Diabetes care最新文献

{"title":"The Diabetes Prevention Program and Its Outcomes Study: NIDDK's Journey Into the Prevention of Type 2 Diabetes and Its Public Health Impact.","authors":"Jill P Crandall, Dana Dabelea, William C Knowler, David M Nathan, Marinella Temprosa","doi":"10.2337/dc25-0014","DOIUrl":"10.2337/dc25-0014","url":null,"abstract":"<p><p>The current-day epidemic of type 2 diabetes, largely driven by increased adiposity and reduced physical activity in the setting of genetic susceptibility, is a major public health challenge. The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) presciently proposed the Diabetes Prevention Program (DPP), a multicenter randomized clinical trial, designed by investigators in conjunction with NIDDK staff and initiated in 1996. The primary goal of DPP was to determine whether an intensive lifestyle intervention (ILS) or metformin in comparison with placebo would reduce the development of diabetes in a high-risk population with prediabetes. After mean 2.8 years, ILS reduced diabetes risk by 58% and metformin by 31%, leading to study termination ahead of schedule due to demonstrated efficacy of both interventions. In 2002, an extension of the DPP study, the Diabetes Prevention Program Outcomes Study (DPPOS), was initiated for examination of the longer-term course and consequences of diabetes prevention. Over 21 years of median total follow-up, in comparison with the placebo group, cumulative diabetes incidence was reduced by 24% and 17% in the original ILS and metformin groups, respectively, with median increases in diabetes-free survival of 3.5 and 2.5 years/person. During long-term follow-up, there were no significant effects of the original DPP interventions on microvascular or cardiovascular outcomes. However, compared with prevalence of microvascular outcomes among participants who progressed to diabetes, prevalence among those who did not progress was significantly lower. Longer-term follow-up of the cohort continues with examination of relationships between diabetes and prediabetes and an expanded array of diabetes- and aging-related morbidities.</p>","PeriodicalId":93979,"journal":{"name":"Diabetes care","volume":" ","pages":"1101-1111"},"PeriodicalIF":16.6,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12178622/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144063395","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Assessing Neighborhood Deprivation Reveals Rural-Urban Disparities in CGM Access Among Children With Type 1 Diabetes.","authors":"Daniel R Tilden, Christie A Befort, Brent Lockee, Amey Wagemode, David Williams, Mark A Clements","doi":"10.2337/dc25-0077","DOIUrl":"10.2337/dc25-0077","url":null,"abstract":"","PeriodicalId":93979,"journal":{"name":"Diabetes care","volume":" ","pages":"e88-e90"},"PeriodicalIF":16.6,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12178611/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144113150","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"High Transepidermal Water Loss at the Site of Wound Closure Is Associated With Increased Recurrence of Diabetic Foot Ulcers: The NIDDK Diabetic Foot Consortium TEWL Study.","authors":"Chandan K Sen, Gayle M Gordillo, Sashwati Roy, Jordan Jahnke, Mithun Sinha, Lava Timsina, Shomita S Mathew-Steiner, Michael S Conte, Crystal Holmes, Teresa L Z Jones, Rodica Pop-Busui, Giselle Kolenic, Cathie Spino, Geoffrey C Gurtner","doi":"10.2337/dc25-0300","DOIUrl":"10.2337/dc25-0300","url":null,"abstract":"<p><strong>Objective: </strong>The National Institute of Diabetes and Digestive and Kidney Diseases Diabetic Foot Consortium tested the hypothesis that compromised restoration of the skin barrier function of closed diabetic foot ulcers (DFUs), as measured by high transepidermal water loss (TEWL), is associated with an increased risk of DFU recurrence.</p><p><strong>Research design and methods: </strong>This was a multicenter noninterventional study measuring TEWL in 418 adult participants with diabetes and a recently healed DFU. TEWL was measured at the center of the closed wound and at an anatomically similar reference area on the contralateral foot within 2 weeks of wound closure (visit 1); measurements were repeated at a wound closure confirmation visit 2 weeks later (visit 2). Participants were observed for up to 16 weeks to assess for wound recurrence. Participant self-reported and clinician assessments of DFU wound recurrence were recorded.</p><p><strong>Results: </strong>DFU recurrence by week 16 occurred in 21.5% of participants. Mean TEWL at the center of the healed DFU at visit 1 was higher for those with recurrence compared with those without (P = 0.006). Among participants with high TEWL (>30.05 g · m-2 · h-1), 35% reported wound recurrence by 16 weeks versus 17% of those with low TEWL. The odds ratio for recurrence for participants with high TEWL was 2.66 (P < 0.001). Self-reported wound recurrence was highly concordant with clinician assessment of wound recurrence.</p><p><strong>Conclusions: </strong>Compromised wound healing mechanisms culminating in wound closure associated with defective skin barrier function is associated with increased risk of DFU recurrence. Measurement of TEWL has value as a predictor of functional wound healing and could affect clinical practice, leading to better outcomes.</p>","PeriodicalId":93979,"journal":{"name":"Diabetes care","volume":" ","pages":"1233-1240"},"PeriodicalIF":16.6,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12178626/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144188661","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Inadequately Controlled Type 2 Diabetes and Hypercortisolism: Improved Glycemia With Mifepristone Treatment.","authors":"Ralph A DeFronzo, Vivian Fonseca, Vanita R Aroda, Richard J Auchus, Timothy Bailey, Irina Bancos, Robert S Busch, John B Buse, Elena A Christofides, Bradley Eilerman, James W Findling, Yehuda Handelsman, Steven E Kahn, Harold J Miller, Jonathan G Ownby, John C Parker, Athena Philis-Tsimikas, Richard Pratley, Julio Rosenstock, Michael H Shanik, Lance A Sloan, Guillermo Umpierrez, Samir Shambharkar, Iulia Cristina Tudor, Tina K Schlafly, Daniel Einhorn","doi":"10.2337/dc25-1055","DOIUrl":"https://doi.org/10.2337/dc25-1055","url":null,"abstract":"<p><strong>Objective: </strong>In many individuals, type 2 diabetes (T2D) remains poorly controlled despite taking multiple glucose-lowering therapies. Several studies have demonstrated that endogenous hypercortisolism is prevalent among these individuals. We tested whether cortisol-directed therapy improves their glycemic control.</p><p><strong>Research design and methods: </strong>In this prospective, multicenter, double-blind study, 136 individuals with T2D (hemoglobin A1c [HbA1c] 7.5%-11.5% [58-102 mmol/mol] on multiple medications) and hypercortisolism (by dexamethasone suppression test) were randomized 2:1 to the glucocorticoid receptor antagonist mifepristone (300-900 mg once daily; n = 91) or placebo (n = 45) for 24 weeks, with stratification by presence/absence of an adrenal imaging abnormality. The primary end point was the change in HbA1c. Secondary end points included changes in glucose-lowering medications, weight, and waist circumference and safety.</p><p><strong>Results: </strong>Mean baseline HbA1c in the study cohort was 8.55% (69.9 mmol/mol). At 24 weeks, the least squares mean (LSM) difference from placebo in HbA1c was -1.32% (95% CI -1.81 to -0.83; P < 0.001). Participants receiving mifepristone experienced reductions in body weight and waist circumference (placebo-adjusted LSM differences of -5.12 kg [95% CI -8.20 to -2.03] and -5.1 cm [-8.23 to -1.99], respectively). Of participants on mifepristone, 46% discontinued therapy, compared with 18% on placebo. Adverse events with mifepristone (>10% of participants) included hypokalemia, fatigue, nausea, vomiting, headache, peripheral edema, diarrhea, and dizziness, consistent with mifepristone's known tolerability profile. Increases in blood pressure also occurred.</p><p><strong>Conclusions: </strong>In individuals with inadequately controlled T2D and hypercortisolism, cortisol-directed medical therapy with mifepristone reduced HbA1c, with a manageable tolerability profile.</p>","PeriodicalId":93979,"journal":{"name":"Diabetes care","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-06-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144478306","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Role of Adipose Tissue Compartments for Cardiovascular Risk in Diabetes Endotypes.","authors":"Oana-Patricia Zaharia, Yuliya Kupriyanova, Pavel Bobrov, Christian Binsch, Birgit Knebel, Tim Mori, Iryna Yurchenko, Dania Marel Mendez Cardenas, Theresa Kössler, Nina Trinks, Martin Schön, Kálmán B Bódis, Robert Wagner, Vera Schrauwen-Hinderling, Michael Roden","doi":"10.2337/dc24-2023","DOIUrl":"https://doi.org/10.2337/dc24-2023","url":null,"abstract":"<p><strong>Objective: </strong>The severe insulin-resistant diabetes (SIRD) endotype is associated with metabolic dysfunction-associated steatotic liver disease and higher cardiovascular risk. We investigated whether skeletal muscle or adipose tissue lipids are elevated in SIRD.</p><p><strong>Research design and methods: </strong>Participants (N = 420) of the German Diabetes Study (GDS) were assigned to diabetes clusters using a validated algorithm. 1H-magnetic resonance methods were used to quantify intramyocellular lipids (IMCLs), intrahepatic lipids (IHLs), and visceral adipose tissue (VAT) and subcutaneous adipose tissue (SAT) volumes.</p><p><strong>Results: </strong>Aside from elevated IHLs (P < 0.01), SIRD showed higher VAT and SAT than other endotypes after adjustment for BMI (all P < 0.05) but not for multiple comparisons. All endotypes featured comparable IMCLs. VAT volume and IHLs correlated with cardiovascular risk scores (Framingham r = 0.661 and 0.548, respectively, P < 0.05). Polygenic risk scores for VAT were associated with higher cardiovascular risk.</p>","PeriodicalId":93979,"journal":{"name":"Diabetes care","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-06-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144319010","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Weight Gain Was Associated With Worsening Glycemia and Cardiovascular and Kidney Outcomes in Patients With Type 2 Diabetes Independent of Diabetes Medication in the GRADE Randomized Controlled Trial.","authors":"Deborah J Wexler, W Timothy Garvey, Alokananda Ghosh, Erin J Kazemi, Heidi Krause-Steinrauf, Andrew J Ahmann, Janet Brown-Friday, Sabina Casula, Andrea L Cherrington, Tom A Elasy, Stephen P Fortmann, Jonathan A Krakoff, Sunder Mudaliar, Margaret Tiktin, Naji Younes","doi":"10.2337/dc24-2825","DOIUrl":"10.2337/dc24-2825","url":null,"abstract":"<p><strong>Objective: </strong>Weight gain with glucose-lowering medications may interfere with effective type 2 diabetes (T2D) management. We evaluated weight change and the effect of weight gain on outcomes over 5 years on four diabetes medications.</p><p><strong>Research design and methods: </strong>The Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE) randomized trial compared the addition of insulin glargine, glimepiride, liraglutide, or sitagliptin to metformin in participants with T2D. We report weight change and hazard ratio (HR) per kilogram of weight change for HbA1c >7.5%; cardiovascular disease (CVD), kidney disease, and neuropathy outcomes; and diabetes treatment satisfaction.</p><p><strong>Results: </strong>Participants (n = 4,980) were 57 ± 10 years, 44% non-White, with HbA1c 7.5% ± 0.5%, and BMI 34.3 ± 6.8 kg/m2. Mean (95% CI) weight change (kg) during the first year was -3.5 (-3.8,-3.2) with liraglutide,-1.07 (-1.4,-0.78) with sitagliptin, 0.45 (0.16, 0.74) with glargine, and 0.89 (0.60, 1.2) with glimepiride (P < 0.0001). Thereafter, weight decreased in all groups. Weight gain within the first 6 months was associated with increased risk of HbA1c >7.5%, with modest differences by treatment, and with subsequent CVD (HR 1.03 [95% CI 1.005, 1.06]). Weight gain at 1 year was associated with increased risk of HbA1c >7.5% (HR 1.05 [1.04, 1.07]) and kidney disease (HR 1.03 [1.01, 1.06]). Baseline weight, but not weight gain, was associated with new-onset neuropathy. Weight gain was associated with lower diabetes treatment satisfaction.</p><p><strong>Conclusions: </strong>Liraglutide and sitagliptin were associated with initial weight loss and glargine and glimepiride with slight weight gain, followed by weight loss in metformin-treated T2D. Weight gain was associated with worsening glycemia and increased risk of cardiovascular and kidney outcomes largely independent of treatment.</p>","PeriodicalId":93979,"journal":{"name":"Diabetes care","volume":" ","pages":"935-944"},"PeriodicalIF":16.6,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12094209/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144063348","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Impact of Islet Transplantation on Diabetes Complications and Mortality in Patients Living With Type 1 Diabetes.","authors":"Quentin Perrier, Clément Jambon-Barbara, Laurence Kessler, Orianne Villard, Fanny Buron, Bruno Guerci, Sophie Borot, Matthieu Roustit, Ekaterine Berishvilli, Luc Rakotoarisoa, Marie-Christine Vantyghem, Emmanuel Morelon, Eric Renard, Camille Besch, Thierry Berney, Pierre-Yves Benhamou, Sandrine Lablanche","doi":"10.2337/dc25-0059","DOIUrl":"10.2337/dc25-0059","url":null,"abstract":"<p><strong>Objective: </strong>This study aimed to evaluate the impact of islet transplantation (IT) on diabetes complications, death, and cancer incidence.</p><p><strong>Research design and methods: </strong>This retrospective, multicenter, cohort study included patients from three IT clinical trials (intervention group) and from the French health insurance claims database Système National des Données de Santé (SNDS) (control group). Two cohorts of IT recipients were analyzed: IT recipients after kidney transplantation (IAK) and IT recipients alone (ITA). They were matched with patients living with type 1 diabetes (T1D) from the SNDS using a propensity score. The primary outcome was a composite criterion including death, dialysis, amputation, nonfatal stroke, nonfatal myocardial infarction, and transient ischemic attack. The secondary outcome was cancer. Hazard ratio (HRs) and P values were obtained using Cox proportional hazards analysis and log-rank test, respectively.</p><p><strong>Results: </strong>The study included 61 ITA recipients matched to 610 T1D control patients and 45 IAK recipients matched to 45 T1D control patients over a median follow-up period >10 years. Compared with T1D control patients, ITA and IAK recipients had a lower composite outcome risk (HR 0.39 [95% CI 0.21-0.71; P = 0.002] and 0.52 [0.30-0.88; P = 0.014], respectively) that seemed driven by reduced mortality (0.22 [0.09-0.54]; P < 0.001) for ITA and reduced dialysis (0.19 [0.07-0.50]; P < 0.001) for IAK. Both groups showed no significant changes in cancer risk.</p><p><strong>Conclusions: </strong>This study suggests long-term benefits of IT on diabetes-related outcomes. Furthermore, despite the use of immunosuppressive drugs following IT, we observed no significant increase in the risk of cancer. Altogether, these findings highlight a favorable risk-benefit ratio of IT in treating patients with unstable T1D.</p>","PeriodicalId":93979,"journal":{"name":"Diabetes care","volume":" ","pages":"1007-1015"},"PeriodicalIF":0.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12094206/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144003773","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"High-Dose Semaglutide (Up to 16 mg) in People With Type 2 Diabetes and Overweight or Obesity: A Randomized, Placebo-Controlled, Phase 2 Trial.","authors":"Vanita R Aroda, Nils B Jørgensen, Bharath Kumar, Ildiko Lingvay, Anne Sofie Laulund, John B Buse","doi":"10.2337/dc24-2425","DOIUrl":"10.2337/dc24-2425","url":null,"abstract":"<p><strong>Objective: </strong>Studies have demonstrated dose-dependent efficacy of glucagon-like peptide 1 receptor agonists for glycemic control and body weight. The aim of this trial was to characterize the dose-dependent effects of semaglutide (up to 16 mg/week) in people with type 2 diabetes and overweight or obesity.</p><p><strong>Research design and methods: </strong>In this parallel-group, participant- and investigator-blinded, phase 2 trial, 245 individuals with type 2 diabetes and BMI ≥27 kg/m2 on metformin were randomized to weekly semaglutide (2, 8, or 16 mg s.c.) or placebo for 40 weeks. Doses were escalated every 4 weeks, followed by a maintenance period. Dose modifications were not allowed. Primary and secondary efficacy end points included change from baseline to week 40 in HbA1c and body weight, respectively.</p><p><strong>Results: </strong>Estimated treatment difference between 16 and 2 mg was -0.3 percentage points (%-points) (95% CI -0.7 to 0.2; P = 0.245) for HbA1c change and -3.4 kg (-6.0 to -0.8; P = 0.011) for weight change for the treatment policy estimand and -0.5%-points (-1.0 to -0.1; P = 0.015) and -4.5 kg (-7.6 to -1.4; P = 0.004), respectively, for the hypothetical estimand. Dose-response modeling confirmed these findings. Treatment-emergent adverse events (AEs) and treatment discontinuations due to AEs, primarily gastrointestinal, were more frequent in the semaglutide 8 and 16 mg groups than in the 2 mg group. No severe hypoglycemic episodes were reported.</p><p><strong>Conclusions: </strong>Higher semaglutide doses for type 2 diabetes and overweight or obesity provide modest additional glucose-lowering effect, with additional weight loss, at the expense of more AEs and treatment discontinuations. A study for evaluating high-dose semaglutide in obesity is currently underway.</p>","PeriodicalId":93979,"journal":{"name":"Diabetes care","volume":" ","pages":"905-913"},"PeriodicalIF":0.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12094194/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144061108","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Standardized Measurement of Type 1 Diabetes Polygenic Risk Across Multiancestry Population Cohorts.","authors":"Amber M Luckett, Richard A Oram, Aaron J Deutsch, Hector I Ortega, Diane P Fraser, Kaavya Ashok, Alisa K Manning, Josep M Mercader, Manuel A Rivas, Miriam S Udler, Michael N Weedon, Anna L Gloyn, Seth A Sharp","doi":"10.2337/dc25-0142","DOIUrl":"10.2337/dc25-0142","url":null,"abstract":"","PeriodicalId":93979,"journal":{"name":"Diabetes care","volume":" ","pages":"e81-e83"},"PeriodicalIF":16.6,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12094190/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144061234","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Screening for Metabolic Dysfunction-Associated Steatotic Liver Disease-Related Advanced Fibrosis in Diabetology: A Prospective Multicenter Study.","authors":"Cyrielle Caussy, Bruno Vergès, Damien Leleu, Laurence Duvillard, Fabien Subtil, Amna Abichou-Klich, Valérie Hervieu, Laurent Milot, Bérénice Ségrestin, Sylvie Bin, Alexia Rouland, Dominique Delaunay, Pierre Morcel, Samy Hadjadj, Claire Primot, Jean-Michel Petit, Sybil Charrière, Philippe Moulin, Massimo Levrero, Bertrand Cariou, Emmanuel Disse","doi":"10.2337/dc24-2075","DOIUrl":"10.2337/dc24-2075","url":null,"abstract":"<p><strong>Objective: </strong>Screening for advanced fibrosis (AF) resulting from metabolic dysfunction-associated steatotic liver disease (MASLD) is recommended in diabetology. This study aimed to compare the performance of noninvasive tests (NITs) with that of two-step algorithms for detecting patients at high risk of AF requiring referral to hepatologists.</p><p><strong>Research design and methods: </strong>We conducted a planned interim analysis of a prospective multicenter study including participants with type 2 diabetes and/or obesity and MASLD with comprehensive liver assessment comprising blood-based NITs, vibration-controlled transient elastography (VCTE), and two-dimensional shear-wave elastography (2D-SWE). AF risk stratification was determined by a composite criterion of liver biopsy, magnetic resonance elastography, or VCTE ≥12 kPa depending on availability.</p><p><strong>Results: </strong>Of 654 patients (87% with type 2 diabetes, 56% male, 74% with obesity), 17.6% had an intermediate/high risk of AF, and 9.3% had a high risk of AF. The area under the empirical receiver operating characteristic curves of NITs for detection of high risk of AF were as follows: fibrosis-4 index (FIB-4) score, 0.78 (95% CI 0.72-0.84); FibroMeter, 0.74 (0.66-0.83); FibroTest, 0.78 (0.72-0.85); Enhanced Liver Fibrosis (ELF) test, 0.82 (0.76-0.87); and SWE, 0.84 (0.78-0.89). Algorithms with FIB-4 score/VCTE showed good diagnostic performance for referral of patients at intermediate/high risk of AF to specialized care in hepatology. An alternative FIB-4 score/ELF test strategy showed a high negative predictive value (NPV; 88-89%) and a lower positive predictive value (PPV; 39-46%) at a threshold of 9.8. The FIB-4 score/2D-SWE strategy had an NPV of 91% and a PPV of 58-62%. The age-adapted FIB-4 score threshold resulted in lower NPVs and PPVs in all algorithms.</p><p><strong>Conclusions: </strong>The FIB-4 score/VCTE algorithm showed excellent diagnostic performance, demonstrating its applicability for routine screening in diabetology. The ELF test using an adapted low threshold at 9.8 may be used as an alternative to VCTE.</p>","PeriodicalId":93979,"journal":{"name":"Diabetes care","volume":" ","pages":"877-886"},"PeriodicalIF":0.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143070368","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}