Andrew O. Odegaard, Jenny Chang, Luohua Jiang, Syma Rashid, Sarah Rydell, N. Reed Mitchell, Anne E. Bantle, Elizabeth Seaquist, Andrew Reikes, Mark A. Pereira
OBJECTIVE To test the effect of substituting plain water (the ideal standard) for habitual artificial sweetened beverage (ASB) intake by people with type 2 diabetes (T2D) on primary measures of diabetes control. RESEARCH DESIGN AND METHODS The Study of Drinks with Artificial Sweeteners in People with T2D (SODAS) was conducted at two academic health centers and was a randomized, two-arm, parallel trial with a 2-week run-in period and a 24-week active intervention period. Adults with T2D (n = 181; HbA1c 6.5–8.5%; aged ≥35 years) who regularly consumed commercial ASBs were randomized to receive and consume 24 oz daily for 24 weeks of either 1) a commercial ASB of choice (control); or 2) an unflavored, sparkling or still, bottled or canned water of choice in place of ASBs. The outcomes measures were collected at baseline, 12, and 24 weeks and included the primary measure (HbA1c) and related secondary measures (fructosamine, fasting glucose and insulin, body weight, and continuous glucose monitor metrics). RESULTS A total of 179 participants provided complete data over 24 weeks. From baseline to 24 weeks, the mean difference in change of HbA1c was 0.29% (SE 0.12; P = 0.013) higher in the water arm compared with the ASB arm. There were no significant effects on secondary clinical measures, but data were directionally consistent with the primary results. CONCLUSIONS For people with T2D and HbA1c <8.5% who regularly consume ASBs, this trial provided no evidence that substituting water would improve glycemic-related clinical care measures over 24 weeks.
{"title":"The Effect of Substituting Water for Artificially Sweetened Beverages on Glycemic and Weight Measures in People With Type 2 Diabetes: The Study of Drinks With Artificial Sweeteners (SODAS), a Randomized Trial","authors":"Andrew O. Odegaard, Jenny Chang, Luohua Jiang, Syma Rashid, Sarah Rydell, N. Reed Mitchell, Anne E. Bantle, Elizabeth Seaquist, Andrew Reikes, Mark A. Pereira","doi":"10.2337/dc25-1516","DOIUrl":"https://doi.org/10.2337/dc25-1516","url":null,"abstract":"OBJECTIVE To test the effect of substituting plain water (the ideal standard) for habitual artificial sweetened beverage (ASB) intake by people with type 2 diabetes (T2D) on primary measures of diabetes control. RESEARCH DESIGN AND METHODS The Study of Drinks with Artificial Sweeteners in People with T2D (SODAS) was conducted at two academic health centers and was a randomized, two-arm, parallel trial with a 2-week run-in period and a 24-week active intervention period. Adults with T2D (n = 181; HbA1c 6.5–8.5%; aged ≥35 years) who regularly consumed commercial ASBs were randomized to receive and consume 24 oz daily for 24 weeks of either 1) a commercial ASB of choice (control); or 2) an unflavored, sparkling or still, bottled or canned water of choice in place of ASBs. The outcomes measures were collected at baseline, 12, and 24 weeks and included the primary measure (HbA1c) and related secondary measures (fructosamine, fasting glucose and insulin, body weight, and continuous glucose monitor metrics). RESULTS A total of 179 participants provided complete data over 24 weeks. From baseline to 24 weeks, the mean difference in change of HbA1c was 0.29% (SE 0.12; P = 0.013) higher in the water arm compared with the ASB arm. There were no significant effects on secondary clinical measures, but data were directionally consistent with the primary results. CONCLUSIONS For people with T2D and HbA1c &lt;8.5% who regularly consume ASBs, this trial provided no evidence that substituting water would improve glycemic-related clinical care measures over 24 weeks.","PeriodicalId":11140,"journal":{"name":"Diabetes Care","volume":"113 1","pages":""},"PeriodicalIF":16.2,"publicationDate":"2025-12-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145711358","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}
Jianhong Ge, Siyu Han, Mengya Shi, Makoto Harada, Shixiang Yu, Jiaqi Zheng, Cornelia Prehn, Jerzy Adamski, Gabi Kastenmüller, Sabrina Schlesinger, Wolfgang Koenig, Birgit Linkohr, Barbara Thorand, Karsten Suhre, Christian Gieger, Annette Peters, Rui Wang-Sattler
OBJECTIVE This study aimed to identify metabolites characterizing the progression from normal glucose metabolism (NORM) to prediabetes (PreT2D) and type 2 diabetes (T2D), focusing on stage-specific metabolic shifts (early: NORM to PreT2D; late: PreT2D to T2D) and mechanistic relevance. RESEARCH DESIGN AND METHODS We analyzed 8,240 observations from the KORA cohort, profiling 104 targeted and 312 non-targeted metabolites across three time points: baseline (S4) and follow-ups (F4 and FF4) spanning 14 years. Trajectory analyses of 1,050 individuals identified 211 incident PreT2D and 112 incident T2D cases. Linear mixed-effects models (basic: adjusted for age, sex, BMI, lifestyle; sensitivity: additionally adjusted for glycemic factors like fasting glucose, and cardiovascular factors such as systolic blood pressure (BP) were used to evaluate metabolic differences across glycemic states. Mediation and Mendelian randomization (MR) analyses examined mechanistic and causal relationships. RESULTS We identified 140 Bonferroni-significant metabolites (45 targeted, 109 non-targeted, 14 overlapping), including 68 early-stage metabolites (significant in PreT2D/T2D vs. NORM), primarily energy metabolism markers such as fatty acid oxidation metabolites (e.g., 37 lipids) and TCA cycle metabolites (e.g., citrate). Twenty late-stage metabolites (significant in T2D vs. PreT2D/NORM) included amino acids like BCAAs and γ-glutamyl derivatives. Fewer significant associations were observed in incident cases. Sensitivity models validated 50% of early-stage but not late-stage metabolites. Fasting glucose mediated 35.1% of the γ-glutamyl-valine-T2D association, while MR analysis found no causal roles for C2, BCAAs, or γ-glutamyl-valine. CONCLUSIONS Energy metabolism shifts occur early, while amino acid alterations emerge later stages. These stage-specific signatures may guide diabetes prevention strategies.
本研究旨在确定表征正常葡萄糖代谢（NORM）到前驱糖尿病（pre2d）和2型糖尿病（T2D）进展的代谢物，重点关注阶段特异性代谢转变（早期：NORM到pre2d，晚期：pre2d到T2D）及其机制相关性。研究设计和方法我们分析了来自KORA队列的8240项观察结果，在基线（S4）和随访（F4和FF4）三个时间点上分析了104项靶向和312项非靶向代谢物，时间跨度为14年。对1050例个体进行轨迹分析，发现211例pre2d和112例T2D。线性混合效应模型（基本：根据年龄、性别、BMI、生活方式进行调整；敏感性：根据空腹血糖等血糖因子和收缩压（BP）等心血管因素进行额外调整）评估不同血糖状态下的代谢差异。中介和孟德尔随机化（MR）分析检验了机制和因果关系。结果：我们鉴定了140个bonferroni显著代谢物（45个靶向，109个非靶向，14个重叠），包括68个早期代谢物（在pre2d /T2D与NORM中显著），主要是能量代谢标志物，如脂肪酸氧化代谢物（如37种脂质）和TCA循环代谢物（如柠檬酸盐）。20种晚期代谢物（在T2D vs. pre2d /NORM中显著）包括氨基酸，如BCAAs和γ-谷氨酰衍生物。在偶发病例中观察到的显著关联较少。敏感性模型验证了50%的早期代谢物，但没有验证晚期代谢物。空腹葡萄糖介导了35.1%的γ-谷氨酰缬氨酸- t2d关联，而MR分析发现C2、BCAAs或γ-谷氨酰缬氨酸没有因果关系。结论：能量代谢变化发生在早期，而氨基酸改变出现在后期。这些阶段特异性特征可以指导糖尿病预防策略。
{"title":"Integrative Metabolomics of Targeted and Non-Targeted Analyses in T2D Progression","authors":"Jianhong Ge, Siyu Han, Mengya Shi, Makoto Harada, Shixiang Yu, Jiaqi Zheng, Cornelia Prehn, Jerzy Adamski, Gabi Kastenmüller, Sabrina Schlesinger, Wolfgang Koenig, Birgit Linkohr, Barbara Thorand, Karsten Suhre, Christian Gieger, Annette Peters, Rui Wang-Sattler","doi":"10.2337/dc25-1707","DOIUrl":"https://doi.org/10.2337/dc25-1707","url":null,"abstract":"OBJECTIVE This study aimed to identify metabolites characterizing the progression from normal glucose metabolism (NORM) to prediabetes (PreT2D) and type 2 diabetes (T2D), focusing on stage-specific metabolic shifts (early: NORM to PreT2D; late: PreT2D to T2D) and mechanistic relevance. RESEARCH DESIGN AND METHODS We analyzed 8,240 observations from the KORA cohort, profiling 104 targeted and 312 non-targeted metabolites across three time points: baseline (S4) and follow-ups (F4 and FF4) spanning 14 years. Trajectory analyses of 1,050 individuals identified 211 incident PreT2D and 112 incident T2D cases. Linear mixed-effects models (basic: adjusted for age, sex, BMI, lifestyle; sensitivity: additionally adjusted for glycemic factors like fasting glucose, and cardiovascular factors such as systolic blood pressure (BP) were used to evaluate metabolic differences across glycemic states. Mediation and Mendelian randomization (MR) analyses examined mechanistic and causal relationships. RESULTS We identified 140 Bonferroni-significant metabolites (45 targeted, 109 non-targeted, 14 overlapping), including 68 early-stage metabolites (significant in PreT2D/T2D vs. NORM), primarily energy metabolism markers such as fatty acid oxidation metabolites (e.g., 37 lipids) and TCA cycle metabolites (e.g., citrate). Twenty late-stage metabolites (significant in T2D vs. PreT2D/NORM) included amino acids like BCAAs and γ-glutamyl derivatives. Fewer significant associations were observed in incident cases. Sensitivity models validated 50% of early-stage but not late-stage metabolites. Fasting glucose mediated 35.1% of the γ-glutamyl-valine-T2D association, while MR analysis found no causal roles for C2, BCAAs, or γ-glutamyl-valine. CONCLUSIONS Energy metabolism shifts occur early, while amino acid alterations emerge later stages. These stage-specific signatures may guide diabetes prevention strategies.","PeriodicalId":11140,"journal":{"name":"Diabetes Care","volume":"41 1","pages":""},"PeriodicalIF":16.2,"publicationDate":"2025-12-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145657319","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}
Roy Eldor, Noa Avraham, Orit Rosenberg, Miriam Shpigelman, Avivit Golan-Cohen, Tali Cukierman-Yaffe, Eugene Merzon, Assaf Buch
In the article cited above, the affiliations for author Assaf Buch were incorrectly given as Diabetes Unit, Institute of Endocrinology, Metabolism and Hypertension, Tel Aviv Sourasky Medical Center, Tel-Aviv, Israel, and Department of Nutritional Sciences, School of Health Sciences, Ariel University, Ariel, Israel. The sole affiliation for this author is Department of Nutritional Sciences, School of Health Sciences, Ariel University, Ariel, Israel. The online version of the article (https://doi.org/10.2337/dc25-0690) has been updated with the correct affiliation information.
{"title":"Erratum. Gradual Titration of Semaglutide Results in Better Treatment Adherence and Fewer Adverse Events: A Randomized Controlled Open-Label Pilot Study Examining a 16-Week Flexible Titration Regimen Versus Label-Recommended 8-Week Semaglutide Titration Regimen Diabetes Care 2025;48:1607–1611","authors":"Roy Eldor, Noa Avraham, Orit Rosenberg, Miriam Shpigelman, Avivit Golan-Cohen, Tali Cukierman-Yaffe, Eugene Merzon, Assaf Buch","doi":"10.2337/dc26-er02a","DOIUrl":"https://doi.org/10.2337/dc26-er02a","url":null,"abstract":"In the article cited above, the affiliations for author Assaf Buch were incorrectly given as Diabetes Unit, Institute of Endocrinology, Metabolism and Hypertension, Tel Aviv Sourasky Medical Center, Tel-Aviv, Israel, and Department of Nutritional Sciences, School of Health Sciences, Ariel University, Ariel, Israel. The sole affiliation for this author is Department of Nutritional Sciences, School of Health Sciences, Ariel University, Ariel, Israel. The online version of the article (https://doi.org/10.2337/dc25-0690) has been updated with the correct affiliation information.","PeriodicalId":11140,"journal":{"name":"Diabetes Care","volume":"29 1","pages":""},"PeriodicalIF":16.2,"publicationDate":"2025-12-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145664506","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}
Leah M. Schumacher, Sarah Bauerle Bass, Jamy Ard, Daniel J. Rubin, Sharon J. Herring, Ajay D. Rao, Resa M. Jones, David B. Sarwer
New obesity management guidelines, including those from the American Diabetes Association, advocate the use of shared decision-making (SDM) for obesity treatment. SDM is an evidence-based approach for promoting person-centered care and is widely recommended across medical specialties. However, a variety of issues challenge the use of SDM in daily practice. In this narrative review we discuss factors that may impede the use of SDM in adults with obesity and type 2 diabetes, as well as past efforts to address these barriers. Patient-level factors such as internalized weight bias and lack of knowledge about obesity and its treatment, provider-level factors such as limited training in obesity management and lack of confidence in sensitively discussing weight, and system-level factors like poor treatment access and limited care coordination stymie effective SDM around obesity management. A perceived power imbalance between patients and providers and medical mistrust are additional barriers for some. In the past, researchers have attempted to overcome these barriers to advancing SDM through approaches including patient decision aids, provider training, and clinical decision support systems, with moderate success. This article concludes with recommended strategies for clinical adoption of SDM for patients with obesity and type 2 diabetes, a call for system-level changes to create an environment more conducive to effective SDM, and directions for future research.
{"title":"The New Obesity Treatment Landscape: Challenges and Opportunities to Promote Shared Decision-Making in People With Obesity and Type 2 Diabetes","authors":"Leah M. Schumacher, Sarah Bauerle Bass, Jamy Ard, Daniel J. Rubin, Sharon J. Herring, Ajay D. Rao, Resa M. Jones, David B. Sarwer","doi":"10.2337/dci25-0094","DOIUrl":"https://doi.org/10.2337/dci25-0094","url":null,"abstract":"New obesity management guidelines, including those from the American Diabetes Association, advocate the use of shared decision-making (SDM) for obesity treatment. SDM is an evidence-based approach for promoting person-centered care and is widely recommended across medical specialties. However, a variety of issues challenge the use of SDM in daily practice. In this narrative review we discuss factors that may impede the use of SDM in adults with obesity and type 2 diabetes, as well as past efforts to address these barriers. Patient-level factors such as internalized weight bias and lack of knowledge about obesity and its treatment, provider-level factors such as limited training in obesity management and lack of confidence in sensitively discussing weight, and system-level factors like poor treatment access and limited care coordination stymie effective SDM around obesity management. A perceived power imbalance between patients and providers and medical mistrust are additional barriers for some. In the past, researchers have attempted to overcome these barriers to advancing SDM through approaches including patient decision aids, provider training, and clinical decision support systems, with moderate success. This article concludes with recommended strategies for clinical adoption of SDM for patients with obesity and type 2 diabetes, a call for system-level changes to create an environment more conducive to effective SDM, and directions for future research.","PeriodicalId":11140,"journal":{"name":"Diabetes Care","volume":"29 1","pages":""},"PeriodicalIF":16.2,"publicationDate":"2025-12-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145664507","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}
Kazue Nagai, Hsin-Fang Chung, Kunihiko Hayashi, Annette J. Dobson, Yuki Ideno, Sven Sandin, Yvonne T. van der Schouw, Rebecca Hardy, Debra J. Anderson, Panayotes Demakakos, Eric J. Brunner, Ellen S. Mitchell, Nancy F. Woods, Sophie V. Eastwood, Samar R. El Khoudary, Monique M. Hedderson, Elisabete Weiderpass, Gita D. Mishra
OBJECTIVE To examine the association between race/ethnicity and type 2 diabetes risk in women and assess the interaction between race/ethnicity and BMI. RESEARCH DESIGN AND METHODS We analyzed individual-level data from 730,408 women across 15 cohort studies. Six racial/ethnic groups were identified: White, Chinese, Japanese, South/Southeast Asian, Black, and mixed/other. Cox proportional hazards models with study as a random effect were used to estimate hazard ratios (HRs) for type 2 diabetes associated with race/ethnicity. The joint association of race/ethnicity and BMI was assessed using BMI categories incorporating Asian-specific cutoffs (<18.5, 18.5–22.9, 23.0–24.9, 25.0–27.4, 27.5–29.9, and ≥30 kg/m2), with White women having a BMI of 18.5–22.9 kg/m2as the reference. RESULTS Overall, 37,329 women (5.1%) were diagnosed with type 2 diabetes. By age 70, the cumulative incidence was highest among South/Southeast Asian (24.6%) and Black women (23.6%), with baseline obesity rates of 40.0% (BMI ≥27.5 kg/m2) and 45.6% (BMI ≥30 kg/m2), respectively. After adjusting for BMI, South/Southeast Asian women had the highest diabetes risk compared with White women (HR 4.13, 95% CI 3.78–4.51), while other racial/ethnic groups had about twice the risk. Joint effect analysis showed South/Southeast Asian women with a BMI ≥23 kg/m2had a substantially greater diabetes risk than other racial/ethnic groups with the same BMI, especially those with BMI 27.5–29.9 kg/m2(HR 23.17, 19.21–27.95) and ≥30 kg/m2(HR 35.52, 30.57–41.28). CONCLUSIONS South/Southeast Asian women have a markedly elevated risk of type 2 diabetes, further amplified by modestly higher BMI, highlighting the need for ethnicity-specific diabetes prevention strategies for women.
{"title":"The Association Between Race/Ethnicity and Risk of Type 2 Diabetes in Women Varies by BMI: A Pooled Analysis of Individual Data From 15 Cohort Studies","authors":"Kazue Nagai, Hsin-Fang Chung, Kunihiko Hayashi, Annette J. Dobson, Yuki Ideno, Sven Sandin, Yvonne T. van der Schouw, Rebecca Hardy, Debra J. Anderson, Panayotes Demakakos, Eric J. Brunner, Ellen S. Mitchell, Nancy F. Woods, Sophie V. Eastwood, Samar R. El Khoudary, Monique M. Hedderson, Elisabete Weiderpass, Gita D. Mishra","doi":"10.2337/dc25-1478","DOIUrl":"https://doi.org/10.2337/dc25-1478","url":null,"abstract":"OBJECTIVE To examine the association between race/ethnicity and type 2 diabetes risk in women and assess the interaction between race/ethnicity and BMI. RESEARCH DESIGN AND METHODS We analyzed individual-level data from 730,408 women across 15 cohort studies. Six racial/ethnic groups were identified: White, Chinese, Japanese, South/Southeast Asian, Black, and mixed/other. Cox proportional hazards models with study as a random effect were used to estimate hazard ratios (HRs) for type 2 diabetes associated with race/ethnicity. The joint association of race/ethnicity and BMI was assessed using BMI categories incorporating Asian-specific cutoffs (&lt;18.5, 18.5–22.9, 23.0–24.9, 25.0–27.4, 27.5–29.9, and ≥30 kg/m2), with White women having a BMI of 18.5–22.9 kg/m2as the reference. RESULTS Overall, 37,329 women (5.1%) were diagnosed with type 2 diabetes. By age 70, the cumulative incidence was highest among South/Southeast Asian (24.6%) and Black women (23.6%), with baseline obesity rates of 40.0% (BMI ≥27.5 kg/m2) and 45.6% (BMI ≥30 kg/m2), respectively. After adjusting for BMI, South/Southeast Asian women had the highest diabetes risk compared with White women (HR 4.13, 95% CI 3.78–4.51), while other racial/ethnic groups had about twice the risk. Joint effect analysis showed South/Southeast Asian women with a BMI ≥23 kg/m2had a substantially greater diabetes risk than other racial/ethnic groups with the same BMI, especially those with BMI 27.5–29.9 kg/m2(HR 23.17, 19.21–27.95) and ≥30 kg/m2(HR 35.52, 30.57–41.28). CONCLUSIONS South/Southeast Asian women have a markedly elevated risk of type 2 diabetes, further amplified by modestly higher BMI, highlighting the need for ethnicity-specific diabetes prevention strategies for women.","PeriodicalId":11140,"journal":{"name":"Diabetes Care","volume":"154 1","pages":""},"PeriodicalIF":16.2,"publicationDate":"2025-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145657320","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}
Irene Santos-Pardo, Mikael Andersson Franko, Robin Hofmann, Thomas Nyström
OBJECTIVE The association between diabetes and coronary stent failure is poorly established with second-generation drug-eluting stents (DES). We aimed to evaluate the risk of stent failure in patients with diabetes compared with those without diabetes after implantation of second-generation DES. RESEARCH DESIGN AND METHODS All patients in Sweden who received second-generation DES between 2010 and 2020 were included and categorized into three groups: type 1 diabetes, type 2 diabetes, and without diabetes (reference group). The primary end point was stent failure, defined as in-stent restenosis or stent thrombosis. Adjusted hazard ratios (HRs) with 95% CIs were estimated by Cox regression models. Sensitivity analyses were performed to address missing data in covariates and account for death as a competing risk. RESULTS The study included 160,523 patients: 2,406 with type 1 diabetes, 43,377 with type 2 diabetes, and 114,740 without diabetes. Seventy-one percent were male. Over a mean follow-up of 4.5 years, 5,510 stent failure events occurred. The fully adjusted HR for stent failure was 2.28 (95% CI 1.97–2.65) for patients with type 1 and 1.35 (95% CI 1.27–1.44) for patients with type 2 diabetes, compared with individuals without diabetes. Sensitivity analyses confirmed the robustness of the findings, with both in-stent restenosis and stent thrombosis contributing to the increased risk. CONCLUSIONS We observed a significantly higher risk of second-generation DES stent failure in individuals with type 1 diabetes followed by those with type 2 diabetes, compared with individuals without diabetes. This elevated risk was attributed to both in-stent restenosis and stent thrombosis.
目的：目前尚不清楚第二代药物洗脱支架（DES）与糖尿病之间的关系。我们的目的是评估糖尿病患者与非糖尿病患者在植入第二代DES后支架失效的风险。研究设计和方法纳入2010年至2020年间瑞典所有接受第二代DES的患者，并将其分为三组：1型糖尿病、2型糖尿病和无糖尿病（参照组）。主要终点是支架失效，定义为支架内再狭窄或支架血栓形成。采用Cox回归模型估计95% ci的校正风险比（hr）。进行敏感性分析以解决协变量中缺失的数据，并将死亡作为竞争风险考虑在内。结果：该研究纳入160523例患者：2406例1型糖尿病患者，43377例2型糖尿病患者，114740例无糖尿病患者。71%是男性。在平均4.5年的随访中，发生了5510例支架失效事件。与非糖尿病患者相比，1型糖尿病患者支架失效的完全校正HR为2.28 (95% CI 1.97-2.65)， 2型糖尿病患者为1.35 （95% CI 1.27-1.44）。敏感性分析证实了研究结果的稳健性，支架内再狭窄和支架内血栓形成都增加了风险。结论：我们观察到，与非糖尿病患者相比，1型糖尿病患者和2型糖尿病患者发生第二代DES支架失效的风险明显更高。这种升高的风险归因于支架内再狭窄和支架内血栓形成。
{"title":"Coronary Stent Failure in Patients With Diabetes: A Nationwide Observational Study From SWEDEHEART","authors":"Irene Santos-Pardo, Mikael Andersson Franko, Robin Hofmann, Thomas Nyström","doi":"10.2337/dc25-1624","DOIUrl":"https://doi.org/10.2337/dc25-1624","url":null,"abstract":"OBJECTIVE The association between diabetes and coronary stent failure is poorly established with second-generation drug-eluting stents (DES). We aimed to evaluate the risk of stent failure in patients with diabetes compared with those without diabetes after implantation of second-generation DES. RESEARCH DESIGN AND METHODS All patients in Sweden who received second-generation DES between 2010 and 2020 were included and categorized into three groups: type 1 diabetes, type 2 diabetes, and without diabetes (reference group). The primary end point was stent failure, defined as in-stent restenosis or stent thrombosis. Adjusted hazard ratios (HRs) with 95% CIs were estimated by Cox regression models. Sensitivity analyses were performed to address missing data in covariates and account for death as a competing risk. RESULTS The study included 160,523 patients: 2,406 with type 1 diabetes, 43,377 with type 2 diabetes, and 114,740 without diabetes. Seventy-one percent were male. Over a mean follow-up of 4.5 years, 5,510 stent failure events occurred. The fully adjusted HR for stent failure was 2.28 (95% CI 1.97–2.65) for patients with type 1 and 1.35 (95% CI 1.27–1.44) for patients with type 2 diabetes, compared with individuals without diabetes. Sensitivity analyses confirmed the robustness of the findings, with both in-stent restenosis and stent thrombosis contributing to the increased risk. CONCLUSIONS We observed a significantly higher risk of second-generation DES stent failure in individuals with type 1 diabetes followed by those with type 2 diabetes, compared with individuals without diabetes. This elevated risk was attributed to both in-stent restenosis and stent thrombosis.","PeriodicalId":11140,"journal":{"name":"Diabetes Care","volume":"12 1","pages":""},"PeriodicalIF":16.2,"publicationDate":"2025-11-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145609840","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}
The “dual problem” of U.S. population health is that population health is poor, while health care spending is high. These issues are interrelated, but only partly so. Poor population health does increase the need for health care services, which tends to increase spending. But the more important roots of poor population health lie in social policy rather than in health care—particularly an inadequate social insurance system that leads to many people being denied the income needed for health. Further, high spending is chiefly related to high prices, not high volumes, for health care services. This stems from a private, administratively wasteful, multipayer approach to health care finance in which no entity has sufficient monopsony power to hold down prices. This article discusses several ways to address these issues, with diabetes as an exemplary case. Two central themes are 1) the need for a better system of income supports to help ensure the conditions that promote health and 2) the need to reform our approach to health care finance, so as to address wasteful spending and help orient health care toward providing consistent care across the life course. Ultimately, what’s keeping the U.S. from better population health is us. But we could fix that.
{"title":"What’s Keeping the U.S. From Better Population Health?","authors":"Seth A. Berkowitz","doi":"10.2337/dci25-0003","DOIUrl":"https://doi.org/10.2337/dci25-0003","url":null,"abstract":"The “dual problem” of U.S. population health is that population health is poor, while health care spending is high. These issues are interrelated, but only partly so. Poor population health does increase the need for health care services, which tends to increase spending. But the more important roots of poor population health lie in social policy rather than in health care—particularly an inadequate social insurance system that leads to many people being denied the income needed for health. Further, high spending is chiefly related to high prices, not high volumes, for health care services. This stems from a private, administratively wasteful, multipayer approach to health care finance in which no entity has sufficient monopsony power to hold down prices. This article discusses several ways to address these issues, with diabetes as an exemplary case. Two central themes are 1) the need for a better system of income supports to help ensure the conditions that promote health and 2) the need to reform our approach to health care finance, so as to address wasteful spending and help orient health care toward providing consistent care across the life course. Ultimately, what’s keeping the U.S. from better population health is us. But we could fix that.","PeriodicalId":11140,"journal":{"name":"Diabetes Care","volume":"164 1","pages":""},"PeriodicalIF":16.2,"publicationDate":"2025-11-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145583113","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}
Jennifer R. Snaith, Ruth Frampton, Dorit Samocha-Bonet, Jerry R. Greenfield
OBJECTIVE Overweight and obesity are prevalent in type 1 diabetes and contribute to cardiovascular risk. Tirzepatide, a gastric inhibitory polypeptide and glucagon-like peptide 1 receptor coagonist, has not been studied in type 1 diabetes. RESEARCH DESIGN AND METHODS We conducted a 12-week, phase 2, double-blind, placebo-controlled trial in adults with type 1 diabetes and BMI >30 kg/m2. Participants were randomized to once-weekly subcutaneous tirzepatide (2.5 mg for 4 weeks, 5.0 mg for 8 weeks) or placebo. The primary end point was change in body weight at 12 weeks. RESULTS Twenty-two of 24 adults with type 1 diabetes completed the study. After 12 weeks, the mean change in weight was −10.3 kg (95% CI −12.8 to −7.7 kg) in the tirzepatide group and −0.7 kg (95% CI −1.4 to 2.8 kg) in the placebo group, with an estimated treatment difference of −8.7 kg (95% CI −12.0 to −5.5 kg; P < 0.0001), representing 8.8% weight loss. In the tirzepatide group, 100% and 45% of participants experienced weight loss of ≥5% and ≥10% respectively, compared with 9% and 0% in the placebo group. Tirzepatide improved HbA1c (mean difference −0.4% [95% CI −0.7 to 0.0%] vs. placebo; P = 0.05) and reduced total daily insulin dose (−24.2 units/day tirzepatide and −0.3 units/day placebo; difference from baseline vs. placebo −35.1% [95% CI −46.5 to −21.3%; P = 0.0002]). There were no significant adverse events in either group. CONCLUSIONS Among adults with type 1 diabetes and obesity, tirzepatide was superior to placebo for weight loss over 12 weeks.
目的超重和肥胖在1型糖尿病患者中普遍存在，并会增加心血管风险。替西肽是一种胃抑制多肽和胰高血糖素样肽1受体促凝剂，尚未在1型糖尿病中进行研究。研究设计和方法我们在1型糖尿病和BMI的成人患者中进行了一项为期12周的2期双盲安慰剂对照试验。30 kg / m2。参与者随机接受每周一次的替西帕肽（2.5 mg， 4周，5.0 mg， 8周）或安慰剂治疗。主要终点是12周时体重的变化。结果：24名成人1型糖尿病患者中有22人完成了研究。12周后，替西肽组的平均体重变化为- 10.3 kg (95% CI为- 12.8至- 7.7 kg)，安慰剂组的平均体重变化为- 0.7 kg (95% CI为- 1.4至2.8 kg)，估计治疗差异为- 8.7 kg (95% CI为- 12.0至- 5.5 kg; P < 0.0001)，体重减轻8.8%。在替西帕肽组中，100%和45%的参与者分别经历了≥5%和≥10%的体重减轻，而安慰剂组为9%和0%。替西帕肽改善了HbA1c（与安慰剂相比平均差值为- 0.4% [95% CI - 0.7至0.0%],P = 0.05），并降低了每日总胰岛素剂量（替西帕肽为- 24.2单位/天，安慰剂为- 0.3单位/天，与基线相比差值为- 35.1% [95% CI - 46.5至- 21.3%,P = 0.0002]）。两组均无明显不良事件发生。结论：在患有1型糖尿病和肥胖症的成年人中，替西帕肽在12周的减肥效果优于安慰剂。
{"title":"Tirzepatide in Adults With Type 1 Diabetes: A Phase 2 Randomized Placebo-Controlled Clinical Trial","authors":"Jennifer R. Snaith, Ruth Frampton, Dorit Samocha-Bonet, Jerry R. Greenfield","doi":"10.2337/dc25-2379","DOIUrl":"https://doi.org/10.2337/dc25-2379","url":null,"abstract":"OBJECTIVE Overweight and obesity are prevalent in type 1 diabetes and contribute to cardiovascular risk. Tirzepatide, a gastric inhibitory polypeptide and glucagon-like peptide 1 receptor coagonist, has not been studied in type 1 diabetes. RESEARCH DESIGN AND METHODS We conducted a 12-week, phase 2, double-blind, placebo-controlled trial in adults with type 1 diabetes and BMI &gt;30 kg/m2. Participants were randomized to once-weekly subcutaneous tirzepatide (2.5 mg for 4 weeks, 5.0 mg for 8 weeks) or placebo. The primary end point was change in body weight at 12 weeks. RESULTS Twenty-two of 24 adults with type 1 diabetes completed the study. After 12 weeks, the mean change in weight was −10.3 kg (95% CI −12.8 to −7.7 kg) in the tirzepatide group and −0.7 kg (95% CI −1.4 to 2.8 kg) in the placebo group, with an estimated treatment difference of −8.7 kg (95% CI −12.0 to −5.5 kg; P &lt; 0.0001), representing 8.8% weight loss. In the tirzepatide group, 100% and 45% of participants experienced weight loss of ≥5% and ≥10% respectively, compared with 9% and 0% in the placebo group. Tirzepatide improved HbA1c (mean difference −0.4% [95% CI −0.7 to 0.0%] vs. placebo; P = 0.05) and reduced total daily insulin dose (−24.2 units/day tirzepatide and −0.3 units/day placebo; difference from baseline vs. placebo −35.1% [95% CI −46.5 to −21.3%; P = 0.0002]). There were no significant adverse events in either group. CONCLUSIONS Among adults with type 1 diabetes and obesity, tirzepatide was superior to placebo for weight loss over 12 weeks.","PeriodicalId":11140,"journal":{"name":"Diabetes Care","volume":"1 1","pages":""},"PeriodicalIF":16.2,"publicationDate":"2025-11-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145559351","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}
Ashni Goshrani, Rose Lin, Leonid Churilov, Michele Gaca, Christine Somerville, Andrew Farmer, Kamlesh Khunti, Elizabeth Holmes-Truscott, Negar Naderpoor, David O’Neal, Rury R. Holman, Elif I. Ekinci
BACKGROUND Adaptive and master protocol clinical trials offer significant advantages for diabetes research, including enhanced efficiency and personalized treatment strategies. PURPOSE This scoping review aimed to systematically map the use of adaptive and master protocol designs in interventional trials for type 1 and type 2 diabetes, identify research gaps, and highlight opportunities for broader implementation. DATA SOURCES A systematic literature search was performed using MEDLINE, Embase, CENTRAL, Emcare, Global Health, Web of Science, and clinical trial registries. Gray literature searches complemented database findings. STUDY SELECTION Studies using adaptive, platform, basket, or umbrella trial designs in people with type 1 or type 2 diabetes were included. DATA EXTRACTION Data were charted using a standardized form. Extracted variables included diabetes type, trial design, adaptive features, interventions, end points, and key findings. DATA SYNTHESIS Of 396 articles screened, 6 published adaptive trials met the inclusion criteria: 3 in type 1 diabetes, 1 in type 2 diabetes, and 2 in diabetes-related neuropathy. Most used adaptive features for dose finding, response-adaptive randomization, and sample size reestimation. No published platform, basket, or umbrella trials were identified. Six ongoing adaptive trials in type 1 diabetes were identified through registry searches, four under an adaptive platform master protocol. LIMITATIONS Despite a comprehensive search, some gray literature and unpublished studies may have been missed. Risk of bias was not assessed, consistent with scoping review methodology. CONCLUSIONS Adaptive and master protocol trials remain rare in diabetes. Overcoming barriers through targeted training and awareness, robust regulatory frameworks, and strategic incentives could support broader adoption.
适应性临床试验和主方案临床试验为糖尿病研究提供了显著的优势，包括提高效率和个性化治疗策略。目的：本综述旨在系统地描绘1型和2型糖尿病介入试验中适应性和主方案设计的使用情况，确定研究空白，并强调更广泛实施的机会。使用MEDLINE、Embase、CENTRAL、Emcare、Global Health、Web of Science和临床试验登记处进行系统的文献检索。灰色文献检索补充了数据库的发现。研究选择纳入了在1型或2型糖尿病患者中采用适应性、平台、篮子或伞式试验设计的研究。数据提取采用标准化表格绘制图表。提取的变量包括糖尿病类型、试验设计、适应性特征、干预措施、终点和关键发现。在筛选的396篇文章中，6篇已发表的适应性试验符合纳入标准：3篇1型糖尿病，1篇2型糖尿病，2篇糖尿病相关神经病变。大多数使用自适应特征进行剂量发现、反应自适应随机化和样本量重估。未发现已发表的平台、篮子或伞式试验。通过注册表检索确定了6项正在进行的1型糖尿病适应性试验，其中4项在适应性平台主方案下进行。尽管进行了全面的搜索，一些灰色文献和未发表的研究可能被遗漏。未评估偏倚风险，与范围评价方法一致。结论：适应性试验和主方案试验在糖尿病中仍然很少见。通过有针对性的培训和意识、健全的监管框架和战略激励措施来克服障碍，可以支持更广泛的采用。
{"title":"The Role of Adaptive and Innovative Trial Designs in Diabetes Research: A Scoping Review","authors":"Ashni Goshrani, Rose Lin, Leonid Churilov, Michele Gaca, Christine Somerville, Andrew Farmer, Kamlesh Khunti, Elizabeth Holmes-Truscott, Negar Naderpoor, David O’Neal, Rury R. Holman, Elif I. Ekinci","doi":"10.2337/dc25-1508","DOIUrl":"https://doi.org/10.2337/dc25-1508","url":null,"abstract":"BACKGROUND Adaptive and master protocol clinical trials offer significant advantages for diabetes research, including enhanced efficiency and personalized treatment strategies. PURPOSE This scoping review aimed to systematically map the use of adaptive and master protocol designs in interventional trials for type 1 and type 2 diabetes, identify research gaps, and highlight opportunities for broader implementation. DATA SOURCES A systematic literature search was performed using MEDLINE, Embase, CENTRAL, Emcare, Global Health, Web of Science, and clinical trial registries. Gray literature searches complemented database findings. STUDY SELECTION Studies using adaptive, platform, basket, or umbrella trial designs in people with type 1 or type 2 diabetes were included. DATA EXTRACTION Data were charted using a standardized form. Extracted variables included diabetes type, trial design, adaptive features, interventions, end points, and key findings. DATA SYNTHESIS Of 396 articles screened, 6 published adaptive trials met the inclusion criteria: 3 in type 1 diabetes, 1 in type 2 diabetes, and 2 in diabetes-related neuropathy. Most used adaptive features for dose finding, response-adaptive randomization, and sample size reestimation. No published platform, basket, or umbrella trials were identified. Six ongoing adaptive trials in type 1 diabetes were identified through registry searches, four under an adaptive platform master protocol. LIMITATIONS Despite a comprehensive search, some gray literature and unpublished studies may have been missed. Risk of bias was not assessed, consistent with scoping review methodology. CONCLUSIONS Adaptive and master protocol trials remain rare in diabetes. Overcoming barriers through targeted training and awareness, robust regulatory frameworks, and strategic incentives could support broader adoption.","PeriodicalId":11140,"journal":{"name":"Diabetes Care","volume":"30 1","pages":""},"PeriodicalIF":16.2,"publicationDate":"2025-11-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145559353","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}
Anna R. Kahkoska, Joshua J. Neumiller, Anastasia-Stefania Alexopoulos, Amlan Barik, Elbert S. Huang, Lori M. Laffel, Naushira Pandya, Christine Slyne, Elena Toschi, Ruth S. Weinstock, Medha Munshi
As care for type 1 diabetes (T1D) advances, the number of adults with T1D living into older adulthood (ages ≥65 years) continues to grow. The population of older adults with T1D is highly heterogeneous, and over the life span, various factors may change over time while others may not, necessitating an individualized approach to management. A key care consideration for people with T1D is the ongoing need for exogenous insulin replacement intensive self-monitoring for effective management. At the same time, growing older may bring changes such as increased risk of misdiagnosis of T1D as type 2 diabetes, greater vulnerability to hypoglycemia, accumulating comorbidities and complications, declining independence due to geriatric syndromes, and a growing need for support in using diabetes technologies and navigating complex care transitions. Given the unique clinical and management needs of this population, we sought to present key care challenges in this population and suggest strategies to optimize quality of care in older adults with T1D, including 1) integrating geriatric screenings, age-friendly care frameworks, and regular reassessments into routine T1D management; 2) developing tailored care approaches for cognitive impairment; 3) establishing support systems for diabetes technology use in primary and long-term care settings; and 4) ensuring insurance coverage and access to diabetes technologies and therapies. Forward-thinking strategies to optimize care include individualized glycemic goal setting, the development and adoption of care models that support continuity of diabetes technology use, and individualized management strategies that consider of the goals and capabilities of the person living with T1D and care partners.
{"title":"Challenges and Opportunities for Improving Care for Type 1 Diabetes in Older Adulthood","authors":"Anna R. Kahkoska, Joshua J. Neumiller, Anastasia-Stefania Alexopoulos, Amlan Barik, Elbert S. Huang, Lori M. Laffel, Naushira Pandya, Christine Slyne, Elena Toschi, Ruth S. Weinstock, Medha Munshi","doi":"10.2337/dci25-0078","DOIUrl":"https://doi.org/10.2337/dci25-0078","url":null,"abstract":"As care for type 1 diabetes (T1D) advances, the number of adults with T1D living into older adulthood (ages ≥65 years) continues to grow. The population of older adults with T1D is highly heterogeneous, and over the life span, various factors may change over time while others may not, necessitating an individualized approach to management. A key care consideration for people with T1D is the ongoing need for exogenous insulin replacement intensive self-monitoring for effective management. At the same time, growing older may bring changes such as increased risk of misdiagnosis of T1D as type 2 diabetes, greater vulnerability to hypoglycemia, accumulating comorbidities and complications, declining independence due to geriatric syndromes, and a growing need for support in using diabetes technologies and navigating complex care transitions. Given the unique clinical and management needs of this population, we sought to present key care challenges in this population and suggest strategies to optimize quality of care in older adults with T1D, including 1) integrating geriatric screenings, age-friendly care frameworks, and regular reassessments into routine T1D management; 2) developing tailored care approaches for cognitive impairment; 3) establishing support systems for diabetes technology use in primary and long-term care settings; and 4) ensuring insurance coverage and access to diabetes technologies and therapies. Forward-thinking strategies to optimize care include individualized glycemic goal setting, the development and adoption of care models that support continuity of diabetes technology use, and individualized management strategies that consider of the goals and capabilities of the person living with T1D and care partners.","PeriodicalId":11140,"journal":{"name":"Diabetes Care","volume":"161 1","pages":""},"PeriodicalIF":16.2,"publicationDate":"2025-11-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145559352","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}
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