.05).
Conclusion: The resilience of the middle-old age adults with type 2 diabetes treated with insulin at home is sub optimal. Medical staff and family members should assist them in developing a proper medical coping style and provide them social support to boost their resilience.

Disclosure
Q. Yang: None. Q. He: None. L. Cheng: None.
753-P: Eating Behavior in Adults with Type 2 Diabetes from a Phase 2 Study of Retatrutide
Authors: KANU CHISOM , BOYE KRISTINA , LING POON JIAT , GOETZ IRIS A. , WILLIAMSON SUZANNE E. , LOU JITONG , COSKUN TAMER 
Published: June 2024

Retatrutide (RETA), a triple-hormone receptor agonist of GIP, GLP-1, and glucagon receptors, showed clinically meaningful improvements in HbA1c and robust body weight reductions in adults with T2D in a Phase 2 study. We compared eating behavior during treatment with RETA vs. placebo or dulaglutide (DU) in this study.
Adults with T2D were randomized to subcutaneous placebo QW, DU 1.5 mg QW, or RETA 0.5, 4, 8, or 12 mg QW for 36 weeks in this double-blind, double-dummy Phase 2 study. Eating behavior was assessed at baseline and Week 36 using the 51-item Eating Inventory comprised of three domains: Cognitive Restraint of Eating, Disinhibition, and Perceived Hunger.
Overall, 281 adults with mean baseline age 56 y, T2D duration 8.1 y, HbA1c 8.3%, and BMI 35.0 kg/m2 were randomized. At Week 36, adults treated with RETA 8 mg and 12 mg had significantly reduced Eating Inventory Disinhibition and Perceived Hunger scores vs. placebo. Adults treated with RETA 12 mg also had significantly reduced Disinhibition and Perceived Hunger scores vs. DU and a significantly reduced Cognitive Restraint of Eating score vs. placebo at Week 36.
RETA treatment significantly improved some eating behaviors such as overeating and hunger management more than placebo or DU in a dose-dependent manner, and improved other eating behaviors such as portion control and avoiding high calorie foods more than placebo in adults with T2D.

Disclosure
C. Kanu: None. K. Boye: Employee; Eli Lilly and Company. J. Poon: Employee; Eli Lilly and Company. Stock/Shareholder; Eli Lilly and Company. I.A. Goetz: Employee; Eli Lilly and Company. S.E. Williamson: Consultant; Eli Lilly and Company, Takeda Pharmaceutical Company Limited, GlaxoSmithKline plc, Novo Nordisk, Lundbeck. J. Lou: None. T. Coskun: Employee; Eli Lilly and Company. Stock/Shareholder; Eli Lilly and Company.

Funding
Eli Lilly and Company
763-P: CagriSema Improves Insulin Sensitivity in Diet-Induced Obese Rats
Authors: SECHER ANNA , BRAND CHRISTIAN L. , RAUN KIRSTEN 
Published: June 2024

Introduction & Objective: CagriSema (CS), a combination of the long-acting analogues of amylin (cagrilintide) and glucagon-like peptide-1 (semaglutide), is in clinical development for treatment of obesity and type 2 diabetes. Rodent studies have shown that CS treatment results in weight loss. It is unknown whether CS also leads to improvement of insulin sensitivity in diet-induced obese (DIO) rats which was the objective of this study.
Methods: DIO male rats were allocated into three groups (n=6) matched on body weight (BW), fat mass and fat-free mass: vehicle control (VC), CS, and a vehicle group that was weight matched (VWM) to CS by calorie restriction. BW and food intake (FI) were measured at baseline and during treatment. Food availability in VWM was adjusted daily. CS rats received 2 nmol/kg, sc, qd of each drug. After 21 days of treatment rats were instrumented (isoflurane) with carotid (sampling) and jugular (infusions) catheters. After 9-11 days recovery rats were subjected to a 180 min hyper-insulinemic (15 pmol/kg/min) euglycemic (~5.7 mM) clamp. 3H-glucose and 14C-2-deoxy-glucose (2DG) were employed to measure hepatic glucose production (HGP), glucose uptake (GU), and tissue 2DG uptake.
Results: FI initially decreased to 10% of baseline and BW reduced by 10% in CS and VWM rats. FI progressively returned to VC at the end of treatment without increase in BW. No change in fasting plasma glucose was observed, but insulin decreased by 40% (p&lt;0.03) in CS compared to VC. Clamp glucose infusion rates increased by 4.2- and 2.6-fold over VC in CS (p&lt;0.001) and VWM (ns), respectively. No significant differences in HGP but GU increased by 3.3- (p=0.002) and 1.6-fold (ns) over VC in CS and VWM, respectively. 2DG uptake increased in muscle but not in fat tissues in CS compared to VC.
Conclusion: CS increased insulin sensitivity in DIO rats by improving glucose uptake in muscle but not in fat tissues. An ongoing, higher-powered study will investigate the effects of CS and the two mono-components on insulin sensitivity in DIO rats.

Disclosure
A. Secher: Employee; Novo Nordisk A/S. Stock/Shareholder; Novo Nordisk A/S. C.L. Brand: Employee; Novo Nordisk A/S. Stock/Shareholder; Novo Nordisk A/S. K. Raun: Employee; Novo Nordisk A/S. Stock/Shareholder; Novo Nordisk A/S.
767-P: A Phase 1b/2a Study of the Safety and Tolerability of GSBR-1290, a Novel Oral Small Molecule Glucagon-Like Peptide 1 Receptor Agonist (GLP-1RA), in Healthy Overweight/Obese Volunteers (HOV) and Participants with Type 2 Diabetes Mellitus (T2DM)
Authors: COLL BLAI , ZHANG JINQIANG , CHEN LIBO , IBARRA LANI , YUE HUIBIN , BARTH ALINE , BACH MARK A. 
Published: June 2024

Introduction: GSBR-1290 is a novel, oral, non-peptide GLP-1RA and a potential alternative to injectable or oral peptides used for the treatment of T2DM and obesity. These studies were designed to evaluate the safety, tolerability, and efficacy of GSBR-1290.
Methods: Phase 1b: The safety and tolerability of multiple ascending doses of GSBR-1290 (5-90mg) and its effects on body weight (BW) were investigated in 24 HOV over 4 weeks. Phase 2a: The effects of GSBR-1290 on safety, tolerability, HbA1c, glucose, and BW were investigated in 54 participants with T2DM (45 and 90mg) over 12 weeks and in an interim 8-week analysis of 40 HOV (120mg).
Results: Phase 1b: There were no study discontinuations (d/c) due to adverse events (AEs). Most AEs were mild and GI-related, consistent with GLP-1RAs. BW was significantly reduced (up to 4.9% placebo-adjusted, p=0.013) over 4 weeks. Phase 2a T2DM: Two participants d/c from the study due to an AE (1 attributed to study drug: 2.8% d/c rate). Placebo-adjusted HbA1c (45 mg: -1.01%, p=0.008; 90 mg: -1.02%, p=0.001), BW (45 mg: -3.51%, p=0.0019; 90 mg: -3.26%, p=0.0013), and plasma glucose (45 mg: -2.70, p=0.01; 90 mg: -2.50, p=0.0008) were significantly reduced at day 84. Phase 2a Obesity: There were no study d/c due to AEs. Placebo-adjusted BW decreased though day 56 (120 mg: -4.74%; p&lt;0.0001). Complete 12-week results from the cohort of 24 additional participants will be available at presentation. For all phase 2a, AEs were mild-moderate and GI-related, with no SAEs related to GSBR-1290.
Conclusions: GSBR-1290 demonstrated favorable safety and tolerability in this Phase 1b/2a study in participants with T2DM and in HOV. GSBR-1290 demonstrated clinical benefits in lowering BW, blood glucose, and HbA1c. These data provide clinical proof-of-concept of GSBR-1290 and support further clinical development in T2DM and obesity.

Disclosure
B. Coll: Employee; Structure Therapeutics, Inc. J. Zhang: Employee; Structure Therapeutics, Inc. L. Chen: Employee; Structure Therapeutics, Inc. L. Ibarra: Employee; Structure Therapeutics, Inc. H. Yue: Employee; Structure Therapeutics, Inc. A. Barth: Employee; Structure Therapeutics, Inc. M.A. Bach: Employee; Structure Therapeutics, Inc.

Funding
Structure Therapeutics, Inc
77-PUB: Deep Learning–Powered Islet Quantification for Type 1 Diabetes
Authors: KANG SANGHOON , PENALOZA APONTE JESUS D. , MORILLO MICHAEL , ELASHKAR OMAR , WADDINGTON NICHOLAS , LAMB DAMON , JU HUIWEN , CAMPBELL-THOMPSON MARTHA , KIM SARAH 
Published: June 2024

Introduction & Objective: Islets in patients with type 1 diabetes (T1D) display a high degree of heterogeneity in sizes, numbers, architecture, endocrine and immune cell type compositions, and capillary density, compared to nondiabetic controls (ND). Extensive whole slide imaging (WSI) data collected through the JDRF Network for Pancreatic Organ donors with Diabetes (nPOD) is an opportunity to analyze T1D progression. We aimed to enhance the efficiency of quantitative WSI analysis using deep learning.
Methods: Multiple computational approaches were explored, including OpenCV, Hover-Net, Segment Anything Model (SAM), and a pixel classifier. We leveraged HiPerGator, UF supercomputer, and QuPath, open-source software widely used for WSI analysis. We tested the developed workflow using 30 WSI data (two slides from the pancreas tail region for five subjects in three disease states: ND, autoantibody+, and T1D).
Results: Among the tested approaches, we selected two deep learning models, SAM and the pixel classifiers implemented in QuPath. SAM was employed to yield precise boundaries of the islets within the Region of Interest (ROI) boxes implemented by the stain classifier. The pixel classifier was further applied to segment the areas corresponding to insulin and glucagon within each islet. We automated counting CD3+ cells detected inside and within 20um outside around the perimeter of the islets. For the testing data, we acquired accurate quantitative measurements for the areas of insulin and glucagon inside islets and the count of CD3+ cells.
Conclusion: With the developed workflow, we enhanced the efficiency of quantifying features of the WSI data. It also assists in defining insulitis more accurately by counting the number of CD3+ cells. We intend to utilize our workflow to extract features from a large set of WSI obtained through the JDRF nPOD program. Analyzing extracted features from WSI will aid in understanding T1D progression.

Disclosure
S. Kang: None. J.D. Penaloza Aponte: None. M. Morillo: None. O. Elashkar: None. N. Waddington: Employee; Pfizer Inc. D. Lamb: None. H. Ju: None. M. Campbell-Thompson: None. S. Kim: None.

Funding
JDRF (3-SRA-2022-1157-S-B)
775-P: Influence of Eating Behavior on Therapeutic Effects of GLP-1 Receptor Agonists over a One-Year Period
Authors: KOIDE YUYA , KATO TAKEHIRO , KUBOTA SODAI , SAKAI MAYU , TAKAHASHI YOSHIHIRO , TAKAO KEN , MIZUNO MASAMI , HIROTA TAKUO , HORIKAWA YUKIO , NISHIMURA KAYOKO , HAYASHI MAKOTO , DAIDO HISASHI , MARUYAMA TAKAKO , KURODA EIJI , YABE DAISUKE 
Published: June 2024

To evaluate the relationship of GLP-1RA therapy on HbA1c and body weight with eating behavior, a multicenter, prospective, observational study was conducted in Japanese individuals with T2D who had begun taking GLP-1RAs. The participants received two questionnaires: the Dutch Eating Behavior Questionnaire (DEBQ) and the Food Frequency Questionnaire (FFQg) and received blood tests and anthropometric measurements before and one year after initiation of a GLP-1RA. The DEBQ includes 33 questions regarding External, Emotional, and Restrained eating behaviors, i.e., eating prompted by external stimuli such as the appearance and smell of food, eating prompted by emotions such as anger and anxiety, and eating restrained by considerations for health, for example, respectively. Fifty-seven individuals (age 60.7±13.1 years; duration of diabetes 14.8±14.9 years, and BMI 29.1±5.6) participated in the study. HbA1c, body weight and % body fat were significantly reduced by GLP-1RA treatment overall [HbA1c (%), 8.1±1.5 to 7.0±1.2, p&lt;0.001; body weight (kg), 78.2±19.0 to 74.2±19.7, p&lt;0.001; and % body fat (%), 35.3±7.6 to 32.9±8.7, p&lt;0.001], while muscle mass was not affected [muscle mass (kg), 47.4±11.0 to 47.4±10.9, p=0.929]. Macronutrient intake was significantly decreased in all participants. The DEBQ external eating score (2.95±0.77 to 2.49±0.69, p &lt;0.001) significantly decreased, while the restrained eating score (2.83±0.73 to 3.00±0.76, p =0.133) and the emotional eating score (1.99±0.86 to 1.85±0.66, p=0.516) did not show significant change. In correlation analyses, a higher external eating score was found to be significantly associated with a greater reduction in HbA1c (Pearson's correlation coefficient r= -0.28, p= 0.036) and body weight (r= -0.300, p=0.025). Thus, GLP-1RAs exert a greater therapeutic effect in individuals with diabetes who are prompted to eat by external stimuli such as the appearance and smell of food than by emotional triggers or health considerations.

Disclosure
Y. Koide: None. T. Kato: None. S. Kubota: None. M. Sakai: None. Y. Takahashi: None. K. Takao: None. M. Mizuno: None. T. Hirota: None. Y. Horikawa: None. K. Nishimura: None. M. Hayashi: None. H. Daido: None. T. Maruyama: None. E. Kuroda: None. D. Yabe: Advisory Panel; Novo Nordisk. Speaker's Bureau; Novo Nordisk. Research Support; Novo Nordisk. Advisory Panel; Boehringer-Ingelheim. Speaker's Bureau; Boehringer-Ingelheim. Research Support; Boehringer-Ingelheim. Advisory Panel; Eli Lilly and Company. Speaker's Bureau; Eli Lilly and Company. Research Support; Eli Lilly and Company. Advisory Panel; Sanofi. Speaker's Bureau; Sanofi, Sumitomo Dainippon Pharma Co., Ltd., Kyowa Kirin Co., Ltd. Research Support; Terumo Corporation, Taiho Pharmaceutical Co. Ltd.
780-P: Soli-SWITCH—Efficacy and Safety of Switching to iGlarLixi from Premixed Insulins (PI) in People with Type 2 Diabetes (T2D)
Authors: HALUZIK MARTIN , CYPRYK KATARZYNA , ALVAREZ AGUSTINA , LAUAND FELIPE , CORP DIT GENTI VALERIE , BAKINER OKAN , LIM SOO 
Published: June 2024

Introduction & Objective: iGlarLixi, a once-daily injectable fixed-ratio combination of insulin glargine 100 U/mL + lixisenatide, has demonstrated improved glycemic control in people with T2D vs its monocomponents and may be a simplified treatment option vs PI. The Soli-SWITCH study (EudraCT number 2021-003711-25) assessed the efficacy and safety of switching to iGlarLixi in people with T2D currently receiving PI.
Methods: In this phase 4, 24-week, single-arm study, participants switched from PI to iGlarLixi at baseline. Key inclusion criteria: age ≥18 years, diagnosed with T2D, received PI for ≥3 months and &lt;10 years, ± oral antidiabetic drugs; HbA1c ≥7.5% to ≤10.0%. Those who experienced severe hypoglycemia &lt;6 months before screening were excluded. The primary endpoint was change in HbA1c from baseline to Week 24. Key secondary endpoints included the proportion of participants achieving HbA1c &lt;7% at Week 24 and safety.
Results: Overall, 162 participants received iGlarLixi (60% aged ≥65 years; 55% male; 88% PI twice-daily dosing; median duration of diabetes, 16.0 years). Mean PI dose at baseline was 39.5 units (U) (standard deviation [SD] 13.4), mean iGlarLixi dose at Week 24 was 40.6 U (SD 13.3). Mean baseline HbA1c (8.5%) was reduced by 1.2% (SD 0.9%; 95% confidence interval [CI], -1.4, -1.1) at Week 24. At Week 24, 37.6% participants had achieved a HbA1c target of &lt;7% (95% CI: 30.0, 45.7). Median body weight change from baseline to Week 24 was -0.9 kg (95% CI: -1.5, -0.3). Fasting and post-prandial plasma glucose decreased from baseline to Week 24 by 45.6 mg/dL (SD 52.4) and 67.6 mg/dL (SD 65.1), respectively. Confirmed symptomatic hypoglycemia occurred in 38.3% of participants (ADA level 1: 35.8%; ADA level 2: 15.4%; ADA level 3: 0.0%). No new safety signals were observed.
Conclusion: Switching from PI to iGlarLixi offered a simplified treatment option, with improved glycemic outcomes in people with T2D, with added weight benefits and low hypoglycemia risk.

Disclosure
M. Haluzik: Advisory Panel; Sanofi, Novo Nordisk, Eli Lilly and Company, AstraZeneca, Bayer Inc., Johnson & Johnson Medical Devices Companies. Consultant; Merck & Co., Inc., Sanofi, Novo Nordisk, Eli Lilly and Company, AstraZeneca, Bayer Inc., Boehringer-Ingelheim, Johnson & Johnson Medical Devices Companies, Novatin. Research Support; Sanofi. Speaker's Bureau; Sanofi, Novo Nordisk. K. Cypryk: Research Support; Novo Nordisk, Sanofi. Speaker's Bureau; Novo Nordisk, Eli Lilly and Company, Sanofi, Merck & Co., Inc. A. Alvarez: Employee; Sanofi. Stock/Shareholder; Sanofi. F. Lauand: Employee; Sanofi. Stock/Shareholder; Sanofi. V. Corp dit Genti: Employee; Sanofi. O. Bakiner: None. S. Lim: None.

Funding
Sanofi