Diabetes, Obesity & Metabolism最新文献

{"title":"Liraglutide and Βeta-Cell Function in Young Adults With Long-Standing Type 1 Diabetes and Residual C-Peptide: A Blinded, Randomized Controlled Trial.","authors":"José Caballero-Corbalán, Per Lundkvist, Daniel Espes, Per-Ola Carlsson","doi":"10.1111/dom.71204","DOIUrl":"10.1111/dom.71204","url":null,"abstract":"<p><strong>Aims: </strong>To evaluate the effect of liraglutide on residual beta-cell function in adults with long-standing type 1 diabetes (T1D) and detectable C-peptide.</p><p><strong>Materials and methods: </strong>In this randomized, blinded, placebo-controlled trial, 18 adults with T1D duration ≥ 5 years and detectable fasting C-peptide were assigned to liraglutide or placebo for 52 weeks. Mixed-meal tolerance tests were performed at baseline and weeks 6, 52, and 65. The primary endpoint was change in stimulated C-peptide area under the curve from baseline to week 52.</p><p><strong>Results: </strong>Liraglutide did not improve stimulated C-peptide compared with placebo at week 52. In exploratory post hoc longitudinal analyses including the post-treatment period (weeks 0-65), stimulated C-peptide declined more steeply in the liraglutide group than in the placebo group, accompanied by increasing insulin requirements over time.</p><p><strong>Conclusions: </strong>In adults with long-standing T1D, liraglutide did not preserve stimulated C-peptide after 52 weeks. Exploratory post hoc longitudinal analyses suggested a steeper decline in stimulated C-peptide with liraglutide than with placebo.</p>","PeriodicalId":158,"journal":{"name":"Diabetes, Obesity & Metabolism","volume":" ","pages":"10093-10098"},"PeriodicalIF":6.1,"publicationDate":"2026-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13646360/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148757159","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":"Efficacy of Luseogliflozin Added to Semaglutide in Patients With Metabolic Dysfunction-Associated Steatohepatitis and Type 2 Diabetes Mellitus: A Randomised, Open-Label Trial.","authors":"Teruki Miyake, Osamu Yoshida, Shinya Furukawa, Masashi Hirooka, Masanori Abe, Yoshio Tokumoto, Ayumi Kanamoto, Takao Watanabe, Ryo Yano, Yuki Okazaki, Atsushi Yukimoto, Yoshiko Nakamura, Eiji Takeshita, Teru Kumagi, Yoichi Hiasa","doi":"10.1111/dom.71233","DOIUrl":"10.1111/dom.71233","url":null,"abstract":"<p><strong>Aims: </strong>Type 2 diabetes drives the progression of metabolic dysfunction-associated steatohepatitis (MASH). We evaluated whether antidiabetic therapy, specifically adding sodium-glucose cotransporter 2 (SGLT2) inhibitor to a glucagon-like peptide-1 receptor agonist (GLP-1RA), improves liver histology in adults with biopsy-proven MASH and type 2 diabetes.</p><p><strong>Materials and methods: </strong>In this 52-week, open-label, randomised, parallel-group trial in Japan, adults with biopsy-confirmed MASH and type 2 diabetes received semaglutide plus luseogliflozin or semaglutide alone at antidiabetic doses. Paired liver biopsies at baseline and Week 52 were evaluated by blinded pathologists. Primary histological endpoints included resolution of MASH without worsening fibrosis, ≥ 1-point improvement in the non-alcoholic fatty liver disease (NAFLD) activity score without worsening fibrosis and ≥ 1-stage improvement in fibrosis without worsening MASH.</p><p><strong>Results: </strong>Sixty participants were randomised (combination, n = 24; monotherapy, n = 36). At Week 52, all histological endpoints numerically favoured combination therapy. Resolution of MASH without worsening fibrosis occurred in 34.9% versus 19.4%, ≥ 1-point improvement in the NAFLD activity score (NAS) in 75.5% versus 55.6% and ≥ 1-stage fibrosis improvement in 26.9% versus 13.9%. In the pre-specified per-protocol analysis, ≥ 1-point improvement in the NAS was nominally significant. Combination therapy reduced body weight, glycated haemoglobin levels, aminotransferase levels and FibroScan-derived liver stiffness.</p><p><strong>Conclusions: </strong>In the pre-specified full analysis set, combination therapy at antidiabetic doses did not significantly improve pre-specified histological endpoints compared with monotherapy. In the pre-specified per-protocol analysis, a nominal improvement in the NAS was observed. Combination therapy improved body weight, glycemic control, aminotransferase levels and liver stiffness, with no new safety concerns identified.</p><p><strong>Trial registration: </strong>UMIN Clinical Trials Registry (UMIN-CTR): UMIN000045003; Japan Registry of Clinical Trials (jRCT): jRCTs061210009.</p>","PeriodicalId":158,"journal":{"name":"Diabetes, Obesity & Metabolism","volume":" ","pages":"10163-10172"},"PeriodicalIF":6.1,"publicationDate":"2026-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13646358/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148765944","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":"Evaluating Whole Fruit Feijoa Powder for Type 2 Diabetes Risk Prevention: A Randomised Controlled Trial.","authors":"I A Mohamed, I R Sequeira-Bisson, J J Lim, L D Plank, R Murphy, S D Poppitt, J L Miles-Chan","doi":"10.1111/dom.71270","DOIUrl":"10.1111/dom.71270","url":null,"abstract":"<p><strong>Background: </strong>Low energy diets (LEDs) are effective for body weight (BW) loss and improvement of type 2 diabetes (T2D) risk biomarkers. Emerging evidence suggests that whole fruit feijoa powder, rich in polyphenols and abscisic acid, may further support T2D prevention. The FERDINAND study investigated whether daily consumption of a whole fruit feijoa powder enhanced LED-driven improvements in fasting plasma glucose (FPG), BW, and other metabolic markers.</p><p><strong>Methods: </strong>At in-clinic screening, 97 participants were enrolled into the trial and randomised to receive 1150 mg/day of whole fruit feijoa powder (Fx, n = 48) or Placebo treatment (n = 49) for 6 months. All participants underwent 2 months of LED-induced weight loss, followed by 4 months of dietary advice for weight loss maintenance. BW, FPG, and secondary outcomes including blood pressure (BP) were assessed at baseline (M0) and the end of months 2 (M2), 4 (M4), and 6 (M6). Data were analysed using linear mixed-effects models as intention-to-treat (ITT) with imputation for missing not-at-random data points.</p><p><strong>Results: </strong>BW decreased in both treatment groups during the 2-month LED, with a gradual upward trajectory over the subsequent 4 months (time_0-6m: p < 0.001). There was no difference in BW between Fx and Placebo over the 6-month intervention (treatment×time_0-6m: p = 0.74). FPG followed the weight loss trajectory in both treatment groups (time_0-6m: p < 0.001), but with no between-group interaction over 6 months (treatment×time_0-6m: p = 0.09, n = 97). Systolic BP (SBP), but not diastolic BP, declined over the 6 months between treatments (treatment×time_0-6m: p = 0.01) in all participants, with SBP in Fx lower than Placebo at M4 and M6 (p < 0.05, both).</p><p><strong>Conclusions: </strong>In adults with overweight (predominantly obesity) and prediabetes, Fx supplementation may enhance blood pressure improvement achieved through BW loss. The polyphenolic matrix of whole fruit feijoa, which contains a high proportion of catechins, may have contributed to vascular benefits.</p>","PeriodicalId":158,"journal":{"name":"Diabetes, Obesity & Metabolism","volume":" ","pages":"10709-10724"},"PeriodicalIF":6.1,"publicationDate":"2026-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13646332/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148862774","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":"Increasing Trends in Hospitalisation With Diabetic Ketoacidosis at Type 1 Diabetes Diagnosis Among Children and Youth in the United States and England, 2002-2020.","authors":"Chintan V Dave, Kristen Lloyd, Abner Nyandege, Jason Roy, Raquel López-Díez, Sally Radovick, Brian L Strom","doi":"10.1111/dom.71279","DOIUrl":"10.1111/dom.71279","url":null,"abstract":"<p><strong>Background: </strong>There is a paucity of population-level data evaluating trends in the proportion of children and youth hospitalised with diabetic ketoacidosis (DKA) at the time of Type 1 diabetes (T1D) diagnosis.</p><p><strong>Methods: </strong>National Medicaid (US publicly insured claims), MarketScan (US commercially insured claims) and Clinical Practice Research Datalink (CPRD) (English electronic health record) data were used to create cohorts of children with incident T1D. DKA at diagnosis was defined as a DKA hospitalisation occurring within 30 days prior to the diagnosis of T1D. The likelihood of presenting in DKA was modelled using age, sex, race and community-level social vulnerability. Population-level T1D incidence trends were also assessed.</p><p><strong>Results: </strong>Among 116 845 patients (mean [SD] age: 10.4 [4.9]; 46.8% female), 48 291 (41.3%) presented in DKA. These proportions increased between 2002 and 2019, rising by 11.1% (from 34.4% to 45.5%) in Medicaid, 2.8% (from 42.0% to 44.8%) in MarketScan and 18.6% (from 17.9% to 36.5%) in CPRD, and further increasing in 2020 (Medicaid, 52.4%; MarketScan, 52.9%; CPRD, 44.1%). T1D incidence increased from 2002 to 2019 from 10 to 17, 12 to 20 and 5 to 13 per 100 000 children, respectively, reaching 21, 22 and 15 per 100 000 in 2020, respectively. DKA was higher among children aged 6 months to 2 years (70.4%), and among Black (45.4%) and Hispanic (45.4%) backgrounds. An increased relative risk of DKA was evident among children under 2 years: 1.97 (95% CI: 1.92-2.02), Black children: 1.14 (1.06-1.23), Hispanic children: 1.12 (1.10-1.15), and those residing in higher areas of social vulnerability: 1.20 (1.02-1.40).</p><p><strong>Conclusion: </strong>This study found a relative increase in the proportion of children presenting with DKA at T1D diagnosis, occurring in parallel with rising T1D incidence. This uptrend, which preceded but was exacerbated by the COVID-19 pandemic, underscores worsening epidemiological trends, especially notable in England and among publicly insured US children.</p>","PeriodicalId":158,"journal":{"name":"Diabetes, Obesity & Metabolism","volume":" ","pages":"10615-10624"},"PeriodicalIF":6.1,"publicationDate":"2026-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13646372/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148838698","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":"Time-Dependent Accrual of Cardiorenal Benefit With SGLT2 Inhibitors in Chronic Kidney Disease: A Reconstructed Individual Patient Data Meta-Analysis of Randomized Trials.","authors":"Shotaro Yoshida, Mashiro Iwatsubo, Takahiro Nakamura, Makiko Oda, Yusuke Sakamaki","doi":"10.1111/dom.71195","DOIUrl":"10.1111/dom.71195","url":null,"abstract":"","PeriodicalId":158,"journal":{"name":"Diabetes, Obesity & Metabolism","volume":" ","pages":"10857-10861"},"PeriodicalIF":6.1,"publicationDate":"2026-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13646366/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148676385","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":"Effects of 6-OHDA-Mediated Chemical Denervation of Sympathetic Axons in Inguinal Subcutaneous White Adipose Tissue.","authors":"Gilian Gunsch, Gargi Mishra, Magdalena Blaszkiewicz, Erica de Sousa, Jake W Willows, Katharine W Alltop, Annemarie Towle, Shawn Collins, Andre Khalil, Isabel F Snodgrass, Lara Agha, Kiran Prakash, Rashmika Maganuru, Sugasini Dhavamani, John W Newman, Kristy L Townsend","doi":"10.1111/dom.71251","DOIUrl":"10.1111/dom.71251","url":null,"abstract":"<p><strong>Aims: </strong>White adipose tissue (WAT) innervation by sensory and sympathetic axons contributes to tissue functions, but the consequences of selectively disrupting sympathetic input to WAT remain incompletely defined.</p><p><strong>Materials and methods: </strong>We utilised 6-hydroxydopamine (6-OHDA) as a validated approach to achieve bilateral sympathetic denervation of mouse inguinal subcutaneous WAT (ing-scWAT) and investigated impacts on adipose and whole-body metabolism.</p><p><strong>Results: </strong>Sympathetic denervation did not impact body weight or adipose mass by 16 days post-denervation but significantly altered energy expenditure. Sympathetic denervation increased both sensory neuropeptide levels and sensory innervation at 7 days, which may explain the minimal whole-body impacts, since sensory nerves can contribute to many of the same metabolic processes as sympathetic nerves in adipose. In acute studies, intra-ing-scWAT norepinephrine delivery increased calcitonin gene related peptide (CGRP) levels in the depot, while CGRP administration reduced norepinephrine levels, underscoring previous reports of nerve cross talk at the tissue level. Multi-omics profiling of sympathetically denervated ing-scWAT revealed selective remodelling of lipid signalling pathways, including accumulation of polyunsaturated fatty acid-derived oxylipins from the cytochrome P450 pathway, alongside perturbations in tricarboxylic acid cycle metabolism. These changes were distinct from CL316,243 treatment. Single-nuclei transcriptomics identified cell-type-specific re-programming, including altered oxidative phosphorylation and lipid metabolic pathways in adipocytes and increased immune cell representation with sympathetic denervation.</p><p><strong>Conclusions: </strong>Together, these data demonstrate that sympathetic denervation of scWAT induces coordinated metabolic, lipidomic, and transcriptional changes in the tissue as well as alterations to energy balance. Nerve crosstalk and potential compensation by sensory axons may help explain the findings.</p>","PeriodicalId":158,"journal":{"name":"Diabetes, Obesity & Metabolism","volume":" ","pages":"10459-10474"},"PeriodicalIF":6.1,"publicationDate":"2026-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13646377/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148816717","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":"Trends in Cost of Care With Tirzepatide in Adults Aged Over 55 Years With Obesity or Overweight Without Diabetes: A Matched Cohort Analysis.","authors":"Navneet Upadhyay, Ali Bonakdar, Keshab Subedi, Soutrik Banerjee, Benjamin Behrend, Emily R Hankosky","doi":"10.1111/dom.71250","DOIUrl":"10.1111/dom.71250","url":null,"abstract":"<p><strong>Aims: </strong>Compare healthcare cost trends among older adults with obesity or overweight treated with tirzepatide versus no treatment.</p><p><strong>Materials and methods: </strong>Retrospective cohort study using real-world data from US Komodo Research Dataset, 8 November 2022 to 30 September 2025. Adults > 55 years with obesity, or overweight with ≥ 1 weight-related comorbidity, without T2 diabetes who initiated tirzepatide for weight management were compared with propensity score-matched individuals who did not receive any incretin-based therapies. Changes in all-cause healthcare costs (excluding tirzepatide; per-person-per-month) between cohorts were assessed at 3-6, 6-12 and 12-18 months using a difference in differences (DiD) framework. Informative censoring and differential follow-up were addressed with inverse-probability-of-censoring-weights and pairwise censoring.</p><p><strong>Results: </strong>Each cohort comprised 15843 individuals. Healthcare cost DiD estimates (95% CI) for the tirzepatide versus control cohorts were -$145 (-266, -25; 12.3% reduction; p = 0.022) during 6-12 months and -$319 (-544, -94; 25.4% reduction; p = 0.015) during 12-18 months; using pairwise censoring, estimates were -$181 (-319, -43; p = 0.021) and -$607 (-1007, -207; p = 0.023), respectively. Cost offsets with tirzepatide were driven by higher medical costs in controls during 12-18 months (-$211 [-$407, -$15]; p = 0.065) and fewer inpatient/emergency department visits with tirzepatide versus controls; incidence rate ratio (95% CI) 0.69 (0.50, 0.94; p = 0.021) during 12-18 months.</p><p><strong>Conclusions: </strong>Monthly cost offsets for persistent tirzepatide users versus untreated individuals grew over time, offsetting $319 (ranging from $94 to $544) tirzepatide costs by 12-18 months. These results have implications for the $195 monthly net Medicare cost for the Bridge programme, suggesting tirzepatide may generate near-term cost savings in an older population that stays on treatment.</p>","PeriodicalId":158,"journal":{"name":"Diabetes, Obesity & Metabolism","volume":" ","pages":"10418-10427"},"PeriodicalIF":6.1,"publicationDate":"2026-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13646331/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148811499","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":"EASO's New Obesity Framework and Incident Type 2 Diabetes: A Prospective Cohort Study.","authors":"Zejin Hao, Lifeng Pi, Junping Zhang, Yuanyuan Deng, Yuhang Chen, Ying Hu, Jixiong Xu, Jiancheng Wang","doi":"10.1111/dom.71232","DOIUrl":"10.1111/dom.71232","url":null,"abstract":"<p><strong>Aim: </strong>We prospectively investigated the association between the European Association for the Study of Obesity (EASO) modified obesity definition and the incidence of type 2 diabetes mellitus (T2DM).</p><p><strong>Materials and methods: </strong>We analysed data from the NAfld in the Gifu Area Longitudinal Analysis (NAGALA) cohort, an ongoing community-based health screening program in Japan. Obesity was defined using both traditional body mass index (BMI) categories and the new EASO definition (BMI 23-27.5 kg/m² plus waist-to-height ratio ≥ 0.5 and at least one obesity-related comorbidity). T2DM was identified during follow-up based on haemoglobin A1c (HbA1c) ≥ 6.5%, fasting plasma glucose ≥ 7.0 mmol/L, or self-reported physician diagnosis of diabetes.</p><p><strong>Results: </strong>The study included 13 825 adults without diabetes at baseline. According to the new EASO definition, 10.3% of the study population (1424 individuals, representing 31.3% of those originally classified as overweight by BMI) were reclassified as having obesity. Compared with individuals with normal weight, those with EASO-defined overweight showed an increased risk of T2DM [hazard ratio (HR): 1.48, 95% confidence interval (CI): 1.10-2.00], while those with EASO-defined new obesity demonstrated a significantly elevated risk (HR: 5.06, 95% CI: 3.86-6.62). After multivariable adjustment for age, sex, smoking status, alcohol consumption, physical activity, and HbA1c, the adjusted HR for EASO-defined new obesity remained significantly elevated at 2.68 (95% CI: 2.03-3.54). When compared with normal-weight individuals without comorbidities, EASO-defined new obesity was associated with a higher T2DM risk (HR: 4.14, 95% CI: 2.77-6.19) than normal-weight individuals with comorbidities (HR: 1.95, 95% CI: 1.30-2.92).</p><p><strong>Conclusions: </strong>The new EASO framework may improve the identification of individuals at high risk of incident type 2 diabetes mellitus compared with traditional BMI criteria alone.</p>","PeriodicalId":158,"journal":{"name":"Diabetes, Obesity & Metabolism","volume":" ","pages":"10153-10162"},"PeriodicalIF":6.1,"publicationDate":"2026-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148757540","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":"Continuous Glucose Monitoring Systems in Europe: Regulatory Landscape and Certification Process Challenges Under MDR 2017/745.","authors":"Concetta Irace, Bassil Akra","doi":"10.1111/dom.71202","DOIUrl":"10.1111/dom.71202","url":null,"abstract":"<p><strong>Aims: </strong>To analyze the certification process for continuous glucose monitoring (CGM) systems in Europe under the applicable Medical Device Regulation (MDR) 2017/745 and to highlight potential issues that may impact the reliability of CGM devices following introduction to the market.</p><p><strong>Methods: </strong>We undertook a detailed review of MDR 2017/745 using publicly available European Commission information portals to assess the current implementation status. Specifically, we examined where checks and balances intended to ensure the accuracy and safety of CGM devices were not in place and identify where delays in implementation of key functions may reduce transparency and efficacy of the Conformité Européenne certification process.</p><p><strong>Results: </strong>Key elements of the MDR have not been implemented, creating inertia for manufacturers and the Notified Bodies that undertake conformity assessments. Delays in implementing the European Databank on Medical Devices (EUDAMED), which was designed to harmonize pre- and post-marketing collection of medical device information, have limited access to critical evidence for Notified Bodies and delayed strengthening of post-market surveillance.</p><p><strong>Conclusions: </strong>The current process of CGM Conformity Assessment under MDR 2017/745 limits access to regulatory submissions of clinical evidence reports, reference methodologies and other documentation necessary for CGM devices to be assessed as safe, accurate and effective in the populations of people with diabetes in whom they may be used. Additional checks and balances are required to increase transparency of the conformity assessment process prior to CE marking, and improve the traceability of CGM devices in the post-marketing period.</p>","PeriodicalId":158,"journal":{"name":"Diabetes, Obesity & Metabolism","volume":" ","pages":"10081-10092"},"PeriodicalIF":6.1,"publicationDate":"2026-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148760850","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":"The Impact of Kidney Function on Diabetic Ketoacidosis and Severe Hypoglycemia Among Adults With Type 1 Diabetes: Insights From the T1D Exchange Real-World Observation Study.","authors":"Tae Won Yi, Slaven Sikirica, Saketh Rompicherla, Susan Thapa, Michael Davies, Francesco Vendrame, David Lam, Nirali Shah, Guillermo Umpierrez, Osagie Ebekozien, Bruce A Perkins, David Z I Cherney","doi":"10.1111/dom.71191","DOIUrl":"10.1111/dom.71191","url":null,"abstract":"","PeriodicalId":158,"journal":{"name":"Diabetes, Obesity & Metabolism","volume":" ","pages":"10862-10866"},"PeriodicalIF":6.1,"publicationDate":"2026-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148682919","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}