bluuebunny/crossref_metadata_2025_split huggingface dataset:
372-P: Effect of Whey Protein Consumption on Hypoglycemia Risk in Type 1 Diabetes Patients Fasting during Ramadan—A Randomized Crossover Trial
Authors: ALAMOUDI REEM , ALOTAIBI MOHAMMED N. , RADI SUHAIB , ALASSIRI MISHARY A. , ALSHARIF SARAH S. , BASULAYMAN DALIA S. , ALAHDAL LAMA , ALJUIAD FETOON M. , KHAN MUHAMMAD A. , ZARIF HAWAZEN A. 
Published: June 2024

Many patients with type1 diabetes (T1DM) choose to fast during Ramadan despite the risks involved.
Objective: To examine the effectiveness of whey protein consumption with Suhoor (predawn meal) on the number of hypoglycemic events and time spent in hypoglycemia in T1DM during fasting Ramadan.
Methods: Prospective randomized cross-over design. T1DM planning to fast Ramadan recruited. Data collected using pre/post-Ramadan questionnaires, and FCGM - Freestyle Libre.
Results: 41 T1DM patients were randomized to whey protein consumption with Suhoor for a week then crossed over to Suhoor with no whey protein the second week. 33 were on MDI and 8 CSII. Mean age 24 ±4.2 years (range 18-32), DM duration 14.1 ±7.3 years, 22 (53.7%) female. Pre-Ramadan: A1c 7.6 ±1.07 (5.8-10.3). 19 (46.3 %) reported frequent hypoglycemia (≥3/week), and 3 (7.3 %) reported hypoglycemia unawareness. DaR risk score 9 ±2.4, 5 (12.2%) moderate risk and 36 (87.8%) high risk. During the whey protein vs. no whey protein week mean number of days breaking of fast with main cause being hypoglycemia was 0.73 ±1.1 vs 1.15 ±1.4, p=0.004. No severe, DKA, or hospital admission reported during either regimen. FCGM detected mean hypoglycemia events per patient per week of whey protein vs none regimen was 0.7 vs 1.1, p=0.07; for post-Suhoor (3-6am), and 0.3 vs 0.6, p=0.05 for pre-Iftar (4-6pm). AGP report: GMI 7.5 ±1.5 vs 7.4 ±1.5, p=0.7, Time in target (70-180 mg/dl) 46.4 ±17.3% vs49.4 ±17.3%, p=0.1, Time below target (&lt;70mg/dl) 5.1 ±5.6% vs 5.9 ±5.3%, p=0.2, Time above target (&gt;180mg/dl) 48.5 ±18.6% vs 44.7 ±18.6%, p=0.09, and Glucose variability 39.8 ±8.04% vs 40.8 ±8%, p=0.3. 51.2% of patients thought whey protein consumption with Suhoor was beneficial, and 68.4% would use it in future Ramadan.
Conclusion: Adding whey protein to Suhoor meal reduced the need to break fasting but did not affect TBR or hypoglycemic events. Larger studies needed to study effectiveness of this approach.
ClinicalTrials.gov registered

Disclosure
R. Alamoudi: None. M.N. Alotaibi: None. S. Radi: None. M.A. Alassiri: None. S.S. Alsharif: None. D.S. Basulayman: None. L. Alahdal: None. F.M. Aljuiad: None. M.A. Khan: None. H.A. Zarif: Advisory Panel; Abbott, Medtronic, Novo Nordisk.
374-P: Impact of Sulfonylurea (SU) Use on Hypoglycemia and Continuous Glucose Monitoring (CGM) Metrics after 16 Weeks of iGlarLixi in Insulin-Naïve Adults with Type 2 Diabetes (T2D) and Mean A1C &gt;10%
Authors: RATZKI-LEEWING ALEXANDRIA , DEX TERRY A. , MENEGHINI LUIGI , RODRIGUES AMÉLIE , FRIAS JUAN P. 
Published: June 2024

Introduction & Objective: In a 16-week open-label trial (NCT05114590) of insulin naïve adults (≥ 18 yrs; 70.2% Hispanic/Latino) with T2D (mean A1c &gt;10%) suboptimally controlled on ≥2 oral antihyperglycemic drugs (OADs) ± glucagon-like peptide-1 receptor agonist (GLP-1 RA), iGlarLixi increased TIR by 26.2% (P&lt;0.001), as measured by blinded CGM. We report a post-hoc analysis of SU users vs non-SU users.
Methods: We quantified on-treatment hypoglycemia incidence and mean changes in CGM and glucose control endpoints from baseline to Week 16 in SU vs non-SU users (Table).
Results: In total 124 participants were enrolled, 91 (73%) used a background SU (76% self-identified as Hispanic/Latino). Total hypoglycemia incidence was low and similar for SU vs non-SU users with no reported severe events. Nocturnal hypoglycemia was only reported by SU users (Table). Mean improvements in CGM (including TIR) and glucose control endpoints were numerically greater in non-SU vs SU users (Table).
Conclusion: In people with T2D suboptimally controlled on ≥2 OADs ± GLP-1 RA, iGlarLixi for 16 weeks improved glycemic control. Compared to SU users, non-SU users achieved greater improvements in glucose control without nocturnal hypoglycemia. To safely optimize T2D diabetes management, iGlarLixi may be best prescribed without a concurrent SU.

Disclosure
A. Ratzki-Leewing: Research Support; Sanofi. Advisory Panel; Dexcom, Inc. Consultant; Abbott. Advisory Panel; Sanofi-Aventis U.S. Other Relationship; American Diabetes Association. Consultant; Novo Nordisk, Eli Lilly and Company. T.A. Dex: Stock/Shareholder; Pfizer Inc. Employee; Sanofi. Stock/Shareholder; Viatris Inc., Teva Pharmaceutical Industries Ltd. L. Meneghini: Employee; Sanofi. A. Rodrigues: Consultant; Sanofi. J.P. Frias: Research Support; Akero Therapeutics, Inc. Consultant; Akero Therapeutics, Inc. Research Support; Altimmune Inc. Consultant; Altimmune Inc. Research Support; Boehringer-Ingelheim. Consultant; Boehringer-Ingelheim. Research Support; 89bio, Inc. Consultant; 89bio, Inc. Research Support; Eli Lilly and Company. Advisory Panel; Eli Lilly and Company. Speaker's Bureau; Eli Lilly and Company. Research Support; Merck & Co., Inc. Consultant; Merck & Co., Inc. Research Support; Novartis Pharmaceuticals Corporation. Consultant; Novartis Pharmaceuticals Corporation, Novo Nordisk. Board Member; Novo Nordisk. Research Support; Novo Nordisk, Pfizer Inc. Consultant; Pfizer Inc. Advisory Panel; Sanofi. Speaker's Bureau; Sanofi. Research Support; Sanofi. Stock/Shareholder; Biomea Fusion, Inc. Employee; Biomea Fusion, Inc.

Funding
Sanofi US
388-P: Reproducibility of Urinary Albumin-to-Creatinine Ratio and Its Association with Prediabetes Risk in Healthy Adults with Parental Type 2 Diabetes
Authors: EVERETT MATTHEW , ASUZU PEACE , WAN JIM Y. , DAGOGO-JACK SAMUEL 
Published: June 2024

Introduction & Objective: We investigated the reproducibility of consecutive uACR measurements and association with progression to prediabetes among African American (AA) and European American (EA) offspring of parents with T2D.
Methods: Normoglycemic participants in the Pathobiology of Prediabetes in a Biracial Cohort study were followed quarterly for 5.5 years (mean 2.62 years) for the primary outcome of incident prediabetes. Baseline and follow-up assessments included oral glucose tolerance test, anthropometry, uACR, and lipid profile. Baseline and annual uACR data from study participants were analyzed. We then assessed the correlation of baseline and repeated annual uACR measurements and association with incident prediabetes.
Results: Baseline uACR levels from 308 participants (167 AA, 141 EA; mean age 45.1 ± 10.3 yr; BMI 30.4 ± 7.34 kg/m2) ranged from 1-29 mg/g; were similar in AA vs. EA participants (6.40 mg/g ± 4.80 vs. 6.80 ± 5.40 mg/g, P=0.52); and higher in women than men (7.30 mg/g ± 5.30 vs. 4.60 ± 3.90 mg/g, P&lt;0.0001). uACR levels were analyzed for the subsequent year (Year 2, N=170). Baseline uACR values were significantly correlated with Year 2 (rho=0.412, P&lt;0.0001) and Year 3 values (rho=0.241, P=0.0023). The mean change in uACR was 2.69 + 19.49 mg/g (41.1%) (Year 2-Baseline) and 1.11 + 15.1 (17.0%) (Year 3-Baseline). During 5.5 years of follow-up, 104 participants developed prediabetes and 204 maintained normoglycemia. Baseline uACR was significantly associated with the risk of progression to prediabetes (rho=0.186, P=0.0011), as was Year 2 uACR (rho=0.247, P=0.0013).
Conclusions: In our study of normoglycemic, normoalbuminuric adults with parental diabetes, uACR in random urine specimens during three consecutive years were significantly correlated, though individual values varied by 17%-41%. Furthermore, baseline uACR and Year 2 were significantly associated with 5-year progression to prediabetes.

Disclosure
M. Everett: None. P. Asuzu: None. J.Y. Wan: None. S. Dagogo-Jack: Consultant; Merck Sharp & Dohme Corp., Medtronic, Bayer Inc. Stock/Shareholder; Aerami.
39-PUB: A Comprehensive Tool for Analyzing Continuous Glucose Monitoring Data
Authors: ZHANG XIAOHUA D. , ZHANG RENA D. , KUEI LIN YU , FISHER SIMON J. 
Published: June 2024

Introduction & Objective: While existing software packages are available for Continuous Glucose Monitoring (CGM) data analysis, they lack the incorporation of novel CGM-based metrics, specifically focusing on the dynamics of health status, Shannon entropy, and fractal analysis.
Methods: We crafted R functions to execute the computation of essential parameters such as summary statistics, time within/above/below designated glucose thresholds, and glycemic variability indices. Moreover, we introduced novel metrics that capture the dynamics of health status, as well as complexity and fractality analysis. We implemented artificial intelligence methods to provide an integrated approach to diabetes care, incorporating both newly developed and existing CGM-based metrics. To facilitate widespread accessibility, we wrapped these functions into an R package, showcased its utility in analyzing CGM studies involving subjects with Type 1 diabetes and will offer it freely to the public for utilization.
Results: An R package was developed to cover a comprehensive analysis from quality control, exploratory analysis, regular statistical analysis and machine learning modeling on CGM studies. This package has more functionalities than any one of existing CGM analysis tools like GlyCulator, EasyGV (Easy Glycemic Variability), CGM-GUIDE© (Continuous Glucose Monitoring Graphical User Interface for Diabetes Evaluation), GVAP (Glycemic Variability Analyzer Program), Tidepool, CGManalyzer, cgmanalysis, GLU, CGMStatsAnalyser, iglu, rGV, and cgmquantify.
Conclusion: By addressing the limitations of current software programs and introducing advanced features, this software holds the potential to contribute significantly to the field of CGM data analysis and improve the management of diabetes.

Disclosure
X.D. Zhang: None. R.D. Zhang: None. Y. Lin: None. S.J. Fisher: None.

Funding
National Institutes of Health (UL1TR001998); National Institutes of Health (U01DK135111); National Institutes of Health (P30 DK020579); National Institutes of Health (OT2HL161847)
396-P: Consequences of Knockout of the Histone Demethylase KDM6B from Myeloid Cells Are Context-Dependent in Diabetic Kidney Disease
Authors: HONG LISA Y.Q. , KAUR HARMANDEEP , TIN TRAN DUC , LIU YOUAN , NAGARJUN BATCHU SRI , ADVANI ANDREW 
Published: June 2024

Introduction & Objective: Epigenetic processes and inflammation have each emerged as key players in the development of diabetic kidney disease. Here, we compared the consequences of knockout of the epigenetic enzyme and histone demethylase, KDM6B from myeloid cells in diabetic mice and mice with obstructive uropathy.
Methods: Myeloid cell KDM6B knockout (KDM6BMyeloidKO) mice were generated by breeding Kdm6bfl/fl mice with LysMCre+mice and compared to LysMCre+ controls (KDM6BCtrl). M-CSF levels were measured by cytokine array of media conditioned by bone marrow-derived macrophages (BMDMs). Mice were studied either 12 weeks after diabetes induction with streptozotocin (STZ) or 1 week after unilateral ureteral obstruction (UUO) surgery. Kidney injury and inflammation were assessed by qRT-PCR.
Results: Basal M-CSF secretion was reduced in KDM6BMyeloidKO BMDMs in comparison to KDM6BCtrl BMDMs (KDM6BCtrl 62pg/mL, KDM6BMyeloidKO 4pg/mL, p&lt;0.01), suggestive of a shift towards M1-like polarization. Kidney injury (as assessed by Havcr1 mRNA) was increased ~90-fold in STZ-diabetic mice and ~615-fold in UUO mice. Similarly, kidney inflammation (as assessed by Ccl2 mRNA) was increased ~9-fold in STZ-diabetic mice and ~72-fold in UUO mice. Blood glucose levels were equally elevated in STZ-diabetic KDM6BCtrl and KDM6BMyeloidKO mice. Knockout of KDM6B from myeloid cells attenuated Havcr1 and Ccl2 upregulation in UUO mice but not in STZ-diabetic mice.
Conclusion: Kidney inflammation in STZ-diabetic mice is typically mild, and myeloid cell involvement is primarily through M1-like responses that are independent of the histone demethylase KDM6B. In contrast, myeloid KDM6B contributes to the more advanced inflammation and injury associated with obstructive uropathy. These findings underscore the importance of the physiological context in determining the actions of ostensibly ‘epigenetic enzymes’ in kidney disease, including that caused by diabetes.

Disclosure
L.Y.Q. Hong: None. H. Kaur: None. D. Tran: None. Y. Liu: None. S. Batchu: None. A. Advani: None.
40-PUB: Impact of the Initiation of is-CGM Soon after Type 1 Diabetes Mellitus Diagnosis in Adults on Glycemic Indices and Fear of Hypoglycemia—Data from RCT
Authors: HOHENDORFF JERZY , WRÓBEL MARTA , GRZELKA-WOZNIAK AGATA , KANIA MICHAL , LAPINSKA LIDIA , ROKICKA DOMINIKA , KOWALSKA IRINA , STROJEK KRZYSZTOF , ZOZULINSKA-ZIOLKIEWICZ DOROTA , MALECKI MACIEJ 
Published: June 2024

Use of CGMS has become the standard of glucose control in patients with T1DM. It was shown that use of CGM improves TIR and TBR, and QoL. We aimed to assess the impact of soon after diagnosis (within 1-6 months) initiation of is-CGM on glycemic indices and fear of hypoglycemia (FoH) in adults newly diagnosed with T1DM. After 14 days of wearing the blinded sensor, participants were randomly assigned (1:1) to is-CGM (intervention group) or to self-monitoring of blood glucose (SMBG) with glucometers and blinded CGM (control group). The primary outcomes were change in TB70 and FoH assessed in HFS and main secondary outcomes were change in mean glucose, TIR, TAR between baseline and 4 weeks after randomization. Finally, in this RCT, 23 patients aged 25.6±5.1 were analyzed (14 males, 9 females). All participants were on MDI. Main results of the study are shown in Table 1. The study was terminated early due to changes in reimbursement policy in Poland, as during the study groups of patients eligible for reimbursement were significantly expanded and next generation of is-CGMS was introduced on market. However, our study has shown that, in T1DM patients early after diabetes diagnosis, TIR is high and hypoglycemia risk low. In spite small study group, our data suggest that introducing is-CGM decreases mean glucose; additionally, trend to further increase TIR and decrease TAR was seen.

Disclosure
J. Hohendorff: Research Support; Abbott. Speaker's Bureau; Dexcom, Inc., Ascensia Diabetes Care. M. Wróbel: None. A. Grzelka-Wozniak: Consultant; Novo Nordisk. Other Relationship; Boehringer-Ingelheim, Novo Nordisk, AstraZeneca, Roche Diabetes Care, Sanofi. M. Kania: None. L. Lapinska: None. D. Rokicka: None. I. Kowalska: Advisory Panel; Abbott. Speaker's Bureau; AstraZeneca, Boehringer-Ingelheim, Eli Lilly and Company, Novo Nordisk, Sanofi. Advisory Panel; Ascensia Diabetes Care. Speaker's Bureau; Berlin-Chemie AG. K. Strojek: None. D. Zozulinska-Ziolkiewicz: Advisory Panel; Abbott, BIOTON. Speaker's Bureau; Boehringer-Ingelheim, Eli Lilly and Company, Ascensia Diabetes Care, Novo Nordisk, Medtronic, Sanofi, Servier Laboratories. Advisory Panel; Eli Lilly and Company. M. Malecki: Advisory Panel; Eli Lilly and Company, Novo Nordisk, Sanofi, Abbott, Dexcom, Inc., Boehringer-Ingelheim. Speaker's Bureau; AstraZeneca, Merck & Co., Inc. Advisory Panel; Krka. Speaker's Bureau; Servier Laboratories.

Funding
Diabetes Poland Grant 2021
403-P: Body-Weight Cycling and Risk of Diabetic Kidney Disease in People with Type 1 Diabetes
Authors: CAMOIN MARION , MOHAMMEDI KAMEL , SAULNIER PIERRE-JEAN , HADJADJ SAMY , GAUTIER JEAN-FRANÇOIS , RIVELINE JEAN-PIERRE , VENTECLEF NICOLAS , POTIER LOUIS , VELHO GILBERTO 
Published: June 2024

Introduction & Objective: Chronic kidney disease (CKD) is a major issue in the management of people with type 1 diabetes (T1D). Intraindividual body weight variability (BWV) or cycling is associated with increased risk of cardiovascular events and all-cause death in T1D. We conducted a retrospective analysis of data from the DCCT/EDIC studies for the association between BWV and the risk of renal events.
Methods: Five BWV indices were calculated for 1,432 participants of the DCCT/EDIC studies taking into account body-weight measurements during the DCCT follow-up (average 6±2 years). Variability independent of the mean (VIM) was the main variable of interest. Six criteria of progression to CKD were studied during DCCT/EDIC follow-up (21 ± 4 years). Cox models were fitted to estimate associations of BWV indices with the outcomes. Hazard Ratios (HR) with 95% confidence interval (CI) were computed for 1 SD of the indices expressed as a Z-score.
Results: Progression to CKD stage 3 (eGFR&lt;60ml/min/m2) during follow-up occurred in 128 participants (8.9%). A high VIM was significantly associated with occurrence of stage 3 CKD (adjusted HR 1.36 [95% CI, 1.12-1.63], p= 0.002), doubling of serum creatinine (1.36 [1.15-1.60], p=0.0005), decline in eGFR&gt;3ml/min/m2 per year (1.47 [1.14-1.89], p=0.003), and “Certain drop in eGFR” KDIGO criterion (1.20 [1.02-1.41], p = 0.03), after adjustment for nephropathy risk factors at baseline and throughout follow-up, and use of nephroprotective drugs. VIM was also associated with the incidence of microalbuminuria (1.21 [1.08-1.36], p = 0.002) and macroalbuminuria (1.36 [1.14-1.61], p= 0.0009), adjusted for baseline covariates, but associations did not remain significant following adjustment for follow-up covariates. Similar results were observed for the other BWV indices.
Conclusion: BWV is significantly associated with an increased risk of renal events in people with T1D, regardless BMI and traditional risk factors.

Disclosure
M. Camoin: None. K. Mohammedi: None. P. Saulnier: Advisory Panel; Novo Nordisk. S. Hadjadj: Consultant; AstraZeneca. Research Support; Asten Santé, Air Liquide. Consultant; Bayer Inc., Boehringer-Ingelheim, Eli Lilly and Company. Research Support; LVL, Nestlé Health Science. Consultant; Novo Nordisk. Board Member; Valbiotis. Consultant; Sanofi. Research Support; Vitalaire. J. Gautier: Board Member; Sanofi. Other Relationship; Sanofi. Speaker's Bureau; AstraZeneca, Novo Nordisk. Research Support; Novo Nordisk. Advisory Panel; Pfizer Inc. J. Riveline: Board Member; Abbott, Novo Nordisk A/S, Sanofi, Eli Lilly and Company, Medtronic, Dexcom, Inc., Insulet Corporation, Air Liquide, AstraZeneca. N. Venteclef: None. L. Potier: Research Support; Abbott. Consultant; AstraZeneca, Bayer Inc., Eli Lilly and Company, Novo Nordisk, Sanofi, Boehringer-Ingelheim. G. Velho: None.
407-P: Kidney Transplant Infection Risks—CGM Parameters Insights and Glucagon-Like Peptide-1 Receptor Agonist (GLP1-RA) Strategies
Authors: CAMPANA MARIO S. 
Published: June 2024

Introduction: Cytomegalovirus (CMV) and BK are common viral infections in kidney transplant (KT) recipients that tend to appear within the first year after KT. Uncontrolled post-transplant diabetes mellitus (PTDM) and Type 2 diabetes mellitus (T2DM) have been associated with an increased risk for these opportunistic infections. This study aims to examine the association of CMV and/or BKA infections with CGM parameters like time in range (TIR) and GLP1-RA status.
Methods: This is a prospective follow-up study conducted at the Transplant Institute of the University of Alabama at Birmingham. We analyzed the data of 50 adults with PTDM and T2DM who underwent KT between 10/2022 to 10/2023. Patients were followed for 12 months for CMV and/or BKA new infections defined by positive serology. The association of TIR and GLP1-RA was reported as a risk ratio using univariable and multivariable modified poison regression analyses with standard error models adjusted for age, sex, race, and insulin type.
Results: Overall, 25 (50%) participants had CMV/BK infections. Mean age was 56.6 years, 56% were female, 66% African American, 70% with pre-existing type 2 diabetes, and 56% using GLP1-RA. Of the 19 participants with a TIR &gt;70%, 3 (15.8%) experienced infection as compared to 22/32 (71.0%) with a TIR ≤70%. Of the 28 participants with GLP1-RA, 12 (42.9%) experienced infection as compared to 13/22 (59.1%) without GLP1-RA. Adjusting for confounders, risk of infections was lower for the participants with TIR &gt;70% than those with ≤70% (RRadj=0.22, 95% CI: 0.07 - 0.66; p= 0.007) and for the participants with GLP1-RA than those without (RRadj = 0.77, 0.42 - 1.39; p=0.384).
Conclusion: KT patients with diabetes mellitus who were started on CGM for the first time, with a TIR &gt;70% and GLP1-RA usage had a lower risk of transplant-related infections: BK and CMV. Early use of CGM with monitoring of TIR as a potential marker of diabetes control will improve transplant outcomes and rates of rejection.

Disclosure
M.S. Campana: None.
41-PUB: Pharmacy Intervention in the Management of Poorly Controlled Type 2 Diabetes
Authors: STERRETT YAMINI R. , REDDY VARSHA , BEHNKE ANDREW , LUCAS KARA 
Published: June 2024

The prevalence of type 2 diabetes continues to increase worldwide leading to increased health and economic burden on healthcare system. Pharmacists are an essential part of healthcare delivery, play a significant role in patient outreach and can assist with medication titration. Our study was a retrospective review of clinical pharmacists in the management of patients with poorly controlled type 2 diabetes, defined as a A1c level of &gt;9.0%, and the efficacy of reduction in A1c using this intervention. This study involved six clinical pharmacists who provided diabetes management using ADA Standards of Care guidelines for outpatient family medicine and internal medicine clinics with 115 patients who completed the study. Patients referred included those with an A1c &gt;9% and were contacted on a one to four week basis up to the discretion of pharmacist with patients followed for at least three months with a goal of a reduction in A1c to &lt;9%. Results were significant for a decrease in A1c levels in 90% of patients. Average starting A1c was found at 10.5% ± 2.3 to 8.0 ± 1.6 with a decline in A1c over an average period of 6.7 months of 2.5% ± 2.4 (p value &lt;0.001).
In conclusion, the use of clinical pharmacists in the management of type 2 diabetes showed a statistically significant reduction in A1c prior to referral to an endocrinologist. This model poses a possible solution to help lighten the burden that diabetes produces on the health care system.

Disclosure
Y.R. Sterrett: None. V. Reddy: None. A. Behnke: Research Support; Abbott. K. Lucas: None.