{"title":"Short-Term Changes in General and Central Adiposity and Subsequent Cardiometabolic Risk in Japanese Adults Undergoing Routine Health Screening.","authors":"Shinta Yamamoto, Hiroshi Okada, Tomohiro Shinozaki, Kenya Kasahara, Nozomi Kuramoto, Takahiro Ichikawa, Hanako Nakajima, Arata Sano, Yoshitaka Hashimoto, Emi Ushigome, Naoko Nakanishi, Masahide Hamaguchi, Hiroaki Murata, Kazushiro Kurogi, Eri Tsuda, Naoki Yoshida, Masato Ito, Michiaki Fukui","doi":"10.1111/dom.71336","DOIUrl":"10.1111/dom.71336","url":null,"abstract":"<p><strong>Objective: </strong>Annual health screening provides repeated measurements of body mass index (BMI) and waist-based indices, but the implications of short-term changes in general and central adiposity for cardiometabolic risk remain unclear. We examined whether 1-year changes in BMI and waist-to-height ratio (WHtR) were associated with subsequent cardiometabolic outcomes and cardiovascular-kidney-metabolic (CKM) syndrome progression.</p><p><strong>Methods: </strong>We analysed longitudinal health examination data from 144 394 Japanese employees aged 40-74 years between 2008 and 2023. One-year changes in BMI and WHtR were calculated from two consecutive annual examinations, and outcomes were assessed during the following year. Outcomes included incident hypertension, dyslipidemia, hyperuricemia, diabetes, major adverse cardiovascular events, all-cause mortality, and CKM stage progression. Pooled logistic regression with natural cubic splines was used to assess nonlinear associations, with analyses stratified by baseline BMI or WHtR quartiles.</p><p><strong>Results: </strong>Increases in BMI and WHtR were consistently associated with higher risks of hypertension, dyslipidemia, hyperuricemia, and early CKM stage progression across baseline body size categories. For diabetes, increases in BMI and WHtR were associated with higher risk, whereas decreases were also associated with higher risk among leaner individuals. Associations with major adverse cardiovascular events were generally U-shaped. BMI loss was associated with higher mortality odds, although estimates were imprecise and potentially affected by reverse causation.</p><p><strong>Conclusions: </strong>One-year changes in BMI and WHtR were associated with subsequent cardiometabolic risk and CKM stage progression. Anthropometric changes, particularly weight loss, may serve as signals for further assessment rather than causal determinants of risk.</p>","PeriodicalId":158,"journal":{"name":"Diabetes, Obesity & Metabolism","volume":" ","pages":"11343-11357"},"PeriodicalIF":6.1,"publicationDate":"2026-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148965736","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":"Real-World Adverse Event Reporting Patterns of Tirzepatide Versus Semaglutide: A Stratified Study of General and Healthcare Professional Cohorts in FAERS.","authors":"XingYu Liu, WenFang Wang","doi":"10.1111/dom.71373","DOIUrl":"10.1111/dom.71373","url":null,"abstract":"<p><strong>Background: </strong>Both the GLP-1 receptor agonist semaglutide and the novel dual GIP/GLP-1 receptor agonist tirzepatide have emerged as first-line therapeutic options for metabolic diseases. However, their real-world comparative safety profiles are difficult to interpret due to differential reporting composition in spontaneous reporting databases. This study compared their post-marketing adverse event (AE) reporting patterns and examined how reporter identity influences signal prominence.</p><p><strong>Methods: </strong>AE reports (May 2022-June 2026) from FAERS were analysed using ROR, PRR, information component (IC) and empirical Bayes geometric mean (EBGM); a signal required simultaneous four-method convergence; additionally, the Benjamini-Hochberg false discovery rate (FDR) procedure was used to ensure signal robustness against multiple testing. Head-to-head comparisons used the ratio of reporting odds ratios (RORR) with 95% CIs, run in parallel across general population and healthcare professional (HCP)-restricted subset, with sensitivity analyses by indication, seriousness, geography and calendar quarter.</p><p><strong>Results: </strong>A total of 151 654 tirzepatide and 64 987 semaglutide reports were analysed (HCP: 5.04% vs. 23.42%). Only semaglutide met four-method criteria for gastrointestinal (ROR 3.64) and metabolic (ROR 4.25) disorders in the general population (GI RORR 0.58, 95% CI 0.57-0.59). Pancreatitis signalled for both agents but attenuated to equivalence within T2DM (RORR 0.98, 95% CI 0.83-1.15). Diabetic ketoacidosis signalled exclusively for semaglutide in the HCP cohort (ROR 3.52); tirzepatide showed higher hypoglycaemia reporting (RORR 1.91, 95% CI 1.49-2.44). In the HCP cohort, tirzepatide GI ROR rose to 2.53 and semaglutide acquired eye disorder reporting signals (ROR 2.61). All sensitivity analyses (stratified by indication, seriousness, geography restriction and calendar quarter) confirmed directional stability of these comparative reporting patterns across subgroups.</p><p><strong>Conclusion: </strong>This FAERS-based analysis identifies distinct AE reporting patterns between tirzepatide and semaglutide that are sensitive to reporter type; all findings are hypothesis-generating and require confirmation with defined exposure denominators.</p>","PeriodicalId":158,"journal":{"name":"Diabetes, Obesity & Metabolism","volume":" ","pages":"11721-11734"},"PeriodicalIF":6.1,"publicationDate":"2026-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149015048","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":"Addendum to \"The Duodenal Mucosa Plays a Key Role in Metabolic Regulation: Emerging Physiology and New Opportunities for Cell-Directed and Barrier-Related Interventions for the Treatment of Diabetes and Obesity\".","authors":"","doi":"10.1111/dom.71379","DOIUrl":"10.1111/dom.71379","url":null,"abstract":"","PeriodicalId":158,"journal":{"name":"Diabetes, Obesity & Metabolism","volume":" ","pages":"12020-12021"},"PeriodicalIF":6.1,"publicationDate":"2026-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149068933","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":"Plasma Proteomic Signatures for Early Risk Stratification Across Cardiovascular-Kidney-Metabolic Stages 0-2.","authors":"Xingyu Li, Hongqiang Zhang, Suijian Wang, Jie Shi, Junhao Zhang, Minghui Chen, Minzhe Zhao, Tong Yue, Xueying Zheng","doi":"10.1111/dom.71399","DOIUrl":"10.1111/dom.71399","url":null,"abstract":"<p><strong>Aims: </strong>Cardiovascular-kidney-metabolic (CKM) stages 0-2 represent a potentially modifiable period before overt cardiovascular complications, yet molecular markers that identify individuals at higher downstream risk remain insufficiently defined. We investigated whether plasma proteomic signatures could characterize early CKM-related molecular risk and improve prediction of incident cardiovascular, kidney and mortality outcomes.</p><p><strong>Materials and methods: </strong>We analysed 43 709 UK Biobank participants with CKM stages 0-2 and measurements of 2920 plasma proteins. Multivariable Cox models evaluated protein associations with 11 incident outcomes after excluding participants with the corresponding condition at baseline. We further assessed modelled prediagnostic protein patterns, stage-related proteomic patterns across baseline CKM stage groups, and the incremental value of outcome-specific and recurrent protein panels beyond clinical models using Predicting Risk of Cardiovascular Disease Events (PREVENT)-aligned covariates.</p><p><strong>Results: </strong>A total of 157 proteins showed directionally concordant associations across all 11 outcomes, including 155 positive and 2 inverse associations. Population-level models across time-to-outcome intervals identified differences in GDF15, TNFRSF10B, WFDC2 and NT-proBNP between incident cases and matched reference participants. Eleven of the 155 proteins with positive associations across all 11 outcomes were consistently elevated across baseline CKM stage groups 0-2. In repeated internal validation, outcome-specific proteomic signatures improved discrimination beyond the clinical model, with ΔC-index values of 0.024-0.070. An exploratory recurrent 12-protein panel retained incremental value in internal evaluation, with ΔC-index gains of 0.018-0.052.</p><p><strong>Conclusions: </strong>In early-stage CKM, plasma proteomic signatures captured preclinical molecular risk and improved prognostic discrimination beyond conventional clinical factors. These findings support further evaluation of targeted proteomic panels for earlier CKM risk stratification and preventive cardiometabolic management.</p>","PeriodicalId":158,"journal":{"name":"Diabetes, Obesity & Metabolism","volume":" ","pages":"11901-11914"},"PeriodicalIF":6.1,"publicationDate":"2026-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149101422","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}
Leandra Serio, Michele Rossi, Amir Askarinejad, Enrico Tartaglia, Tommaso Bucci, Enrica Marrone, Dinesh K Kalra, Claudio Ferri, Gregory Y H Lip
{"title":"SGLT2 Inhibitors and Cardiovascular Outcomes in Patients With Fabry Disease: Observations From a Federated Research Network.","authors":"Leandra Serio, Michele Rossi, Amir Askarinejad, Enrico Tartaglia, Tommaso Bucci, Enrica Marrone, Dinesh K Kalra, Claudio Ferri, Gregory Y H Lip","doi":"10.1111/dom.71324","DOIUrl":"10.1111/dom.71324","url":null,"abstract":"<p><strong>Background and aim: </strong>Fabry disease (FD) is frequently complicated by renal impairment and cardiovascular events; however, evidence on sodium-glucose cotransporter-2 inhibitors (SGLT2i) in this population is scarce. Accordingly, we assessed the association between SGLT2i exposure and cardiovascular outcomes in adults with FD.</p><p><strong>Methods: </strong>We conducted a retrospective cohort study using the TriNetX Global Collaborative Network, including adults with Fabry disease and eGFR ≥ 20 mL/min/1.73 m<sup>2</sup>, excluding Type 1 diabetes. Patients were stratified by SGLT2 inhibitor exposure. The primary outcome was a composite of all-cause death, acute myocardial infarction and acute or acute-on-chronic heart failure at 2 and 5 years; secondary outcomes included individual components and progression to advanced kidney disease. Patients with prior non-fatal outcomes were excluded from the respective analyses. Propensity score matching (1:1) and Cox proportional hazards models were used. Sensitivity analyses included alternative follow-up periods, restriction to Fabry disease diagnosed from 2013 onwards and a stricter Fabry disease definition requiring ≥ 2 diagnoses; subgroup analyses were performed by sex and age.</p><p><strong>Results: </strong>Among 14 940 FD patients, 1028 (6.9%) had recorded exposure to SGLT2 inhibitors (mean age: 65.5 ± 12.0 years; 53.0% male), who were older and had a higher comorbidity burden and worse baseline renal profile than non-exposed patients. After PSM, 732 patients per group (exposed and non-exposed patients) were available for analysis. At 2 years, SGLT2i exposure was associated with a lower risk of the composite outcome (HR 0.61; 95% CI 0.38-0.97) and all-cause death (HR 0.56; 95% CI 0.33-0.95). At 5 years, results were consistent for the composite outcome (HR 0.56; 95% CI 0.39-0.79) and all-cause death (HR 0.62; 95% CI 0.42-0.93), with reduced myocardial infarction risk (HR 0.53; 95% CI 0.30-0.90).</p><p><strong>Conclusions: </strong>In a large real-world FD cohort, SGLT2i exposure was associated with lower cardiovascular risk and mortality, supporting further prospective investigation.</p>","PeriodicalId":158,"journal":{"name":"Diabetes, Obesity & Metabolism","volume":" ","pages":"11206-11216"},"PeriodicalIF":6.1,"publicationDate":"2026-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13731061/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148910177","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}
Chelsea Stefanska, Ryan Chung, Salman Ramjaun, Danyao Jin, Ciara Doherty, Kieran McCafferty, Samuel Seidu
{"title":"The SGLT2i Treatment Gap in UK Primary Care: A Cross-Sectional RWE Study of Prescribing in Clinical Practice.","authors":"Chelsea Stefanska, Ryan Chung, Salman Ramjaun, Danyao Jin, Ciara Doherty, Kieran McCafferty, Samuel Seidu","doi":"10.1111/dom.71298","DOIUrl":"10.1111/dom.71298","url":null,"abstract":"<p><strong>Aims: </strong>Sodium-glucose co-transporter 2 inhibitors (SGLT2i) improve cardiovascular and renal outcomes in type 2 diabetes mellitus (T2DM), chronic kidney disease (CKD) and chronic heart failure (CHF). Despite clinical guideline recommendations, SGLT2i uptake in UK primary care remains suboptimal and information on utilisation is limited. This study aims to quantify and describe the UK primary care population with T2DM, CKD and/or CHF who are eligible for but not currently prescribed an SGLT2i.</p><p><strong>Materials and methods: </strong>A cross-sectional study was conducted using routinely collected electronic health records from the Optimum Patient Care Research Database. Adults aged ≥ 18 years on 1 July 2024 were included. Descriptive analyses estimated disease prevalence (defined by morbidity-coded diagnosis), SGLT2i eligibility (defined using NICE clinical guidelines) and current SGLT2i treatment (defined as any SGLT2i prescription in the previous 2 months) by conditions and selected characteristics. Main results are based on diagnosed disease; in a separate CKD sensitivity analysis, indicative CKD (without a morbidity code) was defined using kidney function test results.</p><p><strong>Results: </strong>In the study population of 9.8 million adults, prevalence was 6.52% for T2DM, 4.95% for diagnosed CKD (6.07% including indicative CKD) and 1.40% for CHF. Among all SGLT2i-eligible individuals, 17.5% were currently prescribed an SGLT2i. Current SGLT2i treatment was lowest in CKD-only patients (3.8% treated among eligible) and highest in those meeting eligibility criteria for all three indications (32.9% treated). SGLT2i treatment was lower in women and older adults.</p><p><strong>Conclusions: </strong>SGLT2i therapy is significantly underutilised in UK primary care, particularly for CKD. Equitable implementation of SGLT2i clinical guidelines is vital to improve cardio-renal-metabolic care.</p>","PeriodicalId":158,"journal":{"name":"Diabetes, Obesity & Metabolism","volume":" ","pages":"11278-11287"},"PeriodicalIF":6.1,"publicationDate":"2026-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13731052/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148928588","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":"Dose-Normalised Time in Range (dn-TIR) Improves Following Hybrid Closed-Loop (HCL) Therapy in Type 1 Diabetes: A Real-World Cohort Study From Australia and the United Kingdom.","authors":"Jude Wellens-Mensah, Akash Konantambigi, Keimee Lopez, Jessica Triay, Vasant Shenoy, Gaurav Puri, Emma Wilmot, Thozhukat Sathyapalan, Harshal Deshmukh","doi":"10.1111/dom.71342","DOIUrl":"10.1111/dom.71342","url":null,"abstract":"<p><strong>Objective: </strong>To evaluate dose-normalised time in range (dn-TIR) and its log relative change (Δdn-TIR) as measures of within-person glycaemic change relative to total daily insulin exposure following hybrid closed-loop therapy (HCL/AID).</p><p><strong>Research design and methods: </strong>We conducted a retrospective two-cohort study of people with type 1 diabetes commencing hybrid closed-loop/automated insulin delivery (HCL/AID) therapy in Australia and the United Kingdom (UK). dn-TIR was calculated as time in range (TIR) 3.9-10.0 mmol/L (70-180 mg/dL) divided by total daily insulin dose (TDD) and Δdn-TIR as log[(TIR/TDD)post/(TIR/TDD)pre].</p><p><strong>Results: </strong>The study comprised 86 people living with type 1 diabetes in Australia and 288 in the UK. In the fixed Australian dn-TIR cohort, TIR increased from 53.2% ± 20.7% to 70.4% ± 14.6% (n = 86; p < 0.001), whereas mean TDD changed from 53.3 to 52.0 units/day (n = 86; p = 0.724). Median Δdn-TIR was 0.224 [IQR: -0.033, 0.583]. In the UK cohort, TIR increased from a median 54% [34, 68] to 66% [54, 74] (n = 257; p < 0.001), whereas mean TDD changed from 44.1 to 46.3 units/day (n = 242; p = 0.152). Median Δdn-TIR was 0.194 [IQR: -0.097, 0.541].</p><p><strong>Conclusions: </strong>HCL/AID therapy improved TIR relative to TDD in two real-world cohorts. dn-TIR and Δdn-TIR are not replacements for established CGM metrics or direct measures of insulin sensitivity; they may provide an adjunct longitudinal description of whether glycaemic improvement was accompanied by proportionately greater, similar or lower insulin exposure.</p>","PeriodicalId":158,"journal":{"name":"Diabetes, Obesity & Metabolism","volume":" ","pages":"11270-11277"},"PeriodicalIF":6.1,"publicationDate":"2026-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13731000/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148917663","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}
Scott A Willis, Annalena Phillipp, Kevin Deighton, Christopher Goodwin, Daniel J Cuthbertson, Shelley E Keating, Christopher J A Pugh, Jonathan G Stine, Gaël Ennequin, Alexis Couret, David J Stensel, Guruprasad P Aithal, Thomas Yates, James A King
{"title":"Higher Cardiorespiratory Fitness Is Associated With a Lower Burden of Metabolic Syndrome Traits: A Cross-Sectional Analysis of 39 197 UK Adults.","authors":"Scott A Willis, Annalena Phillipp, Kevin Deighton, Christopher Goodwin, Daniel J Cuthbertson, Shelley E Keating, Christopher J A Pugh, Jonathan G Stine, Gaël Ennequin, Alexis Couret, David J Stensel, Guruprasad P Aithal, Thomas Yates, James A King","doi":"10.1111/dom.71367","DOIUrl":"10.1111/dom.71367","url":null,"abstract":"<p><strong>Aims: </strong>To investigate associations of cardiorespiratory fitness (CRF) with metabolic syndrome (MetS) trait count, MetS prevalence and individual MetS traits in a large population-based cohort.</p><p><strong>Materials and methods: </strong>This cross-sectional study analysed data for 39 197 adults from a UK-based independent healthcare charity (mean ± SD: age, 45.8 ± 9.0 years; BMI, 26.3 ± 4.1 kg⋅m<sup>-2</sup>; 31% female). CRF was estimated as peak oxygen uptake from submaximal treadmill or cycle ergometer protocols and analysed continuously and as sex- and mode-specific quintiles. MetS was defined using established criteria, with outcomes examined as trait count (0-5), presence (≥ 3 traits) and individual traits. Associations were assessed using negative binomial regression for trait count and Poisson regression for MetS presence. Models were sequentially adjusted for demographics (primary model), adiposity (BMI) and hepatic steatosis (fatty liver index [FLI]).</p><p><strong>Results: </strong>Each 1 mL⋅kg<sup>-1</sup>⋅min<sup>-1</sup> higher CRF was associated with a 2.9% lower MetS trait count and 6.0% lower MetS prevalence (p < 0.001). Compared with the highest CRF quintile, the lowest quintile had a 2.4-fold higher MetS trait count and 5.4-fold higher MetS prevalence (p < 0.001). Associations persisted after BMI and FLI adjustment, although attenuated. Spline analyses demonstrated graded, non-linear inverse associations, steepest at lower CRF levels. Higher CRF was inversely associated with all individual MetS traits, strongest for central obesity.</p><p><strong>Conclusions: </strong>Higher CRF was associated with lower metabolic risk burden and MetS prevalence, which remained after adjustment for adiposity-related measures. These findings support the potential public health relevance of modest fitness improvements, particularly among the least fit adults, as a strategy that may help reduce MetS burden even when adiposity changes are limited.</p>","PeriodicalId":158,"journal":{"name":"Diabetes, Obesity & Metabolism","volume":" ","pages":"11608-11620"},"PeriodicalIF":6.1,"publicationDate":"2026-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13731045/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148987291","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}
Yaming Li, Fang Zhang, Wei Liu, Xiuhai Su, Bin Zhou, Na Xu, Junjie Shang, Chen Fang, Liujun Fu, Fangqiong Li, Chao Zheng, Jinyou Duan
{"title":"Efficacy and Safety of Crisugabalin for Inadequately Controlled Diabetic Peripheral Neuropathic Pain: A Randomized, Active-Controlled, Phase 2 Trial.","authors":"Yaming Li, Fang Zhang, Wei Liu, Xiuhai Su, Bin Zhou, Na Xu, Junjie Shang, Chen Fang, Liujun Fu, Fangqiong Li, Chao Zheng, Jinyou Duan","doi":"10.1111/dom.71401","DOIUrl":"10.1111/dom.71401","url":null,"abstract":"<p><strong>Aims: </strong>Crisugabalin (HSK16149), a selective γ-aminobutyric acid (GABA) analog, has shown preliminary efficacy in controlling diabetic peripheral neuropathic pain (DPNP), but efficacy in patients with inadequate response to prior pregabalin treatment remains unknown.</p><p><strong>Materials and methods: </strong>This multicentre randomized controlled trial was conducted from April 18, 2024 to July 18, 2024. Adults patients with DPNP and inadequate response to pregabalin were randomized at a 1:1 ratio to receive crisugabalin (40 mg/day) or pregabalin (300 mg/day) for 4 weeks. The primary endpoint was the mean change of SF-MPQ pain score from baseline to 4 weeks of treatment.</p><p><strong>Results: </strong>Ninety-three patients were randomized: 47 and 46 in the crisugabalin and pregabalin groups, respectively. The efficacy analysis included 90 patients (mean age, 58.9 years; 49 men). The least square mean (LSM) difference in the mean change of SF-MPQ pain score was -7.2 (95% CI: -12.4, -2.0; ANCOVA p = 0.007) between the two groups. The rate of treatment-emergent adverse events was 29.5% (13/44) and 47.8% (22/46) in the crisugabalin and pregabalin groups, respectively.</p><p><strong>Conclusions: </strong>Treatment with crisugabalin 40 mg/day resulted in greater pain reduction in comparison to pregabalin 300 mg/day over a period of 4 weeks in DPNP patients with inadequate response to prior pregabalin treatment.</p>","PeriodicalId":158,"journal":{"name":"Diabetes, Obesity & Metabolism","volume":" ","pages":"11946-11954"},"PeriodicalIF":6.1,"publicationDate":"2026-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13731062/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149101447","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}
Yang Liu, Yulong Chen, Yimei Chen, Xiaohong Jian, Xingguang Zhang, Yufeng Li, Weiwei Zhu, Jing Shen, Yiming Mu
{"title":"Accuracy and Safety of the LinX Continuous Glucose Monitoring System in Adults With Diabetes: A Prospective Multicentre Open-Label Clinical Performance Study.","authors":"Yang Liu, Yulong Chen, Yimei Chen, Xiaohong Jian, Xingguang Zhang, Yufeng Li, Weiwei Zhu, Jing Shen, Yiming Mu","doi":"10.1111/dom.71392","DOIUrl":"10.1111/dom.71392","url":null,"abstract":"<p><strong>Background: </strong>Accurate continuous glucose monitoring (CGM) is essential for diabetes management. This study evaluated the accuracy and safety of the LinX CGM system over 15 days in adults with diabetes.</p><p><strong>Methods: </strong>In this prospective, multicentre, open-label clinical performance study, 87 adults who wore two LinX sensors were enrolled. Reference glucose was measured using a Biosen analyser. Primary endpoints were the proportions of readings within ±15%/±40% of reference values and mean absolute relative difference (MARD).</p><p><strong>Results: </strong>Overall MARD was 8.66% (95% CI: 8.27%-9.05%). For glucose concentrations in the range of 3.9-10.0 mmol/L (70-180 mg/dL), 87.2% of readings were within ±15%; for concentrations ≥ 10.0 mmol/L (≥ 180 mg/dL), 90.2% were within ±15%. Within ±40%, agreement rates were 99.8% and 100.0%, respectively. Sensor survival at 15 days was 96.0%. No serious adverse events occurred.</p><p><strong>Conclusion: </strong>The LinX CGM system demonstrated good analytical accuracy and favourable short-term safety over a 15-day wear period in adults with diabetes.</p><p><strong>Trial registration: </strong>Chinese Clinical Trial Registry: ChiCTR2200064004.</p>","PeriodicalId":158,"journal":{"name":"Diabetes, Obesity & Metabolism","volume":" ","pages":"11927-11935"},"PeriodicalIF":6.1,"publicationDate":"2026-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149101684","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}