Diabetes Care最新文献

{"title":"Human Physiologic Responses to Insulin in Indigenous Americans Identify a Metabolic Susceptibility Profile Linked to Diabetes","authors":"Venkatesh L. Murthy, Paolo Piaggi, Phillip Lin, Shilin Zhao, Lindsey K. Stolze, Andrew S. Perry, Robert L. Hanson, John Jeffrey Carr, James G. Terry, Leslie J. Baier, Clifton Bogardus, Clary Clish, Eric R. Gamazon, Jonathan Krakoff, Ravi V. Shah","doi":"10.2337/dc25-0151","DOIUrl":"https://doi.org/10.2337/dc25-0151","url":null,"abstract":"OBJECTIVE To identify metabolic signatures of insulin action/secretion in Indigenous Americans (IAs) and their association with diabetes. RESEARCH DESIGN AND METHODS We defined circulating metabolomic signatures of insulin action/secretion in 446 IAs, including glucose disposal rate during low-dose insulin clamp (Mlow) and endogenous glucose production (EGP) during insulin infusion (suppression of hepatic glucose production). We then determined associations of these metabolic scores with glucose tolerance (in a separate set of ∼700 IAs) and diabetes/metabolic risk in ∼2,000 individuals (from Coronary Artery Risk Development in Young Adults [CARDIA] study). We used tissue-specific gene–metabolite mapping to pinpoint genetic pathways of type 2 diabetes (T2D) implicated by metabolomic signatures. RESULTS In young IAs (mean age 29 years; mean BMI 34.9 kg/m2) without diabetes, phenotype–metabolome associations across multiple insulin action phenotypes were linked to mechanisms of fatty acid and amino acid metabolism and inflammation (among others). Metabolite-based scores of insulin action were strongly related to incident diabetes in our discovery IA population (Mlow; 49 metabolites; standardized hazard ratio [HR] 0.49; 95% CI 0.35–0.69; P < 0.0001) and also associated with measures of insulin resistance in a distinct IA population (|ρ| ∼0.3–0.5 correlation) and in the CARDIA group (median age 33 years). At ∼20 years of follow-up in CARDIA, we observed a strong BMI- and glucose-independent association of the metabolite profile of Mlow (HR 0.65; 95% CI 0.56–0.74; P < 0.0001) and EGP suppression (HR 0.66; 95% CI 0.57–0.76; P < 0.0001) with incident diabetes, directionally opposed to BMI and glucose. Genes implicated by the metabolomic signatures were strongly linked to T2D. CONCLUSIONS Metabolic signatures of clamp-determined insulin action are strongly associated with incident diabetes, suggesting causal–functional pathways of T2D.","PeriodicalId":11140,"journal":{"name":"Diabetes Care","volume":"55 1","pages":""},"PeriodicalIF":16.2,"publicationDate":"2025-05-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144104708","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Sodium–Glucose Cotransporter 2 Inhibitor Use and Risk of Liver-Related Events in Patients With Type 2 Diabetes: A Meta-analysis of Observational Cohort Studies","authors":"Alessandro Mantovani, Riccardo Morandin, Maria Giovanna Lando, Veronica Fiorio, Grazia Pennisi, Salvatore Petta, Norbert Stefan, Herbert Tilg, Christopher D. Byrne, Giovanni Targher","doi":"10.2337/dc25-0282","DOIUrl":"https://doi.org/10.2337/dc25-0282","url":null,"abstract":"BACKGROUND There is uncertainty regarding effect of sodium–glucose cotransporter 2 (SGLT2) inhibitors on the risk of major adverse liver-related outcomes (MALOs). PURPOSE We performed a meta-analysis of observational cohort studies to quantify the magnitude of the association between SGLT2 inhibitor use and risk of developing MALOs for people with type 2 diabetes mellitus (T2DM). DATA SOURCES We systematically reviewed three large electronic databases from inception to January 2025. STUDY SELECTION We included active-comparator, new-user cohort studies with comparison of SGLT2 inhibitors versus other glucose-lowering medications in patients with T2DM. DATA EXTRACTION The primary outcome was incidence rate of MALOs defined as a composite of hepatic decompensation events, hepatocellular carcinoma, liver transplantation, or liver-related deaths. Secondary outcomes included each of the above as individual events. Meta-analysis was performed with random-effects models. DATA SYNTHESIS We identified eight cohort studies with aggregate data on 626,104 patients with T2DM (397,806 SGLT2 inhibitor new users and 228,298 new users of other glucose-lowering agents). During a median of 2.7 years, SGLT2 inhibitor use was associated with significantly lower risk of MALOs (random-effects hazard ratio 0.83, 95% CI 0.72–0.95; I2 = 83.1%) and liver-related deaths (0.64, 0.50–0.82; I2 = 0%). The significant risk reduction in MALOs was observed in comparisons of SGLT2 inhibitors with dipeptidyl peptidase 4 inhibitors, metformin, or pioglitazone but not glucagon-like peptide 1 receptor agonists. Sensitivity analyses did not modify these results. A funnel plot did not show significant publication bias. LIMITATIONS Observational design of the cohort studies and high level of heterogeneity are the main limitations. CONCLUSIONS SGLT2 inhibitor use was associated with lower risk of MALOs for patients with T2DM.","PeriodicalId":11140,"journal":{"name":"Diabetes Care","volume":"70 1","pages":"1042-1052"},"PeriodicalIF":16.2,"publicationDate":"2025-05-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144104681","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"One-Hour Plasma Glucose Predicts the Progression From Normal Glucose Tolerance to Prediabetes","authors":"Muhammad Abdul-Ghani, Mohamed Abu-Farha, Tamam Abdul-Ghani, Alberto Chavez-Velazquez, Auora Merovci, Ralph A. DeFronzo, Fahad Alajmi, Michael Stern, Fahd Al-Mulla","doi":"10.2337/dc24-2832","DOIUrl":"https://doi.org/10.2337/dc24-2832","url":null,"abstract":"OBJECTIVE To examine the ability of the 1-h plasma glucose (PG) concentration during the oral glucose tolerance test (OGTT) to predict the risk of progression to prediabetes in individuals with normal glucose tolerance (NGT). RESEARCH DESIGN AND METHODS A total of 1,557 participants from the San Antonio Heart Study who were free of type 2 diabetes at baseline, had a baseline OGTT, and had a repeat OGTT after 7.5 years of follow-up were evaluated. The ability of 1-h PG concentration to predict the development of prediabetes, based on American Diabetes Association criteria, was evaluated. RESULTS Approximately one-quarter of participants with NGT (24.7%) progressed to prediabetes at 7.5 years (22.5% with 1-h PG <155 mg/dL and 42.5% with 1-h PG >155 mg/dL). The 1-h PG was the strongest predictor of developing prediabetes, and a 1-h cut point of 120 mg/dL had 61% sensitivity and 67% specificity in identifying individuals with NGT at high risk of developing prediabetes. Participants with a 1-h PG of 120–155 mg/dL and who experienced a deterioration in glucose tolerance (progression to prediabetes) at follow-up were characterized by severe insulin resistance and metabolic abnormalities characteristic of the insulin resistance syndrome. Therefore, we suggest the term pre-prediabetes for this group to emphasize their high future risk of deteriorating glucose tolerance. CONCLUSIONS An increase in 1-h PG concentration precedes the development of prediabetes and identifies individuals with a 1-h PG of 120–155 mg/dL who are at increased risk of developing prediabetes. Therefore, we suggest the term pre-prediabetes for this group with an elevated risk of deteriorating glucose tolerance.","PeriodicalId":11140,"journal":{"name":"Diabetes Care","volume":"3 1","pages":""},"PeriodicalIF":16.2,"publicationDate":"2025-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144067118","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Stroke Incidence Evolution in People With Newly Diagnosed Diabetes and Impaired Glucose Tolerance: A 34-Year Follow-up of the Da Qing Diabetes Study","authors":"Yanyan Chen, Jinping Wang, Xinxin Feng, Xin Qian, Siyao He, Qier An, Xiang Yin, Xuan Wang, Yali An, Qiuhong Gong, Shuhan Zhou, Hui Li, Xiuwei Zhai, Xiaoping Chen, Guangwei Li","doi":"10.2337/dc24-2675","DOIUrl":"https://doi.org/10.2337/dc24-2675","url":null,"abstract":"OBJECTIVE To examine the incidence of stroke in Chinese adults with newly diagnosed type 2 diabetes (NDD), impaired glucose tolerance (IGT), and normal glucose tolerance (NGT) over a 34-year follow-up period. RESEARCH DESIGN AND METHODS This cohort study included participants with NDD, IGT, and NGT initially identified in 1986 in the Da Qing Diabetes Prevention Study who were followed up for 34 years. Patients with IGT were randomized into a 6-year lifestyle intervention or control group. The stroke incidence and hazard ratios (HRs) were determined across the three glucose-level groups. RESULTS Over 34 years, the cumulative stroke incidence in the NDD, IGT nonintervention, and IGT intervention groups were 65.4%, 62.8%, and 49.8%, respectively. The annual incidence in the NDD group was significantly higher than that in the NGT group (24.3 vs. 18.5 per 1,000 person-years), after adjusting for age and sex. After adjusting for risk factors, the risk of stroke was significantly higher in the NDD (HR 1.80, 95% CI 1.46–2.21, P < 0.001), IGT nonintervention (HR 1.52, 95% CI 1.11–2.07, P = 0.008), and IGT intervention (HR 1.33, 95% CI 1.17–1.63, P = 0.01) groups than in the NGT group. A reduced stroke risk was observed in the overall IGT intervention group compared with the NDD group (HR 0.77, 95% CI 0.64–0.94, P = 0.009), especially in women (HR 0.64, 95% CI 0.47–0.88, P = 0.006). CONCLUSIONS Over 34 years, ∼50% of Chinese adults with NDD and IGT experienced stroke. Further efforts in diabetes management and intervention are required.","PeriodicalId":11140,"journal":{"name":"Diabetes Care","volume":"96 1","pages":""},"PeriodicalIF":16.2,"publicationDate":"2025-05-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144066518","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Trends in Cystic Fibrosis–Related Diabetes Epidemiology Between 2003 and 2018 From the U.S. Cystic Fibrosis Foundation Patient Registry","authors":"Celia L. Kohler, Tim Vigers, Laura Pyle, Kristen Miller, Edith T. Zemanick, Antoinette Moran, Scott D. Sagel, Christine L. Chan","doi":"10.2337/dc25-0044","DOIUrl":"https://doi.org/10.2337/dc25-0044","url":null,"abstract":"OBJECTIVE A number of disease-modifying therapies have been introduced for people with cystic fibrosis (CF) over the past two decades. The cumulative effects of this changing landscape on CF–related diabetes (CFRD) are unclear. We examined trends in CFRD epidemiology over time using data from the U.S. Cystic Fibrosis Foundation Patient Registry (CFFPR). RESEARCH DESIGN AND METHODS CFFPR data from 2003 to 2018 were queried to determine annual screening, incidence, and prevalence rates of CFRD. Individuals with incident CFRD were compared with individuals without CFRD. Survival analyses were performed to estimate the cumulative hazard of CFRD given predictors of interest over the 15 years of study. Data were also grouped into three time periods (2003–2008, 2009–2013, and 2014–2018) to investigate whether the hazard of developing CFRD varied over time. RESULTS CFRD screening rates increased from 2003 to 2018, particularly in 10- to 18-year-olds. Although screening rates increased in adults, overall rates remained low. In 10- to 18-year-olds, the incidence of CFRD was stable over time, while incident cases in adults steadily decreased, approaching incident rates in adolescents. Despite this, the prevalence of CFRD has gradually increased in adults, likely reflecting increased longevity. Age, female sex, Black race, severe mutation class, liver disease, poorer lung function, pancreatic insufficiency, enteric feeds, and low and high BMI were all risk factors associated with CFRD. CONCLUSIONS Findings support the need for the development of tailored CFRD screening algorithms and increased subspecialists to care for a growing population of adults with CF and CF-associated comorbidities.","PeriodicalId":11140,"journal":{"name":"Diabetes Care","volume":"29 1","pages":""},"PeriodicalIF":16.2,"publicationDate":"2025-05-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144066520","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Diet, Gut Microbiota, and Histidine Metabolism Toward Imidazole Propionate Production in Relation to Type 2 Diabetes","authors":"Hongbo Yang, Kai Luo, Brandilyn A. Peters, Yi Wang, Yanbo Zhang, Martha Daviglus, Amber Pirzada, Christina Cordero, Bing Yu, Robert D. Burk, Robert Kaplan, Qibin Qi","doi":"10.2337/dc24-2816","DOIUrl":"https://doi.org/10.2337/dc24-2816","url":null,"abstract":"OBJECTIVE To examine associations of serum imidazole propionate (ImP), histidine, and their ratio with incident type 2 diabetes (T2D) and related dietary and gut microbial factors in U.S. Hispanic/Latino people. RESEARCH DESIGN AND METHODS In the Hispanic Community Health Study/Study of Latinos, we evaluated serum ImP, histidine, and ImP-to-histidine ratio at baseline (2008–2011) and their cross-sectional associations with dietary intake and prospective associations with incident T2D over ∼12 years (n = 4,632). In a subsample with gut microbiota data during a follow-up visit (2016–2018), we examined gut microbial species associated with serum ImP and their potential interactions with dietary intake. RESULTS Serum ImP and ImP-to-histidine ratio were positively associated with incident T2D (hazard ratio [95% CI] = 1.17 [1.00–1.36] and 1.33 [1.14–1.55], respectively, comparing highest and lowest tertiles), whereas histidine was inversely associated with incident T2D (hazard ratio = 0.75 [95% CI 0.64–0.86]). A higher amount of fiber intake was associated with lower serum ImP level and ImP-to-histidine ratio, whereas histidine intake was not associated with serum ImP level in the overall sample. Fifty-three bacterial species, including 19 putative ImP producers, were associated with serum ImP. Histidine intake was positively associated with serum ImP and ImP-to-histidine ratio only in participants with a high ImP-associated gut microbiota score (P = 0.03 and 0.02, respectively, for interaction). The associations of fiber intake with serum ImP and ImP-to-histidine ratio were partly mediated by ImP-associated gut microbiota (proportion mediated = 31.4% and 19.8%, respectively). CONCLUSIONS This study suggested an unfavorable relationship between histidine metabolism toward ImP production, potentially regulated by dietary intake and gut microbiota, and risk of T2D in U.S. Hispanics/Latino people.","PeriodicalId":11140,"journal":{"name":"Diabetes Care","volume":"35 1","pages":""},"PeriodicalIF":16.2,"publicationDate":"2025-05-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143930755","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Persistent Hyperglycemia and Insulin Resistance With the Risk of Worsening Cardiac Damage in Adolescents: A 7-Year Longitudinal Study of the ALSPAC Birth Cohort","authors":"Andrew O. Agbaje, Justin P. Zachariah, Alan R. Barker, Craig A. Williams, Dimitris Vlachopoulos, Christoph Saner, Tomi-Pekka Tuomainen","doi":"10.2337/dc24-2459","DOIUrl":"https://doi.org/10.2337/dc24-2459","url":null,"abstract":"OBJECTIVE Insulin resistance (IR) and dysglycemia can induce cardiac remodeling in adulthood, but little evidence exists with respect to cardiac remodeling in youth with and without evidence of new-onset glucose metabolic alterations. This study investigated whether changes in metabolic status from adolescence to young adulthood are associated with the risk of progressive cardiac remodeling and examined potential mechanistic pathways. RESEARCH DESIGN AND METHODS From the Avon Longitudinal Study of Parents and Children (ALSPAC), U.K. cohort, 1,595 adolescents, mean (SD) age 17.7 (0.4) years, who had data on fasting plasma glucose and insulin levels, and echocardiography left ventricular (LV) mass indexed for height raised to the power of 2.7 (LVMI2.7) and in whom these factors repeatedly were measured at a clinic visit when they were aged 24 years were included. HOMA-IR was computed, hyperglycemia was defined as glucose concentration of ≥5.6 mmol/L and ≥6.1 mmol/L, and LV hypertrophy was defined as LVMI2.7 ≥51g/m2.7. RESULTS The prevalence of LV hypertrophy increased from 2.4% at baseline to 7.1% at follow-up. Each unit increase of glucose (β = 0.37 g/m2.7 [95% CI 0.23–0.52]; P < 0.001) and HOMA-IR (1.10 g/m2.7 [0.63–1.57]; P < 0.001) was independently associated with increased LVMI2.7 over 7 years. Persistent hyperglycemia of 5.6 mmol/L and 6.1 mmol/L was associated with higher odds (odds ratio [OR] 1.46 [95% CI 1.35–1.47], P < 0.001; and 3.10 [95% CI 1.19–8.08], P = 0.021, respectively) of worsening LV hypertrophy over 7 years. Increased fat mass (62% mediation) significantly mediated the association of increased HOMA-IR with increased LVMI2.7. CONCLUSIONS Persistent adolescent hyperglycemia and worsening IR were associated with the risk of worsening structural and functional cardiac damage, and these were largely explained by increased fat mass.","PeriodicalId":11140,"journal":{"name":"Diabetes Care","volume":"41 1","pages":""},"PeriodicalIF":16.2,"publicationDate":"2025-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143920099","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Is the Current Lifestyle Modification Approach to Diabetes Prevention in the U.S. a Success?","authors":"Justin B. Echouffo-Tcheugui, Rosette J. Chakkalakal, Mohammed K. Ali","doi":"10.2337/dci24-0040","DOIUrl":"https://doi.org/10.2337/dci24-0040","url":null,"abstract":"Prediabetes is an intermediate stage between normal glycemia and diabetes and is highly prevalent, especially in adults, but is also increasingly common in young individuals. Randomized clinical trials have demonstrated that lifestyle modification is cost-effective in preventing diabetes. Implementation studies showed the feasibility of delivering real-world structured lifestyle modification programs adapted from the U.S. Diabetes Prevention Program trial. However, the current approach to diabetes prevention in the U.S. has been largely inadequate thus far, as evidenced by the stagnant numbers of people with prediabetes and the growing number of those with diabetes. The many gaps in the implementation of the National Diabetes Prevention Program (NDPP) can be characterized as due to macro-level barriers (failures of pay-for-performance reimbursement, an undersupply of lifestyle change programs), micro-level barriers (low and disparate reach, low referral and retention rates in the program), variable fidelity in implementation, and limitations of a one-size-fits-all intervention. All of these issues point to a need for reexamining strategies for diabetes prevention in the U.S., which is yet to show benefits or value at the population level. This article details how prediabetes is currently suboptimally addressed in clinical practice and communities in the U.S. and articulates why there is an urgent need to rethink our approach to addressing prediabetes, possibly through integration of synergistic individual- and societal-levels approaches.","PeriodicalId":11140,"journal":{"name":"Diabetes Care","volume":"12 1","pages":""},"PeriodicalIF":16.2,"publicationDate":"2025-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143920104","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Capillary Ketone Level and Future Ketoacidosis Risk in Patients With Type 1 Diabetes Using Sodium–Glucose Cotransporter Inhibitors","authors":"Priya Bapat, Sharon Dhaliwal, Cimon Song, Yucheng Zhang, Daniel Scarr, Abdulmohsen Bakhsh, Dalton Budhram, Natasha J. Verhoeff, Alanna Weisman, Michael Fralick, Noah M. Ivers, David Z.I. Cherney, George Tomlinson, Doug Mumford, Leif Erik Lovblom, Bruce A. Perkins","doi":"10.2337/dc25-0125","DOIUrl":"https://doi.org/10.2337/dc25-0125","url":null,"abstract":"OBJECTIVE We aimed to determine if routine capillary blood ketone testing on well days predicts future diabetic ketoacidosis (DKA) in type 1 diabetes (T1D) using sodium–glucose cotransporter inhibitors (SGLTi). RESEARCH DESIGN AND METHODS We examined previously collected data from empagliflozin-assigned participants in a T1D trial that included weekly fasted ketone levels. Over 6–12 months, ketone levels were subdivided into 28-day periods, and the outcome was subsequent adjudicated DKA or severe ketosis. RESULTS Among 1,194 participants, 325 had 49 DKA and 568 severe ketosis events. On-treatment maximum ketone levels were higher in the 28 days before an outcome compared with levels in those without an outcome, with area under receiver operating characteristic curve of 0.76 (95% CI 0.71–0.82). Maximum ketone level ≥0.8 mmol/L had sensitivity of 66.0%, specificity of 79.6%, and diagnostic odds ratio of 7.6. CONCLUSIONS Routine surveillance of capillary ketone levels in T1D using SGLTi may represent a DKA mitigation strategy and implies a potential threshold for continuous ketone monitoring.","PeriodicalId":11140,"journal":{"name":"Diabetes Care","volume":"4 1","pages":""},"PeriodicalIF":16.2,"publicationDate":"2025-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143920105","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Cellular Versus Acellular Matrix Products for Diabetic Foot Ulcer Treatment: The Dermagraft and Oasis Longitudinal Comparative Efficacy Study (DOLCE)—A Randomized Clinical Trial","authors":"Harrison Shawa, Ramanjot Kaur, Catherine Tchanque-Fossuo, Hadar Lev-Tov, Kaitlyn West, Pallas Sulgi Lim, Nuen Tsang Yang, Mirabel Dafinone, Rawlings Everett Lyle, Chin-Shang Li, David Rocke, Sara Dahle, Roslyn Rivkah Isseroff","doi":"10.2337/dc24-1233","DOIUrl":"https://doi.org/10.2337/dc24-1233","url":null,"abstract":"OBJECTIVE To determine whether cellular matrix (CM) products result in better healing rates than acellular matrix (ACM) products for nonhealing diabetic foot ulcers. RESEARCH DESIGN AND METHODS The Dermagraft and Oasis Longitudinal Comparative Efficacy Study (DOLCE) was a randomized, single-blinded, three-arm controlled trial. Patients (aged ≥18 years) with a full-thickness nonhealing diabetic foot ulcer who met inclusion/exclusion criteria were enrolled. RESULTS Of 169 eligible patients, 138 were enrolled and 117 randomly assigned. For 12 weeks, patients received standard of care (SOC), CM, or ACM. The primary outcome was the percentage of wounds healed by 12 weeks. Of the 117 participants, 41 were in the CM group, 48 in the ACM group, and 28 in the SOC group. There were 21 withdrawals, but seven had reached the first primary end point. Complete re-epithelialization of the ulcer by 12 weeks occurred in 59% of the 117 total participants: 49% in the CM group, 69% in the ACM group, and 57% in the SOC group (P = 0.16 by χ2 test). At 28 weeks, 25 participants (61%) in the CM group, 27 (56%) in the ACM group, and 18 (64%) in the SOC group had healed (P = 0.78). No differences were found in wound recidivism or adverse event occurrence between groups. CONCLUSIONS No difference in efficacy was found between SOC, ACM, and CM, suggesting that SOC can reduce the economic burden of diabetic foot ulcer treatment.","PeriodicalId":11140,"journal":{"name":"Diabetes Care","volume":"37 1","pages":""},"PeriodicalIF":16.2,"publicationDate":"2025-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143920102","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}