bluuebunny/crossref_metadata_2025_split huggingface dataset:
918-P: Effect of Remogliflozin in Improving NYHA Class Compared with Empagliflozin in Type 2 Diabetes Patients with Heart Failure (Remit HF)
Authors: BARKATE HANMANT V. , PANCHAL YASH , BHUSHAN SUMIT , CHOUDHARI SANJAY Y. , PETARE ANUP U. 
Published: June 2024

Background: In patient of T2DM and HF, reduced ejection fraction (HFrEF) constitutes the majority of HF cases, posing significant risk of mortality. NYHA classification, recommended in global HF guidelines, independently predicts mortality. SGLT2i have shown to reduce the incidence of hospitalization for HF. Hence, this study was planned to evaluate the effectiveness of Remogliflozin in improving the NYHA class in patients of T2DM with HF.
Methods: In this prospective, multicentre study, 250 patients of T2DM with HFrEF having NYHA Class I to III, were enrolled. 125 patients were allocated each to Remogliflozin (R) and Empagliflozin (E) group.
Results: Baseline distribution of patients in NYHA class was comparable in both groups. At baseline, 4%, 78.4%, and 17.6% of the patients in R-group were in NYHA class I, II, and III respectively, which improved to 50.91% in class I, 42.73% in class II, and 6.36% in class III at week 24 (Figure 1). Similarly, in E-group, about 4.8%, 64.8%, and 30.4% of the patients were in NYHA class I, II, and III and improved to 48.5% in class I, 40.9% in class II, and 10.5% in class III at week 24. Percentage improvement in NYHA class by ≥1 grade was seen in both R and E-group (80% vs 76%) at 24 weeks. The positive improvement in NYHA class indicates that the treatment provided improved patient’s function class and QoL. Both groups showed significant improvement in echo parameters (LVEF, LVdd) with no new safety concerns reported.
Conclusion: The improvement in NYHA class was comparable between Remogliflozin and Empagliflozin in patients of T2DM patients and HF (HFrEF). These clinical benefits were irrespective of baseline NYHA class and was associated with early and sustained improvement in NYHA class over study duration.

Disclosure
H.V. Barkate: Employee; Glenmark Pharmaceuticals. Y. Panchal: None. S. Bhushan: None. S.Y. Choudhari: Employee; Glenmark Pharmaceuticals, Sun Pharmaceutical Industries Ltd. A.U. Petare: Employee; Glenmark Pharmaceuticals.
944-P: Impact of Salt Reduction on Nocturia in Patients with Type 2 Diabetes—The TOP-STAR Study
Authors: SAIJO YUTO , OKADA HIROSHI , NAKAJIMA HANAKO , KOGURE AKINORI , OSAKA TAKAFUMI , TSUTSUMI TAKESHI , TANAKA TORU , HASEGAWA GOJI , MOGAMI SHINICHI , MITSUHASHI KAZUTERU , KITAGAWA NORIYUKI , HASHIMOTO YOSHITAKA , YANO MIHO , TANAKA MUHEI , KITAMURA AKANE , ISHII MICHIYO , NAKAMURA NAOTO , KISHI AKIO , USHIGOME EMI , HAMAGUCHI MASAHIDE , FUKUI MICHIAKI 
Published: June 2024

Title: Impact of Salt Reduction on Nocturia in Type 2 Diabetes Patients: The TOP-STAR Study
Introduction & Objective: This study addresses the prevalence of nocturia in type 2 diabetes patients, a condition often exacerbated by SGLT2 inhibitors. Recognizing the potential role of dietary salt in nocturnal urination, the study aims to evaluate the effect of salt reduction instruction combined with tofogliflozin therapy. We hypothesize that dietary salt restriction, alongside SGLT2 inhibitor use, may alleviate nocturia in this population.
Methods: The TOP-STAR study is a multi-center, open-label, randomized trial involving 80 patients with type 2 diabetes experiencing nocturia. Participants were randomly assigned to two groups: one receiving standard care with tofogliflozin therapy, and the other receiving additional salt reduction instructions. The primary outcome measured was the change in frequency of nocturnal urination over 12 weeks. Secondary outcomes included nocturnal urine volume and overall quality of life assessments.
Results: as follows; the average nocturia frequencies at baseline and 12 weeks were 1.3 [0.9-2.1] and 1.1 [0.5-1.9] vs and 1.5 [0.7-2.1] vs 1.4 [1.0-1.7] times per day respectively. The changes in nocturnal urine volume were -39.2 [-146.7-81.6] vs -71.7 [-218.3-78.4] mL (p=0.29). The changes in diurnal urine volume were 337.1 [41.6-513.4] vs 289.2 [7.2-490.8] mL (p=0.77).
Conclusion: Our findings indicate no significant superiority of salt restriction in reducing the frequency of nocturnal urination. However, tofogliflozin therapy was not associated with an increase in nocturia frequency and may contribute to a decrease in nocturnal urine volume. Notably, a subset of patients adhering strictly to salt reduction showed a trend towards reduced nocturia, suggesting potential individual benefits.

Disclosure
Y. Saijo: None. H. Okada: None. H. Nakajima: None. A. Kogure: None. T. Osaka: None. T. Tsutsumi: None. T. Tanaka: None. G. Hasegawa: None. S. Mogami: None. K. Mitsuhashi: None. N. Kitagawa: None. Y. Hashimoto: None. M. Yano: None. M. Tanaka: None. A. Kitamura: None. M. Ishii: None. N. Nakamura: None. A. Kishi: None. E. Ushigome: Speaker's Bureau; Boehringer-Ingelheim, Daiichi Sankyo, Novo Nordisk Foundation, Taisho Pharmaceutical Holdings Co., Ltd., Sumitomo Dainippon Pharma Co., Ltd. Research Support; Taiyo Kagaku Co., Ltd., Yoshinoya holdings. M. Hamaguchi: None. M. Fukui: None.
947-P: Retrospective CGM-Driven Missed-Meal Bolus Detection Tool
Authors: BENEDETTI ANDREA , MIKHNO ARTHUR , ROY ANIRBAN , SHIN JOHN 
Published: June 2024

Introduction: Remembering to deliver insulin before meals represents a significant burden for people with diabetes (PWD) and often results in late or entirely missed meal boluses.1,2 A new Medtronic CGM-driven retrospective meal-detection (MD) tool was developed and used to retrospectively identify missed meal events in a MiniMed™ 780G system (MM780G) pivotal trial that included an unannounced meal evaluation.
Methods: The CGM-driven missed meal detection tool integrates a Machine Learning model trained on CGM and insulin data for meal identification, combined with a local adjustment of the meal start time. Study participants (N=155, aged 7-75 years with T1D) using the MM780G were directed to abstain from announcing one meal each day for a duration of 5 days, while recording both the time and carb amount of these ‘test’ meals in a diary. The new MD algorithm was evaluated on 600 unannounced meals and its performance was characterized by recall rate and delay of missed meals.
Results: The model was able to detect 91% (recall) of test meals with a mean delay of 12.9 (38.4) minutes.
Conclusion: The Medtronic missed meal-detection algorithm can accurately mark missed meal events and support in-depth analysis of glycemic outcomes. Providing healthcare professionals with a more comprehensive understanding of mealtime behavior will enable more informed therapy decisions and the possibility of improved glycemic outcomes.

Disclosure
A. Benedetti: None. A. Mikhno: Employee; Medtronic. A. Roy: Employee; Metronics. J. Shin: None.
955-P: Effective Use of U-200 Insulin in OmniPod 5, Medtronic 780G, and Tandem X2 Systems
Authors: AKCAN TUGCE , NEEDLEMAN LEOR , BASINA MARINA 
Published: June 2024

Objectives: Commercially available insulin pumps are approved for U-100 insulin. Patients with high insulin dose requirements need to change infusion sets every 1-2 days, creating inconvenience and increasing costs. We evaluated the safety and feasibility of using U-200 insulin in hybrid closed-loop systems.
Methods: We reviewed clinical data and insulin pump uploads from three patients using U-200 insulin in their pumps, each diagnosed with a different type of diabetes: Type 1, Type 2, and post-pancreatitis. Each patient used a different hybrid closed-loop system in automated mode: OmniPod 5, Medtronic 780G, and Tandem X2. Insulin doses were reduced by 50% when programming the pump settings for U-200, with minor individual variations.
Results: Using U-200 insulin extended the infusion set wear from 1-2 days to 3 days. For the patient using the Medtronic 780G, Time in Range (TIR) improved by 57% in the month after transitioning to U-200 insulin. The Glucose Management Indicator (GMI) decreased from 9.6% to 7.4%, with SmartGuard mode active 73% of the time. Similarly, for the patient using the Tandem X2, TIR increased by 33% over a month, and GMI improved from 8.7% to 7.5%, with the patient in Control IQ mode 94% of the time. The patient using OmniPod 5 showed a 6% improvement in TIR and was in automated mode 100% of the time, with GMI improving from 6.7% to 6.5%. There was no increase in time spent in hypoglycemia with U-200 insulin. All three patients reported enhanced quality of life and increased satisfaction with their pump therapy.
Conclusion: The use of U-200 insulin in hybrid closed-loop system algorithms was safe and effective, offering a viable option for automated insulin delivery systems (AIDS) in patients with high insulin needs. This approach could also broaden the application of AIDS to different types of diabetes, as evidenced by our patients. This is the first reported case series to date. Further studies are necessary to establish standardized recommendations for using concentrated insulins in AIDS.

Disclosure
T. Akcan: None. L. Needleman: None. M. Basina: None.
959-P: Multiple Daily Injection (MDI) to Automated Insulin Delivery (AID) vs. Non-AID Insulin Pump for Newly Diagnosed People with Type 1 Diabetes Offers Improvement in Glycemic Control
Authors: ROMPICHERLA SAKETH , MILLER KELLEE , CHAO LILY C. , AKTURK HALIS K. , ALONSO GUY T. , DAVIS GEORGIA M. , DESALVO DANIEL , WEINSTOCK RUTH S. , HSIEH SUSAN , KAMBOJ MANMOHAN K. , RAPAPORT ROBERT , EBEKOZIEN OSAGIE , COLLABORATIVE T1DX-QI 
Published: June 2024

Automated insulin delivery relates to lower HbA1c values in people with type 1 diabetes (PwT1D) participating in clinical trials, but real-world evidence is lacking.
This observational crossover study used medical record data from PwT1D newly diagnosed between 2019-2023 from 32 centers in the T1D Exchange Quality Improvement Collaborative. We used real-world Electronic medical record (EMR) data to examine HbA1c levels among people with type 1 diabetes (PwT1D) classified as MDI users after T1D diagnosis and changed to AID during follow-up, versus people who changed to non-AID pump therapy. We compared HbA1c levels when initially using MDI to HbA1c levels after starting insulin pump therapy with and without AID.
There were 1,578 PwT1D who changed from MDI to AID after median (IQR) duration of 2.1 (2.3) years and 2,825 who changed to non-AID pump therapy after 0.8 (1.2) years. Among PwT1D who changed to AID, median (IQR) HbA1c decreased from 7.7 (1.7) to 7.4 (1.7) and HbA1c decreased from 8.0 (1.9) to 7.9 (1.9) among those changing to non-AID pump therapy. Odd Ratio (95% CI) of having an HbA1c &lt; 7.0% was 1.60 (1.34, 1.92) when changing to AID compared to non-AID pump therapy after adjusting for confounders.
We saw a greater decline in HbA1c levels and severe hypoglycemic episodes observed in AID users vs those using non-AID pump therapy.

Disclosure
S. Rompicherla: None. K. Miller: Consultant; Dexcom, Inc. Research Support; Dexcom, Inc. L.C. Chao: None. H.K. Akturk: Consultant; Medtronic. Research Support; Medtronic. Consultant; Dexcom, Inc. Research Support; MannKind Corporation, Tandem Diabetes Care, Inc. Consultant; Tandem Diabetes Care, Inc. G.T. Alonso: Advisory Panel; MannKind Corporation. G.M. Davis: Research Support; Insulet Corporation. Consultant; Medscape. D. DeSalvo: Advisory Panel; Insulet Corporation. Consultant; Dexcom, Inc. R.S. Weinstock: Research Support; Eli Lilly and Company, Tandem Diabetes Care, Inc., Diasome, Amgen Inc., MannKind Corporation, Insulet Corporation, Novo Nordisk. Other Relationship; Dexcom, Inc. S. Hsieh: None. M.K. Kamboj: None. R. Rapaport: None. O. Ebekozien: Advisory Panel; Sanofi, Medtronic. Research Support; Vertex Pharmaceuticals Incorporated. Speaker's Bureau; Vertex Pharmaceuticals Incorporated. Research Support; Medtronic, Lilly Diabetes, Abbott, Dexcom, Inc.

Funding
Helmsley Charitable Trust
96-OR: Pancreatic Adverse Events and Mortality in Patients with Immune Checkpoint Inhibitor–Associated Diabetes Mellitus—A 10-Year Follow-up Study
Authors: RAZA RIZVI SHAFAQ , JEET KAUR RAVINDER , REID COREY , DESJARDINS DONNA , KUDVA YOGISH C. 
Published: June 2024

Objectives/Introduction: Immune mediated pancreatic injury is a well-known side effect of immune checkpoint inhibitors (ICI) but there are lack of data regarding Pancreatic Adverse Events (PAEs) in patients with ICI related diabetes mellitus (ICI-DM).
Methods: We collected data from 31 subjects who were evaluated for ICI-DM at Mayo Clinic, Rochester from 2014 to 2023. PAEs were defined as new onset pancreatic disease (NOPD) or worsening of preexisting pancreatic disease (PPD) including acute or chronic pancreatitis, pancreatic cyst and pancreatic atrophy ± fatty replacement after ICI.
Results: We divided subjects into 2 cohorts: those with Cohort 1 with PAEs (n=14) and Cohort 2 without PAE (n=17) with more details in Table. There were no significant differences in age, BMI, PPD, pembrolizumab use, steroid use, HbA1c at DM onset or worsening of DM, follow-up time and mortality between the 2 cohorts. Cohort 1 experienced 16 PAEs; 9 subjects without PPD developed 11 new events (NOPD) and 5 subjects with PPD experienced PAEs. None of the other 4 subjects with PPD in cohort 2 experienced PAEs
Conclusion: In a single center, reasonable size cohort of ICI DM, pancreatic disease was induced or aggravated without increase in mortality. Further studies of this population are needed.

Disclosure
S. Rizvi: None. R. Kaur: None. C. Reid: None. D. Desjardins: None. Y.C. Kudva: Research Support; Dexcom, Inc. Other Relationship; Tandem Diabetes Care, Inc., Medtronic.
960-P: Perceived Consequences of AID Systems for the Care of People with Diabetes in Switzerland, Austria, and Germany
Authors: HERMANNS NORBERT , EHRMANN DOMINIC , ROOS TIMM , HEINEMANN LUTZ , KULZER BERNHARD 
Published: June 2024

AID systems are becoming increasingly popular among people with type 1 diabetes (pwt1d). As part of the Diabetes Report, we asked Pwt1d (n=1920) and parents of children with type 1 diabetes (n=210) in three countries (Germany, Austria and Switzerland) about the expected consequences of the increased use of AID systems. On a 5-point Likert scale (1=strongly disagree - 5=strongly agree), respondents were rather indifferent regarding the need for training programs specifically for AID systems. In contrast, the expectation of increased autonomy among AID users was very positive. On the other hand, respondents were rather negative about the statements that many users do not get along with AID systems, that there is less contact with the diabetes team as a result, that diabetes therapy becomes riskier as a result of AID systems, or that treatment in a diabetes clinic becomes more superfluous as a result. Generally, parents of children with diabetes were even more positive about AID systems than pwt1d (all p&lt;0.05), while there were no significant differences between the 3 countries (all p&gt;0.05). Pwt1d or their parents expect greater autonomy through the use of AIDs, whereas negative expectations regarding th AID impact on future diabetes care were rather low.

Disclosure
N. Hermanns: Speaker's Bureau; Berlin-Chemie AG, Sanofi-Aventis Deutschland GmbH. Research Support; Sanofi-Aventis Deutschland GmbH. Speaker's Bureau; Roche Diabetes Care. Research Support; Roche Diabetes Care. Speaker's Bureau; Dexcom, Inc. Advisory Panel; Abbott Diagnostics, Ypsomed AG. D. Ehrmann: Advisory Panel; Dexcom, Inc. Speaker's Bureau; Dexcom, Inc., Sanofi-Aventis Deutschland GmbH. Advisory Panel; Roche Diabetes Care. Speaker's Bureau; Roche Diabetes Care, Berlin-Chemie AG. T. Roos: 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. B. Kulzer: Advisory Panel; Abbott Diagnostics, Berlin-Chemie AG, Dexcom, Inc., Sanofi, embecta, Novo Nordisk, Roche Diabetes Care. Speaker's Bureau; Bayer Inc., Insulet Corporation, Lilly Diabetes.
966-P: Diabetes Technology Outcomes in the Vulnerable Early Childhood Population at a Large Diabetes Clinic
Authors: TABATABAI IDEEN , ALONSO GUY T. , FORLENZA GREGORY P. 
Published: June 2024

Intro: As more diabetes technology is approved for children down to age 2 and off-label use expands, clinical outcomes data for young children on these devices are sparse. We evaluated real-world device usage and the glycemic results in this vulnerable population.
Methods: Retrospective data were collected on all patients with T1D under age 7 years at a large, tertiary care center diabetes clinic (n=230; age 1.1 to 6.8 years). We performed two-sample t-tests by device use (AID vs MDI) for glycemic outcomes (HbA1c, Time in Range 70-180 mg/dL (TIR), Time Below range (TBR) &lt; 70, Time Above Range (TAR) &gt;180 and &gt;250 mg/dL) and insulin dosing parameters. Patients seen in the last 12 months were included.
Results: Use of AID was associated with significantly greater TIR, lower HbA1c, less TBR &lt; 70 mg/dL, and less glucose variability (all p&lt;0.05) (Table 1). Notably, TAR &gt;250 mg/dL was significantly reduced by 9%. AID users have significantly increased total daily insulin use (0.75u/kg/day on AID vs 0.62u/kg units on MDI, p=0.005), but without significant difference in basal to bolus ratios (mean basal 42 to 44% of TDD, p = ns).
Conclusion: In young children with type 1 diabetes at a large clinic, the majority of patients use CGM and AID, but nearly 1/3 do not use AID. Among those using AID, glycemic improvement outcomes were similar to clinical trial results, particularly in minimizing incidence of hyperglycemia and hypoglycemia.

Disclosure
I. Tabatabai: None. G.T. Alonso: Advisory Panel; MannKind Corporation. G.P. Forlenza: Research Support; Abbott, Dexcom, Inc. Consultant; Dexcom, Inc. Research Support; Insulet Corporation. Consultant; Insulet Corporation. Research Support; Medtronic. Advisory Panel; Medtronic. Research Support; Tandem Diabetes Care, Inc. Consultant; Tandem Diabetes Care, Inc.
973-P: New Paradigms for Wearability with the Tandem Mobi System
Authors: HABIF STEPHANIE , MANNING MICHELLE L. , LEAS SCOTT , MORGAN LEXI , MESSER LAUREL H. 
Published: June 2024

Background: Lack of wearability options is a top cited barrier to insulin pump therapy. A new tubed insulin pump, Tandem Mobi, has a very small footprint (2 x 1.5 x .5 inches), and optional 5-inch tubing and adhesive sleeve for on-body wear, in addition to traditional wear options. Here we qualitatively assess&lt;u&gt; &lt;/u&gt;feedback from early users, specifically to understand new options for wearing the system.
Methods: Adults (18+ years) with type 1 diabetes participated in an early product launch October-December 2023 (n=145), and wore the Tandem Mobi for &gt;6 weeks (prior therapy = 83% Tandem t:slim X2, 12% other pumps, 5% multiple daily injections). Daily surveys were sent for open-ended user experience feedback. A total of 309 verbatim comments on the topic of wearability were received and analyzed.
Results: 102 adults using Tandem Mobi responded to surveys. Fifty-seven participants commented on using the adhesive sleeve with 5-inch tubing for on-body wear (figure). Other wear options mentioned included using pump case attached to clothing, or tucking into a pocket or bra. 15% of respondents mentioned the Tandem Mobi wearability allowed them to “forget they are wearing a pump.”
Conclusions: The Tandem Mobi’s on-body wear combined with the ability to disconnect presents a new paradigm for pump wearability. Users cite the convenience of a patch pump with the utility of a tubed pump, potentially reducing barriers to insulin pump therapy by increasing optionality.

Disclosure
S. Habif: Employee; Tandem Diabetes Care, Inc. M.L. Manning: Employee; Tandem Diabetes Care, Inc. S. Leas: Employee; Tandem Diabetes Care, Inc. L. Morgan: Employee; Tandem Diabetes Care, Inc. Stock/Shareholder; Tandem Diabetes Care, Inc. L.H. Messer: Employee; Tandem Diabetes Care, Inc.

Funding
Tandem Diabetes Care
98-OR: ß-Cell Dysfunction and Mitochondrial Loss Occur Independently of Insulitis in Type 1 Diabetes Pathogenesis
Authors: HUBER MOLLIE , WIDENER ADRIENNE , SMURLICK DYLAN , HILLER HELMUT , BEERY MARIA , VERNEY ELLEN , KUSMARTSEVA IRINA , CAMPBELL-THOMPSON MARTHA , ATKINSON MARK A. , MATHEWS CLAYTON E. , PHELPS EDWARD 
Published: June 2024

Introduction: Type 1 diabetes (T1D) is characterized by a period of β cell dysfunction prior to β cell death. During this time, β cells lack a first-phase insulin response and exhibit an intolerance to glucose. However, the underlying mechanisms of this dysfunction remain unclear. Here, we use live human pancreas tissue slices (LPTS) to investigate the possible mechanisms underlying β cell dysfunction in T1D.
Methods: LPTS from organ donors without diabetes (ND, n=13), donors without T1D and positive for one (sAAb+, n=6) or multiple T1D-relavent autoantibodies (mAAb+, n=2), and individuals with short-duration T1D (T1D+, n=9) were studied. Simultaneous time-lapse Ca2+ imaging and CD3+ T-cell tracking were conducted to assess alterations in β-cell function. Additionally, fixed pancreas sections (ND, n=8; sAAb+, n=7; mAAb+, n=7; T1D+, n=6) were probed with a panel of 22 antibodies to investigate mechanisms underlying β-cell dysfunction including insulin, CD3, ATP5B (a mitochondrial ATP synthase subunit), and ATPIF1 (ATP synthase inhibitor).
Results: Islets within LPTS from ND and AAb+ donors exhibited typical Ca2+ mobilization in response to high glucose (HG) and potassium chloride (KCl) stimulations. Islets from T1D+ donors had significantly diminished Ca2+ responses to HG compared to ND donors (p&lt;0.05, one-way ANOVA). Low glucose and KCl stimulations between ND, AAb+, and T1D+donors were similar, indicating that the dysfunction occurs in the glucose metabolism pathway. Additionally, there were no significant differences in HG responses in insulitic and non-insulitic islets from T1D+ LPTS with both being dysfunctional. Fixed tissue staining revealed a significant (p&lt;0.0001, two-way ANOVA) decrease in mitochondria in β cells from T1D+ donors.
Conclusion: The loss of HG responses in T1D+ β cells independent of the local T cell infiltration, coupled with the decrease in mitochondria, indicates that the dysfunction likely originates in the β cell and contributes to T1D pathogenesis.

Disclosure
M. Huber: None. A. Widener: None. D. Smurlick: None. H. Hiller: None. M. Beery: None. E. Verney: None. I. Kusmartseva: None. M. Campbell-Thompson: None. M.A. Atkinson: None. C.E. Mathews: None. E. Phelps: Research Support; Immunocore, Ltd, MESO SCALE DIAGNOSTICS, LLC.

Funding
T32DK108736F31DK130607P01; AI42288 R01DK132387