bluuebunny/crossref_metadata_2025_split huggingface dataset:
722-P: One Year Real-World Evidence of Effectiveness of Carbohydrate-Restricted Nutrition Therapy in Adults with Prediabetes across Age Groups and Gender
Authors: ROBERTS CAROLINE G.P. , ADAMS REBECCA N. , ATHINARAYANAN SHAMINIE J. , VOLK BRITTANIE M. , ZOLLER ALISON R. , MCKENZIE AMY L. 
Published: June 2024

Prediabetes (preD) affects 38% of US adults with a higher prevalence in men than women and a growing presence among younger adults. Virta Health provides carbohydrate restricted nutrition therapy (CRNT) through continuous remote care (CRC) to US adults with preD, but the impact of the program across age and gender groups is unknown. This retrospective real-world study assessed differences in health marker change over one year between age groups, and secondarily between genders, with linear mixed effects models. One year retention was high across age groups (65%, 76%, 75%; ages 18-44, 45-64, 65+) and gender (74% male, 72% female), and a random sample (N=750) of patients enrolled one year was selected for this analysis. Broadly, all age groups and both genders improve multiple health markers over time (weight, A1c, triglycerides, HDLc, liver enzymes) with no or minimal change in Total Cholesterol, LDLc, and aspartate aminotransferase, and with few differences between groups. These results provide real-world evidence that CRNT favorably impacts glycemia, cardiometabolic health, and hepatic function in adults with prediabetes across age groups and in both men and women.

Disclosure
C.G.P. Roberts: Other Relationship; Virta Health Corp. R.N. Adams: Employee; Virta Health Corp. Stock/Shareholder; Virta Health Corp. S.J. Athinarayanan: Employee; Virta Health Corp. B.M. Volk: Employee; Virta Health Corp. Stock/Shareholder; Virta Health Corp. A.R. Zoller: Employee; Virta Health Corp. Stock/Shareholder; Virta Health Corp. A.L. McKenzie: Employee; Virta Health Corp. Stock/Shareholder; Virta Health Corp. Employee; Abbott.
723-P: "One Size Does Not Fit All” among Church-Based Black Adult Diabetes Prevention Program Participants
Authors: WILLIAMS LOVORIA B. , KAY RAYENS MARY , GUSTAFSON ALISON A. , KARLE ERIKA , MOSER DEBRA K. 
Published: June 2024

Black adults bear disproportionate obesity and Type 2 Diabetes.Group-based translation of the Diabetes Prevention Program is the gold standard with Black participants in these interventions having the lowest weight loss. Weight loss in the early intervention weeks predicts post-treatment outcomes. One limitation of these group-based interventions is that all receive the same treatment without personalized attention to those needing more support. We examined the weight loss effects of adding telephone motivational-interviewing (MI) sessions for Nonresponders (4-wk loss ≤ 1%) to their DPP intervention. Through a cluster randomized community based participatory design among Black churches, 216 participants received 18 group-based classes over 24 weeks delivered by trained Community Health Workers. Nonresponders in both intervention and control groups were identified with those in the intervention group receiving an additional weekly telephone MI session by CHWs to develop personalized strategies to overcome barriers to weight loss. Participants were 55 years (SD=11) with mean weight 234lbs (SD=53). Repeated measures mixed modeling evaluated the percent weight change from baseline to weeks 12 and 24, including class attendance as covariate, with separate models for Responders and Nonresponders. Significant effects in the Responder model (n=154) were time and classes attended (p&lt;u&gt;&lt;&lt;/u&gt;.001 for both). Among Nonresponders (n=62), significant effects were treatment group and classes attended (p .020 and.035, respectively). Nonresponders in the personalized telephone MI group achieved 2.7% weight loss compared to controls (0.3%). These results suggest that identifying potential Nonresponders early and adding personalized attention may enhance the effectiveness of group-based DPP programs.

Disclosure
L.B. Williams: None. M. Rayens: None. A.A. Gustafson: None. E. Karle: None. D.K. Moser: None.

Funding
National Institutes of Health (DK125801)
74-PUB: Knowledge, Attitude, and Practice of Individuals with Obesity—Insights from a Large Nationwide Survey
Authors: KAPOOR NITIN , GHOSH SUJOY , CHAWLA MANOJ S. , KESAVADEV JOTHYDEV , ANUJ MAHESHWARI , AGARWAL SANJAY , MAKKAR BRIJ , DESHPANDE NEETA 
Published: June 2024

Introduction & Objective: Understanding the awareness and behaviour of the public towards obesity can assist in implementing obesity management programs. Accordingly, this large-scale study evaluates the knowledge, attitude, and practice of individuals with different BMI statuses towards obesity awareness and management.
Methods: This pan-Indian study was conducted in the Asian-Indian population and responses to questions pertaining to their demographics, lifestyle habits, and awareness towards obesity and its management were collected. Comparison was made between different BMI groups classified using the Asian criteria: Underweight (&lt;18.5kg/m2), Normal (18.5-22.9kg/m2), Overweight (23.0-24.9 kg/m2), and Obese (&gt;25kg/m2). The data was expressed as proportions or descriptive statistics as applicable, and significance was calculated at α=5%.
Results: The survey included responses from 60325 individuals, with majority being obese (67.3%) or being overweight (15.3%). Overall distribution of gender (P&lt;0.0001) and education status (P&lt;0.0001) was significantly different across the groups. Majority of individuals with obesity (56.7%) considered obesity as a disease. The willingness to receive weight loss information was unaffected by their BMI status. A higher incidence of diabetes mellitus (P=0.0313) and dyslipidaemia (P=0.0206) was noted in individuals with obesity. Inclination to lose weight was highest in the group with obesity (69%), but all groups displayed similar weight loss efforts. Lifestyle habits facilitating obesity including longer idle times during weekdays (P&lt;0.0001), weekends (P&lt;0.0001) and higher frequency of eating out (P&lt;0.0001) were significantly higher among the obese compared to the normal group.
Conclusion: The majority of the participants had obesity and their admission of obesity as a disease indicates its impact on the quality of life in the Indian population and the need for devising treatment strategies.

Disclosure
N. Kapoor: None. S. Ghosh: None. M.S. Chawla: Advisory Panel; Novo Nordisk. Speaker's Bureau; Novo Nordisk. Advisory Panel; Biocon. Speaker's Bureau; Biocon. Advisory Panel; Eris Lifesciences Ltd. Speaker's Bureau; Eris Lifesciences Ltd. Advisory Panel; Torrent Pharmaceuticals Ltd. Speaker's Bureau; Torrent Pharmaceuticals Ltd. Advisory Panel; USV Private Limited, Lupin Pharmaceuticals, Inc. J. Kesavadev: None. M. Anuj: None. S. Agarwal: None. B. Makkar: None. N. Deshpande: None.
740-P: Persistence and Adherence of Once-Weekly GLP-1 Receptor Agonists in Patients with Type 2 Diabetes and Atherosclerotic Cardiovascular Disease in a Real-World Setting
Authors: DUNN TYLER , ZHU YONG , GRONROOS NOELLE , XIE LIN , NOONE JOSHUA , SARGENT ANDREW , YEDIGAROVA LARISA , BILLINGS LIANA K. 
Published: June 2024

Introduction & Objective: Multiple clinical trials have shown cardiovascular benefits from glucagon-like peptide 1 receptor agonists (GLP-1 RAs) in patients with type 2 diabetes (T2D). This study describes persistence and adherence of once weekly (OW) GLP-1 RAs use by patients with T2D and atherosclerotic cardiovascular disease (ASCVD) in a real-world setting.
Methods: The study used data from the Optum Research Database from 01 Jan 2017 through 28 Feb 2023 and identified adult patients with T2D and ASCVD with ≥1 pharmacy claim for OW GLP-1 RAs. The date of the first claim was the index date and the start of a variable follow up period. Persistence was defined as the number of days from the index date to either discontinuation of OW GLP-1 RAs or end of variable follow up. Percentages of persistent patients (those without discontinuation) were reported at 6, 12, and 18 months, as well as over the full variable follow up period. Adherence, measured as proportion of days covered (PDC) over the full variable follow up period, was reported for patients with at least 6, 12, and 18 months of follow up.
Results: Among a total of 29516 patients, the mean follow up duration was 535 days and mean persistence was 371 days; 63.9% of patients were persistent throughout their variable follow up period. Basic demographic and clinical characteristics were similar between persistent and non-persistent patients. At 6 months, 80.2% of patients were persistent; the percentage was 63.2% and 54.3% at 12 and 18 months, respectively. PDC was 0.72, 0.68, and 0.66 among patients with at least 6, 12, or 18 months of follow up, respectively.
Conclusions: Patients had at least two-thirds of PDC and 63.9% of them were persistent throughout their follow up. Identifying factors influencing persistence and adherence is imperative to guide interventions aimed at enhancing these aspects, thereby maximizing the cardiovascular benefits derived from GLP-1 RAs.

Disclosure
T. Dunn: Employee; Novo Nordisk. Y. Zhu: Employee; UnitedHealth Group. Stock/Shareholder; UnitedHealth Group. Other Relationship; UnitedHealth Group, Novo Nordisk. N. Gronroos: Other Relationship; UnitedHealth Group, Novo Nordisk. Stock/Shareholder; UnitedHealth Group. Employee; UnitedHealth Group. L. Xie: None. J. Noone: Employee; Novo Nordisk. A. Sargent: Other Relationship; Novo Nordisk. Employee; UnitedHealth Group. Other Relationship; UnitedHealth Group. L. Yedigarova: Employee; Novo Nordisk. Stock/Shareholder; AbbVie Inc. L.K. Billings: Advisory Panel; Novo Nordisk, Pfizer Inc.

Funding
Novo Nordisk, Inc.
744-P: Dosing Patterns of Tirzepatide (TZP) in Patients with Type 2 Diabetes (T2D) from a Commercially Insured U.S. Population
Authors: MODY REEMA , DESAI KARISHMA , TENG CHIA-CHEN , REZNOR GALLY , STOCKBOWER GRACE , GRABNER MICHAEL , BENNEYWORTH BRIAN D. 
Published: June 2024

Intro & Objective: Tirzepatide (TZP) is a once weekly glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 (GLP-1) receptor agonist (RA) approved in the US for treatment of T2D and obesity. The goal of this retrospective observational study was to understand the dosing patterns of TZP in people with T2D in a US commercially insured population.
Methods: Adult patients (pts) with T2D, with ≥1 Rx claim for TZP from 5/2022 to 8/2023, and ≥6 months of health plan enrollment before and after initiation were identified from the Healthcare Integrated Research Database (HIRD®). Baseline demographics and 6 months’ follow-up dosing patterns were described.
Results: The cohort included 15,665 pts (mean age 53 years, 59% female, 51% baseline GLP-1 RA use). Of the 96% of pts with a single prescription on each fill date, 43% started on 2.5 mg and 41% on 5 mg dose of TZP. The most common dose at 3rd fill was 5 mg (Figure 1). 70% of pts had ≥1 dose escalation; 56% on the 2nd and 23% on the 3rd fill. Median time to first escalation was 45 days; 33% escalated from 2.5 mg to 5 mg and 37% from 5 mg to 7.5 mg. Of the patients with no dose changes and ≥3 fills (n=2505), 57% stayed on the 5 mg dose and 26% of people on 2.5 mg.
Conclusion: Real-world evidence suggests that most patients with T2D had at least one dose increase for TZP, with 5 mg being the most prescribed and retained dose in the first 6 months of treatment with TZP.

Disclosure
R. Mody: Employee; Eli Lilly and Company. K. Desai: Employee; Carelon Research. Stock/Shareholder; Anthem, Inc. C. Teng: Employee; Carelon Research. G. Reznor: None. G. Stockbower: None. M. Grabner: Employee; Carelon Research. Stock/Shareholder; Anthem, Inc. B.D. Benneyworth: Employee; Eli Lilly and Company. Stock/Shareholder; Eli Lilly and Company.
75-OR: In-Silico Replay of Insulin Degludec and Liraglutide Clinical Trial Data in Subjects with Type 2 Diabetes
Authors: GANJIARJENAKI MOHAMMADREZA , FABRIS CHIARA , EL FATHI ANAS , LV DAYU , KOVATCHEV BORIS , BRETON MARC D. 
Published: June 2024

Introduction & Objective: The UVLab platform - equipped with a metabolic model and 6062 virtual subjects (VS) with type 2 diabetes (T2D) - describes T2D heterogeneity. This work evaluates UVLab's ability to replicate the findings from a 26-week phase 3 clinical trial (NCT01336023) comparing degludec (IDeg), liraglutaide (Lira), and a fixed-ratio combination of the two (IDegLira).
Methods: IDeg, Lira, and IDegLira were administered to the VS according to clinical trial protocol. Subpopulations matching early trial glycemic metrics were selected; later data were not used to inform the simulations. Hemoglobin A1c (HbA1c), fasting plasma glucose (FPG), daily drug dose, and hypoglycemia events (HE) over the 26-week study were compared between clinical trial and simulations.
Results: Subpopulations of 208, 283, and 417 VS for the IDeg, Lira, and IDegLira arm, respectively, were selected using a method matching mean and standard deviation of HbA1c, FPG, and HE from trial baseline, week-4, and week-8 (IDegLira only) data. Figure 1 shows the evolution of glycemic metrics, comparing clinical trial and simulations. Overall median absolute relative error across all metrics and arms was 2.6% [0.6-11%].
Conclusion: UVLab effectively replicates trial outcomes, affirming its predictive capability for T2D treatment. This endorses in-silico models for treatment planning and enhancement of clinical trials.

Disclosure
M. Ganjiarjenaki: None. C. Fabris: Research Support; Novo Nordisk A/S. Other Relationship; Novo Nordisk A/S, Dexcom, Inc. A. El Fathi: None. D. Lv: None. B. Kovatchev: Research Support; Dexcom, Inc., Novo Nordisk, Tandem Diabetes Care, Inc. Other Relationship; Dexcom, Inc., Johnson & Johnson Medical Devices Companies, Novo Nordisk, Sanofi. M.D. Breton: Consultant; Dexcom, Inc. Research Support; Dexcom, Inc. Speaker's Bureau; Tandem Diabetes Care, Inc. Research Support; Tandem Diabetes Care, Inc., Novo Nordisk. Speaker's Bureau; Vertex Pharmaceuticals Incorporated. Consultant; PhysioLogic Devices. Advisory Panel; Sanofi. Speaker's Bureau; Sanofi.
754-P: Effect of Retatrutide on Kidney Parameters in People with Type 2 Diabetes and/or Obesity—A Post-Hoc Analysis of Two Phase 2 Trials
Authors: HEERSPINK HIDDO L. , LU ZEQING , DU YU , DUFFIN KEVIN L. , COSKUN TAMER , HAUPT AXEL , HARTMAN MARK L. 
Published: June 2024

The prevalence of chronic kidney disease due to T2D and obesity is rapidly increasing. Retatrutide (RETA), an agonist of GIP, GLP-1 and glucagon receptors, showed marked effects in reducing body weight and HbA1c in people with T2D and/or obesity/overweight (OB). This post-hoc analysis assessed the impact of RETA on kidney parameters. Data from all participants in 2 phase 2 studies were included: T2D (N=281): RETA (0.5, 4, 8, 12 mg) vs dulaglutide 1.5 mg vs PBO (N=45-50/arm); OB (non-T2D; N=338): RETA (1, 4, 8, 12 mg) vs PBO (N=62-70/arm). Assessments included CKD-EPI creatinine eGFR (Cr-eGFR), cystatin C-based eGFR and urine albumin-to-creatinine ratio (UACR). Change from baseline was analyzed using mixed models for repeated measures; pairwise contrasts were used to compare RETA to PBO. At 36 wks in T2D, no difference was observed in Cr-eGFR between all RETA groups and PBO; UACR was significantly reduced vs PBO with RETA 12 mg (Fig). In OB, RETA 8 and 12 mg increased Cr-eGFR and decreased UACR compared to PBO at 48 wks. Results were similar when GFR was estimated from cystatin C. Blood pressure (BP) was significantly reduced in both studies. RETA 8 and 12 mg increased eGFR in people with OB but not in those with T2D. UACR and BP were reduced vs PBO with higher doses of RETA in both trials. These data suggest possible benefits on kidney function that warrant further investigation in larger populations.

Disclosure
H.L. Heerspink: Consultant; AstraZeneca, Bayer Inc., Boehringer-Ingelheim, CSL Behring, Eli Lilly and Company. Advisory Panel; Gilead Sciences, Inc. Consultant; Janssen Pharmaceuticals, Inc., Novartis AG, Novo Nordisk, Traveere Pharmaceuticals. Z. Lu: None. Y. Du: None. K.L. Duffin: Employee; Eli Lilly and Company. T. Coskun: Employee; Eli Lilly and Company. Stock/Shareholder; Eli Lilly and Company. A. Haupt: Employee; Lilly Diabetes. Stock/Shareholder; Lilly Diabetes. M.L. Hartman: Employee; Eli Lilly and Company. Stock/Shareholder; Eli Lilly and Company.

Funding
Eli Lilly and Company
756-P: Glucagon-Like Peptide-1 Receptor Agonists and the Risk of Endoscopy Failure or Aspiration—A Cohort Study
Authors: ALKABBANI WAJD , SUISSA KARINE , GU KRISTINE D. , JANE CROMER SARA , PAIK JULIE M. , BYKOV KATSIARYNA , HOBAI ION , WEXLER DEBORAH J. , PATORNO ELISABETTA 
Published: June 2024

Introduction & Objective: Several cases of aspiration during endoscopy have been reported in glucagon-like peptide-1 receptor agonists (GLP1RA) users due to residual gastric contents. We conducted a population-based cohort study to assess whether GLP1RA use, compared to sodium-glucose cotransporter 2 inhibitors (SGLT2i), is associated with an increased risk of endoscopy discontinuation or aspiration.
Methods: Using two insurance claim databases, we identified adults with type 2 diabetes who underwent an endoscopy and were on either GLP1RA or SGLT2i within 30 days before the procedure. Outcomes were discontinued procedure, aspiration, or intubation, occurring within 24 hours after endoscopy. We estimated the risk ratio (RR) after 1:1 propensity score (PS) matching.
Results: We identified 29,384 PS-matched pairs (mean age 61 years; 52% female). Among GLP1RA users, the risk/1000 patients was 14.4 for procedure discontinuation, 2.5 for aspiration, and 2.9 for intubation. Compared to SGLT2i, GLP1RA use was associated with a slightly higher risk of endoscopy discontinuation (RR=1.25; 95% CI=1.09-1.44) and no increased risk of aspiration or intubation.
Conclusion: In this study, we observed no association between GLP1RA use and aspiration or intubation during endoscopy; however, GLP1RA users were more likely to have the procedure discontinued, compared to patients on SGLT2i.

Disclosure
W. Alkabbani: None. K. Suissa: None. K.D. Gu: None. S. Cromer: Other Relationship; Johnson & Johnson Medical Devices Companies. Advisory Panel; Alexion Pharmaceuticals, Inc. Other Relationship; Wolters Kluwer Health. J.M. Paik: None. K. Bykov: None. I. Hobai: None. D.J. Wexler: Other Relationship; Novo Nordisk. E. Patorno: Research Support; Boehringer-Ingelheim, Food and Drug Administration (FDA), National Institutes of Health, Patient-Centered Outcomes Research Institute.
761-P: Use of Tirzepatide in Type 1 Diabetes
Authors: CHILDS BELINDA P. , TADE MACKENZIE , SEBES JENNIFER , MOLT LISA , CHILDS ALLISON 
Published: June 2024

In a retrospective chart review, we assessed the efficacy and safety of GLP1/GIP agonists, specifically tirzepatide, in managing Type 1 Diabetes (T1D). The study involved 15 patients (7 males, 8 females; average age 48 years; average diabetes duration 34 years), using Continuous Glucose Monitors (CGM). Among them, 8 on insulin pumps and 7 Multiple Daily Injections (MDI). Six had prior exposure to GLP1 agonists. The intervention, recognized as off-label, included careful insulin titration and ketone monitoring. Over 6-12 months, significant findings emerged: A1c levels significantly decreased at 6 months (Cohen's d = -0.79), indicating short-term effectiveness, but this change wasn't sustained at 1 year, suggesting the need for ongoing or modified approaches for long-term glycemic control. Additionally, there was a reduction in average Body Mass Index (BMI) with baseline 34.7, 6 month 31.7, 1 year 28.9 (Box and Whisker availble) and insulin requirements (attached) at both intervals, reflecting improved metabolic health and insulin sensitivity. Risks were mitigated through strategic insulin reduction. However, one patient discontinued due to severe hypoglycemia despite these adjustments. Mild nausea and constipation were reported in 3 patients. These findings, while preliminary, highlight the potential benefits of GLP1/GIP agonists in T1D management, warranting further investigation despite the risk of hypoglycemia and other side effects.

Disclosure
B.P. Childs: Research Support; Abbott. Advisory Panel; Provention Bio, Inc. M. Tade: None. J. Sebes: None. L. Molt: None. A. Childs: None.
78-PUB: Machine Learning–Assisted Segmentation of Pancreas MRI
Authors: TIRADO-VELEZ PEDRO L. , KANG SANGHOON , JU HUIWEN , CAMPBELL-THOMPSON MARTHA , KIM SARAH , LAMB DAMON 
Published: June 2024

Introduction & Objective: Pancreas volume (PV) may be a useful biomarker for T1D, but manual segmentation of PV from an MRI is time consuming. The objective of this project was to develop and evaluate the efficiency of a machine-learning (ML) pipeline for pancreas MRI segmentation to calculate pancreas volume.
Methods: Manual and ML-assisted PV MRI segmentations were created from a sample of 68 including 15 controls (no diabetes) from an existing dataset (PMID: 30552130). We linked a local 3D Slicer (PMID: 22770690) instance with a hardware-accelerated MONAI Label server instance on the UF HiPerGator cluster for our ML-assisted segmentations. We evaluated the relative efficiency of ML-assisted vs. manual to create high quality segmentation of the pancreas.
Results: ML-assisted segmentations are of high-quality. ML-assisted segmentation resulted in a reduction of average time per segmentation by 5 minutes and a reduction of average total mouse-clicks by 28% when completed by a minimally-trained (non-radiologist) staff.
Conclusion: ML-assted segmentation can result in significant productivity gains for pancreas segmentation without loss of data quality or accuracy, reducing costs associated with radiological MRI segmentation for PV.

Disclosure
P.L. Tirado-Velez: None. S. Kang: None. H. Ju: None. M. Campbell-Thompson: None. S. Kim: None. D. Lamb: None.

Funding
JDRF (3-SRA-2022-1157-S-B)