Diabetic Medicine最新文献

{"title":"‘The seagull theory: Where people fly in, gather information… fly out and nothing ever comes about’: A qualitative exploration of barriers and enablers to research participation among adults with type 2 diabetes living in Australian rural communities","authors":"Joanne Jordan,&nbsp;Jo-Anne Manski-Nankervis,&nbsp;Meaghan Read,&nbsp;Timothy Skinner,&nbsp;Jane Speight,&nbsp;Elizabeth Holmes-Truscott","doi":"10.1111/dme.70027","DOIUrl":"10.1111/dme.70027","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Aim</h3>\u0000 \u0000 <p>Rural communities are under-represented in diabetes research, with implications for the generalisability, implementation and reach of research outcomes. Increased efforts to conduct diabetes research in, or inclusive of, rural communities are predicated on effective participant recruitment. This study explores the motivations for, barriers to and enablers of research participation among adults with type 2 diabetes (T2D) in Australian rural communities.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Method</h3>\u0000 \u0000 <p>A phenomenological qualitative study was conducted involving adults (18+ years) living with T2D in rural communities, using multi-modal recruitment approaches and purposeful sampling across Australian states and gender. Audio-recorded, semi-structured interviews explored participants' perceptions of research participation. An abductive coding approach was undertaken to identify salient themes.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Twenty-one participants were recruited across all six Australian states, median (range) age of 63 (41–78) years and 65% were women. Barriers to research participation include diabetes stigma, lack of community awareness of T2D, few research opportunities, geographical distances of rural communities from research sites and individual time and resource constraints. Enablers strongly focused on increased engagement and involvement of rural communities in research and offering education or access to diabetes care as part of research activities. Motivations for research participation included opportunities to help or advocate for rural and T2D communities and highlight under-resourcing of rural healthcare services.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>Study findings inform practical strategies that may improve recruitment mechanisms for T2D research in rural communities, for example, community-driven recruitment methods. Evaluation of the effectiveness of such strategies in research practice will be needed.</p>\u0000 </section>\u0000 </div>","PeriodicalId":11251,"journal":{"name":"Diabetic Medicine","volume":"42 5","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-03-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/dme.70027","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143691499","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Managing discordance between HbA_1c and glucose management indicator.","authors":"Erna Lenters-Westra, Marion Fokkert, Eric S Kilpatrick, Erwin Schleicher, Scott Pilla, Emma English, Peter van Dijk","doi":"10.1111/dme.70023","DOIUrl":"https://doi.org/10.1111/dme.70023","url":null,"abstract":"<p><strong>Aims: </strong>The assessment of haemoglobin A1c (HbA_1c) continues to play an essential role in diabetes care; however, major advances in new technologies widen the armament available to clinicians to further refine treatment for their patients. Whilst HbA_1c remains a critical glycaemic marker, advances in technologies such as Continuous Glucose Monitoring (CGM) now offer real-time glucose monitoring, allowing a more instant assessment of glycaemic control. Discrepancies between laboratory-measured HbA_1c and Glucose Management Indicator (GMI) values are a significant clinical issue. In this article, we present a checklist of potential sources of error for both GMI and HbA_1c values and provide suggestions to mitigate these sources in order to continue to improve diabetes care.</p><p><strong>Methods: </strong>We identified key literature pertaining to GMI measurement, HbA_1c measurement, and potential factors of discordance between the two. Using these sources, we explore the potential factors leading to discordance and how to mitigate these when found.</p><p><strong>Results: </strong>We have constructed a quick reference checklist covering the main sources of discordance between HbA_1c and GMI, with accompanying narrative text for more detailed discussion. Discordance can arise due to various factors, including CGM accuracy, sensor calibration, red blood cell turnover and other physiological conditions.</p><p><strong>Conclusions: </strong>GMI will likely continue to be used in the upcoming years by both persons with diabetes and their health care providers, and so it is important for users of CGM devices to be equipped with the knowledge to understand the potential causes of discordance between GMI and HbA_1c values.</p>","PeriodicalId":11251,"journal":{"name":"Diabetic Medicine","volume":" ","pages":"e70023"},"PeriodicalIF":3.2,"publicationDate":"2025-03-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143691488","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Patient relevant outcomes for type 1 diabetes management: A qualitative evidence synthesis.","authors":"Jessica Hanae Zafra-Tanaka, Adela Del Valle, Nathaly Aya Pastrana, J Jaime Miranda, David Beran","doi":"10.1111/dme.70016","DOIUrl":"https://doi.org/10.1111/dme.70016","url":null,"abstract":"<p><strong>Aims: </strong>Identify and define relevant outcomes for people living with T1DM and their caregivers, and explore the differences across contexts and life stages. This exercise will inform the development of a Core Outcome Set (COS), an essential list of outcomes that should be measured for T1DM.</p><p><strong>Methods: </strong>A systematic review of qualitative studies published between 2010 and 2024 using PubMed (Medline), EMBASE, PsychINFO, and CINHAL was conducted. Studies that explored the perspectives and opinions of people living with T1DM or their caregivers around care and the healthcare system were included. Qualitative evidence synthesis was used to identify relevant outcomes for people living with T1DM and their caregivers. People living with T1DM and patient representatives were consulted to provide feedback on the results.</p><p><strong>Results: </strong>119 studies were included; 85/119 (71.4%) conducted in high-income countries. Through the qualitative evidence synthesis, we found three levels of outcomes: (1) individual level (diabetes burden, psychological distress, self-efficacy, hypoglycemia burden, and diabetes burnout), (2) caregivers and family level (caregiver burden, social support, support provided by diabetes management team, and financial impact), and (3) systemic level (access to healthcare, administrative burden, structural support).</p><p><strong>Conclusions: </strong>We found that outcomes can be categorized into three different levels (individual, caregivers/family, and systemic). COS usually considers individual level outcomes, but it was found that outcomes beyond the individual, such as those at the caregiver/family and healthcare levels, also matter for people living with T1DM. To meet the needs, all these levels should be measured.</p>","PeriodicalId":11251,"journal":{"name":"Diabetic Medicine","volume":" ","pages":"e70016"},"PeriodicalIF":3.2,"publicationDate":"2025-03-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143669307","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluation of hyperglycaemic emergency admissions to a major tertiary centre over a two-year period.","authors":"Serena Chong, Hannah Rubinstein, Tang Wong, Ann Poynten","doi":"10.1111/dme.70024","DOIUrl":"https://doi.org/10.1111/dme.70024","url":null,"abstract":"","PeriodicalId":11251,"journal":{"name":"Diabetic Medicine","volume":" ","pages":"e70024"},"PeriodicalIF":3.2,"publicationDate":"2025-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143656317","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Extended use of real-time continuous glucose monitoring in adults with insulin-requiring type 2 diabetes: Results from the first 26 weeks of the 2GO-CGM trial","authors":"Claire S. Lever,&nbsp;Jonathan A. Williman,&nbsp;Alisa Boucsein,&nbsp;Antony Watson,&nbsp;Rachael S. Sampson,&nbsp;Oscar T. Sergel-Stringer,&nbsp;Celeste Keesing,&nbsp;Benjamin J. Wheeler,&nbsp;Martin I. de Bock,&nbsp;Ryan G. Paul","doi":"10.1111/dme.70025","DOIUrl":"10.1111/dme.70025","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Aims</h3>\u0000 \u0000 <p>The first 26 weeks of the 2GO-CGM trial assessed the efficacy and safety of real-time continuous glucose monitoring (rtCGM) use within a supported specialist model of care in a cohort of community-based adults with insulin-requiring type 2 diabetes in New Zealand.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>A 26-week randomised one-way crossover ‘waitlist-controlled’ trial comparing rtCGM (Dexcom G6) with self-monitoring of blood glucose (SMBG). All participants completed 2 weeks of SMBG before being randomised to 12 weeks (phase 1) use of SMBG followed by 12 weeks (phase 2) use of rtCGM (Group A) or 24 weeks of rtCGM (Group B). A time-adjusted within₋subject analysis was conducted to estimate the overall treatment effect of rtCGM versus SMBG.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Sixty-seven participants were randomised to Group A or B, and all were included in the analysis (53% indigenous Māori, 57% female, median age 53 [range 16–69] years). Baseline-adjusted mean time in range (3.9–10.0 mmol/L) was 15% (95% CI 10–20; <i>p</i> = &lt;0.001) higher with rtCGM use versus SMBG use. There was no evidence of a difference in Hba1c between rtCGM and SMBG use (−3.4 mmol/mol [0.31%], 95% CI −9.4 to 2.7 mmol/mol [−0.86 to 0.24%], <i>p</i> = 0.27). One participant withdrew in phase 2 due to unmanageable skin reactions to the CGM device. There were no severe hypoglycaemia or ketoacidosis events in either group during the study.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>Use of rtCGM demonstrates safe and sustained glycaemic improvement in rtCGM use with insulin-requiring type 2 diabetes during the first 26 weeks of the 2GO-CGM study.</p>\u0000 </section>\u0000 </div>","PeriodicalId":11251,"journal":{"name":"Diabetic Medicine","volume":"42 5","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/dme.70025","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143656322","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Correspondence between the Diabetes Eating Problems Survey–Revised and eating disorder diagnosis: Examining the current cut-off for clinically significant eating disorder symptoms","authors":"Ashley A. Moskovich,&nbsp;Caitrin Murphy,&nbsp;Samantha Schram,&nbsp;Francesca Scheiber,&nbsp;Rhonda M. Merwin","doi":"10.1111/dme.70022","DOIUrl":"10.1111/dme.70022","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Aims</h3>\u0000 \u0000 <p>Eating disorders (EDs) are associated with severe health complications and early death in individuals with type 1 diabetes, making the accurate detection of EDs crucial so that treatment can be initiated. The Diabetes Eating Problems Survey–Revised (DEPS-R) is commonly used to identify individuals with type 1 diabetes with a probable ED, with scores ≥20 recommended as a clinical cut-off. However, the correspondence between a score ≥20 and an ED diagnosis has yet to be examined. This study examines the accuracy, sensitivity, and specificity of the DEPS-R ≥20 for detecting EDs in a sample of adults with type 1 diabetes participating in a study of eating and weight concerns.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>Adults with type 1 diabetes (<i>N</i> = 83) completed the DEPS-R and a structured diagnostic ED interview (Eating Disorder Examination [EDE]). Each participant's EDE and DEPS-R scores were dichotomized (EDE: 1 = ED diagnosis, 0 = otherwise; DEPS-R: 1 = DEPS-R ≥20, 0 = otherwise) and DEPS-R ≥20 accuracy, sensitivity, and specificity for identifying EDs were calculated. A logistic regression was used to determine whether there was a significant association between the dichotomized EDE and DEPS-R scores.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>A DEPS-R ≥20 accurately detected the presence or absence of an ED in 81.8% of the cases, with a sensitivity of 76.7% and a specificity of 88.2%. The logistic regression exhibited a significant association between the EDE and DEPS-R binary variables (coefficient estimate = 3.2, 95% CI [2.0, 4.6]).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>While the majority of individuals with an ED were identified using DEPS-R ≥20, a subset failed to be detected. Clinicians should keep this in mind when using the DEPS-R and may consider additional screening methods.</p>\u0000 </section>\u0000 </div>","PeriodicalId":11251,"journal":{"name":"Diabetic Medicine","volume":"42 5","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-03-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143623947","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"LncRNA CASC2 mediates SOCS6 mRNA stabilization via U2AF2 recruitment to modulate macrophage polarisation in diabetic retinopathy.","authors":"Fan Xiao, Feipeng Wu, Peipei Zhong, Tian Hu, Rong Luo","doi":"10.1111/dme.70014","DOIUrl":"https://doi.org/10.1111/dme.70014","url":null,"abstract":"<p><strong>Background: </strong>Diabetic retinopathy (DR) is a prevalent microvascular complication of diabetes and a leading cause of vision loss among diabetic individuals. Retinal pigment epithelium (RPE) cells play a crucial role in the pathophysiology of DR by releasing cytokines and exosomal cargo, such as long non-coding RNAs (lncRNAs), that modulate local immune responses, maintain retinal immune homeostasis and influence macrophage polarisation. Recent studies suggest that lncRNA cancer susceptibility candidate 2 (CASC2) may be involved in the regulation of DR progression. However, the regulatory mechanisms linking CASC2 with RPE cells and its role in macrophage polarisation remain insufficiently understood.</p><p><strong>Methods: </strong>Various types of cells, including human retinal pigment epithelial cells (ARPE-19), THP-1 monocytes and additional retinal cell lines, were cultured under normal glucose and high glucose conditions. ARPE-19 cells were exposed to oxidative stress, inflammatory stimulation, or hypoxic conditions. Plasma and aqueous humour samples were collected from DR patients and diabetic controls. Exosomes were extracted from AREP-19 cells and characterised. Various gene and protein expression analyses were performed using techniques including quantitative reverse transcription polymerase chain reaction, Western blot, immunofluorescence, flow cytometry, enzyme-linked immunosorbent assay, and histological staining. Cell proliferation and migration were assessed using Cell Counting Kit-8 assays and Transwell migration assays, respectively. The interactions among CASC2, suppressor of cytokine signalling 6 (SOCS6), and U2 small nuclear RNA auxiliary factor 2 (U2AF2) were explored using RNA immunoprecipitation and dual-luciferase reporter assays. An in vivo diabetic rat model was established.</p><p><strong>Results: </strong>lncRNA CASC2 expression levels were significantly lower in plasma and aqueous humour from DR patients compared to those from diabetic patients without retinopathy. Overexpression of CASC2 significantly attenuated DR and inflammatory damage both in vitro and in vivo. We demonstrated that exosomal CASC2 from ARPE-19 cells mediated macrophage polarisation by inhibiting M1 polarisation and promoting M2 polarisation. Our findings suggest that CASC2 regulates this polarisation through the stabilisation of SOCS6 mRNA via U2AF2.</p><p><strong>Conclusion: </strong>CASC2 derived from RPE cells was transported to macrophages, inducing M2 polarisation by stabilising SOCS6 mRNA through the recruitment of U2AF2. This research may provide a foundation for developing novel therapeutic strategies for DR.</p>","PeriodicalId":11251,"journal":{"name":"Diabetic Medicine","volume":" ","pages":"e70014"},"PeriodicalIF":3.2,"publicationDate":"2025-03-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143596442","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Shortcut to the needle in the haystack? Screening for maturity onset diabetes of the young in a population of women with gestational diabetes","authors":"Sine Knorr,&nbsp;Laura L. Knudsen,&nbsp;Anne L. Madsen,&nbsp;Lene R. Madsen,&nbsp;Lene Mortensen,&nbsp;Henrik H. Thomsen,&nbsp;Lars Peter Sørensen,&nbsp;Per G. Ovesen,&nbsp;Jens Fuglsang,&nbsp;Ulla Kampmann","doi":"10.1111/dme.70021","DOIUrl":"10.1111/dme.70021","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Aims</h3>\u0000 \u0000 <p>Pregnant women are occasionally misdiagnosed with gestational diabetes (GDM) when they may have glucokinase monogenic diabetes (GCK-MODY). Differentiating between GCK-MODY and GDM is critical due to the distinct treatment strategies required during and after pregnancy. Since pregnancy often elicits the first glucose tolerance test, it provides a unique opportunity to identify individuals with GCK-MODY. However, testing all pregnant women with GDM for GCK-MODY is expensive, and the use of clinical criteria is warranted. An Irish study suggested using a combined criteria of a pre-pregnancy body mass index (BMI) &lt;25 kg/m² and fasting glucose ≥5.5 mmol/L to differentiate GCK-MODY from GDM. Therefore, we aimed to identify women with GCK-MODY during pregnancy using these combined criteria in a Danish population of women with GDM. Additionally, we aimed to screen for other MODY subtypes.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>We recruited women from the Central Denmark Region diagnosed with GDM between April 2019 and December 2022. Women meeting the criteria of pre-pregnancy BMI &lt;25 kg/m² and fasting glucose ≥5.5 mmol/L were offered screening for MODY (17 known genetic variants) using Illumina's Next Generation Sequencing.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Of the 1270 women with GDM, 46 met the MODY screening criteria. Of these, 41 were offered MODY screening, 34 participated and 1 woman was identified with MODY (MODY 8–CEL variant).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>The current Danish GDM screening guidelines do not apply with recommending the use of pre-pregnancy BMI &lt;25 kg/m² and fasting glucose ≥5.5 mmol/L as criteria for identifying women with GCK-MODY among women with GDM in the Danish population.</p>\u0000 </section>\u0000 </div>","PeriodicalId":11251,"journal":{"name":"Diabetic Medicine","volume":"42 5","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-03-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/dme.70021","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143572449","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"CODIFI2: Randomised controlled trial to compare clinical and cost-effectiveness of swabs versus tissue sampling to inform management of infected diabetic foot ulcers","authors":"E. Andrea Nelson,&nbsp;Sarah T. Brown,&nbsp;Colin C. Everett,&nbsp;Angela Oates,&nbsp;Michael Backhouse,&nbsp;Howard Collier,&nbsp;Joanna Dennett,&nbsp;Rachael Gilberts,&nbsp;Ben Lipsky,&nbsp;Michelle M. Lister,&nbsp;Jane E. Nixon,&nbsp;David Russell,&nbsp;Tim Sloan,&nbsp;Fran Game","doi":"10.1111/dme.70009","DOIUrl":"10.1111/dme.70009","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> BAims/Hypothesis</h3>\u0000 \u0000 <p>CODIFI2 compared wound swabbing and tissue sampling in people with infected diabetic foot ulcers (DFU) to determine the effects on clinical outcomes.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>Multicentre, Phase III, prospective, non-blind, 2-arm parallel group, randomised controlled trial comparing time to ulcer healing (primary outcome), proportions healed, antimicrobial regimen, ulcer area reduction, hospitalisation duration, and time to death for swab compared to tissue sampling. Allocation was via a central and independent randomisation system, with minimisation by DFU site, number, type, size, location, and duration.</p>\u0000 \u0000 <p>Follow-up was 52–104 weeks, with healing confirmed by a blinded assessor. Samplesize target was 730 participants for 90% power to detect a 12.5% difference in healing at 52 weeks.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Between May 2019 and May 2022, 149 participants were recruited (75 Swab, 74 Tissue) from 21 UK sites. The 52-week cumulative incidence of confirmed healing as the first event was 45.3% (33.5%–56.4%) and 44.6% (33.0–55.6%) for swab vs. tissue. The hazard ratio (HR) for healing for tissue vs. swab was 1.01 (95% CI 0.65–1.55). The median (IQR) days in hospital was 17 (12–39) for swab and 16 (10–32) for tissue. Seventeen swab and 7 tissue participants died during follow-up, and 18.7% and 24.3% of participants in the swab and tissue groups, respectively, had an amputation.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions/Interpretation</h3>\u0000 \u0000 <p>This trial was underpowered to determine whether swab or tissue sampling impacted the rate of healing or time to healing. Clinical prescribing and patient outcomes differed slightly between groups; hence, the clinical benefit of tissue sampling is not established.</p>\u0000 </section>\u0000 </div>","PeriodicalId":11251,"journal":{"name":"Diabetic Medicine","volume":"42 5","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-03-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/dme.70009","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143572436","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Marked improvement in HbA1c following introduction of biosimilar insulin to treatment regimen of children and youth with type 1 diabetes in Mali: A randomised controlled trial","authors":"Stéphane Besançon,&nbsp;Aveni Haynes,&nbsp;Amagara Domon Togo,&nbsp;Jessica Lynn Sandy,&nbsp;Jayanthi Maniam,&nbsp;Asa Traoré Sidibe,&nbsp;Sylla Djéneba,&nbsp;Carine de Beaufort,&nbsp;Montserrat Castellsague Perolini,&nbsp;Giacomo Gastaldi,&nbsp;David Beran,&nbsp;Cecile Eigenmann,&nbsp;Graham David Ogle","doi":"10.1111/dme.70007","DOIUrl":"10.1111/dme.70007","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Aims</h3>\u0000 \u0000 <p>Evidence on outcomes of treating type 1 diabetes (T1D) with long-acting basal insulins in low-resourced settings is lacking. This study aimed to evaluate the impact of switching children and youth with T1D in the low-income country of Mali from human insulin via syringe to long-acting biosimilar insulin glargine delivered by reusable pens combined with short-acting insulin via syringe.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>A two-group parallel design randomised trial was conducted enrolling 260 youth aged &lt;25 years, diagnosed with T1D for ≥12 months without prior use of analogue insulin. Youth were randomised 1:1 to either continue receiving current therapy or switch to analogue insulin. The primary outcome was HbA1c, collected at baseline and 3-monthly for 12 months.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Primary outcome data were available for 130 (100%) youth in the intervention group and 128 (98.5%) in the control group. Over the 12-month study period, mean HbA1c decreased from 103 to 65 mmol/mol (11.6%–8.1%) (<i>p</i> &lt; 0.001) in the intervention group and from 101 to 93 mmol/mol (11.4% to 10.7%) in the control group (<i>p</i> &lt; 0.01), an absolute difference of 30 mmol/mol (95% CI: −37, −24) (<i>p</i> &lt; 0.001). The proportion of participants with HbA1c ≥130 mmol/mol (≥14%) decreased from 38.5% to 0% in the intervention group, versus 40.6% to 21.9% in the control group.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>Switching to a basal-bolus insulin regimen including biosimilar glargine resulted in marked improvements in HbA1c and diabetic ketoacidosis episodes. With relevant training, resources, and support, use of long-acting analogue insulin for treating T1D in Mali was feasible and acceptable to participants and healthcare professionals.</p>\u0000 </section>\u0000 </div>","PeriodicalId":11251,"journal":{"name":"Diabetic Medicine","volume":"42 5","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143540527","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}