Diabetologia最新文献

{"title":"Adipocyte-derived exosomal ANGPTL2 promotes beta cell dysfunction via the EIF2α/ATF4/CHOP stress pathway in mice","authors":"Xiaoqi Zhong,Qiuna Wei,Qi Cheng,Mingwen Weng,Shengxin Wang,Hong Chen,Yuting Ruan","doi":"10.1007/s00125-026-06885-1","DOIUrl":"https://doi.org/10.1007/s00125-026-06885-1","url":null,"abstract":"","PeriodicalId":11164,"journal":{"name":"Diabetologia","volume":"1 1","pages":""},"PeriodicalIF":8.2,"publicationDate":"2026-10-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149089109","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":"Environmental sustainability of offloading care pathways for people with a diabetes-related foot ulcer: a life-cycle assessment","authors":"Jaap J. van Netten,Florine I. de Haes,Sicco A. Bus,Marieke E. Sijm-Eeken","doi":"10.1007/s00125-026-06891-3","DOIUrl":"https://doi.org/10.1007/s00125-026-06891-3","url":null,"abstract":"Abstract Aims/hypothesis Insights into the environmental impact of diabetes care are scarce and are absent regarding treatments for diabetes-related foot disease. We aimed to compare the environmental impacts of three offloading pathways for people with a plantar foot ulcer. Methods We performed a bottom-up, process-based life-cycle assessment according to ISO standards. We defined three evidence-based offloading pathways from first visit to healing: total contact cast (TCC), non-removable walker and removable walker. Inventory data were collected for all activities within scope (materials, waste, transport, energy consumption). Life-cycle assessment was performed using ReCiPe-2016 midpoint and endpoint methods, employing SimaPro and Ecoinvent 3.10. Monte Carlo simulation with 1,000,000 individuals provided the environmental impact per offloading pathway. Results Environmental impact was lowest for the removable walker pathway and highest for the TCC for all 18 midpoints and five endpoints. For global warming, the mean impact was 141 kg CO 2 -equivalents (CO 2 -eq) (SD: 88; 95% prediction interval 67, 377) for the TCC pathway, 108 kg CO 2 -eq (SD: 62; 95% prediction interval 59, 276) for the non-removable walker and 90 kg CO 2 -eq (SD: 57; 95% prediction interval 36, 244) for the removable walker. The largest environmental impact came from patient transport (59–78% of all impact per pathway in CO 2 -eq). Conclusions/interpretation Diabetes-related plantar foot ulcer treatment pathways with a walker are likely to result in lower environmental impact compared with the TCC pathway, with the lowest impact for the removable walker pathway. This resulted from using a single device (i.e. no replacements required) and, for the removable walker, fewer visits, despite longer time to healing. Taking environmental impact into account may alter clinical decision-making in offloading treatment.","PeriodicalId":11164,"journal":{"name":"Diabetologia","volume":"10 1","pages":""},"PeriodicalIF":8.2,"publicationDate":"2026-10-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149089112","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":"BAF60A governs beta cell identity to control systemic glucose homeostasis","authors":"Shuaishuai Zhu,Ziyin Zhang,Ruo-Ran Wang,Wei Chen,Qiyao Xu,Xinyuan Qiu,Xiuyu Ji,Rui Zhang,Rui Wei,Hongxing Fu,Sheng Yan,Zhuo-Xian Meng","doi":"10.1007/s00125-026-06884-2","DOIUrl":"https://doi.org/10.1007/s00125-026-06884-2","url":null,"abstract":"","PeriodicalId":11164,"journal":{"name":"Diabetologia","volume":"1 1","pages":""},"PeriodicalIF":8.2,"publicationDate":"2026-10-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149089108","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":"Management of type 2 diabetes, 2026. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD)","authors":"Melanie J. Davies,Vanita R. Aroda,Mandeep Bajaj,Nuha A. ElSayed,Francesco Giorgino,Jennifer Green,Rita R. Kalyani,Nisa M. Maruthur,Chantal Mathieu,Sylvia E. Rosas,Peter Rossing,Tommy Slater,Tsvetalina Tankova,Pinar Topsever,Apostolos Tsapas,John B. Buse","doi":"10.1007/s00125-026-06855-7","DOIUrl":"https://doi.org/10.1007/s00125-026-06855-7","url":null,"abstract":"","PeriodicalId":11164,"journal":{"name":"Diabetologia","volume":"06 1","pages":""},"PeriodicalIF":8.2,"publicationDate":"2026-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149089110","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":"Metabolic implications of hepatic, pancreatic and abdominal adipose tissue depots in Asian Indians across normoglycaemia, prediabetes and type 2 diabetes.","authors":"Amerta Ghosh, Koel Dutta, Surya Prakash Bhatt, Irshad Ahmad Ansari, Lovely Gupta, Shivam Pandey, Abhishek Suman, Anoop Misra","doi":"10.1007/s00125-026-06807-1","DOIUrl":"10.1007/s00125-026-06807-1","url":null,"abstract":"<p><strong>Aims/hypothesis: </strong>The aim of this study was to evaluate hepatic, pancreatic and abdominal fat depots across glycaemic categories in Asian Indians with matched BMI, and to identify predictors of dysglycaemia.</p><p><strong>Methods: </strong>In this cross-sectional study, 45 adults (15 each with normoglycaemia or living with prediabetes and newly diagnosed type 2 diabetes) were matched for BMI. Fat fractions in the liver and pancreas were quantified on the basis of the proton density fat fraction (PDFF) measured using multi-echo chemical-shift-encoded MRI (CSE-MRI). We quantified the cross-sectional area of following abdominal fat compartments by MRI: subcutaneous adipose tissue (SCAT) (anterior, posterior, superficial, deep), intra-abdominal adipose tissue (IAAT), intra-peritoneal adipose tissue, retroperitoneal adipose tissue etc. Total body fat (%) and total fat mass (g) were measured using dual-energy x-ray absorptiometry (DEXA). Insulin sensitivity and beta cell function were derived from HOMA indices.</p><p><strong>Results: </strong>The hepatic fat fraction (HFF) was nearly twofold higher in the prediabetes group (10.78 ± 6.50%) and the type 2 diabetes group (10.35 ± 9.95%) compared with the normoglycaemia group (5.34 ± 4.69%), with significant differences for both comparisons (p=0.009 and p=0.026, respectively). The fat fractions in the pancreas were similarly elevated in individuals living with prediabetes (5.83 ± 4.73%) and type 2 diabetes (5.35 ± 4.75%) compared with the normoglycaemic group (2.97 ± 3.56%, p<0.05). IAAT, superficial SCAT, posterior SCAT and retroperitoneal adipose tissue were significantly higher in individuals living with prediabetes and those with type 2 diabetes than in the normoglycaemic group (p<0.05). Superficial SCAT and posterior SCAT were also significantly higher in individuals living with prediabetes compared to those with type 2 diabetes (p<0.05). After adjustment for age and BMI, only fat fractions in the liver remained an independent predictor of dysglycaemia (OR 1.11 per 1% increase; p=0.023). Each 1% increase in the fat fraction in the liver increased odds of prediabetes by 16% and those of overall dysglycaemia by 11%. HOMA-β was preserved or elevated in individuals living with prediabetes but decreased in those with type 2 diabetes.</p><p><strong>Conclusions/interpretation: </strong>Asian Indians living with prediabetes or type 2 diabetes at a modestly increased BMI of approximately 25 kg/m² exhibit marked ectopic fat. The fat fraction in the liver independently predicted dysglycaemia. These findings highlight the need for early and aggressive interventions at the stage of normoglycaemia and prediabetes to avert beta cell decline and diabetes progression in Asian Indians.</p><p><strong>Trial registration: </strong>Clinical Trials Registry of India (CTRI/2023/06/054228).</p>","PeriodicalId":11164,"journal":{"name":"Diabetologia","volume":" ","pages":"2911-2921"},"PeriodicalIF":10.4,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148653167","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":"A narrative systematic review of definitions and diagnostic criteria for disordered eating and eating disorders in type 1 diabetes.","authors":"Emmanouela Konstantara, Pil Lindgreen, Lisa Kuriakose, Natalie Zaremba, Rebecca Upsher, Janet Treasure, Khalida Ismail, Marietta Stadler","doi":"10.1007/s00125-026-06805-3","DOIUrl":"10.1007/s00125-026-06805-3","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Aims/hypothesis: &lt;/strong&gt;Type 1 diabetes and disordered eating (T1DE) affects 8-37.1% of adults and is associated with high rates of morbidity and mortality. The absence of a standardised case definition of T1DE and its severity hinders effective screening, diagnosis and treatment. This systematic review aimed to (1) synthesise existing case definitions and diagnostic criteria for T1DE in adults and (2) identify key characteristics to inform consensus for future diagnostic criteria.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;A systematic review was conducted following the Preferred Reporting Items for Systematic reviews and Meta-Analysis (PRISMA) guidelines. Eligible studies involved adults (≥18 years) with type 1 diabetes assessing disordered eating; paediatric studies, mixed samples without disaggregated data, non-empirical designs and non-English publications were excluded. PubMed, MEDLINE, EMBASE, CINAHL and PsycINFO were searched up to November 2025 for peer-reviewed studies involving adults with T1DE. Qualitative and quantitative data on definitions, diagnostic criteria and assessment tools were extracted. Study quality was appraised using a modified Graphical Appraisal Tool for Epidemiological studies (GATE) checklist. Due to heterogeneity of data, a narrative synthesis of findings was performed to describe current definitions of T1DE.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Sixty-one studies met the inclusion criteria, with a pooled sample of 111,208 participants (76% women) from over 22 countries. T1DE was defined using a heterogeneous array of terms, diagnostic frameworks and assessment tools (29 distinct methods). The Diabetes Eating Problem Survey-Revised (DEPS-R) was the most used questionnaire, but many studies relied on criteria adapted from general eating disorder classifications or generic questionnaires. Approximately three-quarters of the studies assessed insulin omission behaviours, but the operationalisation of the cognitions for insulin omission varied widely. Beyond physiological markers such as HbA&lt;sub&gt;1c&lt;/sub&gt; and BMI, studies explored various diabetes-related and psychological constructs, although often considering diabetes and disordered eating separately rather than as an integrated condition.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions/interpretation: &lt;/strong&gt;This systematic review highlights the lack of a unified, evidence-based definition of T1DE, resulting in inconsistent screening, diagnostic and reporting practices. Establishing clear, consistent, evidence-based diagnostic criteria and screening questionnaires for T1DE is critical to improving early detection and developing targeted interventions. These findings provide a foundation for refining T1DE definitions as a stepping stone to an international consensus definition.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Study registration: &lt;/strong&gt;PROSPERO registration no. CRD420250223622 FUNDING: King's College London and King's College Hospital through the KMRT KCH Joint Research Committee studentship. This work was ","PeriodicalId":11164,"journal":{"name":"Diabetologia","volume":" ","pages":"2712-2740"},"PeriodicalIF":10.4,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13541810/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148618830","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effects of time-restricted eating on markers of glucose metabolism and regulation in individuals with prediabetes or type 2 diabetes: a systematic review and meta-analysis of randomised controlled trials.","authors":"Frida Viple, Sofie S Pedersen, Tue H Andersen, Anne Raben, Anne-Ditte Termannsen, Jonas Salling","doi":"10.1007/s00125-026-06792-5","DOIUrl":"10.1007/s00125-026-06792-5","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Aims/hypothesis: &lt;/strong&gt;This systematic review and meta-analysis aimed to investigate the effects of time-restricted eating (TRE) on glucose metabolism and regulation in individuals with prediabetes (fasting blood glucose of 5.6-6.9 mmol/l or HbA&lt;sub&gt;1c&lt;/sub&gt; of 39-47 mmol/mol [5.7-6.4%]) or type 2 diabetes (fasting blood glucose ≥7 mmol/l or HbA&lt;sub&gt;1c&lt;/sub&gt; ≥48 mmol/mol [6.5%]).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;A literature search was performed in MEDLINE, Embase and CENTRAL from inception to 5 August 2025. Moreover, forward and backward citation searches were performed. Eligible studies were RCTs in adults with prediabetes or type 2 diabetes, lasting ≥2 weeks, reporting markers of glucose metabolism and regulation, comparing TRE (≤12 h eating window) with a non-time-restricted control diet. Studies involving pregnancy, other fasting regimens, or non-peer-reviewed publications were excluded. Data were pooled as weighted mean differences with 95% CIs using random-effects generic inverse variance models in Cochrane Review Manager Web, and results are presented as forest plots. The certainty of evidence was defined using Grading of Recommendations, Assessment, Development and Evaluations methodology, and risk of bias was estimated by using the Revised Cochrane risk-of-bias tool for randomised trials (RoB 2).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Out of 2043 records identified through the database search, as well as 1249 from forward and backward citation searches, ten RCTs including 599 participants were included. The mean length of the studies was 4 months, and the eating windows ranged from 4 to 10 h per day. The pooled meta-analysis showed no overall effect of TRE on HbA&lt;sub&gt;1c&lt;/sub&gt; (-3.33 mmol/mol; 95% CI -6.87, 0.20 (-0.30% points; -0.63, 0.02); p=0.06, moderate certainty). Nevertheless, following stratification by subgroups, TRE resulted in a reduction in HbA&lt;sub&gt;1c&lt;/sub&gt; of 0.93 mmol/mol (-1.70, -0.17 [-0.09% points; -0.16, -0.02]; p=0.02) in individuals with prediabetes but not in individuals with type 2 diabetes (-4.68 mmol/mol; -10.08, 0.72 (-0.43% points; -0.92, 0.07); p=0.09). TRE reduced fasting blood glucose in the pooled analysis (-0.30 mmol/l; -0.53, -0.07; p&lt;0.01, moderate certainty) as well as in the subgroup analyses in individuals with prediabetes (-0.14 mmol/l; -0.27, -0.01; p=0.03) and with type 2 diabetes (-0.48 mmol/l; -0.78, -0.17; p&lt;0.01). Moreover, TRE lowered body weight by 1.6 kg (-2.2, -1.0; p&lt;0.001) in the pooled analysis. The evidence was limited by imprecision arising from wide confidence intervals in some of the included studies, which may be due to small sample sizes. Lastly, the effects of TRE on markers of insulin sensitivity, beta cell function and continuous glucose monitoring measurements were inconclusive.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions/interpretation: &lt;/strong&gt;Moderate-certainty evidence indicates that TRE reduces fasting blood glucose but not HbA&lt;sub&gt;1c.&lt;/sub&gt; The subgroup analyses revealed that TRE imp","PeriodicalId":11164,"journal":{"name":"Diabetologia","volume":" ","pages":"2741-2758"},"PeriodicalIF":10.4,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148590824","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":"Remodelling of body composition surrounding the diagnosis of type 2 diabetes in three longitudinal cohorts.","authors":"Jiaxing Du, Kun Zeng, Fen Zhang, Yanyan Wang, Mei Liu, Jiayu Huang, Sujun Chen, Yanhan Zhao, Yan Lin","doi":"10.1007/s00125-026-06797-0","DOIUrl":"10.1007/s00125-026-06797-0","url":null,"abstract":"<p><strong>Aims/hypothesis: </strong>The temporal evolution of body composition surrounding type 2 diabetes diagnosis is unclear. To clarify this process, we characterised and compared the trajectories of BMI, boplledy roundness index (BRI) and handgrip strength (HGS) in the years preceding and following the diagnosis.</p><p><strong>Methods: </strong>We analysed data from participants aged ≥50 years from the Health and Retirement Study (HRS, waves 7-14), the English Longitudinal Study of Ageing (ELSA, waves 2-6), and the Survey of Health, Ageing and Retirement in Europe (SHARE, waves 2-9). Incident diabetes cases were matched 1:4 with control participants based on age, sex and education level, with the timeline centred on the year of diagnosis. Linear mixed-effects models (LMMs) allowing for non-linear trends were employed to estimate the trajectories of BMI, BRI and HGS, and to assess the temporal evolution of differences between cases and controls.</p><p><strong>Results: </strong>The analysis included 74,790 participants for BMI, 19,895 for BRI, and 69,560 for HGS. Over a follow-up period of up to 14 years surrounding diagnosis, BMI trajectories exhibited a distinct inverted U shape, peaking approximately 2-4 years prior to diagnosis. BRI showed an overall upward trend, but its growth in cases was accelerated during weight gain and attenuated during weight loss relative to controls. HGS declined universally; although the rates of decline were similar between groups in HRS and ELSA, cases in the SHARE cohort experienced a significantly accelerated decline compared with controls.</p><p><strong>Conclusions/interpretation: </strong>When evaluated through multidimensional surrogate indicators, the trajectory of type 2 diabetes involves patterns that are indicative of a rise then a fall in total body mass, persistent visceral accumulation (albeit attenuated during weight loss), and probably accelerated muscle depletion. The dynamic evolution of these proxy metrics provides novel insights for capturing the full picture of body composition remodelling.</p>","PeriodicalId":11164,"journal":{"name":"Diabetologia","volume":" ","pages":"2810-2818"},"PeriodicalIF":10.4,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148359723","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":"A narrative review of what cohorts have taught us and how they have laid the foundation for much of our understanding of type 2 diabetes.","authors":"Sun H Kim, Ipsa Arora, Charles Agyemang, Ranjit M Anjana, Bjørn Olav Åsvold, Marieke Blom, Shilpa N Bhupathiraju, Amélie Bonnefond, Juliana C N Chan, Timothy M E Davis, Kristian Hveem, Marit E Jørgensen, Anton Lager, Lars Lind, Olle Melander, Andrea Natali, Jackie Price, Parminder Raina, Michael Roden, Olov Rolandsson, Mary R Rooney, Seyed Mohammad Mousavi, Andrei C Sposito, Reimar W Thomsen, Barbara Thorand, Rob M Van Dam, Kavita Venkataraman, Sarah H Wild, Ji Hee Yu, Petra J M Elders, Joline W Beulens, Femke Rutters","doi":"10.1007/s00125-026-06812-4","DOIUrl":"10.1007/s00125-026-06812-4","url":null,"abstract":"<p><p>This narrative review provides a historical perspective on how observational research on type 2 diabetes has been developed and consolidated over the last 50 years and how well-designed cohort studies will provide us with knowledge for research and practice in the future and aid guideline development. We have included data from a large number of cohorts from every continent that have been used to study the development and/or progression of type 2 diabetes, including cohorts that are general population-based, disease-based, intervention-based and registry-based. We have structured the results from the past 50 years based on the following themes: diagnosis and screening, complications, risk factors and pathophysiology. We also discuss the strengths and weaknesses of observational research when compared with other research designs. Finally, we discuss the emerging and future directions for type 2 diabetes research using cohorts, which include novel developments, such as artificial intelligence, precision health and the exposome. We conclude that cohort research has significantly advanced our understanding of type 2 diabetes and aided guideline development, and complements experimental work, such as human randomised controlled trials and animal studies. Both approaches are essential and complementary in our pursuit to provide a more comprehensive understanding of the development and progression of type 2 diabetes, and to change dogma, practice and policies for better outcomes.</p>","PeriodicalId":11164,"journal":{"name":"Diabetologia","volume":" ","pages":"2685-2711"},"PeriodicalIF":10.4,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13541953/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148825233","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Efficacy of the digital therapeutic glucura combined with CGM in the treatment of type 2 diabetes: a randomised controlled trial over 6 months","authors":"Guido Freckmann,Inke R. König,Hanna Grube,Maren Vens,Oliver Witt,Vanessa Kappelmeier,Kim L. Pethahn,Christian Sina,Othmar Moser,Torsten Schröder","doi":"10.1007/s00125-026-06880-6","DOIUrl":"https://doi.org/10.1007/s00125-026-06880-6","url":null,"abstract":"Abstract Aims/hypothesis CGM is increasingly recommended for non-insulin-treated type 2 diabetes according to the ADA Standards of Care 2026. However, its clinical benefit in high-quality standard care remains limited. This study evaluated whether addition of the digital therapeutic glucura, which delivers personalised lifestyle intervention and self-management guidance, improves glycaemic outcomes beyond CGM and standard care. Methods The study was a 6-month, multicentre, open-label RCT conducted at 24 sites in Germany (ID: DRKS00032537). Adults (≥18 years) with non-insulin-treated type 2 diabetes (HbA 1c 53–97 mmol/mol [7.0–11.0%], BMI≥25 kg/m 2 ) receiving standard care were randomly assigned (1:1) by centralised stratified block randomisation to glucura or a control app. Participants and study personnel were not masked to group assignment. Both groups used intermittent CGM every 3 months during the study. CGM sensors were not used prior to the study. The primary endpoint was the change in HbA 1c from baseline to 6 months. Secondary outcomes included weight change and patient-centric measures. Results Of 327 randomised participants (intervention: n =165; control: n =162), 320 were analysed (ITT population). The standalone CGM control group improved HbA 1c levels by 3.3 mmol/mol (0.30 percentage points); however, the intervention group showed greater reductions of 8.7 mmol/mol (0.80 percentage points) with an adjusted difference of –5 mmol/mol (−0.46 percentage points; 95% CI −7, −3 mmol/mol; p =0.00003). Within the intervention group, more participants achieved HbA 1c targets (&lt;53 mmol/mol [&lt;7.0%]: 55% vs 31%, OR 3.38, exploratory p =0.0002; &lt;48 mmol/mol [&lt;6.5%]: 27% vs 7%, OR 6.63, exploratory p =0.0001). The mean weight loss was also greater in the intervention group (4.11% vs 1.79%, p &lt;0.0001). Significant improvements in mental health and diabetes-related distress were also observed. The positive effects were consistent across all subgroups. No device-related serious adverse events were observed. Conclusions/interpretation In non-insulin-treated type 2 diabetes, CGM plus standard care yielded less metabolic benefit than CGM combined with glucura. The combination of glucura and CGM also translated into improvements beyond glycaemic management. Trial registration German Clinical Trials Register DRKS00032537 Funding The study was funded by Perfood Laboratories GmbH","PeriodicalId":11164,"journal":{"name":"Diabetologia","volume":"175 1","pages":""},"PeriodicalIF":8.2,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149092445","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}