bluuebunny/crossref_metadata_2025_split huggingface dataset:
637-P: The Impact of the Lockdown on Romanian Patients with Type 1 Diabetes and Basedow-Graves’ Disease
Authors: GHERBON ADRIANA , FRANDES MIRELA , TIMAR ROMULUS 
Published: May 2022

Introduction: The lockdown imposed in Romania to limit the spread of COVID-infection has led to socio-psychological changes, especially stress affecting the endocrine system.
Objectives: Monitoring the impact of the lockdown imposed in Romania on patients with type 1 diabetes (DM 1) and compensated Basedow-Graves’ disease (BGD) , in treatment with antithyroid drugs (AD) .
Material and Method: This retrospective observational study included 151 patients with DM 1 and BGD and was based on an original questionnaire published online with questions about blood glucose, HbA1c, and TSH, diabetologist and endocrinologist contact, access to treatment, and factors influencing the glycemic control.
Results: We observed that 71.52% reported that they were afraid to go to the hospital when their general condition was altered (p &lt;0.001) , and 80.13% stated that the stress increased during the restrictions (p &lt;0.001) . A percent of 68.87% felt overwhelmed by the multitude of information about their disease, which they had to manage on their own (p˂0.001) . However, 67.54% of patients stated that they were able to contact the diabetologist and endocrinologist more often, via telemedicine (p˂0.001) and only 37.74% agreed that they did not encounter difficulties in managing type 1 diabetes during the pandemic, compared to 25.16% who had difficulties. Also, 33.77% of patients had decompensations of BGD, although initially the TSH value was within normal limits under treatment with AD.
Conclusions: Stress and anxiety were among the main causes that led to increased blood sugar levels and decompensation of BGD, suggesting that the psychological impact of the pandemic could bring long-term complications. References 1. Aragona M et al. Type 1 diabetes and COVID-19: The"lockdown effect." Diabetes Res Clin Pract. 2020 Dec;170:108468. 2. Gherbon A et al. Transient hyperthyroidism following the ingestion of complementary medications containing kelp seaweed: A case-report. Medicine. 20Sep;98 (37) .

Disclosure
A.Gherbon: None. M.Frandes: None. R.Timar: None.
649-P: Real-Time Continuous Glucose Monitoring in the Hospital Identifies and Prompts Treatment for Hypoglycemia
Authors: BAKER MATT , WELSH JOHN 
Published: May 2022

Reliance on point-of-care (POC) blood glucose measurements for inpatient diabetes management can result in long between-measurement intervals, which contribute to undetected and untreated dysglycemia. The G6 real-time continuous glucose monitoring (RT-CGM) system (Dexcom) allows for remote monitoring. In the hospital, this may reduce the need for close interactions and infectious disease transmission between patients and hospital staff. A man in his mid-60s was admitted to a non-intensive care unit in an acute care facility with a diagnosis of COVID-19. His preadmission type 2 diabetes was managed with twice-daily intermediate-acting insulin and prandial rapid-acting insulin; steroids and POC glucose testing (prandial and bedtime with a FreeStyle Precision Pro meter [Abbott]) were added to this regimen. A G6 was placed on the abdomen and was set to alert the staff to glucose values ≤85 mg/dL or predicted to be &lt;55 mg/dL within 20 minutes. Two hypoglycemic events occurred which triggered three G6 alerts (Figure) . The G6 alerts prompted ad hoc POC measurements that confirmed the hypoglycemic events, prompted appropriate interventions, and documented the patient’s return to euglycemia. All seven G6 readings were within 20 mg/dL or 20% of POC values ≤100 or &gt;100 mg/dL, respectively. Inpatient RT-CGM use can detect existing or impending hypoglycemia and assist in diabetes management.

Disclosure
M.Baker: Other Relationship; Dexcom, Inc. J.Welsh: Employee; Dexcom, Inc.

Funding
Dexcom, Inc.
677-P: Impact of Third Dose COVID-Vaccination on Glycaemic Control in Individuals with Type 1 Diabetes Using Flash Glucose Monitoring
Authors: PIERALICE SILVIA , MONTE LAVINIA , DEFEUDIS GIUSEPPE , TABACCO GAIA , NAPOLI NICOLA , POZZILLI PAOLO 
Published: May 2022

Background: Coronavirus (COVID-19) disease portends a poor prognosis in patients with type 1 diabetes (T1D) . As a consequence, the booster dose of Covid-vaccination should be prioritized in these patients. Nonetheless, concerns exist about vaccine-induced dysglycemia.
Objectives: Aim of this study was to assess the short-term effects of booster dose of Covid-vaccination on glycaemic control assessed by flash glucose monitoring (FGM) in people with T1D.
Methods: In this observational cross-sectional study we investigated changes in daily insulin requirement (IR) and glycaemic control between 7 days before and 7 days after the third dose of vaccination with BioNTech Pfizer among 30 individuals with T1D on multiple daily insulin injections wearing a flash glucose monitoring (FGM) device. The following parameters of glycaemic variability were analysed: mean glucose, time in range (TIR) , time above range (TAR) , time below range (TBR) and coefficient of variation (CV) .
Results: No significant differences were found for mean glycemia, TIR, TAR and TBR over the course of the vaccination from 7 days prior to receiving the third-dose vaccination until 7 days after. Nonetheless, CV and IR were significantly higher (CV, p-value = 0.001; IR, p-value = 0.05) in the week after the vaccination compared to the week earlier. The median value of CV was 35.5% [33-37] before and 36.9% [34-39] after the booster dose, whereas the median value of IR changed from 0.55 UI/Kg/day to 0.61 UI/Kg/day.
Conclusions: Our study suggests that the booster dose of Covid-vaccination impact on glycaemic variability and insulin requirement in people with T1D, probably due to the pro-inflammatory cytokines and immune responses. While this observation should be investigated in larger studies, potential glycaemic aberrations in response to Covid-immunization should be considered by health care professionals and glucose monitoring intensified within the days around the vaccination.

Disclosure
S.Pieralice: None. L.Monte: None. G.Defeudis: None. G.Tabacco: None. N.Napoli: Advisory Panel; Novo Nordisk, Consultant; Lilly Diabetes. P.Pozzilli: Advisory Panel; Dompé, Consultant; Abbott, Speaker’s Bureau; Dompé, Lilly Diabetes, Medtronic, Sanofi.
680-P: Effect of the FreeStyle Libre System on Diabetes Treatment for People with T2D: Results from a Retrospective Cohort Study Using Canadian Private Payer Claims Database
Authors: HARRIS STEWART B. , LEVRAT-GUILLEN FLEUR 
Published: May 2022

Introduction: Therapeutic inertia is a major contributor to people with diabetes not achieving glycemic goals. We assessed for patients with T2D the impact of using the FreeStyle Libre system (FSL) vs. blood glucose monitoring (BGM) on treatment intensification.
Method: We carried out a matched retrospective cohort study using secondary private payer claims data including &gt;30 million diabetes drug and device claims filled by over 850,000 patients with T2D &gt;18 in Canada over 24 months. Each month, patients were classified by level of therapy progression: 1. No diabetes drug therapy; 2. Mono Oral Antihyperglycemic Agents (OHAs) ; 3. Dual OHAs; 4. Triple OHAs; 5. Quad or more OHAs; 6. Injectable GLP1-RA (±concomitant OHAs) ; 7. Basal insulin (±concomitant OHAs) ; 8. MDI insulin (±concomitant OHAs) .
Results: A total of 373,871 patients met the inclusion criteria. Across all treatment cohorts, the FSL treatment groups were found to have a statistically higher probability of treatment intensification relative to BGM:
Conclusion: Reimbursement of FSL for patients with T2D in Canada is associated with decreased time lag for glucose lowering therapy compared to those using BGM alone. These findings suggest that FSL data impact clinicians to facilitate earlier and more intensive therapy modifications and thus reduce treatment inertia.

Disclosure
S.B.Harris: Consultant; Abbott, AstraZeneca, Eli Lilly and Company, Novo Nordisk, Sanofi, Other Relationship; Abbott, AstraZeneca, Bayer Inc., Dexcom, Eli Lilly and Company, HLS Therapeutics, Janssen Pharmaceuticals, Inc., Novo Nordisk, Sanofi, Research Support; Applied Therapeutics Inc., AstraZeneca, Canadian Institutes of Health Research, Juvenile Diabetes Research Foundation (JDRF) , Novo Nordisk, Sanofi, The Lawson Foundation. F.Levrat-guillen: Employee; Abbott.

Funding
Funded by Abbott Diabetes Care
703-P: Significant Weight Reduction and Improvement in Glycemic Control among People with T2D after Participation in Diabefly Digital Therapeutics Program
Authors: VERMA RITIKA , KHADER MOHAMMED A. , MALDE FORUM , LATHIA TEJAL , TANNA SNEHAL R. , KOTHARI SNEHA , THAKKAR PIYA , THAKUR SANTOSH B. , GUNTUR SAIMALA , SINGAL ARBINDER K. 
Published: May 2022

Background: Digital therapeutics platforms provide accessible and multidisciplinary care for the management of T2D. The current study explored the effectiveness of the Diabefly program for improving glycemic control in people with T2D.
Methods: Diabefly program provides a combination of mobile application, remote lifestyle coaching, live video consultations by experts (psychologist, physiotherapist and nutritionist) , and digital logging of parameters. The outcome of the study was to evaluate the change in HbA1c, fasting blood sugar (FBS) , postprandial blood sugar (PPBS) , weight, and body mass index (BMI) at the beginning and end of the program. All the outcomes were evaluated using paired t-test with P&lt;0.considered as significant.
Results: A significant mean reduction in HbA1c levels by 1.69 ± 1.91% from a baseline of 8.66 ± 2.05% was observed (P&lt;0.001) . Among all the participants, 93.02% (160/172) showed a reduction in their HbA1c, out of which 56.25% (90/160) showed a HbA1c reduction of more than 1%. Similarly, weight and BMI were also significantly reduced by 2.59 ± 3.31 kg and 0.92 ± 1.15 kg/m2 from a baseline of 75.94 ± 16.24 kg and 27.49 ± 4.71 kg/m2 respectively (P&lt;0.0for both) . Among all the participants, 70.34% (121/172) reduced their weight, out of which 32.23% (39/121) showed a weight reduction of at least 5 kg. Among participants (n=42) with complete FBS and PPBS data, a significant mean reduction by 51.44 ± 58.87 mg/dL and 90.90 ± 78.96 mg/dL from a baseline of 164.87 ± 63.83 mg/dL and 227.95 ± 82.34 mg/dL was observed respectively (P&lt;0.0for both) .
Conclusion: Effective glycemic control and significant weight reduction was achieved at the end of the program. Thus, Diabefly program can help in providing continuous support to implement lifestyle changes between quarterly doctor visits and greater usage of a remote lifestyle coaching can be a useful adjunct to doctor’s prescription for holistic management of diabetes.

Disclosure
R. Verma: Employee; Fitterfly Healthtech Pvt Ltd, Wellthy Therapeutics Pvt Ltd. M.A. Khader: Employee; Fitterfly HealthTech Pvt Ltd. T. Lathia: Advisory Panel; Abbott, AstraZeneca, Biocon, Boehringer Ingelheim International GmbH, Novartis Pharmaceuticals Corporation, Novo Nordisk, Sanofi. S. Guntur: Employee; Fitterfly Health Tech Pvt. Ltd. A.K. Singal: Other Relationship; Fitterfly Healthtech Pvt Ltd.
742-P: Antidrug Antibodies Do Not Impact Pharmacokinetics, Efficacy, and Safety of Tirzepatide: Analysis of Data from 7 Phase 3 Studies
Authors: CALDERON BORIS , MULLINS GARRETT R. , HODSDON MICHAEL , LI GRACE , ANGLIN GREG , URVA SHWETA , SCHNECK KAREN , BARDOS JENNIFER N. , MARTINS RICARDO F. , BROWN KATELYN 
Published: May 2022

Tirzepatide (TZP) is a dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon like peptide (GLP) -1 receptor agonist developed for the treatment of type 2 diabetes. Patients receiving TZP may develop an immune response to the 39 amino acid synthetic peptide. This study aimed to evaluate treatment emergent (TE) anti-drug antibodies (ADA) in TZP-treated participants across 7 Phase 3 trials and its potential effect on pharmacokinetics (PK) , efficacy, and safety. A multi-tiered immunogenicity testing strategy was used to detect and characterize ADA. ADA were characterized for their ability to cross react to native GIP (nGIP) and GLP-1 (nGLP-1) , neutralize TZP activity on GIP and GLP-1 receptors, and neutralize nGIP and nGLP-1. ADA were assessed at baseline and throughout the course of the study up to week 40 (SURPASS 1, 2, and 5) or week 52 (SURPASS 3, 4, Japan-mono, and Japan-combo) . Among all ADA-evaluable patients across the Phase 3 trials (N=5025) , TE ADA developed in 51.1% of patients treated with TZP, and the proportions were similar across the 3 TZP dose groups (5, 10, and 15 mg) . At baseline, 7.0% of patients had pre-existing ADA. Maximum ADA titers ranged from 1:20 to 1: 81920 (median 1:160) among TE ADA+ patients. Neutralizing antibodies (NAb) against TZP activity on GIP and GLP-1 receptors were observed in 1.9% and 2.1% of the TE ADA+ patients, respectively. Less than 1.0% of TZP-treated TE ADA+ patients had cross-reactive NAb against nGIP or nGLP-1. TE ADA status, ADA titer, and NAb had no discernible impact on PK profile nor HbA1c effects of TZP. The percentage of TE ADA+ and TE ADA- patients with hypersensitivity reactions was similar. A higher proportion of TE ADA+ patients reported injection site reactions, of which all were nonserious and non-severe, and the vast majority occurred and/or resolved irrespective of TE ADA status or titer level.Overall, immunogenicity was not associated with any impact on TZP PK, efficacy, or safety.

Disclosure
B. Calderon: Employee; Eli Lilly and Company. G.R. Mullins: Employee; Eli Lilly and Company. M. Hodsdon: Employee; Eli Lilly and Company. Stock/Shareholder; Eli Lilly and Company. G. Li: Employee; Eli Lilly and Company. G. Anglin: Employee; Eli Lilly and Company. Stock/Shareholder; Eli Lilly and Company. S. Urva: Employee; Eli Lilly and Company. K. Schneck: Employee; Eli Lilly and Company. J.N. Bardos: Employee; Eli Lilly and Company. Stock/Shareholder; Eli Lilly and Company. R.F. Martins: Employee; Eli Lilly and Company. Stock/Shareholder; Eli Lilly and Company. K. Brown: Employee; Eli Lilly and Company.

Funding
Funded by Eli Lilly and Company.
746-P: The Real-World Observational Prospective Study of Health Outcomes with Dulaglutide and Liraglutide in Type 2 Diabetes Patients (TROPHIES) : Final 24-Month Primary Endpoint Analysis
Authors: GIORGINO FRANCESCO , GUERCI BRUNO , GARCIA-PEREZ LUIS-EMILIO , FUECHTENBUSCH MARTIN , LEBREC JEREMIE , ORSINI FEDERICI MARCO , DIB ANNE , HEITMANN ELKE , YU MARIA , BOYE KRISTINA 
Published: May 2022

TROPHIES was a 24-month, prospective, non-comparative, observational study in adult patients with T2D initiating their first injectable glucose-lowering treatment with once-weekly dulaglutide (DU; N=1,014) or once-daily liraglutide (LIRA; N=991) in France, Germany, and Italy. Primary objective: to assess the time patients remained on their first GLP-1 RA without a significant treatment change due to treatment- or diabetes-related factors. Kaplan-Meier (KM) probability (95% CI) of no significant treatment change at 24 months was 0.71 (0.68-0.74) and 0.53 (0.49-0.56) in the DU and LIRA cohorts, respectively (Figure) . Two-hundred and eighty-six (28.2%) and 448 (45.2%) patients receiving DU and LIRA, respectively, had a significant treatment change. The main driver of treatment change in the DU and LIRA cohorts was intensification with an add-on therapy (insulin or OAD) and intensification with dose increase of GLP-1 RA, respectively. KM probability (95% CI) of GLP-1 RA persistence at 24 months was high in both cohorts: DU 0.82 (0.80-0.85) ; LIRA 0.75 (0.72-0.78) .
In summary, the probabilities of no significant treatment change over 24 months were estimated as higher in the DU cohort than in the LIRA cohort in this non-comparative analysis, with good persistence in both cohorts.

Disclosure
F. Giorgino: Advisory Panel; AstraZeneca, Boehringer Ingelheim International GmbH, Novo Nordisk. Consultant; Lilly Diabetes, Sanofi. Research Support; Lilly Diabetes, Roche Diabetes Care, Takeda Pharmaceutical Company Limited. B. Guerci: Advisory Panel; Amgen Inc., Medtronic. Board Member; Abbott Diagnostics, AstraZeneca, Bayer AG, Eli Lilly and Company, Novartis Pharmaceuticals Corporation. Consultant; Boehringer Ingelheim International GmbH, Intercept Pharmaceuticals, Inc., Novo Nordisk. L. Garcia-Perez: Employee; Eli Lilly and Company. Stock/Shareholder; Eli Lilly and Company. M. Fuechtenbusch: Advisory Panel; Berlin-Chemie AG. Consultant; Boehringer Ingelheim International GmbH, Eli Lilly and Company, Merck Sharp & Dohme Corp. Speaker's Bureau; AstraZeneca, Novo Nordisk. J. Lebrec: Consultant; Eli Lilly and Company. M. Orsini Federici: Employee; Eli Lilly and Company. A. Dib: Employee; Eli Lilly and Company. Stock/Shareholder; Eli Lilly and Company. E. Heitmann: None. M. Yu: Employee; Eli Lilly and Company. Stock/Shareholder; Eli Lilly and Company. K. Boye: Employee; Eli Lilly and Company. Stock/Shareholder; Eli Lilly and Company.
77-OR: Native LDL Upregulate the NLRP3 Inflammasome in Human Adipose Tissue: A Mechanism for Higher Risk for Type 2 Diabetes in Subjects with HyperapoB
Authors: BISSONNETTE SIMON , LAMANTIA VALÉRIE , CYR YANNICK , DEVAUX MARIE , RABASA-LHORET RÉMI , CHRETIEN MICHEL , SALEH MAYA , FARAJ MAY 
Published: May 2022

Background and Hypothesis: Elevated plasma apoB-lipoproteins (hyperapoB, mostly LDL) predicts the incidence of type 2 diabetes (T2D) and its risk factors including systemic activation of the interleukin-1 system (measured as plasma IL-1 receptor antagonist, IL-1Ra) . Moreover, native LDL induce white adipose tissue (WAT) dysfunction. Underlying mechanisms for these findings remain unclear. Activation of WAT NLRP3 inflammasome and secretion of IL-1β promotes WAT dysfunction and related risk factors for T2D. We hypothesized that native LDL upregulate WAT NLRP3 inflammasome/IL-1β pathway.
Methods: This data represents baseline analysis of a 3-month clinical trial with omega-3 fatty acid supplementation in nondiabetic men (N=13) and women (N=27) . We assessed insulin secretion and sensitivity by Botnia clamps, postprandial fat metabolism after a high-fat-meal (68% fat) , and priming and/or activation of NLRP3 inflammasome in subject hip WAT biopsies ex vivo using native LDL, lipopolysaccharides (LPS) (priming control) and/or ATP (activation control) .
Results: Incubation of WAT with native LDL (1.2 g apoB/L) increased IL-1β secretion in ATP- but not LPS-treated WAT. Subjects with higher than median plasma apoB (1.23±0.15 g/L) had higher WAT IL-1β-secretion than those with lower apoB, using multiple combination of LDL, LPS and/or ATP, independent of adiposity, macronutrient intake or plasma lipids. WAT NLRP3 mRNA expression and IL-1β secretion correlated positively with hyperinsulinemia, insulin resistance, postprandial hypertriglyceridemia and hyperchylomicronemia and plasma IL-1Ra. Adjusting for sex and WAT IL-1β-secretion or sex and plasma IL-1Ra eliminated the association of plasma apoB with these risk factors (except hypertriglyceridemia) .
Conclusion: Native LDL are priming signals of WAT NLRP3 inflammasome, which may explain higher risk for T2D in subjects with hyperapoB. ClinicalTrials.gov (NCT04496154) .

Disclosure
S.Bissonnette: None. V.Lamantia: None. Y.Cyr: None. M.Devaux: None. R.Rabasa-lhoret: Consultant; HLS Therapeutics Inc., Pfizer Inc., Other Relationship; Abbott Diabetes, AstraZeneca, Boehringer Ingelheim International GmbH, Dexcom, Inc., Eli Lilly and Company, Insulet Corporation, Janssen Pharmaceuticals, Inc., Medtronic, Merck & Co., Inc., Novo Nordisk Canada Inc., Sanofi, Vertex Pharmaceuticals Incorporated, Research Support; Canadian Institutes of Health Research, Cystic Fibrosis Canada, Diabetes Canada, Fondation Francophone pour la Recherche en Diabète (FFRD) , JDRF, National Institutes of Health, Société Francophone du Diabète (SFD) , Speaker's Bureau; Canadian Medical & Surgical Knowledge Translation Research Group (CMS) , CPD Network, Tandem Diabetes Care, Inc. M.Chretien: None. M.Saleh: None. M.Faraj: None.

Funding
Canadian Institutes of Health Research (CIHR) (FRN# 123409)
785-P: Comparison of Six Months Experience on Hybrid Closed Loop MiniMed 670G System and Advanced Hybrid Closed Loop MiniMed 780G System Using a Structured Initiation Protocol in Children and Adolescents with Type 1 Diabetes
Authors: PETROVSKI GORAN , CAMPBELL JUDITH , ALKHALAF FAWZIYA , HUSSAIN KHALID 
Published: May 2022

Background: The objective of this study was to evaluate glycemic outcomes using a structured initiation protocol for Hybrid Closed Loop (HCL) MiniMed 670G and Advanced Hybrid Closed Loop (AHCL) Minimed 780G system in children and adolescents with Type 1 Diabetes (T1D) previously treated with Multiple Daily Injections.
Methods: The data from two separate (HCL and AHCL system) investigations were analyzed in individuals (aged 7-18 years) with T1D on MDI therapy, both followed a structured initiation protocol. Time in Ranges, HbA1c and system characteristics were analyzed between two systems at 3 and 6 months of Automated Insulin Delivery (AID) .
Results: 30 children (age 10.24 ± 2.6 years, HbA1c 8.2±1.4% (66±15.3 mmol/mol)) with HCL system and 34 children (12.5 ± 3.7 years, 8.6±1.7% (70±18.6 mmol/mol)) with AHCL system completed the planned 12 weeks of AID. TIR (70-180mg/dl) of 73.4±8.9% with HCL and 78.2±4.3% with AHCL (p=0.01) was achieved at 6 months of AID. No episodes of severe hypoglycemia or DKA were reported using both systems.
Conclusion: Individuals using AHCL MiniMed 780G system had more stringent system settings, spent more time in AID with less exits, which possibly lead to further improvements of glycemic control compared to HCL MiniMed 670G system using the same structured protocol.

Disclosure
G.Petrovski: None. J.Campbell: Advisory Panel; Medtronic. F.Alkhalaf: None. K.Hussain: None.