Jeanette M. Stafford, Byron Jaeger, Ramon Casanova, Yitbarek Demesie, Brian Wells, Michael P. Bancks
OBJECTIVE To calculate 3-year predicted risk for diabetes with a model including individualized preventive intervention effects for metformin therapy and intensive lifestyle among U.S. adults with prediabetes. RESEARCH DESIGN AND METHODS We included 2,778 participants with prediabetes from the National Health and Nutrition Examination Survey cycles 2015–2020. Using a validated type 2 diabetes risk prediction model, we calculated predicted risk and summarized the optimal prevention strategy (lowest predicted risk). RESULTS Mean predicted risk in this sample was 18.4% (95% CI 17.6, 19.3) for standard lifestyle recommendations (placebo), 14.4% (95% CI 13.9, 14.8) for metformin, 8.0% (95% CI 7.6, 8.4) for intensive lifestyle, and 7.6% (95% CI 7.2, 7.9) for participants’ respective optimal intervention. The optimal intervention strategy was intensive lifestyle for 91% of the analytic sample. CONCLUSIONS We demonstrate the potential population health benefits for diabetes prevention with use of a clinical decision tool, a diabetes risk prediction model with individualized preventive intervention effects.
目的：通过个体化预防干预二甲双胍治疗和强化生活方式的模型，计算美国成人前驱糖尿病患者的3年预测风险。研究设计和方法我们纳入了2015-2020年国家健康与营养检查调查周期的2778名前驱糖尿病患者。通过验证的2型糖尿病风险预测模型，我们计算预测风险并总结最佳预防策略（最低预测风险）。结果：该样本中标准生活方式推荐（安慰剂）的平均预测风险为18.4% (95% CI 17.6, 19.3)，二甲双胍的平均预测风险为14.4% (95% CI 13.9, 14.8)，强化生活方式的平均预测风险为8.0% (95% CI 7.6, 8.4)，参与者各自最佳干预的平均预测风险为7.6% （95% CI 7.2, 7.9）。91%的分析样本的最佳干预策略是强化生活方式。结论：我们通过使用具有个体化预防干预效果的糖尿病风险预测模型这一临床决策工具，证明了糖尿病预防的潜在人群健康益处。
{"title":"Estimated Optimal Individualized Diabetes Risk Prediction From Preventive Interventions in the U.S. General Population","authors":"Jeanette M. Stafford, Byron Jaeger, Ramon Casanova, Yitbarek Demesie, Brian Wells, Michael P. Bancks","doi":"10.2337/dc25-2268","DOIUrl":"https://doi.org/10.2337/dc25-2268","url":null,"abstract":"OBJECTIVE To calculate 3-year predicted risk for diabetes with a model including individualized preventive intervention effects for metformin therapy and intensive lifestyle among U.S. adults with prediabetes. RESEARCH DESIGN AND METHODS We included 2,778 participants with prediabetes from the National Health and Nutrition Examination Survey cycles 2015–2020. Using a validated type 2 diabetes risk prediction model, we calculated predicted risk and summarized the optimal prevention strategy (lowest predicted risk). RESULTS Mean predicted risk in this sample was 18.4% (95% CI 17.6, 19.3) for standard lifestyle recommendations (placebo), 14.4% (95% CI 13.9, 14.8) for metformin, 8.0% (95% CI 7.6, 8.4) for intensive lifestyle, and 7.6% (95% CI 7.2, 7.9) for participants’ respective optimal intervention. The optimal intervention strategy was intensive lifestyle for 91% of the analytic sample. CONCLUSIONS We demonstrate the potential population health benefits for diabetes prevention with use of a clinical decision tool, a diabetes risk prediction model with individualized preventive intervention effects.","PeriodicalId":11140,"journal":{"name":"Diabetes Care","volume":"41 1","pages":""},"PeriodicalIF":16.2,"publicationDate":"2026-02-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146101414","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}
Felix Teufel, Katherine Orgutsova, Irini Genitsaridi, Rodrigo M. Carrillo-Larco, Jithin Sam Varghese, Maja E. Marcus, Julian W. Sacre, Seyedeh Forough Sajjadi, Faraja Chiwanga, Jennifer Manne-Goehler, Jacqueline Seiglie, David Flood, Jessica Harding, Paraskevi Salpea, Agus Salim, Edward J. Boyko, Dianna J. Magliano, Mohammed K. Ali
OBJECTIVE Undiagnosed diabetes leads to delayed treatment and increased risk of complications, exacerbating global disease burdens. In this study, we estimated the prevalence and absolute numbers of individuals with undiagnosed diabetes globally and across regions and quantified gaps in national diabetes detection efforts. RESEARCH DESIGN AND METHODS We systematically compiled estimates of biomarker-based diabetes prevalence and self-reported diabetes diagnosis using 2003–2024 data from all eligible population-based studies and gray literature. We calculated proportions of individuals with undiagnosed diabetes and case numbers among adults aged 20–79 years. For countries without data, we extrapolated estimates using available data within the same geographic region and country income group. Country-level estimates were benchmarked against the World Health Organization 80% diagnosis target. RESULTS We identified 193 data sources on undiagnosed diabetes from 109 countries. Across all 215 countries/territories, 42.8% of individuals with diabetes were undiagnosed in 2024, equating to 251.7 million (95% uncertainty interval [UI] 250.4–253.0 million) adults. Proportions undiagnosed ranged from 16.2% in Colombia to 90.4% in Burkina Faso and 29.1% in North America and the Caribbean to 72.6% in Africa. A larger proportion of individuals were undiagnosed in low-income (58.7%) compared with high-income countries (28.9%). Middle-income countries accounted for 206.0 million (95% UI 202.3–209.7 million) adults with undiagnosed diabetes (81.8% of all individuals), including 127.1 million (95% UI 121.2–133.0 million [or 50.5%]) adults in China, India, and Indonesia alone. Less than 5% of all countries attained diabetes diagnosis levels ≥80%. CONCLUSIONS Substantial global variability in undiagnosed diabetes indicates opportunities to close existing care gaps, likely requiring context-specific solutions and investments.
{"title":"Global, Regional, and National Estimates of Undiagnosed Diabetes in Adults: Findings From the 2025 IDF Diabetes Atlas","authors":"Felix Teufel, Katherine Orgutsova, Irini Genitsaridi, Rodrigo M. Carrillo-Larco, Jithin Sam Varghese, Maja E. Marcus, Julian W. Sacre, Seyedeh Forough Sajjadi, Faraja Chiwanga, Jennifer Manne-Goehler, Jacqueline Seiglie, David Flood, Jessica Harding, Paraskevi Salpea, Agus Salim, Edward J. Boyko, Dianna J. Magliano, Mohammed K. Ali","doi":"10.2337/dc25-2583","DOIUrl":"https://doi.org/10.2337/dc25-2583","url":null,"abstract":"OBJECTIVE Undiagnosed diabetes leads to delayed treatment and increased risk of complications, exacerbating global disease burdens. In this study, we estimated the prevalence and absolute numbers of individuals with undiagnosed diabetes globally and across regions and quantified gaps in national diabetes detection efforts. RESEARCH DESIGN AND METHODS We systematically compiled estimates of biomarker-based diabetes prevalence and self-reported diabetes diagnosis using 2003–2024 data from all eligible population-based studies and gray literature. We calculated proportions of individuals with undiagnosed diabetes and case numbers among adults aged 20–79 years. For countries without data, we extrapolated estimates using available data within the same geographic region and country income group. Country-level estimates were benchmarked against the World Health Organization 80% diagnosis target. RESULTS We identified 193 data sources on undiagnosed diabetes from 109 countries. Across all 215 countries/territories, 42.8% of individuals with diabetes were undiagnosed in 2024, equating to 251.7 million (95% uncertainty interval [UI] 250.4–253.0 million) adults. Proportions undiagnosed ranged from 16.2% in Colombia to 90.4% in Burkina Faso and 29.1% in North America and the Caribbean to 72.6% in Africa. A larger proportion of individuals were undiagnosed in low-income (58.7%) compared with high-income countries (28.9%). Middle-income countries accounted for 206.0 million (95% UI 202.3–209.7 million) adults with undiagnosed diabetes (81.8% of all individuals), including 127.1 million (95% UI 121.2–133.0 million [or 50.5%]) adults in China, India, and Indonesia alone. Less than 5% of all countries attained diabetes diagnosis levels ≥80%. CONCLUSIONS Substantial global variability in undiagnosed diabetes indicates opportunities to close existing care gaps, likely requiring context-specific solutions and investments.","PeriodicalId":11140,"journal":{"name":"Diabetes Care","volume":"78 1","pages":""},"PeriodicalIF":16.2,"publicationDate":"2026-01-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146089882","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}
Hoi-Ying Li, Tsz-Kwan Chan, Kendrick Co Shih, Bernard M.Y. Cheung, Kai-Hang Yiu, Hung-Fat Tse, Yap-Hang Chan
BACKGROUND Data concerning glucagon-like peptide 1 receptor agonists (GLP-1 RAs) on risk of ischemic optic neuropathy (ION) are conflicting. PURPOSE We synthesize current evidence of GLP-1 RAs on risk of optic nerve or vision-threatening events from randomized controlled trials (RCTs) in patients with type 2 diabetes or cardiometabolic diseases. DATA SOURCE A total of 83,288 participants with type 2 diabetes/cardiometabolic diseases from 20 published RCTs were analyzed following Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA). STUDY SELECTION RCTs investigating GLP-1 RAs for type 2 diabetes/cardiometabolic disease populations and reported optic nerve or vision-related adverse events were assessed. DATA EXTRACTION Primary outcome was a composite of optic nerve and/or vision-threatening serious adverse events, including ION, ocular ischemic syndrome, papilledema, blindness, blurred vision, visual impairment, and reduced visual acuity. Odds ratios (ORs) were derived. DATA SYNTHESIS Type 2 diabetes occurred in 76.4% of participants. Over mean follow-up duration of 2.97 years (estimated cumulative exposure of 240,334 patient-years), GLP-1 RA use was not associated with increased risk of primary end point (OR 1.20, 95% CI 0.73–1.97, I2 = 0%). Prespecified individual adverse events, including ION (OR 1.50, 95% CI 0.49–4.63), and vision loss/disturbance events (OR 1.08, 95% CI 0.60–1.94) were not significantly associated with GLP-1 RA use. LIMITATIONS RCTs reported vision-threatening events as adverse events rather than as prespecified outcomes. CONCLUSIONS Based on a large number of patients who contributed to a meta-analysis of RCTs involving participants with type 2 diabetes and cardiometabolic disease, GLP-1 RAs were not associated with an increased risk of optic nerve/vision-threatening events.
背景：关于胰高血糖素样肽1受体激动剂（GLP-1 RAs）对缺血性视神经病变（ION）风险的影响的数据是相互矛盾的。目的：我们综合目前来自2型糖尿病或心脏代谢疾病患者的随机对照试验（rct）中GLP-1 RAs与视神经或视力威胁事件风险相关的证据。根据首选报告项目进行系统评价和荟萃分析（PRISMA），对来自20项已发表的随机对照试验的83288名2型糖尿病/心脏代谢疾病患者进行了分析。研究选择：研究GLP-1 RAs对2型糖尿病/心脏代谢疾病人群和视神经或视力相关不良事件报告的随机对照试验进行评估。主要结局是视神经和/或威胁视力的严重不良事件的复合，包括离子、眼缺血综合征、乳头水肿、失明、视力模糊、视力障碍和视力下降。获得优势比（ORs）。2型糖尿病发生率为76.4%。平均随访时间为2.97年（估计累计暴露240,334例患者年），GLP-1 RA使用与主要终点风险增加无关（OR 1.20, 95% CI 0.73-1.97, I2 = 0%）。预先指定的个人不良事件，包括ION （OR 1.50, 95% CI 0.49-4.63）和视力丧失/障碍事件（OR 1.08, 95% CI 0.60-1.94）与GLP-1 RA的使用无显著相关。局限性随机对照试验将视力威胁事件报告为不良事件，而不是预先指定的结果。结论：基于一项涉及2型糖尿病和心脏代谢疾病的随机对照试验的荟萃分析，GLP-1 RAs与视神经/视力威胁事件的风险增加无关。
{"title":"GLP-1 Receptor Agonists and Risk of Optic Nerve or Vision-Threatening Events in Patients With Type 2 Diabetes or Cardiometabolic Diseases: A Meta-analysis of Randomized Controlled Trials","authors":"Hoi-Ying Li, Tsz-Kwan Chan, Kendrick Co Shih, Bernard M.Y. Cheung, Kai-Hang Yiu, Hung-Fat Tse, Yap-Hang Chan","doi":"10.2337/dc25-1929","DOIUrl":"https://doi.org/10.2337/dc25-1929","url":null,"abstract":"BACKGROUND Data concerning glucagon-like peptide 1 receptor agonists (GLP-1 RAs) on risk of ischemic optic neuropathy (ION) are conflicting. PURPOSE We synthesize current evidence of GLP-1 RAs on risk of optic nerve or vision-threatening events from randomized controlled trials (RCTs) in patients with type 2 diabetes or cardiometabolic diseases. DATA SOURCE A total of 83,288 participants with type 2 diabetes/cardiometabolic diseases from 20 published RCTs were analyzed following Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA). STUDY SELECTION RCTs investigating GLP-1 RAs for type 2 diabetes/cardiometabolic disease populations and reported optic nerve or vision-related adverse events were assessed. DATA EXTRACTION Primary outcome was a composite of optic nerve and/or vision-threatening serious adverse events, including ION, ocular ischemic syndrome, papilledema, blindness, blurred vision, visual impairment, and reduced visual acuity. Odds ratios (ORs) were derived. DATA SYNTHESIS Type 2 diabetes occurred in 76.4% of participants. Over mean follow-up duration of 2.97 years (estimated cumulative exposure of 240,334 patient-years), GLP-1 RA use was not associated with increased risk of primary end point (OR 1.20, 95% CI 0.73–1.97, I2 = 0%). Prespecified individual adverse events, including ION (OR 1.50, 95% CI 0.49–4.63), and vision loss/disturbance events (OR 1.08, 95% CI 0.60–1.94) were not significantly associated with GLP-1 RA use. LIMITATIONS RCTs reported vision-threatening events as adverse events rather than as prespecified outcomes. CONCLUSIONS Based on a large number of patients who contributed to a meta-analysis of RCTs involving participants with type 2 diabetes and cardiometabolic disease, GLP-1 RAs were not associated with an increased risk of optic nerve/vision-threatening events.","PeriodicalId":11140,"journal":{"name":"Diabetes Care","volume":"217 1","pages":""},"PeriodicalIF":16.2,"publicationDate":"2026-01-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146047916","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}
This article explores four little-known stories about research into, and treatment for, diabetes. Progressing in order from the participant about whose story we know the most to those about whom we know the least demonstrates that clinical research and therapeutic development are collaborative enterprises and that often key innovations and discoveries happen outside the laboratory setting. The role of unlikely individuals and collectives in reforming diabetes care is revealed, to nudge researchers into new and fruitful pathways. Further, this article shows how with a historical approach we can find the right stories of discovery to help both patients and researchers gain new insights into the prevention, management, and treatment of diabetes in all its forms.
{"title":"New Perspectives: Four Unsung Heroes of Diabetes Research","authors":"Vanessa Heggie","doi":"10.2337/dci25-0055","DOIUrl":"https://doi.org/10.2337/dci25-0055","url":null,"abstract":"This article explores four little-known stories about research into, and treatment for, diabetes. Progressing in order from the participant about whose story we know the most to those about whom we know the least demonstrates that clinical research and therapeutic development are collaborative enterprises and that often key innovations and discoveries happen outside the laboratory setting. The role of unlikely individuals and collectives in reforming diabetes care is revealed, to nudge researchers into new and fruitful pathways. Further, this article shows how with a historical approach we can find the right stories of discovery to help both patients and researchers gain new insights into the prevention, management, and treatment of diabetes in all its forms.","PeriodicalId":11140,"journal":{"name":"Diabetes Care","volume":"96 1","pages":"216-222"},"PeriodicalIF":16.2,"publicationDate":"2026-01-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146005903","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}
OBJECTIVE To evaluate whether baseline continuous glucose monitoring (CGM)–derived time below range (TBR) metrics—TBR level 1 (TBR1) (<70 mg/dL) and TBR level 2 (TBR2) (<54 mg/dL)—predicts severe hypoglycemia (SH) during follow-up of individuals with type 1 diabetes. RESEARCH DESIGN AND METHODS Baseline CGM TBR levels and their association with SH adverse events during six clinical trials were analyzed using Wilcoxon rank-sum tests and Spearman correlations. Analyses were stratified by sex, race, and age group. Sensitivity, specificity, and false-positive rates (FPRs) were calculated for thresholds (1–5%), and receiver operating characteristic (ROC) analysis assessed discrimination. RESULTS Participants (n = 1,433; median age 4–43 years; 50–62% female sex; 83–96% White race) had a baseline median TBR2 range of 0.1% to 0.7% and TBR1 from 1.2% to 4.1% across the six clinical trials. Those who developed SH had slightly higher baseline TBR2 (0.41% vs. 0.32%; P = 0.022) and TBR1 (2.58% vs. 2.23%; P = 0.044). Predictive accuracy was limited: sensitivity of TBR2 fell from 48.9% at a 1% cutoff to 18.2% at 5% (specificity 75.9–95.0%), and TBR1 sensitivity declined from 81.8% to 44.3% (specificity 29.6–77.7%), with modest discrimination by ROC analysis (area under the curve = 0.62 [95% CI 0.55–0.69] for TBR2; and 0.65 [95% CI: 0.58–0.71] for TBR1). CONCLUSIONS Baseline TBR1 and TBR2 had limited predictive value for SH. No threshold achieved strong discrimination, a finding that supports the need to integrate additional clinical factors for SH risk stratification.
目的评价基线连续血糖监测（CGM）衍生的低于范围时间（TBR）指标- TBR水平1 (TBR1) （70 mg/dL）和TBR水平2 (TBR2) (54 mg/dL) -是否能预测1型糖尿病患者随访期间的严重低血糖（SH）。研究设计和方法采用Wilcoxon秩和检验和Spearman相关性分析6项临床试验中基线CGM TBR水平及其与SH不良事件的关系。分析按性别、种族和年龄组分层。计算阈值（1-5%）的敏感性、特异性和假阳性率（fpr），并通过受试者工作特征（ROC）分析评估鉴别。结果：在6项临床试验中，参与者（n = 1433，中位年龄4-43岁，50-62%女性，83-96%白人）的TBR2基线中位范围为0.1% - 0.7%，TBR1基线中位范围为1.2% - 4.1%。SH患者的TBR2 （0.41% vs. 0.32%, P = 0.022）和TBR1 （2.58% vs. 2.23%, P = 0.044）基线略高。预测准确性有限：TBR2的敏感性从1%截止时的48.9%下降到5%截止时的18.2%（特异性75.9-95.0%），TBR1的敏感性从81.8%下降到44.3%（特异性29.6-77.7%），ROC分析具有适度的区别（TBR2的曲线下面积= 0.62 [95% CI 0.55-0.69]， TBR1的曲线下面积= 0.65 [95% CI: 0.58-0.71]）。结论：基线TBR1和TBR2对SH的预测价值有限。没有一个阈值能够实现强烈的区分，这一发现支持了整合其他临床因素进行SH风险分层的必要性。
{"title":"Assessing Time Below Range as a Predictor of Severe Hypoglycemia: Insights From Six Clinical Trials","authors":"Eslam Montaser, Clarence Williams, Viral N. Shah","doi":"10.2337/dc25-2353","DOIUrl":"https://doi.org/10.2337/dc25-2353","url":null,"abstract":"OBJECTIVE To evaluate whether baseline continuous glucose monitoring (CGM)–derived time below range (TBR) metrics—TBR level 1 (TBR1) (&lt;70 mg/dL) and TBR level 2 (TBR2) (&lt;54 mg/dL)—predicts severe hypoglycemia (SH) during follow-up of individuals with type 1 diabetes. RESEARCH DESIGN AND METHODS Baseline CGM TBR levels and their association with SH adverse events during six clinical trials were analyzed using Wilcoxon rank-sum tests and Spearman correlations. Analyses were stratified by sex, race, and age group. Sensitivity, specificity, and false-positive rates (FPRs) were calculated for thresholds (1–5%), and receiver operating characteristic (ROC) analysis assessed discrimination. RESULTS Participants (n = 1,433; median age 4–43 years; 50–62% female sex; 83–96% White race) had a baseline median TBR2 range of 0.1% to 0.7% and TBR1 from 1.2% to 4.1% across the six clinical trials. Those who developed SH had slightly higher baseline TBR2 (0.41% vs. 0.32%; P = 0.022) and TBR1 (2.58% vs. 2.23%; P = 0.044). Predictive accuracy was limited: sensitivity of TBR2 fell from 48.9% at a 1% cutoff to 18.2% at 5% (specificity 75.9–95.0%), and TBR1 sensitivity declined from 81.8% to 44.3% (specificity 29.6–77.7%), with modest discrimination by ROC analysis (area under the curve = 0.62 [95% CI 0.55–0.69] for TBR2; and 0.65 [95% CI: 0.58–0.71] for TBR1). CONCLUSIONS Baseline TBR1 and TBR2 had limited predictive value for SH. No threshold achieved strong discrimination, a finding that supports the need to integrate additional clinical factors for SH risk stratification.","PeriodicalId":11140,"journal":{"name":"Diabetes Care","volume":"32 1","pages":""},"PeriodicalIF":16.2,"publicationDate":"2026-01-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145961654","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}
Kagan E. Karakus, Halis K. Akturk, Davida Kruger, Andrew Ahmann, Anuj Bharvaga, Christine R. Langel, Courtney A. Ackeifi, Jonathan Rosen, Laura Pyle, Janet K. Snell-Bergeon, Viral N. Shah
OBJECTIVE In this post hoc analysis, we used the data from the Adjunct Semaglutide Treatment in Type 1 Diabetes (ADJUST-T1D) trial, a double-blind, multicenter, randomized, placebo-controlled trial of semaglutide 1 mg/week in adults with type 1 diabetes [[T1D]and obesity), to evaluate the relationship between insulin dose reduction and weight loss. RESEARCH DESIGN AND METHODS Changes between semaglutide and placebo groups over 26 weeks in total daily insulin dose (TDD), basal and bolus insulin doses, carbohydrate intake, and user-initiated bolus counts were analyzed using linear mixed models. Mediation analysis was used to attribute direct effects of semaglutide versus weight loss on insulin dose reduction. RESULTS From baseline to week 26, there was a significant 22.6% reduction in TDD (95% CI −28.3 to −17.0), which was driven by greater reductions in bolus insulin (−30.5%; 95% CI −39.5 to −21.5) than basal insulin (−15.6%; 95% CI −21.5 to −9.7). The basal/TDD ratio increased from 0.56 to 0.62 (P < 0.001) and insulin dose (in units/kg/day) decreased from 0.72 to 0.60 (P < 0.001) in the semaglutide group. At week 4, an 83% (−11.1 U/day) reduction in TDD was due to a direct drug effect, and 17% (−2.3 U/day) was attributed to weight loss, whereas at week 26, the difference was split evenly between direct effect (−11.4 U/day; 52%) and weight loss (−10.5 U/day; 48%). Daily carbohydrate intake decreased from 137 g (95% CI 107–167) at baseline to 107 g (95% CI 76–137) at 26 weeks. CONCLUSIONS Semaglutide produced rapid, sustained, and primarily bolus-driven insulin dose reductions, with early effects being largely independent of weight loss in adults with T1D and obesity.
{"title":"Effect of Semaglutide on Insulin Dose Reduction in Adults With Type 1 Diabetes and Obesity Using Automated Insulin Delivery Systems: ADJUST-T1D Post Hoc Analysis","authors":"Kagan E. Karakus, Halis K. Akturk, Davida Kruger, Andrew Ahmann, Anuj Bharvaga, Christine R. Langel, Courtney A. Ackeifi, Jonathan Rosen, Laura Pyle, Janet K. Snell-Bergeon, Viral N. Shah","doi":"10.2337/dc25-2249","DOIUrl":"https://doi.org/10.2337/dc25-2249","url":null,"abstract":"OBJECTIVE In this post hoc analysis, we used the data from the Adjunct Semaglutide Treatment in Type 1 Diabetes (ADJUST-T1D) trial, a double-blind, multicenter, randomized, placebo-controlled trial of semaglutide 1 mg/week in adults with type 1 diabetes [[T1D]and obesity), to evaluate the relationship between insulin dose reduction and weight loss. RESEARCH DESIGN AND METHODS Changes between semaglutide and placebo groups over 26 weeks in total daily insulin dose (TDD), basal and bolus insulin doses, carbohydrate intake, and user-initiated bolus counts were analyzed using linear mixed models. Mediation analysis was used to attribute direct effects of semaglutide versus weight loss on insulin dose reduction. RESULTS From baseline to week 26, there was a significant 22.6% reduction in TDD (95% CI −28.3 to −17.0), which was driven by greater reductions in bolus insulin (−30.5%; 95% CI −39.5 to −21.5) than basal insulin (−15.6%; 95% CI −21.5 to −9.7). The basal/TDD ratio increased from 0.56 to 0.62 (P &lt; 0.001) and insulin dose (in units/kg/day) decreased from 0.72 to 0.60 (P &lt; 0.001) in the semaglutide group. At week 4, an 83% (−11.1 U/day) reduction in TDD was due to a direct drug effect, and 17% (−2.3 U/day) was attributed to weight loss, whereas at week 26, the difference was split evenly between direct effect (−11.4 U/day; 52%) and weight loss (−10.5 U/day; 48%). Daily carbohydrate intake decreased from 137 g (95% CI 107–167) at baseline to 107 g (95% CI 76–137) at 26 weeks. CONCLUSIONS Semaglutide produced rapid, sustained, and primarily bolus-driven insulin dose reductions, with early effects being largely independent of weight loss in adults with T1D and obesity.","PeriodicalId":11140,"journal":{"name":"Diabetes Care","volume":"3 1","pages":""},"PeriodicalIF":16.2,"publicationDate":"2025-12-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145807423","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}
Renata Belfort-DeAguiar, Catherine W. Yeckel, Ahmed Elshafie, Ana Paula Comarella, Janice J. Hwang
OBJECTIVE To investigate the relationship between free-living glucose metrics obtained with continuous glucose monitoring (CGM) and validated indices of insulin resistance and insulin secretion in individuals with obesity: OB(+T2D) or OB(−T2D) for with and without type 2 diabetes, respectively. RESEARCH DESIGN AND METHODS Thirty-seven individuals (17 OB(+T2D) and 20 OB(−T2D) wore a CGM device and had a 2-h oral glucose tolerance test (OGTT). Of these, 27 also underwent a two-step hyperglycemic-euglycemic clamp. CGM metrics calculated with EasyGV software were correlated with indices of insulin secretion and insulin resistance from OGTT and clamp. RESULTS CGM metrics, such as mean and glycemic variability indices, were higher in OB(+T2D) than in OB(−T2D) (P < 0.001). CGM mean inversely correlated with insulin resistance indices (insulin sensitivity index from OGTT and glucose infusion rate [GIR] from the clamp) when analyzing all participants together (GIR: r = −0.82, P < 0.001) or separately (P < 0.01). CGM mean negatively correlated with insulin secretion indices only when the two groups were analyzed together (P < 0.05). When analyzing each group separately, CGM mean positively correlated with insulin levels during the OGTT and hyperglycemic step of the clamp in the OB(−T2D), but not the OB(+T2) group. CONCLUSIONS Our findings suggest that CGM metrics, in particular, the simplest metric, CGM mean, was associated with the degree of insulin resistance. Further research is needed to determine whether CGM mean could be a tool to identify normal glucose-tolerant individuals with obesity potentially at risk for progressing to prediabetes and diabetes, and whether its convergence with increased glycemic variability can further contribute to risk prediction of glycemic disorders.
目的探讨通过连续血糖监测（CGM）获得的游离血糖指标与肥胖患者胰岛素抵抗和胰岛素分泌的有效指标之间的关系：患有和不患有2型糖尿病的OB（+T2D）或OB（- T2D）。研究设计和方法37例患者（17例OB（+T2D）和20例OB(- T2D)）佩戴CGM装置并进行2小时口服葡萄糖耐量试验（OGTT）。其中，27人也接受了两步高血糖-血糖钳夹。使用EasyGV软件计算的CGM指标与OGTT和clamp的胰岛素分泌和胰岛素抵抗指标相关。结果：糖尿病患者（+T2D）的CGM指标（如平均指数和血糖变异性指数）高于糖尿病患者（- T2D） （P < 0.001）。在对所有参与者进行综合分析（GIR: r = - 0.82, P < 0.001）或单独分析（P < 0.01）时，CGM均值与胰岛素抵抗指数（OGTT的胰岛素敏感性指数和钳形糖输注率[GIR]）呈负相关。CGM均值仅在两组合并分析时与胰岛素分泌指标呈负相关（P < 0.05）。当分别分析各组时，CGM平均值与OGTT和OB（- T2D）组的高血糖阶段胰岛素水平呈正相关，但OB（+T2）组没有。结论：我们的研究结果表明，CGM指标，特别是最简单的指标，CGM均值，与胰岛素抵抗程度相关。需要进一步的研究来确定CGM平均值是否可以作为一种工具来识别正常的葡萄糖耐受性肥胖个体是否有发展为糖尿病前期和糖尿病的潜在风险，以及它与血糖变异性增加的趋同是否可以进一步有助于血糖疾病的风险预测。
{"title":"Association of Insulin Resistance and Insulin Secretion Indices and Glucose Metrics From Continuous Glucose Monitoring in People With Obesity","authors":"Renata Belfort-DeAguiar, Catherine W. Yeckel, Ahmed Elshafie, Ana Paula Comarella, Janice J. Hwang","doi":"10.2337/dc25-1395","DOIUrl":"https://doi.org/10.2337/dc25-1395","url":null,"abstract":"OBJECTIVE To investigate the relationship between free-living glucose metrics obtained with continuous glucose monitoring (CGM) and validated indices of insulin resistance and insulin secretion in individuals with obesity: OB(+T2D) or OB(−T2D) for with and without type 2 diabetes, respectively. RESEARCH DESIGN AND METHODS Thirty-seven individuals (17 OB(+T2D) and 20 OB(−T2D) wore a CGM device and had a 2-h oral glucose tolerance test (OGTT). Of these, 27 also underwent a two-step hyperglycemic-euglycemic clamp. CGM metrics calculated with EasyGV software were correlated with indices of insulin secretion and insulin resistance from OGTT and clamp. RESULTS CGM metrics, such as mean and glycemic variability indices, were higher in OB(+T2D) than in OB(−T2D) (P &lt; 0.001). CGM mean inversely correlated with insulin resistance indices (insulin sensitivity index from OGTT and glucose infusion rate [GIR] from the clamp) when analyzing all participants together (GIR: r = −0.82, P &lt; 0.001) or separately (P &lt; 0.01). CGM mean negatively correlated with insulin secretion indices only when the two groups were analyzed together (P &lt; 0.05). When analyzing each group separately, CGM mean positively correlated with insulin levels during the OGTT and hyperglycemic step of the clamp in the OB(−T2D), but not the OB(+T2) group. CONCLUSIONS Our findings suggest that CGM metrics, in particular, the simplest metric, CGM mean, was associated with the degree of insulin resistance. Further research is needed to determine whether CGM mean could be a tool to identify normal glucose-tolerant individuals with obesity potentially at risk for progressing to prediabetes and diabetes, and whether its convergence with increased glycemic variability can further contribute to risk prediction of glycemic disorders.","PeriodicalId":11140,"journal":{"name":"Diabetes Care","volume":"29 1","pages":""},"PeriodicalIF":16.2,"publicationDate":"2025-12-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145785836","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}
Andreas Weiss, Lenche Chakievska, Peter Achenbach, Maja Hergl, Sandra Hummel, Raffael Ott, Marlon Scholz, Christiane Winkler, Ezio Bonifacio, Anette-Gabriele Ziegler
OBJECTIVE To stratify the progression rate to clinical stage 3 type 1 diabetes in children with early-stage disease. RESEARCH DESIGN AND METHODS The Fr1da study tested 211,464 children aged 1.75–10 years for islet autoantibodies. Children with early-stage type 1 diabetes were classified as stage 1 or stage 2 by oral glucose tolerance test (OGTT) and hemoglobin A1c (HbA1c) using current American Diabetes Association criteria and were followed 3–6 months. We applied our previously developed progression likelihood score (PLS), a composite of HbA1c, 90-min OGTT glucose, and islet antigen 2 antibodies (IA-2A) titer, and developed a non–OGTT-based score using multivariable Cox proportional hazards models to stratify progression rates to stage 3. RESULTS Of 485 children who participated in staging, 360 (74.2%) were diagnosed with stage 1. Of these, stage 3 developed in 105 (median follow-up 3.3 years). PLS stratified the 2-year risk for stage 3 from 43.7% (95% CI 24.3–58.1) in children with high PLS to 4.7% (1.7–7.7) and 0% in those with intermediate or low PLS. Adding the variable obesity improved the existing model. In children with stage 2 with a single dysglycemic abnormality, PLS could stratify 2-year risk for stage 3 from 42.4% (95% CI 22.8–57.0) to 5.6% (0.0–15.6). A non–OGTT-based score based on IA-2A titer categories, HbA1c, obesity, and autoantibody positivity for IA-2 juxtamembrane epitopes could identify individuals with low (1.7%) and moderate (24.6%) 2-year risk. CONCLUSIONS The PLS and a novel non–OGTT-based score can stratify the short- to medium-term progression rates to stage 3 and should be considered for guiding monitoring practices and clinical trial eligibility.
目的对早期1型糖尿病患儿临床3期进展率进行分层。研究设计和方法Fr1da研究检测了211,464名年龄在1.75-10岁的儿童的胰岛自身抗体。通过口服葡萄糖耐量试验（OGTT）和血红蛋白A1c (HbA1c)，按照美国糖尿病协会现行标准将早期1型糖尿病儿童分为1期或2期，随访3-6个月。我们应用了先前开发的进展可能性评分（PLS），这是一种HbA1c、90分钟OGTT血糖和胰岛抗原2抗体（IA-2A）滴度的组合，并使用多变量Cox比例风险模型开发了一种非OGTT评分，将进展率分层到3期。结果485名参与分期的儿童中，360名（74.2%）被诊断为1期。其中，105人发展为3期（中位随访3.3年）。PLS将高PLS患儿的2年3期风险从43.7% （95% CI 24.3-58.1）分层为4.7%(1.7-7.7)，中低PLS患儿为0%。添加肥胖变量改进了现有模型。在伴有单一血糖异常的2期儿童中，PLS可以将3期的2年风险从42.4% （95% CI 22.8-57.0）分层到5.6%（0.0-15.6）。基于IA-2A滴度分类、HbA1c、肥胖和IA-2近膜表位自身抗体阳性的非ogtt评分可以识别低（1.7%）和中等（24.6%）2年风险的个体。结论：PLS和一种新颖的非ogtt评分可以将中短期进展率分层到3期，应考虑用于指导监测实践和临床试验资格。
{"title":"Stratifying the Rate of Disease Progression by Progression Likelihood Scores in Children and Adolescents With Stage 1 and Stage 2 Type 1 Diabetes in Germany","authors":"Andreas Weiss, Lenche Chakievska, Peter Achenbach, Maja Hergl, Sandra Hummel, Raffael Ott, Marlon Scholz, Christiane Winkler, Ezio Bonifacio, Anette-Gabriele Ziegler","doi":"10.2337/dc25-2184","DOIUrl":"https://doi.org/10.2337/dc25-2184","url":null,"abstract":"OBJECTIVE To stratify the progression rate to clinical stage 3 type 1 diabetes in children with early-stage disease. RESEARCH DESIGN AND METHODS The Fr1da study tested 211,464 children aged 1.75–10 years for islet autoantibodies. Children with early-stage type 1 diabetes were classified as stage 1 or stage 2 by oral glucose tolerance test (OGTT) and hemoglobin A1c (HbA1c) using current American Diabetes Association criteria and were followed 3–6 months. We applied our previously developed progression likelihood score (PLS), a composite of HbA1c, 90-min OGTT glucose, and islet antigen 2 antibodies (IA-2A) titer, and developed a non–OGTT-based score using multivariable Cox proportional hazards models to stratify progression rates to stage 3. RESULTS Of 485 children who participated in staging, 360 (74.2%) were diagnosed with stage 1. Of these, stage 3 developed in 105 (median follow-up 3.3 years). PLS stratified the 2-year risk for stage 3 from 43.7% (95% CI 24.3–58.1) in children with high PLS to 4.7% (1.7–7.7) and 0% in those with intermediate or low PLS. Adding the variable obesity improved the existing model. In children with stage 2 with a single dysglycemic abnormality, PLS could stratify 2-year risk for stage 3 from 42.4% (95% CI 22.8–57.0) to 5.6% (0.0–15.6). A non–OGTT-based score based on IA-2A titer categories, HbA1c, obesity, and autoantibody positivity for IA-2 juxtamembrane epitopes could identify individuals with low (1.7%) and moderate (24.6%) 2-year risk. CONCLUSIONS The PLS and a novel non–OGTT-based score can stratify the short- to medium-term progression rates to stage 3 and should be considered for guiding monitoring practices and clinical trial eligibility.","PeriodicalId":11140,"journal":{"name":"Diabetes Care","volume":"9 1","pages":""},"PeriodicalIF":16.2,"publicationDate":"2025-12-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145765334","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}
Bin Wang, Ningjian Wang, Xin Yin, Yuhui Huang, Guoqi Yu, Jiaxi Yang, Yap Seng Chong, Yingli Lu, Michelle A. Williams, Frank B. Hu, Cuilin Zhang
OBJECTIVE To evaluate the association between gestational diabetes mellitus (GDM) and accelerated biological aging in middle-aged and elderly women. RESEARCH DESIGN AND METHODS We included parous women with a baseline survey on history of GDM and biological aging biomarkers from the UK Biobank. Information regarding prior GDM was collected via a touchscreen questionnaire and linkage to hospital admission records. Biological aging was evaluated using validated phenotypic age (PhenoAge) based on chronological age and nine biomarkers measured at baseline (2006–2010). Biological aging acceleration was determined as the residual by regressing PhenoAge estimates on chronological age. All-cause mortality and incident cardiometabolic disease during follow-up were also assessed. RESULTS Among the 178,363 women (mean age, 57.0 [SD 7.9] years), 1,141 had a history of GDM. In a multivariable-adjusted model, a history of GDM was associated with an increase in PhenoAge acceleration by 2.34 (95% CI 2.02, 2.66) years. The association persisted regardless of the occurrence of type 2 diabetes and related comorbidities after GDM. Consistent results were observed across subgroups, while the GDM-related PhenoAge acceleration was more prominent among women with less physical activity and obesity (both Pinteraction < 0.01). The mediation analysis demonstrated that PhenoAge acceleration explained 57.0% (95% CI 21.0, 86.9), 12.4% (7.3, 20.4), and 21.9% (14.0, 32.5) of the positive associations between GDM and all-cause mortality, type 2 diabetes, and cardiovascular disease, respectively. CONCLUSIONS Women with a history of GDM were biologically older than their non-GDM counterparts. The biological aging acceleration partially accounted for the associations between GDM and adverse health outcomes.
目的探讨中老年妇女妊娠期糖尿病（GDM）与生物加速衰老的关系。研究设计和方法我们纳入了来自UK Biobank的关于GDM病史和生物老化生物标志物的基线调查的产妇。通过触屏问卷和与医院住院记录的联系收集有关既往GDM的信息。生物老化的评估使用基于实足年龄和基线（2006-2010年）测量的9个生物标志物的有效表型年龄（PhenoAge）。通过对实际年龄的PhenoAge估计进行回归，确定生物老化加速为残差。随访期间的全因死亡率和心血管代谢疾病发生率也进行了评估。结果在178363名女性（平均年龄57.0 [SD 7.9]岁）中，1141名有GDM病史。在多变量调整模型中，GDM病史与表型加速增加相关2.34年（95% CI 2.02, 2.66）。无论GDM后是否发生2型糖尿病和相关合并症，这种关联都持续存在。在亚组中观察到一致的结果，而gdm相关的表型加速在体力活动较少和肥胖的女性中更为突出（p - interaction < 0.01）。中介分析表明，表型加速分别解释了57.0% (95% CI 21.0, 86.9), 12.4%（7.3, 20.4）和21.9%（14.0,32.5）的GDM与全因死亡率，2型糖尿病和心血管疾病之间的正相关。结论：有GDM病史的女性比无GDM的女性生理年龄大。生物老化加速部分解释了GDM与不良健康结果之间的关联。
{"title":"Gestational Diabetes Mellitus and Accelerated Biological Aging in Middle-Aged and Elderly Women","authors":"Bin Wang, Ningjian Wang, Xin Yin, Yuhui Huang, Guoqi Yu, Jiaxi Yang, Yap Seng Chong, Yingli Lu, Michelle A. Williams, Frank B. Hu, Cuilin Zhang","doi":"10.2337/dc25-1842","DOIUrl":"https://doi.org/10.2337/dc25-1842","url":null,"abstract":"OBJECTIVE To evaluate the association between gestational diabetes mellitus (GDM) and accelerated biological aging in middle-aged and elderly women. RESEARCH DESIGN AND METHODS We included parous women with a baseline survey on history of GDM and biological aging biomarkers from the UK Biobank. Information regarding prior GDM was collected via a touchscreen questionnaire and linkage to hospital admission records. Biological aging was evaluated using validated phenotypic age (PhenoAge) based on chronological age and nine biomarkers measured at baseline (2006–2010). Biological aging acceleration was determined as the residual by regressing PhenoAge estimates on chronological age. All-cause mortality and incident cardiometabolic disease during follow-up were also assessed. RESULTS Among the 178,363 women (mean age, 57.0 [SD 7.9] years), 1,141 had a history of GDM. In a multivariable-adjusted model, a history of GDM was associated with an increase in PhenoAge acceleration by 2.34 (95% CI 2.02, 2.66) years. The association persisted regardless of the occurrence of type 2 diabetes and related comorbidities after GDM. Consistent results were observed across subgroups, while the GDM-related PhenoAge acceleration was more prominent among women with less physical activity and obesity (both Pinteraction &lt; 0.01). The mediation analysis demonstrated that PhenoAge acceleration explained 57.0% (95% CI 21.0, 86.9), 12.4% (7.3, 20.4), and 21.9% (14.0, 32.5) of the positive associations between GDM and all-cause mortality, type 2 diabetes, and cardiovascular disease, respectively. CONCLUSIONS Women with a history of GDM were biologically older than their non-GDM counterparts. The biological aging acceleration partially accounted for the associations between GDM and adverse health outcomes.","PeriodicalId":11140,"journal":{"name":"Diabetes Care","volume":"154 1","pages":""},"PeriodicalIF":16.2,"publicationDate":"2025-12-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145765335","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}
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}
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