{"title":"Haemoglobin glycation index and in-hospital mortality after acute myocardial infarction in patients with/without diabetes: A prospective, nationwide and multicentre registry.","authors":"Kongyong Cui, Rui Fu, Jingang Yang, Haiyan Xu, Wei Wu, Kaihong Chen, Kefei Dou, Yuejin Yang","doi":"10.1111/dom.16495","DOIUrl":"https://doi.org/10.1111/dom.16495","url":null,"abstract":"<p><strong>Aims: </strong>To assess the prognostic value of haemoglobin glycation index (HGI) for in-hospital mortality in acute myocardial infarction (AMI) patients with varied glucose metabolism status.</p><p><strong>Materials and methods: </strong>A total of 5308 AMI patients were evaluated. HGI was calculated as the measured glycated haemoglobin A1c (HbA1c) minus the predicted HbA1c. The relationship between HbA1c and fasting plasma glucose (FPG) was assessed using linear regression analysis, which is presented as HbA1c = 0.272 × FPG(mmol/L) + 4.302. Predicted HbA1c for each participant was calculated by inserting corresponding FPG levels into this regression equation. The primary endpoint was in-hospital mortality.</p><p><strong>Results: </strong>Overall, 94 diabetic patients (4.5%) and 131 nondiabetic patients (4.1%) died during hospitalization. Restricted cubic splines analysis revealed an L-shaped association between HGI and in-hospital mortality in patients with type 2 diabetes mellitus (T2DM), whereas a strong trend toward a linear negative association was observed in patients without T2DM. In both diabetic and nondiabetic populations, patients with low HGI had a significantly higher risk of in-hospital mortality compared with those with moderate HGI, whereas no significant difference was found between high HGI and moderate HGI groups. In multivariable logistic regression analysis, patients in the low HGI group exhibited a 2.781-fold and 2.830-fold increased risk of in-hospital mortality compared to the moderate HGI group, among diabetic and nondiabetic populations, respectively.</p><p><strong>Conclusions: </strong>This study revealed an L-shaped association between HGI and in-hospital mortality in AMI patients with T2DM, with an inflection point of HGI at 0.69%. In contrast, a linear negative association was observed in AMI patients without T2DM.</p>","PeriodicalId":158,"journal":{"name":"Diabetes, Obesity & Metabolism","volume":" ","pages":""},"PeriodicalIF":5.4,"publicationDate":"2025-06-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144207277","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Long-term cost-effectiveness of tirzepatide for individuals with type 2 diabetes and comorbid obesity.","authors":"Man Tang, Lizheng Shi, Dawei Guan, Debra Winberg, Tiange Tang, Hui Shao, Vivian Fonseca","doi":"10.1111/dom.16466","DOIUrl":"https://doi.org/10.1111/dom.16466","url":null,"abstract":"<p><strong>Objectives: </strong>This study evaluates the cost-effectiveness of tirzepatide (TZP) 10 and 15 mg once weekly (QW) compared to placebo among individuals with type 2 diabetes (T2D) and comorbid obesity in the United States (US).</p><p><strong>Research design and methods: </strong>The Building, Relating, Assessing and Validating Outcomes (BRAVO) Diabetes Model was used to assess the cost-effectiveness of the two TZP doses in individuals with T2D and comorbid obesity from the US healthcare perspective, using a 30-year time horizon. Treatment effects were derived from the SURMOUNT-2 trial and assumed to persist for 5 years. Cost estimates were based on trial data and medication prices from GoodRx. Health utilities for diabetes-related complications were obtained from existing literature. One-way sensitivity analysis and probability sensitivity analysis (PSA) were conducted to examine the robustness. The willingness-to-pay (WTP) threshold was set at $100 000 per quality-adjusted life year (QALY) gained.</p><p><strong>Results: </strong>Compared with placebo, TZP 15 mg QW gained 0.69 QALYs, 0.58 life-years and a cost saving of $1409. TZP 10 mg QW gained 0.60 QALYs, 0.49 life-years and increased costs by $1855, resulting in an incremental cost-effectiveness ratio (ICERs) of $3092 per QALY. Sensitivity analysis confirmed the robustness of results. The probability of cost-effectiveness was 98.9% for TZP 15 mg QW and 98.9% for TZP 10 mg QW had 98.5%.</p><p><strong>Conclusion: </strong>Compared with placebo, both TZP 15 mg and 10 mg QW are cost-effective options for individuals with T2D and comorbid obesity.</p>","PeriodicalId":158,"journal":{"name":"Diabetes, Obesity & Metabolism","volume":" ","pages":""},"PeriodicalIF":5.4,"publicationDate":"2025-06-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144197775","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Management of metabolic dysfunction–associated steatotic liver disease (MASLD)—An expert consensus statement from Indian diabetologists' perspective","authors":"Abdul Hamid Zargar DM, Anil Bhansali DM, Anirban Majumdar DM, Anuj Maheshwari MD, Arpandev Bhattacharyya DM, Arundhati Dasgupta DM, Banshi Damodarlal Saboo MD, Bipin Kumar Sethi DM, Debmalya Sanyal DM, Krishna G. Seshadri MD, Neeta Rohit Deshpande MD, Nitin Kapoor DM, Om Jitendra Lakhani DNB, Pradeep Gopal Talwalkar MD, Pramila Kalra DM, Rabindera Nath Mehrotra DM, Rakesh Kumar Sahay DM, Rishi Shukla DM, Saket Kant DM, Sambit Das DM, Sanjay Chunilal Agarwal MD, Sanjeev Ratnakar Phatak MD, Shanmugasundar G. DM, Shashank Rameshchandra Joshi DM, Shehla Sajid Shaikh DM, Sosale Ramachandra Aravind DNB, Soumik Goswami DM, Sujoy Ghosh DM, Vijay Kumar Panikar DNB, Viswanathan Mohan PhD","doi":"10.1111/dom.16496","DOIUrl":"10.1111/dom.16496","url":null,"abstract":"<p>In India, the increasing prevalence of diabetes and obesity poses a significant threat towards a surge in the incidence of metabolic dysfunction-associated steatotic liver disease (MASLD), formerly known as non-alcoholic fatty liver disease (NAFLD). Concomitant with the evolving guidelines, there is a need to direct and spread awareness among practicing diabetologists to identify and screen high-risk individuals for MASLD for timely management. Its asymptomatic nature and the evolving guidelines on diagnosis have hindered the precise estimates of MASLD in the high-risk group of individuals in a clinical setting. Therefore, an expert panel of diabetologists from India convened to review, discuss and document the approach towards screening, diagnosis and management of MASLD. Serum biomarkers, simple non-invasive tools and imaging techniques could direct the risk stratification of the patients. Early lifestyle interventions including weight loss and exercise are beneficial. The pharmacological landscape of drugs directed to insulin resistance, lipid metabolism, oxidative stress, inflammation, apoptosis and fibrogenesis pathways for the management of MASLD is expanding. In summary, the consensus statements are expected to serve as a useful guide in the screening and management of MASLD in the region and to direct a well-planned study design that could enhance the scientific value of these statements.</p>","PeriodicalId":158,"journal":{"name":"Diabetes, Obesity & Metabolism","volume":"27 S4","pages":"3-20"},"PeriodicalIF":5.4,"publicationDate":"2025-06-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/dom.16496","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144207278","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Burden of type 2 diabetes mellitus and risk factor attribution among older adults: A global, regional, and national analysis from 1990 to 2021, with projections up to 2040.","authors":"Liangquan Lin, Ping Chen, Yan Zhang, Junyu Long, Weihao Wang, Xinying Sun, Xuxi Zhang","doi":"10.1111/dom.16471","DOIUrl":"https://doi.org/10.1111/dom.16471","url":null,"abstract":"<p><strong>Aims: </strong>To investigate the global, regional, and national burden and risk factors of type 2 diabetes mellitus (T2DM) among older adults aged ≥65 years from 1990 to 2021, with projections to 2040.</p><p><strong>Materials and methods: </strong>Using the Global Burden of Disease database, this study analysed global, regional, and national T2DM burden and risk factors across sex, age groups, and Socio-Demographic Index (SDI) levels. Annual percentage changes were calculated, and predictions used a Bayesian age-period-cohort model.</p><p><strong>Results: </strong>Among older adults aged ≥65 years, the global age-standardized prevalence and mortality of T2DM rose by 1.9% and 0.32% per year, respectively, from 1990 to 2021. T2DM's proportion of total disability-adjusted life years (DALYs) and mortality from all diseases increased, as did its share of T2DM cases across all age groups. Mortality rose fastest in the 85-89 group (0.52% annually). High SDI regions exhibited the highest prevalence, whereas lower SDI correlated with higher mortality rates. Eastern Europe and Uzbekistan experienced the fastest DALYs growth. The global burden of T2DM in older adults is projected to continue increasing by 2040. Globally, high body mass index contributed most to T2DM burden, while high temperature and sugar-sweetened beverages (SSBs) showed the fastest-growing DALYs rates. The fastest-growing risk factor in high-SDI regions was sugar-sweetened beverages, while high temperature was the fastest-growing risk in low-SDI regions.</p><p><strong>Conclusions: </strong>Diabetes cases among older adults have tripled globally since 1990 and are projected to keep increasing. Wealthier nations face diet-related risks, while poorer regions are more affected by environmental factors. Region-specific prevention strategies are urgently needed.</p>","PeriodicalId":158,"journal":{"name":"Diabetes, Obesity & Metabolism","volume":" ","pages":""},"PeriodicalIF":5.4,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144197773","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Lucas A Mavromatis, Aditya Surapaneni, Sneha Mehta, Yunwen Xu, Alexander R Chang, Vamsidhar Velcheti, Jiyoung Ahn, Jung-Im Shin, Morgan E Grams
{"title":"Glucagon-like peptide-1 receptor agonists and incidence of obesity-related cancer in adults with diabetes: A target-trial emulation study.","authors":"Lucas A Mavromatis, Aditya Surapaneni, Sneha Mehta, Yunwen Xu, Alexander R Chang, Vamsidhar Velcheti, Jiyoung Ahn, Jung-Im Shin, Morgan E Grams","doi":"10.1111/dom.16445","DOIUrl":"https://doi.org/10.1111/dom.16445","url":null,"abstract":"","PeriodicalId":158,"journal":{"name":"Diabetes, Obesity & Metabolism","volume":" ","pages":""},"PeriodicalIF":5.4,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144197774","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jelle M Beernink, Niels Jongs, Charlotte M Mosterd, Rosalie A Scholtes, Alyssa Caldwell-McGee, Daniel Casillas, Lynette Driscoll, Peter J Greasley, Cecilia Karlsson, Ann Hammarstedt, Vikas S Sridhar, Marcel H A Muskiet, Gozewijn D Laverman, David Z I Cherney, Petter Bjornstad, Daniel H van Raalte, Hiddo J L Heerspink
{"title":"Effects of dapagliflozin on sodium excretion, blood pressure and volume status in patients with type 2 diabetes and/or chronic kidney disease: The DAPASALT trial.","authors":"Jelle M Beernink, Niels Jongs, Charlotte M Mosterd, Rosalie A Scholtes, Alyssa Caldwell-McGee, Daniel Casillas, Lynette Driscoll, Peter J Greasley, Cecilia Karlsson, Ann Hammarstedt, Vikas S Sridhar, Marcel H A Muskiet, Gozewijn D Laverman, David Z I Cherney, Petter Bjornstad, Daniel H van Raalte, Hiddo J L Heerspink","doi":"10.1111/dom.16478","DOIUrl":"https://doi.org/10.1111/dom.16478","url":null,"abstract":"<p><strong>Aims: </strong>We assessed the effects of dapagliflozin on natriuresis and blood pressure in patients with type 2 diabetes and chronic kidney disease (CKD) and evaluated the consistency of these effects across patients with type 2 diabetes without CKD and CKD without type 2 diabetes.</p><p><strong>Materials and methods: </strong>We conducted a mechanistic, nonrandomised, open-label study to evaluate the effects of dapagliflozin on sodium excretion and blood pressure in patients with type 2 diabetes and CKD under a standardised sodium intake (150 mmol/day). Evaluations were performed at baseline (average of Days -3 to -1), treatment start (average of Days 2-4; hereafter referred to as Day 4), treatment end (average of Days 12-14; hereafter referred to as Day 14) and washout (average of Days 15-17). Similar protocols were applied to the type 2 diabetes without CKD and CKD without type 2 diabetes strata. Data from all strata were pooled to assess the consistency of the effects of dapagliflozin.</p><p><strong>Results: </strong>In 13 participants with type 2 diabetes and CKD, 24-h sodium excretion did not increase during treatment, as reflected by changes from baseline (Day 4 change: -0.5 mmol/24-h [95% CI -15.4, 14.5], p = 0.95; Day 14 change: -11.7 mmol/24-h [95% CI -30.4, 7.1]). Compared to baseline, 24-h systolic blood pressure decreased by 6.0 mmHg [95% CI -19.8, 7.7] at Day 4 and by 3.7 mmHg [95% CI -13.7, 6.2] at Day 14. In the pooled stratum of 33 participants, 24-h sodium excretion remained unchanged relative to baseline (Day 4 change: -7.4 mmol/24-h [95% CI -16.2, 1.5], p = 0.10; Day 14 change: -10.1 mmol/24-h [95% CI -25.1, 5.0], p = 0.18), whereas 24-h systolic blood pressure was consistently reduced by 6.8 mmHg ([95% CI -10.4, -3.3], p < 0.001) at Day 4 and by 6.5 mmHg ([95% CI -10.1, -3.0], p < 0.001) at Day 14, with no evidence of heterogeneity across strata.</p><p><strong>Conclusions: </strong>Dapagliflozin reduced blood pressure during standardised sodium intake in patients with type 2 diabetes and/or CKD without increasing sodium excretion, suggesting that the blood pressure-lowering effects occur through mechanisms beyond natriuresis.</p>","PeriodicalId":158,"journal":{"name":"Diabetes, Obesity & Metabolism","volume":" ","pages":""},"PeriodicalIF":5.4,"publicationDate":"2025-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144179525","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jian-Jun Liu, Sylvia Liu, Janus Lee, Huili Zheng, Resham L Gurung, Keven Ang, Huijuan Wu, Su Chi Lim
{"title":"Plasma proprotein convertase subtilisin/kexin type 9 (PCSK9) and the risk of chronic kidney disease progression in patients with type 2 diabetes.","authors":"Jian-Jun Liu, Sylvia Liu, Janus Lee, Huili Zheng, Resham L Gurung, Keven Ang, Huijuan Wu, Su Chi Lim","doi":"10.1111/dom.16486","DOIUrl":"https://doi.org/10.1111/dom.16486","url":null,"abstract":"<p><strong>Aims: </strong>Preclinical studies have associated proprotein convertase subtilisin/kexin type 9 (PCSK9) with the pathogenesis of kidney disease. We aim to study whether plasma PCSK9 predicts the risk of chronic kidney disease (CKD) progression in patients with type 2 diabetes.</p><p><strong>Materials and methods: </strong>A total of 1902 outpatients with type 2 diabetes from a regional hospital and a primary care facility were included in this prospective study. Baseline plasma PCSK9 was measured by immunoassay. CKD progression was defined as a composite of incident end stage kidney disease (ESKD, sustained eGFR < 15 mL/min/1.73 m<sup>2</sup>, maintenance dialysis or renal death) or doubling of serum creatinine.</p><p><strong>Results: </strong>A total of 226 renal events were identified during a median of 7.2 years of follow-up. The Cox regression model showed that one standard deviation (SD) increment of plasma PCSK9 was associated with a 1.27 (95% CI 1.10-1.48) fold increased risk for the composite renal outcome after adjustment for known cardio-renal risk factors. As a categorical variable, participants with PCSK9 in the top tertile had a 1.47 (95% CI 1.02-2.12) fold adjusted risk for the renal outcome compared to those in the lowest tertile. Consistent data were obtained when ESKD was taken as the study outcome or non-renal death was taken as a competing risk.</p><p><strong>Conclusion: </strong>A high level of plasma PCSK9 is independently associated with an increased risk of CKD progression, suggesting the need to further elucidate the role of PCSK9 in diabetic kidney disease. Future studies are warranted to explore whether PCSK9 is a potential target for prevention and treatment of kidney disease.</p>","PeriodicalId":158,"journal":{"name":"Diabetes, Obesity & Metabolism","volume":" ","pages":""},"PeriodicalIF":5.4,"publicationDate":"2025-05-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144172408","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Giovanni Antonio Silverii, Christian Marinelli, Costanza Bettarini, Gloria Giovanna Del Vescovo, Matteo Monami, Edoardo Mannucci
{"title":"GLP-1 receptor agonists and the risk for cancer: A meta-analysis of randomized controlled trials.","authors":"Giovanni Antonio Silverii, Christian Marinelli, Costanza Bettarini, Gloria Giovanna Del Vescovo, Matteo Monami, Edoardo Mannucci","doi":"10.1111/dom.16489","DOIUrl":"https://doi.org/10.1111/dom.16489","url":null,"abstract":"<p><strong>Aims: </strong>To assess if there is a difference in the oncogenic risk between GLP-1 RA and comparators in randomized controlled trials.</p><p><strong>Materials and methods: </strong>A meta-analysis of randomized controlled trials comparing GLP-1RA to any comparators for diabetes and/or obesity, lasting at least 52 weeks. The endpoints included the incidence of overall cancers and single malignancies.</p><p><strong>Results: </strong>Fifty trials were included. GLP-1RA treatment was not associated with a significant difference in risk for overall cancer (MH-OR 1.05, 95% confidence interval [CI] [0.98, 1.13]). Uterine cancer was significantly reduced in the GLP-1RA arm in trials performed in subjects with obesity (MH-OR 0.24, 95% CI [0.06, 0.94]), but not in those aimed at diabetes treatment (MH-OR 0.92, [0.58, 1.47]). We detected an increase in the risk for thyroid cancer (MH-OR 1.55, [1.05, 2.27]), more evident in longer-term trials, and in the risk for colorectal cancer (MH-OR 1.27 [1.03, 1.57]), which, conversely, was significant only in shorter-term trials. No significant difference in the risk was detected for any other cancer.</p><p><strong>Conclusions: </strong>GLP-1 RA do not appear to produce an effect on most malignancies in clinical trials. A reduction of very close obesity-associated cancers seems possible, whereas a risk signal for thyroid cancer was observed, prompting the need for further specific studies. On the other hand, the small increase observed in colorectal cancer in shorter-term trials may be the effect of a disproportionate increase in diagnostic procedures in the GLP-1 RA arm, because of the suspicion raised by common side effects of GLP-1 RA.</p>","PeriodicalId":158,"journal":{"name":"Diabetes, Obesity & Metabolism","volume":" ","pages":""},"PeriodicalIF":5.4,"publicationDate":"2025-05-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144172406","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Post-marketing safety of Lantus and its interchangeable biosimilar Semglee in the United States: A disproportionality analysis using the FDA Adverse Event Reporting System (FAERS) database.","authors":"Lotanna Ezeja, Jingjing Qian","doi":"10.1111/dom.16491","DOIUrl":"https://doi.org/10.1111/dom.16491","url":null,"abstract":"<p><strong>Aims: </strong>On 28 July 2021, Semglee (insulin glargine-yfgn) was approved by the U.S. Food and Drug Administration as the first interchangeable biosimilar to the reference product Lantus (insulin glargine) for treating diabetes mellitus. This study used the FDA Adverse Event Reporting System to identify reporting safety signals of Lantus and Semglee.</p><p><strong>Materials and methods: </strong>Adverse event (AE) reports were organized into high-level group terms (HLGTs) using the Medical Dictionary for Regulatory Activities (MedDRA). Disproportionality analysis, including reporting odds ratio (ROR) and empirical Bayesian geometric mean (EBGM), was performed to detect safety signals for serious AE, death, hospitalization, top 6 HLGTs, and specific AEs on products' FDA prescription labels.</p><p><strong>Results: </strong>Both products showed no significant safety signal of serious AE, death, or hospitalization. Lantus exhibited significant safety signals for device issues (ROR = 1.3, 95% confidence interval [CI] = 1.2-1.4; EBGM = 1.3, 90% CI = 1.2-1.3), medication errors and other product use errors and issues (ROR = 2.8, 95% CI = 2.7-2.9; EBGM = 2.1, 90% CI = 2.0-2.1), metabolic, nutritional, and blood gas investigations (ROR = 11.7, 95% CI = 11.2-12.2; EBGM = 9.6, 90% CI = 9.3-9.9), hyperglycaemia (ROR = 2.7, 95% CI = 2.1-3.5; EBGM = 2.3, 90% CI = 1.9-2.8) and hypoglycaemia (ROR = 4.6, 95% CI = 3.6-5.8; EBGM = 3.7, 90% CI = 3.0-4.5). Semglee had significant safety signals for device issues (ROR = 118.7, 95% CI = 103.9-135.7; EBGM = 22.8, 90% CI = 21.7-23.9), medication errors and other product use errors and issues (ROR = 3.4, 95% CI = 3.0-3.8; EBGM = 2.3, 90% CI = 2.1-2.4), metabolic, nutritional, and blood gas investigations (ROR = 3.0, 95% CI = 2.3-3.9; EBGM = 2.5, 90% CI = 2.0-3.1), product quality, supply, distribution, manufacturing, and quality system issues (ROR = 5.4, 95% CI = 4.6-6.3; EBGM = 4.4, 90% CI = 3.9-5.0), physical examination and organ system status topics (ROR = 2.6, 95% CI = 2.0-3.2; EBGM = 2.2, 90% CI = 1.9-2.7), weight gain (ROR = 3.6, 95% CI = 2.6-4.8; EBGM = 2.7, 90% CI = 2.1-3.5), weight loss (ROR = 2.0, 95% CI = 1.4-2.9; EBGM = 1.7, 90% CI = 1.2-2.2), and lipodystrophy (ROR = 146.0, 95% CI = 96.1-221.8; EBGM = 116.0, 90% CI = 81.7-160.8).</p><p><strong>Conclusions: </strong>Findings identified significant post-marketing safety signals of Lantus and Semglee. Longitudinal studies are warranted to verify these signals.</p>","PeriodicalId":158,"journal":{"name":"Diabetes, Obesity & Metabolism","volume":" ","pages":""},"PeriodicalIF":5.4,"publicationDate":"2025-05-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144172361","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Fully automated insulin delivery systems in type 1 diabetes: A systematic review and meta-analysis.","authors":"Wenqi Fan, Chao Deng, Ruoyao Xu, Zhenqi Liu, Yuhu He, Zhiguang Zhou, Xia Li","doi":"10.1111/dom.16499","DOIUrl":"https://doi.org/10.1111/dom.16499","url":null,"abstract":"<p><strong>Aims: </strong>The landscape of insulin delivery is evolving, transitioning from hybrid automated insulin delivery (AID) to more sophisticated fully AID systems. We aimed to compare the efficacy of fully AID systems with any insulin delivery method in type 1 diabetes (T1D).</p><p><strong>Materials and methods: </strong>Following registration in PROSPERO, CRD42024528669, PubMed, Embase, Cochrane Library and Web of Science were searched up to 26 February 2025 for randomised clinical trials comparing fully AID systems to any insulin delivery method in T1D. The control treatments included conventional insulin therapy (multiple daily injections, continuous subcutaneous insulin infusion and sensor-augmented pumps) and hybrid AID systems. The primary outcome was the mean difference (MD) in the percentage of time blood glucose concentration remained in the target range (3.9-10.0 mmol/L or 4.0-10.0 mmol/L), assessed by random-effects models.</p><p><strong>Results: </strong>We identified 1308 reports; after exclusions, 16 trials (669 patients) were included. Time in range (TIR) was higher using fully AID systems than control treatments (MD 9.99% [95% confidence interval, 3.75% to 16.22%], p = 0.002). This improvement was accompanied by increased diabetes treatment satisfaction (MD 3.70 points [95% confidence interval, 0.22 points to 7.18 points], p = 0.04). Fully AID systems exhibited a favourable effect on TIR when compared with conventional insulin therapy, while exhibiting an opposite effect when compared with hybrid AID (17.44% vs. -3.05%, p < 0.001). Younger patients with T1D, as well as patients with a shorter diabetes duration, exhibited more significant glycaemic improvements with fully AID systems therapy.</p><p><strong>Conclusions: </strong>Fully AID systems improved glycaemic control and diabetes treatment satisfaction compared with other non-AID methods in patients with T1D, especially for younger patients. However, to achieve or exceed the desired benefits of hybrid AID, algorithm upgradation, along with the synergistic integration of multiple hormones, will be crucial for next-generation fully AID systems.</p>","PeriodicalId":158,"journal":{"name":"Diabetes, Obesity & Metabolism","volume":" ","pages":""},"PeriodicalIF":5.4,"publicationDate":"2025-05-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144155422","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}