bluuebunny/crossref_metadata_2025_split huggingface dataset:
78-OR: Breath Acetone Correlates with Capillary Beta Hydroxybutyrate in Type 1 Diabetes
Authors: JONES KAI , PETERSEN MAX C. , MARKOV ALEXANDER M. , KRUTILOVA PETRA , MCKEE ALEXIS M. , BOHNERT KATHRYN L. , ADAMSON SAMANTHA E. , SALAM MAAMOUN , MCGILL JANET B. 
Published: June 2024

Introduction: Prior work has shown a linear relationship between breath acetone (BrACE) and capillary blood beta hydroxybutyrate (BOHB) in persons without diabetes. This innovative study investigates the correlation between capillary BOHB and BrACE in T1D during usual care and while taking an SGLT2 inhibitor in both insulin-sufficient and -deficient states. The primary outcome of the study is the correlation of capillary BOHB and BrACE.
Methods: Participants provided written consent and were randomized to 2 weeks of usual care and 1 day of insulin withdrawal followed by 2 weeks of usual care plus dapagliflozin, 10 mg daily and 1 day of insulin withdrawal or the opposite sequence. Paired BOHB (Precision Xtra®, Abbott) and BrACE (Biosense®, Readout) were obtained 3X daily for 2 weeks, then hourly during supervised insulin withdrawal. Sick day rules were reviewed and insulin doses were minimally adjusted when taking dapagliflozin. The data was tested for normality and the Spearman’s test was utilized due to non-normally distributed data.
Results: Participant age was 48 ±18 years (mean ± SD), baseline A1c 7.0 ± 0.9%, and CGM time in range [70-180mg/dL] 61 ± 18%. During outpatient care, BrACE and BOHB were weakly correlated both without dapagliflozin (n=689 paired readings; Spearman’s ρ = 0.44; 95% CI: 0.37 to 0.50) and with dapagliflozin (n=718 paired readings; ρ = 0.32; 95% CI: 0.25 to 0.39). However, BrACE and BOHB were strongly correlated during supervised insulin withdrawal (n=246 paired values, ρ = 0.81; 95% CI: 0.77 to 0.85). In ROC analysis, BrACE of ≥ 5 demonstrated optimal sensitivity (93%) and specificity (87%) for detecting a capillary BOHB &lt;u&gt;&gt;&lt;/u&gt; 1.5 mmol/L. No serious adverse events occurred.
Conclusion: In adults with T1D, BrACE monitoring provides a noninvasive estimate of ambient ketone levels when compared to blood BOHB but is more useful under supervised conditions with greater range of ketone production and less potential for interference with volatile organic compounds than in typical outpatient settings.

Disclosure
K. Jones: None. M.C. Petersen: None. A.M. Markov: None. P. Krutilova: None. A.M. McKee: Advisory Panel; Medtronic, Novo Nordisk. Employee; Novo Nordisk. K.L. Bohnert: None. S.E. Adamson: None. M. Salam: None. J.B. McGill: Advisory Panel; Bayer Inc., Boehringer-Ingelheim, ClearNote Health, Lilly Diabetes, MannKind Corporation, Novo Nordisk. Research Support; Novo Nordisk.

Funding
JDRF DRCICTS
794-P: Effect of Liraglutide on Abdominal Fat Distribution and Glucose Metabolism in Chinese Patients with Obesity
Authors: DU MENGYANG , YUE JIANG , QI YICHENG , HE SHENGYUN , LU XIAOBING , YANG MINGLAN , WANG LIHUA , LU QING , MA JING 
Published: June 2024

Introduction & Objective: Recent studies have shown that liver fat content (LFC) is associated with impaired glucose metabolism and insulin resistance in the obesity. It has been established that GLP-1RA could significantly reduce LFC in patients with T2DM. This study aimed to observe the effects of liraglutide on abdominal fat distribution and glucose metabolism in Chinese subjects with obesity for 12 weeks, and further explore the correlation between abdominal fat content and glucose profiles.
Methods: This study recruited 71 obese patients (BMI≥28 kg/m²). All the patients have received liraglutide monotherapy for 12 weeks, and received anthropometric measurement, OGTT (Oral glucose tolerance test) and MRI examination at baseline and after 12 weeks treatment. The association between the glycemic metabolism and abdominal fat content was further analysed.
Results: After 12 weeks of liraglutide monotherapy, body weight in the obese participants decreased significantly (P=0.014). Fasting blood glucose (FBG), 2h postprandial blood glucose (2hPBG), HbA1c, HOMA-IR were remarkably improved (all P&lt;0.001). TC and LDL-c were sharply reduced (P=0.004, P=0.027 respectively). LFC was strikingly more in subjects with impaired glucose regulation (IGR) group compared to those with normal glucose tolerance (NGT) at baseline (P=0.002). The decreased LFC in IGR group was significantly greater after liraglutide treatment than those with NGT (P&lt;0.001). Linear regression analysis showed that HOMA-IR at baseline was the independent marker for LFC reduction after liraglutide treatment (B: 0.634; 95%CI:0.100-1.168, P=0.021).
Conclusion: Liraglutide monotherapy for 12 weeks significantly reduced LFC in patients with obesity. The LFC reduction may serve as one of possible mechanisms of blood glucose improvement in obese patients.

Disclosure
M. Du: None. J. Yue: None. Y. Qi: None. S. He: None. X. Lu: None. M. Yang: None. L. Wang: None. Q. Lu: None. J. Ma: None.
808-P: Impact of Fasting on Adherence to Dosing Instructions and Efficacy of Oral Semaglutide during Ramadan in People with Type 2 Diabetes in Real-World Setting—O-SEMA-Fast Subanalysis
Authors: HASSANEIN MOHAMED , ALKADHIM IBRAHIM , ALY HAZEM , BAJAWI DALILA , CINAR TARHAN , DHANWAL DINESH , JABBAR ABDUL , KHADER SAID , KHUDADAH KHALED , MUZAFFAR TALAL , NGOME MARY , NAFACH JALAL , SHAGHOULI AMNA 
Published: June 2024

Introduction & Objective: Oral semaglutide, a glucagon-like peptide 1 receptor agonist, should be administered in empty stomach, with up to 120 ml of water and with no food, beverages or any oral medications intake for a minimum of 30-min post administration to ensure optimal systemic absorption. These instructions could be cumbersome to follow during Ramadan when patients fast for longer duration. This O-SEMA-Fast sub-analysis assessed impact of fasting on adherence to oral semaglutide dosing instructions and subsequently on glycemic and body weight changes.
Methods: O-SEMA-Fast was a non-interventional, prospective study in people with T2D who fasted during Ramadan and on oral semaglutide treatment in United Arab Emirates, Saudi Arabia and Kuwait. Patients were followed up for a period of 20-weeks (end of study, EOS). HbA1c and body weight were measured at baseline and at EOS; changes were analyzed by mixed models for repeated measures.
Results: Of 257 patients in the full analysis set, 215 were eligible as they had recorded administration details in their diaries. Among these, 68.4% (n=147) were found to be adherent to oral semaglutide dosing instructions for ≥80% of days the diary was filled. At baseline, mean HbA1c was 6.69% and 7.0% in adherent and non-adherent (dosing instructions) people, respectively. At EOS, an estimated change in HbA1c from baseline was -0.33 (95% CI: -0.44, -0.23; p&lt;0.0001) and -0.12 (95% CI: -0.36, 0.12; p=0.3138), respectively. Similarly, change in body weight was -3.22 kg (95% CI: -4.03, -2.40, p&lt;0.0001) and -1.64 (95%CI: -2.45, -0.84, p=0.0001), in adherent and non-adherent people.
Conclusion: This O-SEMA Fast sub-analysis indicated that most people adhered to oral semaglutide administration instructions and experienced significant decrease in HbA1c and body weight, making oral semaglutide as a suitable choice of drug for people who fast during Ramadan.

Disclosure
M. Hassanein: Research Support; Novo Nordisk A/S. Advisory Panel; Sanofi. Speaker's Bureau; Abbott, Boehringer-Ingelheim, Medtronic. Advisory Panel; Eli Lilly and Company. I. AlKadhim: Speaker's Bureau; Lilly Diabetes. Research Support; IQVIA Inc. Advisory Panel; Novo Nordisk. Speaker's Bureau; Boehringer-Ingelheim, AstraZeneca, Novo Nordisk. H. Aly: Employee; Novo Nordisk. Stock/Shareholder; Novo Nordisk. D. Bajawi: Consultant; Novo Nordisk, Boehringer-Ingelheim, AstraZeneca, Sanofi. T. Cinar: Employee; Novo Nordisk. D. Dhanwal: Research Support; Novo Nordisk A/S. A. Jabbar: Research Support; Novo Nordisk A/S. S. Khader: Research Support; IQVIA Inc., Novo Nordisk. K. Khudadah: None. T. Muzaffar: Other Relationship; Novo Nordisk. M. Ngome: Employee; Novo Nordisk. J. Nafach: None. A. Shaghouli: None.
809-P: Oral Semaglutide in Indian Type 2 Diabetes Mellitus patients (SOLID) Study—Twelve Months Follow-up
Authors: BHATTACHARYYA SUPRATIK 
Published: June 2024

Background: The oral formulation of semaglutide, a GLP-1R agonist, has emerged as a promising treatment option for diabesity, demonstrating efficacy in both glycemic parameter improvement and weight management.
Materials and Methods: Following market launch in India in 2022, we conducted a prospective, observational cohort study across eight Indian centers to examine the initial utilization patterns of oral semaglutide in routine clinical practice. The present study enrolled subjects diagnosed with type 2 diabetes who possessed one year of follow-up data on oral semaglutide use.
Results: A multi-center, open-label, single-arm study evaluated the efficacy and safety of oral semaglutide monotherapy in 152 patients with type 2 diabetes mellitus. The mean age of the participants was 50.14 years, and the majority were male (59.86%). The baseline characteristics included a mean body mass index of 29.82 kg/m2, a mean body weight of 87.17 kg, and a mean HbA1c of 9.09%. A significant portion of the study population had comorbidities, including hypertension (46%), dyslipidemia (41%), and hypothyroidism (16%). At baseline, 81.7% of patients were initiated on the 3 mg dose of oral semaglutide. The primary outcome measures were the change in HbA1c and body weight from baseline to the follow-up visit after 1 year. The mean reduction in HbA1c and body weight was 1.81% and 5.03 kg, respectively (P &lt; 0.0001 for both). The most common adverse events reported were generalized weakness, nausea, dryness of mouth, and diarrhea. Notably, no hypoglycemia, other serious adverse events, or discontinuations were observed.
Conclusions: Over a 12-month period, individuals with T2DM demonstrated significant improvements in key glycemic parameters, including HbA1c, and reduction in body weight, highlighting the potential of oral semaglutide as a first-line therapeutic option for this population.

Disclosure
S. Bhattacharyya: None.
810-P: Role of Glucagon-Like-Peptide-1 Agonists as an Adjunctive Treatment in Adults with Type 1 Diabetes Mellitus and Overweight/Obesity, Retrospective Cohort, Saudi Arabia 2023
Authors: HABEEB KHOLOOD , BREMA IMAD , ALMEHTHEL MOHAMMED , ALSHEHRI ALI 
Published: June 2024

Introduction & Objective: Diabetes is a major public health problem, in 2021, Diabetes affect 537 million adults, and it is estimated to affect 643 million adults by 2030, associated with 6.7 million adult deaths in 2021(1). The Usefulness of Many non-insulin therapies has been investigated in type-1 diabetes like Metformin, and Sodium-Glucose co-transporter-2 inhibitors. Recent evidence on Semaglutide in early Type-1 diabetes shows a promising effect. The study aimed to determine whether Glucagon-Like Peptide-1 Receptor agonist (GLP-1) added to Insulin in Adults with Type-1 Diabetes Mellitus is effective and safe.
Methods: A retrospective cohort was conducted (Jan 2022-Feb 2023) among all adults with Type-1 Diabetes on GLP-1 agonists and overweight/Obesity, attending the Diabetes or Obesity clinic in King Fahad Medical City through an Electronic system records review. Excluding those on other non-insulin Diabetes medications, or obesity interventions. Many variables were evaluated to assess the efficacy and safety: Hga1c, CGM data, Weight, biochemical profile, retinal exam, hypoglycemia, and DKA incidence. Student T test Chi-square and linear mixed modeling were used for statistical analysis.
Result: 32 patients on GLP-1 agonists were recruited, with a mean age of 30 years, 87% were on Semaglutide (0.5mg or 1mg), while the rest were on Liraglutide (1.2mg-3mg), Estimated Hga1c reduction was 0.84% after 8 months from baseline, p-value &lt;0.001. TIR improved by 15% p value &lt;0.001. 31% of the patients achieved 5% TBWL and 12.5% achieved 15% TBWL p-value &lt;0.001. A significant reduction in insulin total daily dose was observed more in bolus insulin. No Significant hypoglycemia, Retinopathy, or DKA episodes.
Conclusions: GLP-1 agonist as adjunctive therapy to insulin shows a significant Improvement in Glycemic control, weight reduction, and insulin requirement in patients with Type-1 diabetes.

Disclosure
K. Habeeb: None. I. Brema: None. M. Almehthel: None. A. Alshehri: None.
812-P: Safety and Efficacy of Early Initiation of GLP1RA and SGLT2 inhibitors, in Post–Kidney Transplant Patients with Type 2 Diabetes
Authors: ACOSTA FRANCISCA M. , TODD BYRON , HU BEVERLY , FRAUSTO PAOLA , NICHOLS JESSICA , ESCOBAR VASCO MARIA , SOLIS-HERRERA CAROLINA 
Published: June 2024

Introduction: DKD is the most common cause of ESKD. Among kidney transplant recipients (KTRs), 40% have DM. Anti-rejection therapies worsen DM and have increased CV mortality &gt;50%. To date, we do not know what the best early therapy is to treat post-transplant patients with type 2 diabetes (T2D). The use of SGLT2i or GLP1-RA, as early anti-diabetic therapy, could improve glucose, weight, cardiovascular and renal function in these patients.
Methods: Retrospective, observational, single-center study using EMR. Inclusion-criteria included KTR with T2D. After 6 months post-transplant, GLP1RA or combination therapy was initiated. A1c, lipids, eGFR, and weight were taken as major outcomes to determine efficacy. Outcomes were measured before and after 18 months of therapy. SE and SAE were recorded.
Results: Twenty-six patients KTR with T2D; 55±2 years-old, A1c 6.8%+/-0.5; BMI 30.2 +/- 1.4 were included. Five subjects were on SGLT2i+GLP1RA and 21 subjects on GLP1RA. There were no significant differences between groups at baseline. The A1c levels in the combination group decreased (-0.14%±0.4) and the GLP1-group (-0.06%±0.4). LDL (-51mg/dL ± 23 vs +0.2mg/dL±8.3), p=0.009. Triglycerides (-10.8mg/dL±10.8 vs -64.8mg/dL±15.7), p=0.05. eGFR (+1.2mL/min vs +6.3mL/min) p=0.25. Weight (-7.8kg±3 vs -4.6kg±2) p=0.2. No patients discontinued the medication due to side effects.
Conclusion: This single-center retrospective analysis showed that both groups treated with either GLP1RA, or its combination with SGLT2i, are safe and effective after 18 months without significant SE. These novel drugs should be considered as a safe early therapy in KTR patients with T2D. As our numbers are small in this real-world data, further randomized studies are necessary to confirm these findings.

Disclosure
F.M. Acosta: None. B. Todd: None. B. Hu: None. P. Frausto: None. J. Nichols: None. M. Escobar Vasco: None. C. Solis-Herrera: Advisory Panel; Novo Nordisk, Bayer Inc.
820-P: Faster-Acting Insulin Aspart vs. Insulin Aspart for Adults with Type 1 Diabetes Treated with Insulin Pump and Continuous Glucose Monitoring
Authors: RANJAN AJENTHEN G. , SCHMIDT SIGNE , ANDERSEN HANNE-CHARLOTTE , NØRGAARD KIRSTEN 
Published: June 2024

Objective: To evaluate efficacy and safety of faster-acting insulin aspart (Fiasp) compared to insulin aspart (Iasp) in adults with type 1 diabetes using non-automated insulin pump and continuous glucose monitoring (CGM).
Methods: In this double-blinded crossover trial participants were randomly assigned to start with Fiasp or Iasp for 16 weeks and then switch to the alternate therapy for another 16 weeks following a 3-week washout period. Insulin pump settings were adjusted every 3 weeks based on CGM and insulin pump data. Primary outcome was the between-treatment difference in time in range (TIR: 3.9-10.0 mmol/L) from week 14 to 16. Secondary outcomes included other CGM metrics and HbA1c. Safety outcomes included injection site reactions.
Results: Forty adults (20 males) with a median (IQR) age of 54 (44-61) years, type 1 diabetes duration of 27 (20-34) years, HbA1c 59 (55-65) mmol/mol or 7.5 (7.2-8.1) %, BMI 25.7 (24.5-30.3) kg/m2 and total daily insulin dose 37 (29-52) IE completed both study arms. At 16 weeks, TIR was (mean ± SD) 60.6 ± 12.1% for Iasp and 62.5 ± 12.3% for Fiasp, p = 0.24; time above range (&gt;10.0 mmol/L) was 31.5 ± 12.6% for Iasp and 30.1 ± 11.3% for Fiasp, p=0.30; and time below range (&lt;3.9 mmol/L) was 7.8 ± 5.5% for Iasp and 7.5 ± 6.1% for Fiasp, p=0.89. The coefficient of variation was significantly higher with Iasp compared to Fiasp (35.9 ± 4.9% vs 34.0 ± 3.7%, p=0.03). At week 16, HbA1c was 58.0 ± 6.6 mmol/mol with Iasp and 57.5 ± 6.9 mmol/mol with Fiasp (p= 0.43). No differences were observed in SAE including severe hypoglycemia and diabetes ketoacidosis. Fiasp had numerically more events of burning sensation at injection site than Iasp.
Conclusion: At 16 weeks, after frequent adjustments of insulin pump settings, no differences between Fiasp and Iasp treatment were observed in TIR, TAR, TBR and HbA1c in adults with type 1 diabetes using insulin pump and CGM. However, Fiasp significantly reduced glycemic variability compared to Iasp.

Disclosure
A.G. Ranjan: None. S. Schmidt: Employee; Novo Nordisk A/S. Speaker's Bureau; Novo Nordisk A/S. H. Andersen: None. K. Nørgaard: Research Support; Dexcom, Inc., Medtronic. Advisory Panel; Medtronic, Novo Nordisk A/S. Stock/Shareholder; Novo Nordisk A/S. Research Support; Novo Nordisk A/S. Advisory Panel; Convatec. Research Support; Zealand Pharma A/S.

Funding
Steno Diabetes Center Copenhagen is the sponsor of this investigator-initiated trial. Novo Nordisk provided financial support to the conduct of the study and supplied the study medication.
83-OR: Metabolic Dysfunction–Associated Steatotic Liver Disease and Nonalcoholic Fatty Liver Disease Have Similar Clinical Profiles and Mortality
Authors: YOUNOSSI ZOBAIR , PAIK JAMES M. , GOLABI PEGAH , ONG JANUS , HENRY LINDA , ALQAHTANI SALEH , NADER FATEMA 
Published: June 2024

Introduction & Objective: Metabolic dysfunction associated steatotic liver disease (MASLD) has recently replaced the term nonalcoholic fatty liver disease (NAFLD). Concern remains whether evidence generated under NAFLD definition is fully applicable to MASLD. We compared the clinical profile and outcomes of NAFLD to MASLD using population-based data.
Methods: National Health and Nutrition Examination Survey (NHANES-III) with the linked Mortality file (through 2019) were used to compare groups defined as NAFLD and MASLD. Hazard ratios (HRs) of MASLD/NAFLD on all-cause mortality were calculated by cox-regression models.
Results: Among 2,736 NHANES participants with NAFLD (age 47.80 years, 52.48% male, 47.66% obese, 18.26% T2D, 94.71% ≥ 1 cardiometabolic criteria), only 5.29% patients did not meet MASLD criteria. The clinical profile of MASLD was similar except for age (48.56 years) and presence of cardiometabolic risks (50.32% obese, 19.28% T2D, 100% ≥ 1 cardiometabolic criteria). There was excellent concordance between NAFLD and MASLD definitions (Cohen’s kappa coefficient=0.968 [95% CI: 0.962-0.973]). After a median follow-up of 22.83 years, there were no mortality rate differences between MASLD and NAFLD (p-values ≥ 0.05). Adjusting for socio-demographic factors, lack of healthy eating and physical activity, MASLD had a higher all-cause mortality risk (Hazard Ratio (HR)=1.15 [1.05-1.25]). However, after further adjustment for cardiometabolic risks, MASLD was not associated with increased all-cause mortality (p-value&gt;0.80).
Conclusions: NAFLD and MASLD are similar except MASLD subjects are older with slightly higher mortality risk, potentially due to the inclusion of cardiometabolic risk factors. These data provide evidence that NAFLD and MASLD can be used interchangeably.

Disclosure
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. J.M. Paik: None. P. Golabi: None. J. Ong: None. L. Henry: None. S. Alqahtani: Consultant; AbbVie Inc., Bristol-Myers Squibb Company, Merck & Co., Inc., Gilead Sciences, Inc., Janssen Pharmaceuticals, Inc. F. Nader: None.
838-P: Impact of Age on the Efficacy and Safety of Once-Weekly Insulin Icodec vs. Once-Daily Insulin in Type 2 Diabetes (ONWARDS 1–5)
Authors: VIANNA ANDRE G.D. , DESOUZA CYRUS , LAUGESEN CHRISTIAN , FRAGÃO MARQUES MARIANA , HØJLUND NIELSEN PERNILLE , SHAIKH SHEHLA S. , LINGVAY ILDIKO 
Published: June 2024

Introduction & Objective: This post hoc analysis assessed the treatment effects of once-weekly insulin icodec (icodec) vs once-daily (OD) basal insulin comparators across different age groups in adults with T2D.
Methods: Efficacy outcomes and hypoglycemia rates for icodec vs OD comparators across three age subgroups (&lt;55, 55-64 and ≥65 years) were assessed, by trial, in insulin-naïve (ONWARDS 1, 3, 5) and insulin-treated (ONWARDS 2, 4) adults with T2D.
Results: There were no statistically significant treatment by subgroup interactions for change in A1C from baseline to planned end of treatment (EOT) (Figure). A larger reduction in A1C with icodec was seen across age subgroups in ONWARDS 1-5, except for individuals ≥ 65 years in ONWARDS 4, where the opposite trend was seen. Overall, rates of clinically significant and severe hypoglycemic episodes were low in both treatment arms across age subgroups. In ONWARDS 1-5, the proportions of individuals achieving A1C &lt;7% without clinically significant or severe hypoglycemic episodes at planned EOT were higher for icodec vs OD comparators irrespective of age, except for individuals &lt; 55 and ≥ 65 years in ONWARDS 4; no statistically significant difference was seen in the treatment by subgroup interaction across different age subgroups.
Conclusion: Overall, efficacy and hypoglycemia outcomes were consistent for icodec vs OD comparators irrespective of age.

Disclosure
A.G.D. 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. C. Desouza: Advisory Panel; Novo Nordisk, Bayer Inc., Madrigal Pharmaceuticals, Inc. Other Relationship; ADA/ACC Diabetes by Heart Program. Advisory Panel; Asahi Kasei. C. Laugesen: Employee; Novo Nordisk. Stock/Shareholder; Novo Nordisk. M. Fragão Marques: None. P. Nielsen: Employee; Novo Nordisk A/S. Stock/Shareholder; Novo Nordisk A/S. S.S. Shaikh: None. 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.

Funding
Novo Nordisk A/S