bluuebunny/crossref_metadata_2025_split huggingface dataset:
718-P: A High FODMAP Diet Reduces Glycemic Excursion without Increasing Gastrointestinal Symptoms in Individuals with Prediabetes Treated with Metformin—A Randomized Crossover Controlled-Feeding Trial
Authors: CHU NATURAL , POON EMILY W.M. , CHAN JULIANA C. , CHOW ELAINE 
Published: June 2024

Introduction: Diet and gut microbiota interactions may influence efficacy and tolerability of metformin. Pre-treatment with a diet rich in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAPs) may improve postprandial plasma glucose (PG) responses in individuals with prediabetes receiving metformin.
Methods: 26 individuals with impaired glucose tolerance (IGT) [age median(IQR) 58(48-60) years, 46% men, and 2-hour plasma glucose (2hPG) mean±SD 9.2±1.0 mmol/L] participated in a double-blinded, randomized, cross-over controlled-feeding trial. All participants received equicaloric, high or low FODMAP diets for 10 days in combination with 5 days of metformin XR 1000mg daily, separated by at least 2 weeks washout. Continuous glucose monitoring (CGM), oral glucose tolerance tests (OGTT) with insulin and glucagon-like peptide 1 (GLP-1), microbiota profiles and gastrointestinal symptoms were assessed at baseline and each study period.
Results: Both interventions with metformin reduced blood glucose and body weight compared with baseline. High FODMAPs, as compared with low FODMAPs with metformin, led to lower total postprandial CGM glucose incremental area-under-the-curve (ppiAUC0-3h) (891±269 vs 997±307 mmol/L.min-1, p=0.021) and 2h-PG (7.1±1.7 vs. 8.1±1.9 mmol/L, p=0.017). We observed higher 2-hour total GLP-1, lower high-sensitivity C-reactive protein and a higher relative abundance of Bifidobacterium longum after high-FODMAPs with metformin. There were no differences in gastrointestinal symptoms between interventions.
Conclusion: High FODMAPs with metformin improved postprandial PG without increasing gastrointestinal symptoms in people with IGT. Fermentable carbohydrates promote specific short-chain fatty acids-producing bacteria, which may improve glycemic regulation via gut hormones and anti-inflammation.

Disclosure
N. Chu: None. E.W.M. Poon: None. J.C. Chan: Research Support; AstraZeneca, Hua Medicine. Consultant; Sanofi. Research Support; Servier Laboratories. Consultant; Viatris Inc. Research Support; Merck & Co., Inc. Stock/Shareholder; GemVCare Ltd. Board Member; Asia Diabetes Foundation. Speaker's Bureau; Zuellig Pharma Holdings Pte. Ltd. Advisory Panel; Bayer Inc. Speaker's Bureau; Boehringer-Ingelheim. E. Chow: Research Support; Merck KGaA. Speaker's Bureau; AstraZeneca. Advisory Panel; Boehringer-Ingelheim. Research Support; Medtronic. Speaker's Bureau; Zuellig Pharma Holdings Pte. Ltd., Abbott.

Funding
Merck Investigator-sponsored study (MS200084_0060)
720-P: Cardiometabolic Markers Improve with Modest Weight Loss in Prediabetes Population after 12 Months in a Carbohydrate-Restricted Nutrition Therapy Program
Authors: ZOLLER ALISON R. , ADAMS REBECCA N. , ATHINARAYANAN SHAMINIE J. , ROBERTS CAROLINE G.P. , VOLK BRITTANIE M. , MCKENZIE AMY L. 
Published: June 2024

Obesity increases the risk of metabolic conditions such as diabetes and heart disease. While losing weight improves metabolic health, the question remains if there is a minimum weight loss (WL) associated with clinically meaningful improvements in cardiometabolic health markers. Virta Health is a telemedicine clinic offering carbohydrate-restricted nutrition therapy (CRNT) via continuous remote care for patients including those with prediabetes (preD). This retrospective analysis examined the cardiometabolic outcomes of preD patients in five WL categories after 1 year on CRNT using eight linear mixed effect models. A random sample of 250 individuals was used to compare each WL cohort (&lt;5%, 5-9%, 10-14%, 15-19%, ≥20%). Metabolic markers assessed were HbA1c, total cholesterol (TC), LDL-C, HDL-C, TG, ALT, AST, and ALP. Characteristics of WL cohorts combined were 51.7 ± 9.4 years, BMI 37 ± 7.4 kg/m2, 234.9 ± 54.7 lbs, HbA1c 5.8 ± 0.3%, and 65% female. Overall, all cardiometabolic markers improved over time. All markers except TC and LDL-C improved more with greater WL. LDL-C increased (but was still within normal range) with more WL and TC did not differ by WL group. Although greater WL was associated with greater improvements in metabolic health markers, 5% WL produced clinically meaningful improvements in TG and HDL-C in the preD population on CRNT.

Disclosure
A.R. Zoller: Employee; Virta Health Corp. Stock/Shareholder; Virta Health Corp. R.N. Adams: Employee; Virta Health Corp. Stock/Shareholder; Virta Health Corp. S.J. Athinarayanan: Employee; Virta Health Corp. C.G.P. Roberts: Other Relationship; Virta Health Corp. B.M. Volk: Employee; Virta Health Corp. Stock/Shareholder; Virta Health Corp. A.L. McKenzie: Employee; Virta Health Corp. Stock/Shareholder; Virta Health Corp. Employee; Abbott.
726-P: Preventing Glycolysis with the VACUETTE FC Mix Tube—An Accurate Diagnosis of Diabetes
Authors: GRIEBENOW SIRID , DE KOZLOWSKI SANDRA 
Published: June 2024

Background: Diabetes continues to be one of the most prevalent diseases worldwide. According to the IDF (International Diabetes Federation), 537 million people were diagnosed with diabetes in 2021. This number is estimated to reach 643 million by 2030. Gestational Diabetes, which affects vulnerable populations, increased by 13% from 2019-20. Currently, the process for blood collection and analysis of glucose can require a transport time of up to 48 hours to the laboratory. The current practices used to stabilize glucose are to either place the sample in a centrifuge immediately or in an ice slurry and subsequently spin within 15-30 minutes. These practices are not consistently done across laboratories as it is not always practical. The impact of different storage conditions on glucose stability in the FC Mix tube was studied.
Method: The study took place at a laboratory in Austria. A European ethics committee approved the study. Apparently healthy subjects (n=20) were recruited and consented. Subjects were advised to fast prior to blood collection. Venous blood was drawn from each subject into four tubes. Tubes were inverted 10 times prior to centrifugation (1800 g for 10 minutes). Samples were spun and analyzed at different timepoints (0h, 7h, 24h, and 48h) to assess the stability of glucose. A portion of the samples remained in the original tube and a portion was aliquoted following spinning. The platform used was the Beckman Coulter AU680. Statistical evaluation was done using GLIMS.
Results: The evaluation of all results was based on a Total Change Limit of 3.55% for Glucose. Performance testing revealed no clinically significant differences between timepoints. Storage of whole blood specimens for 48h at RT led to a deviation of 3.34% and in a refrigerator for 48h led to a deviation of 2.36%. The measurement of plasma aliquots after 48h revealed a deviation of 1.45% compared to the plasma at 0h.
Conclusion: The FC Mix tube is suitable for stabilizing blood glucose under a variety of storage conditions up to 48h.

Disclosure
S. Griebenow: Other Relationship; Greiner Bio One GmbH. S. de Kozlowski: None.
728-P: Experience with Teplizumab in the PROTECT Type 1 Diabetes (T1D) Study during the COVID-19 Pandemic
Authors: GITELMAN STEPHEN E. , HEROLD KEVAN C. , SIMMONS KIMBER M. , SUMNIK ZDENEK , KNECHT LAURA , NIEMOELLER ELISABETH , TIAN WEI , COMER GAIL M. , MILLER DIANA E. , RAMOS ELEANOR L. 
Published: June 2024

Background & aims: Teplizumab is a humanized anti-CD3 monoclonal antibody approved to delay Stage 3 T1D onset in individuals ≥8 years with Stage 2 T1D. The Phase 3 PROTECT study (NCT03875729) was conducted during the COVID-19 pandemic. COVID 19 incidence was similar between the teplizumab (22.6%) and placebo (PBO; 23.4%) groups. No participants with an AE of COVID-19 were hospitalized or received antiviral treatment. Here we report our experience of an immunomodulatory therapy during a pandemic.
Methods: Participants aged 8-17 years, diagnosed ≤6 weeks with Stage 3 T1D, were randomized 2:1 to two 12-day courses of teplizumab or PBO, administered 6 months apart. Due to the COVID-19 pandemic, modified dosing was permitted, allowing for the 2nd course to be given at 12 months, instead of 6 months. COVID-19 testing was required before each course.
Results: Rates of overall infections were similar (65.9% vs 63.1%) in the teplizumab and PBO groups, respectively. The rate of Grade ≥3 infections was similar between treatment groups; 1 (0.5%) participant had a Grade ≥3 infection in the teplizumab group (cellulitis), compared with 2 (1.8%) participants in the PBO group (cellulitis and gastroenteritis; n=1 each). No serious AEs of infection were reported for participants in the teplizumab group. Few participants experienced AEs of infection that led to study drug discontinuation: 1 (0.5%) participant in the teplizumab (COVID-19) and 2 (1.8%) participants experienced 3 AEs in the PBO group (COVID-19, cellulitis, and device-related bacteremia). COVID-19-related protocol deviations were comparable in both groups and were mainly related to study visit or laboratory testing.
Conclusions: Incidence of infections, and rates of study drug discontinuation related to AEs of infection, were similar for teplizumab and PBO. Notably, COVID-19-related AEs were not increased by teplizumab treatment, supporting the concept that teplizumab is immunomodulatory, rather than immunosuppressive, therapy.

Disclosure
S.E. Gitelman: Advisory Panel; Abata Therapeutics, Avotres Inc., Genentech, Inc., GentiBio, SAB Biotherapeutics, Inc., Sanofi. K.C. Herold: Consultant; Sanofi. K.M. Simmons: Advisory Panel; Provention Bio, Inc. Consultant; Provention Bio, Inc. Research Support; Provention Bio, Inc., Novartis AG. Consultant; Medtronic. Z. Sumnik: None. L. Knecht: Employee; Sanofi, Provention Bio, Inc. E. Niemoeller: Employee; Sanofi-Aventis Deutschland GmbH. Stock/Shareholder; Sanofi. W. Tian: Employee; Sanofi. G.M. Comer: Consultant; Provention Bio, Inc., Sanofi. D.E. Miller: Employee; Provention Bio, Inc., Sanofi. E.L. Ramos: None.

Funding
Provention Bio, a Sanofi company
731-P: Retrospective Observational Study on the Impact of Digital Therapy on Glycemic Control in Indian Type 2 Diabetes Patients
Authors: GUHA SHAIBAL , KUMAR SUBHASH , SINHA AJAY K. , SHANKAR ANAND , DAS AMIT K. 
Published: June 2024

Introduction: Amidst increasing Type 2 Diabetes in India, novel diabetes management methods are essential. This study evaluates the real-world effects of a digital therapeutic on glycemic control in Indian T2DM patients, reflecting the potential of technology-based interventions.
Methods: A retrospective observational study involved 250 Indian T2DM patients using a digital therapeutic for at least six months. The platform provided personalized dietary, exercise guidance, medication reminders, and educational content. Primary outcomes measured were changes in Hemoglobin A1c (HbA1c) levels from baseline to six months. Secondary outcomes included fasting blood glucose changes and patient adherence. Data were analyzed using paired t-tests and regression models to adjust for confounders.
Results: After six months of using the digital therapeutic, patients showed a significant reduction in HbA1c levels (mean decrease of 0.9%, p&lt;0.001). Fasting blood glucose also significantly decreased (average reduction of 20 mg/dL, p&lt;0.01). High adherence to the application was associated with greater improvements in glycemic control. Subgroup analyses indicated more pronounced benefits in patients with higher baseline HbA1c levels.
Conclusion: The digital therapeutic significantly improved glycemic control in Indian T2DM patients, especially those with initially poor control. This indicates digital interventions as effective supplements to conventional diabetes management in India. More extensive, long-term studies are needed to validate these findings and explore lasting effects.

Disclosure
S. Guha: None. S. Kumar: None. A.K. Sinha: None. A. Shankar: None. A.K. Das: None.
738-P: Real-World Effectiveness among Patients with Type 2 Diabetes (T2D) Initiating Tirzepatide (TZP)
Authors: MODY REEMA , DESAI KARISHMA , TENG CHIA-CHEN , REZNOR GALLY , STOCKBOWER GRACE , GRABNER MICHAEL , BENNEYWORTH BRIAN D. 
Published: June 2024

Introduction & Objective: 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 single-cohort retrospective study was to assess effectiveness of TZP in patients (pts) with T2D in a US commercially insured population.
Methods: Adult pts diagnosed with T2D, initiating TZP between 5/2022 and 8/2023, with ≥1 A1C result around initiation and another 6 months post-initiation were identified from the Healthcare Integrated Research Database (HIRD®). Baseline demographics, A1C and weight outcomes at 6-month follow-up for overall cohort and stratified by prior GLP-1 RA use and baseline A1C (&lt;7% vs ≥7%) were described.
Results: Among 2,247 identified pts: mean age 54 years, 58% female, 46% no prior GLP-1 RA use, 59% A1C ≥7%, 61% had overweight/obesity. At 6-month follow up, mean pre-post change in A1C was -1.0% in the overall cohort, -1.4% among pts with baseline A1C ≥7%, and -1.3% in those without prior GLP-1 RA use. Mean change in weight was -6.3 kgs for overall cohort, -5.8 kgs in pts with baseline A1C ≥7%, and -8.1 kgs in those without prior GLP-1 RA use. Further outcomes are summarized in Table 1.
Conclusion: At 6-month follow up, pts initiating TZP in the real world showed reductions in A1C and weight, with greater A1C decreases observed among pts with no prior GLP-1 RA use or with baseline A1C ≥7%.

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.
749-P: Tirzepatide as an Add-on for Participants with Inadequate Glycemic Control Using Basal Insulin—Pooled Subgroup Analysis of SURPASS-5 and -6
Authors: BAJAJ HARPREET S. , BILLINGS LIANA K. , LIU MINZHI , LEVINE JOSHUA A. , RODRÍGUEZ ÁNGEL , PATEL HIREN 
Published: June 2024

Introduction & Objective: In SURPASS-5 and -6, tirzepatide (TZP) added to basal insulin significantly improved glycemic control vs. comparators in participants with type 2 diabetes (T2D) with inadequate glycemic control (HbA1c [%] 7.0-10.5 and 7.5-11.0, respectively). Analyses evaluated key clinical parameters at Week 40 within participant subgroups.
Methods: A post hoc analysis including TZP-treated participants using titrated insulin glargine (100 IU/mL) with or without metformin by subgroup: age (&lt;65, ≥65 years), T2D duration (&lt;10, ≥10 years), and baseline (BL) HbA1c (≤8.5%, &gt;8.5%). Data were pooled for SURPASS-5 and -6 up to Week 40.
Results: Overall, 1072 participants were included. At BL, mean age was 59.3 years; 583 (54.4%) were female; mean T2D duration was 13.5 years; mean weight was 92.3 kg, mean HbA1c was 8.6%, and median insulin dose was 42 IU/day. For all subgroups, TZP treatment significantly reduced HbA1c and weight from BL to Week 40 without heterogeneity. Incidence of clinically significant hypoglycemia was numerically higher for participants in HbA1c &gt;8.5% and T2D duration ≥10 years subgroups (Table).
Conclusion: In this post hoc analysis of people with T2D and inadequate glycemic control with basal insulin with or without metformin, participants treated with TZP experienced significantly improved HbA1c and weight across different subgroups.

Disclosure
H.S. Bajaj: Research Support; Abbott, Amgen Inc., Anji Pharmaceuticals, Boehringer-Ingelheim, Eli Lilly and Company, Novartis Pharmaceuticals Corporation, Novo Nordisk, Pfizer Inc. L.K. Billings: Advisory Panel; Novo Nordisk, Pfizer Inc. M. Liu: Consultant; Eli Lilly and Company. J.A. Levine: Employee; Eli Lilly and Company. Stock/Shareholder; Eli Lilly and Company. Á. Rodríguez: Employee; Eli Lilly and Company. Stock/Shareholder; Eli Lilly and Company. H. Patel: None.
76-OR: Diabetes Technology and Waste—A Real-World Study in a Specialized Practice in Germany
Authors: PETRY SEBASTIAN F. , PETRY FRIEDRICH W. , PETRY JOHANNES K. , GAETH STEFAN , HEINEMANN LUTZ 
Published: June 2024

Introduction & Objective: Diabetes technology is a pillar of modern diabetes therapy. No real-world data about the amount of waste generated was published before. The aim of our study was to quantify this “diabetes technology waste” in a real-world situation in a specialized diabetes practice in Germany. We also evaluated the awareness for this topic.
Methods: 68 patients with diabetes and insulin treatment were enrolled and completed the study. Patients were asked to collect all therapy-associated waste for three months. Their attitude towards sustainability of antidiabetic therapy, waste generation, and their own waste reduction/separation behavior was surveyed.
Results: In total, around 4,300 test strips, 500 glucose sensors, 12,600 lancets, 500 insulin cartridges, 550 pens and 1,000 pieces of aids for insulin pump therapy were collected. Extrapolating these data on the basis of people with intensified conventional insulin therapy, it can be estimated that at least 1.2 billion pieces of diabetes technology waste are generated in Germany per year. Type and quantity of waste clearly differed depending on diabetes type and type of antidiabetic therapy. Most patients (75%) were surprised by the amounts of waste which in turn led to an increased awareness towards the resource consumption of their therapy (69%), an enhanced interest in waste separation (83%) and a demand for the reduction and recycling of devices/aids (97%). Participants demand for disposal or recycling by the companies (76%), waste separation and collection points in medical practices, clinics, and pharmacies (86%), and more support for sustainability from the medical associations (97%).
Conclusion: This first real-world evaluation of the amounts of diabetes technology waste documents impressive data. Study participants complained about the limited number of recycling options. They expressed a demand for improved sustainability of medical products, especially after having collected the associated waste for three months.

Disclosure
S.F. Petry: None. F.W. Petry: None. J.K. Petry: None. S. Gaeth: None. L. Heinemann: Stock/Shareholder; Science Consulting in Diabetes GmbH, Profil Institut für Stoffwechselforschung GmbH. Advisory Panel; embecta. Board Member; Lifecare A/S. Stock/Shareholder; diateam GmbH.
762-P: Semaglutide Awareness among Clinical-Year Medical Students
Authors: NAHAR ALAM NAZMUN , IFFAT MEEM ANJUMAN , SHAMSHER SHIVALI , M NIAZUR RAHMAN S 
Published: June 2024

Introduction & Objective: Semaglutide, a novel type 2 diabetes (T2D) medication, offers significant advantages over other antidiabetic drugs by facilitating weight reduction, preventing cardiovascular complications, and minimizing hypoglycemic risks. Prescriptions for Semaglutide, to treat obesity and T2D have surged by 150% in the past year, according to recent data. While medical students play a crucial role in the healthcare workforce, limited data exists regarding their knowledge on use of Semaglutide. Enhancing students' awareness and understanding of this drug is expected to improve the management of T2D. This study aims to evaluate the knowledge and academic practice of Semaglutide among clinical year medical students.
Methods: We conducted a cross-sectional survey among clinical year medical students (years 3 to 5). Data were collected by administering a questionnaire focused on Semaglutide awareness, including 14 knowledge-based and 8 academic practice-related questions.
Results: Among 243 respondents, the average student scored 57% on the knowledge questionnaire. Year 5 students exhibited higher knowledge scores (78%) compared to other years. The majority of participants reported minimal coverage of Semaglutide in classroom (72%), bedside (74%), and clinical clerkship (71%). Although 86% students agreed on the utility of learning newer drugs through PBL, lectures were chosen as the preferred method when selecting the single best (62%) choice. Participants from all academic years reported minimal observance of Semaglutide prescription during their clinical placements.
Conclusion: Our data highlights a knowledge gap among medical students regarding newer therapeutics for T2D. These results emphasize the importance of integrating educational content on emerging diabetes drugs into various teaching methods throughout the medical curriculum to enhance clinical care standards.

Disclosure
N. Alam: None. A. Meem: None. S. Shamsher: None. S. Rahman: None.
769-P: Efficacy and Safety of GLP1RAs in Liver-Transplanted People with Diabetes—Ad Interim Results of a 24-Month Trial
Authors: GRANCINI VALERIA , COGLIATI IRENE , GAGLIO ALESSIA , RESI VERONICA , ORSI EMANUELA 
Published: June 2024

GLP1 RAs are first line drugs for DM2, due to their effects on glycemic control, cardiorenal protection and weight-loss action. However, consistent data about efficacy and safety in patients with liver transplant (LT) are lacking.
Aim: to assess the efficacy and safety of GLP1RAs in people with LT and diabetes in a period of 24 months.
Methods: 52 patients with DM and LT, were enrolled: follow up visits were planned 6-12-24 months after starting a GLP1RA-based therapy (dulaglutide or injectable semaglutide), as add on to metformin or insulin. We assessed glycemic control, body weight and composition (with bio-impedance analysis), liver fibrosis and steatosis (with transient elastography). Amylase, lipase levels and concomitant therapies were recorded at all visits. Patients had an e-mail contact to report any adverse events (AE). At the ad interim analysis, all patients enrolled underwent the first follow up visit, 29 patients completed the study.
Results: We observed a decrease in blood glucose (BG - 8.0±2.2 to 6.8±1.45 to 7.4±1.7mmol/L) and HbA1c (7.1±0.9 to 6.5±1.0 to 6.4±0.6%), p&lt;0.01. BMI, fat mass e fat free mass showed a slight, non significative, improvement. We found no changes in data from elastography. 3 patients interrupted the treatment due to major AE (2 had pancreatitis 8 and 12 month from baseline, 1 had an increase of lipase &gt; 3 times the normal values. Of them, all suffered from biliary strictures). At the short-term follow up, we already observed the improvement in BG and HbA1c (p&lt;0.01), amylase and lipase didn’t increase significantly. 14 people (26.9%) reported mild nausea, but only 3 patients (5.8%) reduced the drug dose. Among 30 patients requiring insulin at enrollment, 15 (50%) and 5 (16.6%), respectively, reduced or suspended insulin therapy in the first 6 months.
Conclusions: GLP1RAs can be considered effective in patients with LT. Further studies are needed to assess if post-surgery biliary strictures could be a potential contraindication to their use.

Disclosure
V. Grancini: Speaker's Bureau; Vertex Pharmaceuticals Incorporated. I. Cogliati: None. A. Gaglio: Consultant; Boehringer-Ingelheim. V. Resi: None. E. Orsi: Speaker's Bureau; Sanofi, Lilly Diabetes, AstraZeneca.