bluuebunny/crossref_metadata_2025_split huggingface dataset:
816-P: Health Care Resource Utilization and Costs with Timely vs. Delayed Basal Insulin Initiation
Authors: BILLINGS LIANA K. , SHETH SUNNY T. , BRADY BRENNA , RICHARDS MEGAN , RAJPURA JIGAR R. , MITRI JOANNA 
Published: June 2024

Introduction & Objective: Many patients with uncontrolled type 2 diabetes (uT2D) on other glucose-lowering medications (GLMs) eventually require basal insulin, but initiation is often delayed. This study assessed the potential impact of the timing of insulin initiation by examining healthcare utilization and costs among patients with timely vs delayed basal insulin initiation.
Methods: In the 2011-2018 MerativeTM Claims-EHR Database, adults with uT2D who were candidates for basal insulin (HbA1c&gt;7%, ≥2 GLMs totaling ≥180 days’ supply, no new GLM class in the next 90 days) and newly initiated treatment were selected. The index date was the first basal insulin fill. Timely and delayed initiators started treatment &lt;6 months and ≥6 months after meeting criteria for uT2D, respectively. Patients had ≥12 months of pre- and post-enrollment, no claims for type 1 diabetes or pregnancy, and ≥1 claim for T2D. All-cause healthcare utilization and costs were compared between cohorts in the pre- and post-periods.
Results: This study included 1,054 (29.2%) timely and 2,561 (70.8%) delayed initiators. Prior to basal insulin initiation, timely initiators had greater use of inpatient and emergency services, and significantly higher total costs ($26,460±$60,743 vs $21,703±38,825, p&lt;0.01) and mean HbA1c (9.3±1.8 vs 8.9±1.5, p&lt;0.001) compared to delayed initiators. Following treatment, both cohorts had similar utilization, costs and HbA1c values. Total costs from the pre- to post-period decreased in the timely initiator cohort (-$827) despite higher initial costs but increased in the delayed initiator cohort ($4,788).
Conclusion: Given the chronic nature of T2D, decreases in total costs over the study period among timely initiators highlighted the potential benefits of prompt basal insulin initiation for containment of healthcare costs. The same economic benefits were not observed among delayed initiators whose costs increased 22% in the post-period.

Disclosure
L.K. Billings: Advisory Panel; Novo Nordisk, Pfizer Inc. S.T. Sheth: Employee; Novo Nordisk. B. Brady: None. M. Richards: None. J.R. Rajpura: Employee; Novo Nordisk. J. Mitri: Advisory Panel; MannKind Corporation. Consultant; Novo Nordisk. Research Support; Kowa Pharmaceuticals America, Inc. Consultant; Lilly Diabetes, Dianomi-. Employee; sequelmedtech. Consultant; AbbVie Inc., beigene-spouse, cellectar-spouse, kite-spouse, Janssen Pharmaceuticals, Inc., loxo- spouse, AstraZeneca.

Funding
Novo Nordisk Inc.
82-OR: Association of Diabetic Complications and Various Comorbidities with Major Adverse Cardiovascular Events in Type 2 Diabetes and Their Development over Time—A Danish Registry-Based Case-Control Study
Authors: BECH ASGER A. , MADSEN MIA D. , KVIST ANNIKA V. , VESTERGAARD PETER , RASMUSSEN NICKLAS H. 
Published: June 2024

Introduction and Objective: Type 2 diabetes mellitus (T2DM) is associated with an increased risk of cardiovascular disease (CVD). This study aimed to investigate the association between risk factors for major adverse cardiovascular events (MACE) over time.
Methods: In this case-control study, data from Danish registries was utilized to identify peopled diagnosed with T2DM between 1999-2018 (n=347,121) and then subdivided into cases and controls for each of two 10-year time periods; TP1: 1999-2008 and TP2: 2009-2018. Cases were defined as having suffered three-point MACE (nTP1=13,584, nTP2=10,823) with controls matched 1:1 on age, gender, and T2DM duration. Exposures were preselected diabetic complications and comorbidities, identified using ICD-10 and/or ATC codes. The association was analyzed using conditional logistic regression.
Results: Comorbidities strongly associated with MACE included hypertension (ORTP1 = 2.32, 95% CI 2.18-2.47 ORTP2 = 1.92, 95% CI 1.81-2.04), hypercholesterolemia (ORTP1 = 1.73, 95% CI 1.60-1.86, ORTP2 = 1.25, 95% CI 1.17-1.32), diabetic complications; nephropathy (ORTP1 = 1.77, 95% CI 1.48-2.11, ORTP2 = 1.74, 95% CI 1.41-2.15), neuropathy (ORTP1 = 2.27, 95% CI 2.06-2.49 ORTP2 = 1.95, 95% CI 1.78-2.13) and retinopathy (ORTP1 = 1.18, 95% CI 1.05-1.34, ORTP2 = 1.51, 95% CI 1.28-1.78). Hypercholesterolemia and hypertension showed a significant decrease between the periods. Additionally, osteoarthritis (ORTP1 = 0.83, 95% CI 0.75-0.92 ORTP2 = 0.81, 95% CI 0.74-0.88) exhibited a significant inverse association with MACE.
Conclusion: These results suggested that certain risk factors improved over time. However, there is still a need for further improvement in the prevention of MACE in T2DM.

Disclosure
A.A. Bech: None. M.D. Madsen: None. A.V. Kvist: None. P. Vestergaard: None. N.H. Rasmussen: Other Relationship; Boehringer-Ingelheim. Stock/Shareholder; Novo Nordisk, Eli Lilly and Company.

Funding
This work was supported by a research grant from the Danish Diabetes and Endocrine Academy, which is funded by the Novo Nordisk Foundation (NNF22SA0079901)
831-P: Preferences of People with Type 1 Diabetes for Features of Weekly Insulin
Authors: SCHAPIRO DAVID , PEREZ-NIEVES MAGALY , VASS CAROLINE M. , LING POON JIAT , GELSEY FELICIA , PIERCE ANNA , MANSFIELD CAROL 
Published: June 2024

Introduction & Objective: Once-weekly insulin has the potential to increase willingness to initiate and adhere to insulin therapies in people with type 2 diabetes requiring basal-only insulin therapy. However, the role of once-weekly insulin in people already treated with basal-bolus multiple daily injection regimens, such as people with type 1 diabetes (PwT1D), is less understood. This study aimed to quantify the preferences of PwT1D for novel long-acting insulins.
Methods: A discrete choice experiment survey was administered to PwT1D in the United States. The survey included 8 questions offering a choice between experimentally designed pairs of hypothetical, long-acting insulins that varied by 6 attributes: reduction in A1c level after 6 months, daily time in range (TIR), number of serious low blood sugar events, number of nighttime low blood sugar events, weight change over 6 months, and administration frequency. A fixed choice question directly elicited preferences for flexible weekly over daily insulin, holding all other attributes equal. Data were analyzed with random-parameter logits.
Results: The survey was completed by 200 PwT1D (mean: age = 41 years; A1c = 7.6%; 57% female). They were on a basal (100%), mealtime bolus (98%), or intermediate or premixed insulin (2%). Across attributes, respondents ranked achieving the longest TIR as the most important change, followed by equal importance on the largest change in the number of serious low blood sugar events per month, avoiding a 10 pound weight change, the largest change in the number of nighttime low blood sugar events per month, and weekly over daily basal administration. The largest reduction in HbA1c was the least important attribute in respondents’ decisions. In the fixed-choice question, 73% of people preferred flexible weekly over daily dosing for basal insulin.
Conclusion: The most important attributes were changes in TIR and number of serious hypoglycemic events. PwT1D preferred weekly over daily basal insulin when all other attributes were equal.

Disclosure
D. Schapiro: Employee; Eli Lilly and Company. M. Perez-Nieves: Employee; Eli Lilly and Company. Stock/Shareholder; Eli Lilly and Company. C.M. Vass: Other Relationship; Eli Lilly and Company. Consultant; National Institute for Health and Care Excellence (NICE). J. Poon: Employee; Eli Lilly and Company. Stock/Shareholder; Eli Lilly and Company. F. Gelsey: Employee; Eli Lilly and Company. Stock/Shareholder; Eli Lilly and Company. A. Pierce: None. C. Mansfield: None.
84-OR: Performance of FIB-4 Score in Predicting Mortality among Patients with Nonalcoholic
Authors: PAIK JAMES M. , GOLABI PEGAH , JOÃO MENESES MARIA , MACEDO PAULA , HENRY LINDA , YOUNOSSI ZOBAIR 
Published: June 2024

Introduction & Objective: T2D in NAFLD is associated with adverse outcomes. FIB-4 score identifies high-risk NAFLD. The association of FIB-4 with mortality among NAFLD with T2D was assessed.
Methods: NHANES III-linked mortality data were used. NAFLD is defined by ultrasound without other causes of liver disease. Low risk FIB-4: &lt;1.30 age &lt;65/2.0 age≥65; high-risk FIB-4 ≥ 2.67.
Results: There were 738 patients with NAFLD and T2D (mean age, 58.6 [11.0] years; 41.3% male; 55.8% obesity). Compared to non-obese NAFLD+T2D, obese NAFLD+T2D were younger (57.5 vs. 60.0 years), female (64.1% vs. 51.8%) with higher hyperlipidemia rates (91.3% vs. 84.4%). No difference in 10-year cumulative mortality by obesity (obese 21.1% vs. non-obese 26.7%, p=0.077). Proportion of low, intermediate, and high-risk groups (obese 79.0%, 17.5%, 3.5% vs. non-obese 82.2%, 14.0%, 3.7%, p-values&gt;0.20). FIB-4 area under the ROC for 10-year mortality was 0.68 [0.62-0.73]) for non-obese NAFLD+T2D and 0.61 [0.56-0.66] for obese NAFLD+T2D. Compared to non-obese NAFLD+T2D, FIB-4 had lower predictive ability for mortality for obese NAFLD+T2D. Per Youden index, lower FIB-4 threshold of 0.92 provided better 10-year mortality risk in both obese and nonobese NAFLD+T2D.
Conclusion: Presence of obesity among NAFLD+T2D negatively impacts FIB-4 performance. Lower FIB-4 threshold improves the predictive value of FIB-4 in both obese and non-obese NAFLD+T2D.

Disclosure
J.M. Paik: None. P. Golabi: None. M. Meneses: None. P. Macedo: None. L. Henry: None. Z. Younossi: Consultant; Gilead Sciences, Inc., Bainan Biotech, AbbVie Inc., Bristol-Myers Squibb Company, Abbott, Novo Nordisk, Madrigal Pharmaceuticals, Inc., Merck & Co., Inc., Siemens Healthcare Diagnostics, Intercept Pharmaceuticals, Inc.
841-P: Efficacy and Safety of Once-Weekly Insulin Icodec vs. Once-Daily Basal Insulin in Type 2 Diabetes by Ethnicity and Race—ONWARDS 1–5
Authors: LINGVAY ILDIKO , BANGSGAARD KATRINE O. , DESOUZA CYRUS , FRAGÃO MARQUES MARIANA , NAVARRIA ANDREA , VIANNA ANDRE G. 
Published: June 2024

Introduction & Objective: To assess, post hoc, the impact of ethnicity and race on the efficacy and hypoglycemia rates with once-weekly (OW) insulin icodec (icodec) vs once-daily (OD) basal insulin in adults with T2D.
Methods: Efficacy and safety outcomes were assessed within each trial across ethnic (Hispanic/Latino vs non-Hispanic/Latino) and race (Asian, Black/African American, White, Other) subgroups in insulin-naïve (ONWARDS [ON] 1, 3, 5) and insulin-treated (ON 2, 4) adults with T2D.
Results: Across all trials, no statistically significant interaction between treatment and subgroup for improvements in A1C were seen with icodec vs OD insulin (baseline to planned end of treatment) (Figure). Hypoglycemia rates were low in both treatment groups across ethnicities and races, precluding statistical analysis. A greater proportion of individuals in most ethnic and racial subgroups across trials achieved A1C &lt; 7% without clinically significant or severe hypoglycemia with icodec vs OD insulin (no statistically significant treatment by subgroup interaction).
Conclusion: A1C and hypoglycemia endpoints were consistent for OW icodec vs OD insulin, irrespective of ethnicity or race.

Disclosure
I. Lingvay: Consultant; Altimmune, Astra Zeneca, Bayer, Biomea, Boehringer-Ingelheim, Carmot, Cytoki Pharma, Eli Lilly, Intercept, Janssen/J&J, Mannkind, Mediflix, Merck, Metsera, Novo Nordisk, Pharmaventures, Pfizer, Sanofi. Research Support; NovoNordisk, Sanofi, Mylan, Boehringer-Ingelheim. Consultant; TERNS Pharma, The Comm Group, Valeritas, WebMD, and Zealand Pharma. K.O. Bangsgaard: Employee; Novo Nordisk A/S. C. Desouza: Advisory Panel; Novo Nordisk, Bayer Inc., Madrigal Pharmaceuticals, Inc. Other Relationship; ADA/ACC Diabetes by Heart Program. Advisory Panel; Asahi Kasei. M. Fragão Marques: None. A. Navarria: Employee; Novo Nordisk A/S, Rhythm Pharmaceuticals, Inc. A.G. Vianna: Board Member; Abbott, Lilly Diabetes, Novo Nordisk, Medtronic. Speaker's Bureau; AstraZeneca, Novo Nordisk. Research Support; Novo Nordisk, Lilly Diabetes. Speaker's Bureau; Lilly Diabetes. Research Support; Servier Laboratories.

Funding
Novo Nordisk A/S
85-OR: The Impact of Type 2 Diabetes (T2D) on the Outcomes of Liver Transplantation in the United States from 2007–2022
Authors: STEPANOVA MARIA , GOLABI PEGAH , DE AVILA LEYLA , ONG JANUS , ALQAHTANI SALEH , YOUNOSSI ZOBAIR 
Published: June 2024

Introduction & Objective: Type 2 diabetes (T2D) and associated non-alcoholic steatohepatitis (NASH) or metabolic dysfunction associated steatohepatitis (MASH) can negatively impact outcomes of patients with chronic liver disease (CLD). The aim of this study was to assess the impact of pre-transplant T2D on the outcomes of liver transplantations.
Method: From the Scientific Registry of Transplant Recipients (2007-2022), we selected all adults who received a liver transplant and had listing diagnosis of CLD with or without hepatocellular carcinoma (HCC). The study outcome was time to post-transplant mortality.
Results: We included 104,399 subjects (mean age 56±11 years, 66% male). Considering etiologies of CLD, 3% had chronic hepatitis B, 25% chronic hepatitis C, 20% NASH/MASH, 31% alcoholic liver disease, 22% also had HCC. Of all transplant recipients, 26% had a history of pre-transplant T2D. During follow-up (median=59 months), 27% of liver transplant recipients died, 5% had graft failure. Post-transplant mortality rates were higher in recipients with pre-transplant T2D compared to those without T2D: 10% vs. 8% at 1 year, 26% vs. 21% at 5 years, 45% vs. 37% at 10 years (all p&lt;0.0001). In multivariate survival analysis, pre-transplant T2D was independently associated with higher risk of post-transplant mortality: aHR=1.28 [1.24-1.32]. This remained significant in CLD patients without HCC, aHR=1.30 [1.25-1.35] and those with HCC, aHR=1.23 [1.15-1.31] (all p&lt;0.0001). Other risk factors for increased mortality included older age, male sex, black race, being on life support before transplantation and receiving a re-transplant (p&lt;0.01). There was no association between pre-transplant T2D with an increased risk of graft failure (one-sided p&gt;0.05).
Conclusions: About one quarter of patients receiving liver transplantation in the U.S. have T2D. The presence of pre-transplant T2D is independently associated with an increased risk of post-transplant mortality.

Disclosure
M. Stepanova: None. P. Golabi: None. L. de Avila: None. J. Ong: None. S. Alqahtani: Consultant; AbbVie Inc., Bristol-Myers Squibb Company, Merck & Co., Inc., Gilead Sciences, Inc., Janssen Pharmaceuticals, Inc. Z. Younossi: Consultant; Gilead Sciences, Inc., Bainan Biotech, AbbVie Inc., Bristol-Myers Squibb Company, Abbott, Novo Nordisk, Madrigal Pharmaceuticals, Inc., Merck & Co., Inc., Siemens Healthcare Diagnostics, Intercept Pharmaceuticals, Inc.
866-P: Assessing the Generalizability of the FIDELIO-DKD and FIGARO-DKD Criteria to the Canadian Population with Type 2 Diabetes in a Community Endocrinology Setting
Authors: JAZDAREHEE ARIA , JAIN AKSHAY B. 
Published: June 2024

Finerenone improves renal and cardiovascular outcomes in CKD and T2D, as demonstrated in the FIDELIO and FIGARO trials. While the ADA guidelines advise finerenone for residual renal risk, Canadian guidelines lack such recommendations. Previous studies established the applicability of the FIDELIO and FIGARO inclusion criteria to the US population. This study aims to assess if these criteria similarly apply to the Canadian population.
We applied the FIDELIO and FIGARO trial criteria to Canadians with T2D in a community endocrinology setting, who were already optimized for renal risk with RAAS and SGLT2 therapy.
Of 369 individuals with T2D optimized on RAAS and SGLT2 inhibitors, 99 (27%) met FIDELIO or FIGARO criteria. Population characteristics were comparable with the inclusion trials, with median age 71, mean A1c 7.7%, mean eGFR 57, median uACR 284.9 mg/g, and mean SBP 132. Our study population had a higher prevalence of prior myocardial infarction compared to those in the inclusion trials (26.2% vs 7.4% and 13.2%, p &lt;0.05).
Despite Health Canada approval of finerenone, adoption into clinical practice remains slow. We found that 27% of individuals carry residual renal risk despite optimization. The higher proportion of patients in our study with history of cardiovascular disease emphasizes the need to implement finerenone into Canadian guidelines.

Disclosure
A. Jazdarehee: None. A.B. Jain: Advisory Panel; Abbott. Speaker's Bureau; Abbott. Advisory Panel; Boehringer-Ingelheim. Speaker's Bureau; Boehringer-Ingelheim. Advisory Panel; Amgen Inc. Speaker's Bureau; Amgen Inc., AstraZeneca. Advisory Panel; AstraZeneca. Speaker's Bureau; Care to Know, CCRN, Connected in Motion, CPD Network, Dexcom, Diabetes Canada, Eli Lilly, GSK, HLS Therapeutics, Janssen, Master Clinician Alliance, MDBriefcase, Merck, Medtronic, Moderna, Novartis, N. Advisory Panel; Bausch Healthcare, Bayer,, Dexcom, Eli Lilly, Gilead Sciences, GSK, HLS Therapeutics, Insulet, Janssen, Medtronic, Novo Nordisk, Partners in Progressive Medical Education, Pfizer, PocketPills, Roche,.
875-P: GLY-200 (Oral Pharmacologic Duodenal Exclusion Drug) Improves Glycemic Control as Measured by CGM in Patients with Type 2 Diabetes
Authors: NIMGAONKAR ASHISH , BRYANT CHRISTINE , FINEMAN MARK 
Published: June 2024

Background: GLY-200 is an investigational oral non-absorbed polymeric drug designed to bind to and enhance the barrier function of gastrointestinal mucus as a non-invasive alternative to metabolic surgery and duodenal exclusion devices. In healthy volunteers, GLY-200 lowered glucose and increased GLP-1, PYY, and bile acids, indicating pharmacologic effects of duodenal targeting. This 14-day Phase 2 study in patients with type 2 diabetes (T2D) evaluated the safety, tolerability, and pharmacodynamic effects of GLY-200. Improvements in postprandial glucose following standardized mixed-meal challenges and progressive body weight loss were seen in GLY-200 subjects.
Methods: The Ph2 study was a randomized, double-blind, placebo (PBO)-controlled inpatient study in subjects with T2D washed off metformin, BMI 18-40. Treatments included 14 days (BID) of 2.0 g GLY-200 (N=13, BMI 31.8 ± 4.09 kg/m2, baseline HbA1c 7.18 ± 0.66%) or PBO (N=12, BMI 31.7 ± 3.17 kg/m2, baseline HbA1c 7.17 ± 0.73%). A Dexcom G6 Pro was used for continuous blood glucose measuring throughout the study (Day -7 to Day 14).
Results: GLY-200 appeared safe and well-tolerated with most AEs being GI-related. During Week 2, 4-hr pre-dose (fasting) and 4-hr post-meal (postprandial) measurements demonstrated statistically significant reductions in fasting mean weighted glucose (MWG) (p=0.05) and postprandial MWG (breakfast, p=0.07; lunch, p=0.04; dinner, p=0.01) in the 2.0 g GLY-200 group vs. PBO. There was also a statistically significant reduction in 24-hr MWG for 2.0 g GLY-200 group (Week 1: 169.20 mg/dL; Week 2: 169.82 mg/dL) compared to PBO (Week 1: 211.60 mg/dL; Week 2: 216.63 mg/dL). In the second week of treatment with 2.0 g GLY-200, the average percent time in target range was twice that compared to PBO (65.7% vs 32.2%, p=0.02).
Conclusion: As early as Week 1, subjects receiving 2.0 g GLY-200 experienced clinically relevant improvements in both fasting and postprandial glucose as measured with CGM.

Disclosure
A. Nimgaonkar: None. C. Bryant: Employee; Glyscend Inc. M. Fineman: Employee; Glyscend Inc.
881-P: Optimizing Glycemic Control in Type 2 Diabetes Using Novel Endoscopic Pulsed Electric Field Therapy—A Study of Outcomes and Predictive Factors
Authors: ABU DAYYEH BARHAM K. , SARTORETTO ADRIAN , STORM ANDREW C. , MCCOLLISTER HOWARD M. , SEVERSON PAUL A. , HOLT BRONTE , CAMERON GEORGINA , VAUGHAN RHYS , LIPHAM JOHN , EKINCI ELIF I. , O'NEAL DAVID N. 
Published: June 2024

Background: Duodenal dysfunction, specifically in nutrient sensing, iron homeostasis, and inflammation is linked to Type 2 Diabetes. This study assesses Endoscopic Re-Cellularization via Electroporation Therapy (ReCET™), an outpatient procedure using non-thermal pulsed electric field to regenerate the duodenal function.
Methods: Participants (18-70 years, BMI 24-40 kg/m², HbA1c 7.5%-11.0%, on 1-4 non-insulin antidiabetics) received PEF. Primary endpoints were serious adverse events at 12 weeks, with secondary endpoints including efficacy and response predictors at 24 weeks.
Results: 71 patients (age 55, 73% male, BMI 31.7 kg/m², T2D duration 5.8 years, baseline HbA1c 8.6%) participated. Treatment groups received either low or high energy doses. No SAEs occurred. The high energy group exhibited significant glycemic improvement (-1.11 HbA1c reduction vs. -0.32 in low energy group, p=0.015) and improved Time in Range, %TBWL, HOMA-IR, Triglyceride, and Ferritin. Baseline Ferritin and HbA1c were predictors of response (figure 1). Subgroup with baseline Ferritin ≥200 and HbA1c ≥8 showed a -2.04 [95%CI -3.94, -0.14] HbA1c reduction at 24 weeks with high energy.
Conclusions: ReCET™ enhances glycemic control in T2D without SAEs, impacting weight, lipid profile, and iron metabolism. This suggests a novel mechanism complementing existing T2D treatments.

Disclosure
B.K. Abu Dayyeh: Research Support; USGI Medical, Apollo Endosurgery. Consultant; Boston Scientific Corporation, Medtronic. Other Relationship; Endogenex. Research Support; ERBE. A. Sartoretto: Research Support; Endogenex, Erbe Electromedizin GmbH. Advisory Panel; Bariatek. Consultant; Boston Scientific Corporation, Intuitive Surgical. A.C. Storm: Consultant; Intuitive Surgical, Boston Scientific Corporation, Olympus. Research Support; Apollo Endosurgery, Endogenex, Microtech. Consultant; Enterasense. Research Support; OnePass. H.M. McCollister: Consultant; Endogenex. P.A. Severson: Consultant; Endogenex. B. Holt: None. G. Cameron: None. R. Vaughan: None. J. Lipham: Consultant; Endogenex, Ethicon, Inc., Implantica. E.I. Ekinci: Advisory Panel; Lilly Diabetes. Research Support; Novo Nordisk, Boehringer-Ingelheim, Eli Lilly and Company. Board Member; Eli Lilly and Company. Advisory Panel; Abbott. Research Support; Endogenex, Versanis, AstraZeneca. D.N. O'Neal: None.