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IntroductionThe increasing burden of non-communicable diseases, such as hypertension, diabetes and dyslipidaemia, presents key challenges to achieving optimal HIV care outcomes among ageing people living with HIV. These diseases are often comorbid and are exacerbated by psychosocial and structural inequities. This interaction among multiple health conditions and social factors is referred to as a syndemic. In the USA, there are substantial disparities by social position (ie, racial, ethnic and socioeconomic status) in the prevalence and/or control of non-communicable diseases and HIV. Intersecting stigmas, such as racism, classism and homophobia, may drive these health disparities by contributing to healthcare avoidance and by contributing to a psychosocial syndemic (stress, depression, violence victimisation and substance use), reducing success along the HIV and non-communicable disease continua of care. Our hypothesis is that marginalised populations experience disparities in non-communicable disease incidence, prevalence and control, mediated by intersectional stigma and the psychosocial syndemic.Methods and analysisCollecting data over a 4 year period, we will recruit sexual minority men (planned n=1800) enrolled in the MACS/WIHS Combined Cohort Study, a long-standing mixed-serostatus observational cohort in the USA, to investigate the following specific aims: (1) assess relationships between social position, intersectional stigma and the psychosocial syndemic among middle-aged and ageing sexual minority men, (2) assess relationships between social position and non-communicable disease incidence and prevalence and (3) assess relationships between social position and HIV and non-communicable disease continua of care outcomes, mediated by intersectional stigma and the psychosocial syndemic. Analyses will be conducted using generalised structural equation models using a cross-lagged panel model design.Ethics and disseminationThis protocol is approved as a single-IRB study (Advarra Institutional Review Board: Protocol 00068335). We will disseminate results via peer-reviewed academic journals, scientific conferences, a dedicated website, site community advisory boards and forums hosted at participating sites.

ObjectivesWhether the routine delivery of diabetes-related knowledge can change patients' attitudes and hence influence their self-management activities remains unknown in primary healthcare settings in China. Thus, this study aims to explore the complex transformation process between knowledge, attitude and practice (KAP) among patients with diabetes in a city in China.DesignA cross-sectional study.SettingYuhuan City, Zhejiang Province, China.ParticipantsA total of 803 patients with diabetes were invited to attend a questionnaire survey and 782 patients with type 2 diabetes completed the survey. The average age of participants was 58.47 years old, 48.21% of whom only attended primary school or below.Primary and secondary outcome measuresA questionnaire based on existing scales and expert consultation was applied to assess patients' socio-demographic information (SI), disease progression risk and diabetes-related KAP. A structural equation model was built to analyse the relationships between patients' characteristics and KAP.ResultsNo significant association was found between patients' knowledge and attitude (β=0.01, p=0.43). Better knowledge and attitude were both found to be associated with better diet and physical activities (β=0.58, p

IntroductionCurrent efforts to reduce dementia focus on prevention and risk reduction by targeting modifiable risk factors. As dementia and cardiometabolic non-communicable diseases (NCDs) share risk factors, a single risk-estimating tool for dementia and multiple NCDs could be cost-effective and facilitate concurrent assessments as compared with a conventional single approach. The aim of this study is to develop and validate a new risk tool that estimates an individual's risk of developing dementia and other NCDs including diabetes mellitus, stroke and myocardial infarction. Once validated, it could be used by the public and general practitioners.Methods and analysisTen high-quality cohort studies from multiple countries were identified, which met eligibility criteria, including large representative samples, long-term follow-up, data on clinical diagnoses of dementia and NCDs, recognised modifiable risk factors for the four NCDs and mortality data. Pooled harmonised data from the cohorts will be used, with 65% randomly allocated for development of the predictive model and 35% for testing. Predictors include sociodemographic characteristics, general health risk factors and lifestyle/behavioural risk factors. A subdistribution hazard model will assess the risk factors' contribution to the outcome, adjusting for competing mortality risks. Point-based scoring algorithms will be built using predictor weights, internally validated and the discriminative ability and calibration of the model will be assessed for the outcomes. Sensitivity analyses will include recalculating risk scores using logistic regression.Ethics and disseminationEthics approval is provided by the University of New South Wales Human Research Ethics Committee (UNSW HREC; protocol numbers HC200515, HC3413). All data are deidentified and securely stored on servers at Neuroscience Research Australia. Study findings will be presented at conferences and published in peer-reviewed journals. The tool will be accessible as a public health resource. Knowledge translation and implementation work will explore strategies to apply the tool in clinical practice.

OBJECTIVES: COMMANDER-HF was a randomised trial comparing rivaroxaban 2.5 mg two times a day to placebo, in addition to antiplatelet therapy, in patients hospitalised for worsening heart failure with coronary artery disease and sinus rhythm. Patients with diabetes are at increased risk of cardiovascular events and therefore have more to gain. METHODS AND RESULTS: In this post-hoc analysis, we evaluated the efficacy and safety of rivaroxaban in patients with (n=2052) and without diabetes (n=2970). The primary outcome was the composite of cardiovascular death, myocardial infarction (MI) or ischaemic stroke. HRs and 95% CIs with interaction analyses were used to describe event-rates and treatment effects. Patients with diabetes had a higher prevalence of cardiovascular comorbidities (eg, hypertension, obesity) and increased incidence of cardiovascular events. Adjusted HRs for events in people with versus without diabetes were 1.34 (95% CI 1.19 to 1.50) for the primary outcome, 1.21 (95% CI 0.84 to 1.75) for stroke, 1.51 (95% CI 1.14 to 1.99) for MI, 1.17 (95% CI 1.05 to 1.31) for heart failure hospitalisation and 1.06 (95% CI 0.56 to 2.01) for major bleeding. Rivaroxaban had no significant effect on event-rates in patients with and without diabetes (all interaction p values >0.05). Low-dose rivaroxaban was associated with an overall reduction in ischaemic stroke (HR 0.66; 95% CI 0.47 to 0.95), with no apparent subgroup interaction according to diabetes status (p-int=0.93). CONCLUSIONS: In COMMANDER-HF a diagnosis of diabetes conferred higher rates of cardiovascular events that, with exception of ischaemic stroke, was not substantially reduced by rivaroxaban. Rivaroxaban was associated with reduced risk of ischaemic stroke for patients with and without diabetes. TRIAL REGISTRATION NUMBER: NCT01877915; Post-results.

IntroductionTherapeutic options for type 2 diabetes mellitus (T2DM) have expanded over the last decade with the emergence of cardioprotective novel agents, but without such data for older drugs, leaving a critical gap in our understanding of the relative effects of T2DM agents on cardiovascular risk.Methods and analysisThe large-scale evidence generations across a network of databases for T2DM (LEGEND-T2DM) initiative is a series of systematic, large-scale, multinational, real-world comparative cardiovascular effectiveness and safety studies of all four major second-line anti-hyperglycaemic agents, including sodium-glucose co-transporter-2 inhibitor, glucagon-like peptide-1 receptor agonist, dipeptidyl peptidase-4 inhibitor and sulfonylureas. LEGEND-T2DM will leverage the Observational Health Data Sciences and Informatics (OHDSI) community that provides access to a global network of administrative claims and electronic health record data sources, representing 190 million patients in the USA and about 50 million internationally. LEGEND-T2DM will identify all adult, patients with T2DM who newly initiate a traditionally second-line T2DM agent. Using an active comparator, new-user cohort design, LEGEND-T2DM will execute all pairwise class-versus-class and drug-versus-drug comparisons in each data source, producing extensive study diagnostics that assess reliability and generalisability through cohort balance and equipoise to examine the relative risk of cardiovascular and safety outcomes. The primary cardiovascular outcomes include a composite of major adverse cardiovascular events and a series of safety outcomes. The study will pursue data-driven, large-scale propensity adjustment for measured confounding, a large set of negative control outcome experiments to address unmeasured and systematic bias.Ethics and disseminationThe study ensures data safety through a federated analytic approach and follows research best practices, including prespecification and full disclosure of results. LEGEND-T2DM is dedicated to open science and transparency and will publicly share all analytic code from reproducible cohort definitions through turn-key software, enabling other research groups to leverage our methods, data and results to verify and extend our findings.

ObjectiveThe main objective of this exploratory study was to investigate the overlooked perspectives and beliefs of Accredited Social Health Activists (ASHA workers) regarding a collaborative care mental health intervention (HOPE: Healthier Options through Empowerment), mental illness and the health of their rural communities.DesignSemi-structured, one-on-one, qualitative interviews.SettingSeven primary health centres (PHCs) in rural Karnataka, India. All PHCs had previously completed the HOPE study.Participants15 ASHA workers, selected via purposive sampling. ASHAs are high school-educated village women trained as community health workers. ASHAs were included if they had previously participated in the HOPE intervention, a collaborative-care randomised controlled trial that aimed to integrate mental healthcare into existing primary care systems in rural Karnataka.InterventionsNo interventions were introduced.ResultsASHA workers mostly had positive interactions with patients, including encouraging them to attend sessions, helping to explain the topics and techniques, and checking on the patients frequently. ASHA workers were able to identify key barriers to treatment and facilitators to treatment. ASHAs claimed that their knowledge about mental illness improved because of the HOPE study, though gaps remained in their understanding of aetiology and treatment. Several expressed interest in receiving additional mental health training. Overall, ASHAs viewed the HOPE study as a necessary and effective intervention, and requested that it expand.ConclusionsThis paper discusses the perspectives of ASHAs who participated in a novel effort to extend the collaborative care model to their own communities. ASHA workers help maintain relationships with patients that encourage participation, and the efforts of ASHAs often aid in mitigating common barriers to treatment. ASHA workers' beliefs and knowledge regarding mental illness can be changed, and ASHAs can become effective advocates for patients. Future collaborative care interventions would likely benefit from involving ASHA workers in community outreach efforts.

ObjectivesThere have been concerns that patients with chronic conditions may be avoiding in-person physician visits due to fear of COVID-19, leading to lower quality of care. We aimed to investigate changes in physician visits and medication prescriptions for chronic diseases before and during the COVID-19 pandemic at the population level.DesignRetrospective cohort study.SettingNationwide claims data in Japan, 2018-2020.ParticipantsWorking-age population (aged 18-74 years) who visited physicians and received any prescriptions for major chronic diseases (hypertension, diabetes and dyslipidaemia) before the pandemic.Outcome measuresThe outcomes were the monthly number of physician visits, the monthly proportion of physician visits and the monthly proportion of days covered by prescribed medication (PDC) during the pandemic (April-May 2020, as the first state of emergency over COVID-19 was declared on 7 April, and withdrawn nationally on 25 May).ResultsAmong 10 346 patients who visited physicians for chronic diseases before the pandemic, we found a temporary decline in physician visits (mean number of visits was 1.9 in March vs 1.7 in April; p

IntroductionCareer firefighters experience chronic circadian rhythm disruption, increasing their risk of cardiometabolic disease. The recent discovery that eating patterns regulate circadian rhythmicity in metabolic organs has raised the hypothesis that maintaining a consistent daily cycle of eating and fasting can support circadian rhythms and reduce disease risks. Preclinical animal studies and preliminary clinical trials have shown promising effects of time-restricted eating (TRE) to reduce disease risk without compromising physical performance. However, there is a lack of research on TRE in shift workers including firefighters. This study aims to investigate the feasibility and efficacy of 10-hour TRE on health parameters that contribute to cardiometabolic disease risks among career firefighters who work on a 24-hour shift schedule.Methods and analysesThe Healthy Heroes Study is a randomised controlled parallel open-label clinical trial with 150 firefighters over 1 year. Firefighters are randomised with a 1:1 ratio to either the control or intervention group. The control group receives Mediterranean diet nutritional counselling (standard of care, 'SOC'). The intervention group receives the same SOC and a self-selected 10-hour TRE window. After the 2-week baseline, participants enter a 3-month monitored intervention, followed by a 9-month self-guided period with follow-up assessments. The impact of TRE on blood glucose, body weight, body composition, biomarkers (neuroendocrine, inflammatory and metabolic), sleep and mood is evaluated. These assessments occur at baseline, at the end of intervention and at 6, 9 and 12-month follow-ups. Temporal calorie intake is monitored with the smartphone application myCircadianClock throughout the study. Continuous glucose monitors, wrist-worn actigraphy device and questionnaires are used to monitor glucose levels, activity, sleep and light exposure.Ethics and disseminationThe study was approved by the Institutional Review Boards of the University of California San Diego and the Salk Institute for Biological Studies. Results will be disseminated through peer-reviewed manuscripts, reports and presentations.Trial registration numberNCT03533023; Pre result.

IntroductionDepression and diabetes are highly disabling diseases with a high prevalence and high rate of comorbidity, particularly in low-income ethnic minority patients. Though comorbidity increases the risk of adverse outcomes and mortality, most clinical interventions target these diseases separately. Increasing physical activity might be effective to simultaneously lower depressive symptoms and improve glycaemic control. Self-management apps are a cost-effective, scalable and easy access treatment to increase physical activity. However, cutting-edge technological applications often do not reach vulnerable populations and are not tailored to an individual's behaviour and characteristics. Tailoring of interventions using machine learning methods likely increases the effectiveness of the intervention.Methods and analysisIn a three-arm randomised controlled trial, we will examine the effect of a text-messaging smartphone application to encourage physical activity in low-income ethnic minority patients with comorbid diabetes and depression. The adaptive intervention group receives messages chosen from different messaging banks by a reinforcement learning algorithm. The uniform random intervention group receives the same messages, but chosen from the messaging banks with equal probabilities. The control group receives a weekly mood message. We aim to recruit 276 adults from primary care clinics aged 18-75 years who have been diagnosed with current diabetes and show elevated depressive symptoms (Patient Health Questionnaire depression scale-8 (PHQ-8) >5). We will compare passively collected daily step counts, self-report PHQ-8 and most recent haemoglobin A1c from medical records at baseline and at intervention completion at 6-month follow-up.Ethics and disseminationThe Institutional Review Board at the University of California San Francisco approved this study (IRB: 17-22608). We plan to submit manuscripts describing our user-designed methods and testing of the adaptive learning algorithm and will submit the results of the trial for publication in peer-reviewed journals and presentations at (inter)-national scientific meetings.Trial registration numberNCT03490253; pre-results.

Background: Breast cancer (BC) is the second most common cancer in the world. This study aimed to investigate the burden of BC due to some risk factors in the Middle East and North Africa (MENA) countries from 1990 to 2019., Methods: This study is a secondary analysis based on the Global Burden of Disease 2019 data. In this study, we used data for disability-adjusted life years (DALYs) and mortality of BC in MENA countries. Also, we presented data for DALYs and mortality attributed to diabetes, smoking and passive smoking among women with BC., Results: The age-standardised DALY due to BC in women increased slowly from 395 (95% CI: 357 to 458) per 100 000 in 1990 to 473 (95% CI: 409 to 544) per 100 000 in 2019. But Kuwait, Bahrain, Jordan and Turkey saw a decrease in age-standardised DALY trends between 1990 and 2019. In 1990, the age-standardised mortality rate was 12.3 (95% CI: 11.0 to 14.2) per 100 000 people, and by 2019, it had increased to 15.2 (95% CI: 13.3 to 17.3) per 100 000. The rate in 2019 varied between countries. Diabetes, smoking and passive smoking contribute significantly to the burden of disease and mortality from BC, with diabetes playing a more impactful role than the other risk factors. Across the MENA region, the burden and mortality attributed to diabetes vary among countries., Conclusion: In the MENA region, the attributable fraction of risk factors such as diabetes, smoking and secondary smoking over BC deaths and DALY has increased in recent years., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group.)

Objective: The purpose of this study was to analyse the heterogeneity of health information-seeking behaviour (HISB) among patients with type 2 diabetes (T2D) in rural areas based on latent profiles and to explore the relationship between various behaviours and glycaemic control rates and the factors influencing glycaemic control rates., Methods: Between January and July 2022, a stratified cluster random sampling method was used to sample T2D patients in the rural Guangxi Zhuang Autonomous Region. Participants completed a general information questionnaire and a HISB scale. Latent profile analysis (LPA) identified behaviour categories, and χ 2 tests examined differences in glycaemic control rates across these categories. Multivariate logistic regression was used to analyse factors influencing glycaemic control. The glycaemic control rate was defined as the proportion of individuals whose HbA1c levels are less than 7.0%, indicating good control, in relation to the total number of individuals assessed., Results: A total of 2178 valid questionnaires were received in this study, and respondents were divided into three categories according to the LPA of their HISB: negative (18.3%), occlusive (46.8%) and inefficient (34.9%). The glycaemic control rate of patients with T2D in rural areas was 22.6% (494/2178 cases). Multivariate logistic regression analysis revealed that the category of patients' HISB profile, age, course of disease and educational level were the factors influencing the glycaemic control rate (all p<0.05)., Conclusion: Patients with T2D in rural areas had poor glycaemic control and inadequate HISB. Three latent profile categories were identified that reflect the HISB of this group. We recommend that clinical medical professionals develop personalised health management education based on the various latent profile characteristics of patients to promote HISB and thereby achieve optimal glycaemic control., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group.)

Objectives: This study aims to report the trends in the certification of both sight impairment (SI) and severe sight impairment (SSI) in England and Wales during the period of 2010 to 2020, prior to the COVID-19 pandemic. The focus is on diabetic retinopathy/maculopathy as the key causative factor., Design: Retrospective database analysis., Setting: England and Wales., Participants: Individuals certified as SI or SSI., Outcome Measures: Trends in certification of vision impairment in England and Wales due to any cause, with specific attention to diabetic retinopathy., Methods: Certifications of vision impairment made by ophthalmologists in England and Wales were recorded and copies were sent to Moorfields Eye Hospital for epidemiological analysis. All certificates completed in England and Wales over an 11-year period, from April 2009 to March 2020, were queried and analysed on an annual basis. This analysis included all causes, and where both the main cause was diabetic eye disease or where diabetic eye disease was a contributory cause among multiple pathologies. Poisson regression was employed to analyse changes in trends over time for certifications of vision impairment., Results: In England, from 2010 to 2020, there was a small but significant reduction (p<0.001) in the overall rate of certifications for SI and SSI due to any cause, from 43.4 certifications per 100 000 people to 41.7 per 100 000 people. Conversely, in Wales, an initial decline was observed, with a decrease from 50.6 to 40.1 per 100 000 people from 2009/2010 to 2014/2015, respectively. This rate subsequently increased to 51.8 per 100 000 by 2019/2020; however, this was not statistically significant (p=0.087). Individuals in Wales had a 9% higher certification rate compared with those in England (1.09 (95% CI 1.07, 1.10)). For diabetic retinopathy, certifications in England significantly decreased from 72.8 to 41.3 per 100 000 people over the study period; in Wales, the certification rate initially declined from 82.3 to 47.1 per 100 000 by 2016/2017 before increasing to 55.5 per 100 000 in 2019/2020. Despite this fluctuation, there was a significant decrease in certifications due to diabetic retinopathy in Wales during the study period., Conclusions: The findings underscore the importance of understanding regional variations in certification rates, particularly in the context of diabetic retinopathy. Despite fluctuations in Wales, the overall reduction in certifications due to diabetic retinopathy in both regions suggests a critical need for ongoing public health initiatives aimed at preventing vision impairment linked to diabetes. However, to provide a true reflection of the burden of vision impairment and its various causes, ensuring that all eligible people are certified is a prerequisite. Continuing attempts to limit the incidence of vision impairment due to diabetic retinopathy remain a priority., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group.)

Objectives: The Assessment of Burden of Chronic Conditions (ABCC) tool is developed to facilitate a personalised approach to care through assessment and visualisation of a patient's experienced burden of disease, and integrating this in the conversation based on shared decision-making and individualised care plans. An indispensable step in the implementation process is an understanding of the context. The aim of this study is to perform a context analysis to identify barriers and facilitators to the implementation of the ABCC tool by healthcare providers (HCPs) in Dutch primary care., Design: A qualitative context analysis was performed among HCPs prior to using the ABCC tool. The Consolidated Framework for Implementation Research was used to map contextual influences through semistructured interviews. A deductive coding process and content analysis was applied to identify barriers and facilitators for the implementation of the ABCC tool., Participants: HCPs who participated as interventionists in an effectiveness study were recruited for this study., Results: 17 HCPs (16 practice nurses and 1 general practitioner) participated. Data saturation was reached at the 11th interview. HCPs expected several major barriers to the implementation of the ABCC tool:too many different digital environments, high complexity in access, lack of time, no integration of the ABCC tool in guidelines and care standards, and patients not willing to adopt an active role in their care process. The major facilitators for implementation were a clear perception of the ABCC tool's benefits, high compatibility with and relative advantage over current practices and being part of a progressive work culture that stimulates innovation., Conclusions: This study provides insight in the barriers and facilitators to the implementation of an intervention in the patient-HCP conversation. Barriers were present in complexity, available resources, patient needs and resources, and external policies and incentives while facilitators were present in knowledge and beliefs, implementation climate and culture. These barriers and facilitators provide opportunities for the selection and tailoring of implementation strategies for the ABCC tool., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group.)

Objectives: Diabetes mellitus is a chronic disease that entails significant burdens to patients, caregivers and society at large. While self-management behaviours like healthy eating and monitoring of blood glucose help to reduce the care burden, they are still perceived to be burdensome. Mobile applications have emerged as promising digital tools in helping patients to self-manage their conditions. We conducted systematic review to explore the perceptions and experiences of adults with types 1, 2 and gestational diabetes using mobile applications for self-management in diabetes., Design: A systematic review of published primary studies exploring perceptions and experiences of adults living with types 1, 2 and gestational diabetes who used/have used mobile applications for self-management. The study was reported following the best practice guidelines defined in the Preferred Reporting Items for Systematic Reviews and Meta-Analyses., Data Sources: We searched for articles published from January 2007 to December 2023 via MEDLINE (Ovid), Embase (Elsevier), CINAHL (Ovid) and Scopus (Elsevier)., Eligibility Criteria: Primary qualitative studies that describe the perceptions and experiences of adults in using mobile applications in self-management of types 1, 2 and gestational diabetes published between January 2007 and December 2023., Data Extraction and Synthesis: Two independent reviewers screened identified papers for eligibility, extracted data using a pre-defined data extraction form and applied the Critical Appraisal Skills Program tool to appraise the quality of the included studies. Data were narratively synthesised, guided by the 'unified theory of acceptance and use of technology (UTAUT)' framework., Results: A total of 24 qualitative studies deploying interviews and surveys with open-ended questions were included in the review. We identified four major themes, which were mapped against the constructs of the 'UTAUT' framework: 'performance expectancy', 'effort expectancy', 'social influence' and 'facilitating conditions'.More than 50% of the studies described favourable app features relating to monitoring blood glucose, diet and exercise while also emphasising the importance of customising these to patient needs. About 40% of the studies described unfavourable aspects related to uploading of excessive information, monitoring device incompatibility, episodic app crashes and telephone handling issues., Conclusion: The review supports the favourable view of mobile applications as promising tools in helping patients with diabetes to self-manage. However, the challenges on the ease of use and non-customised features of the apps potentially hinder patients' long-term engagement., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY. Published by BMJ Group.)

Objectives: The response to glucagon-like peptide-1 (GLP-1) analogues for weight loss varies significantly. We investigated the anthropometric, demographic and clinical characteristics associated with total body weight loss (TBWL) from subcutaneous GLP-1 analogue therapy in patients with obesity in a real-world setting., Design: Retrospective cohort analysis., Setting: An urban, multidisciplinary obesity community clinic in Vancouver, Canada, from November 2018 to April 2021., Participants: 483 adults with a body mass index (BMI) of ≧30 kg/m 2 who had filled a new prescription for subcutaneous semaglutide or liraglutide, with at least 6-month follow-up, were included (mean follow-up: 17.3 months). Individuals with prior bariatric surgery were excluded., Outcomes: The primary outcome was the %TBWL over a mean follow-up period of 520 days. Participant's TWBL was categorised as non-response (<5% TBWL), moderate response (5%-15% TBWL) or hyper-response (>15% TBWL)., Results: The average %TBWL in the cohort was 12.2%. Among the participants, 17.8% had a non-response, 48.4% had a moderate response and 33.8% had a hyper-response. In the multivariable regression analysis, being a woman was associated with hyper-response (adjusted OR 1.92, CI 1.01 to 3.65, p=0.048). Age, diabetes status, baseline BMI, being sedentary, anxiety and depression were not independently associated with TBWL in response to GLP-1 analogue therapy., Conclusions: In a real-world setting, female sex was found to be associated with a hyper-response to GLP-1 analogue therapy for obesity management. Other clinical factors evaluated, including diabetes status, were not associated with the response. Future research should assess additional variables and support the development of novel biomarkers that are associated with weight loss response., Competing Interests: Competing interests: PS, NK, and JN declare no conflicts of interest for this study. NK is a volunteer board member of the International Society of Hypertension. JB received educational grant funding from Bayer; speaker fees from Novo Nordisk, Bausch Health and AstraZeneca; advisory board of Novo Nordisk, Bausch Health and Bayer. AZ received educational program grant funding from Novo Nordisk and Bausch Health; speaker fees from Novo Nordisk, Bausch Health and Eli Lilly; past advisory board of Eli Lilly., (© Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group.)

Objective: As an emerging technology, Android-based open-source closed-loop system also called Android Artificial Pancreas System (AAPS), has been increasingly validated by evidence for its effectiveness in improving glycaemic outcomes, positioning it as a crucial option for managing type 1 diabetes (T1D). However, there are still only a few studies examining the experiences of using AAPS, and relevant qualitative studies have not been conducted in Asia so far. This study aimed to explore the experiences and opinions of adult patients with T1D on the AAPS., Design: Semi-structured interviews and the Insulin Dosing Systems: Perceptions, Ideas, Reflections and Expectations questionnaires were conducted among patients. The questionnaire was scored on a 100-point scale. Thematic analysis was adopted to analyse the transcribed text. Recruitment of interviewees would be halted when no new themes emerged. The scores of the questionnaire on AAPS satisfaction were calculated, and the Mann-Whitney U test was used to compare the results of different sections of the questionnaire., Setting: Guangdong Province in China., Participants: This study recruited patients with T1D from the Guangdong T1D translational medicine study and the 'Tang Tang Quan' T1D online community in China, who participated in a clinical trial on the efficacy and safety of AAPS., Results: The study interviewed 20 adults with T1D aged 32±9.94 years. The T1D duration was 10.93±6.26 years and the glycated haemoglobin was 7.38±0.53%. Five main themes were identified: (1) expectations and feedback on AAPS; (2) impact on quality of life; (3) impact on blood glucose management; (4) user experiences; (5) suggestions for AAPS. The average score of AAPS satisfaction was 73.69 (65.94, 85.94). Mann-Whitney U test suggested that the satisfaction derived from glucose management with AAPS surpassed the satisfaction attributed to the enhancement of their overall quality of life (p<0.05)., Conclusions: Adults with T1D had generally positive experiences with AAPS. The future focus of AAPS research and development should be on optimising glycaemic management, improving device experience and reducing costs., Trial Registration Number: NCT05726461; Pre-results., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group.)

Introduction: Stress hyperglycaemia at hospital presentation is associated with poorer outcomes. Less is known about the risk of poorer outcomes according to achieved glycaemia early in the admission., Research Design/methods: This was a retrospective observational study of patients admitted to non-critical care wards. The aim was to determine the relationship between the day 2 peak blood glucose and the occurrence of hospital-acquired complications (HACs) or in-hospital mortality. A Cox proportional hazards model, adjusted for relevant covariates, was used to evaluate the impact of day 2 peak glucose on HACs and in-hospital mortality, and we identified peak glucose thresholds correlating with an increase in risk., Results: For the whole cohort, day 2 peak glucose was associated with an increased risk of any HAC, aHR=1.06, 95% CI: 1.04, 1.07; but not in-hospital mortality, aHR=0.98, 95% CI: 0.94, 1.01. The risk of HAC infection increased by 4.6% for every mmol/L rise in day 2 peak glucose (aHR=1.05, 95% CI: 1.02, 1.08) in the diabetes cohort compared with 5.5% (aHR=1.06, 95% CI: 1.00, 1.11) in the non-diabetes cohort. The risk of HAC cardiac in the diabetes cohort increased by 5.3% (aHR=1.05, CI: 1.01, 1.10) per mmol/L increase in day 2 peak glucose; no association was found in the non-diabetes cohort (aHR=1.03, 95% CI: 0.94, 1.13). The risk for in-hospital mortality was associated with day 2 peak glucose, aHR=1.11, 95% CI: 1.03, 1.20, in patients without diabetes, but not in patients with diabetes, aHR=1.00, 95% CI: 0.95, 1.06. There was an increase in the risk of HAC once day 2 peak blood glucose exceeded 19.0 mmol/L (whole cohort), with thresholds of 13.6 mmol/L in the non-diabetes group and 19.5 mmol/L in the diabetes group., Conclusion: The peak glucose on day 2 was a predictor of HAC in the entire cohort and in-hospital mortality in patients without diabetes., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY. Published by BMJ Group.)

Introduction: MODY2 (maturity-onset diabetes of the young type 2, MIM125851) is a monogenic diabetes with an autosomal dominant transmission caused by a variant of the GCK gene. MODY2 is often confused with type 1 or type 2 diabetes, but despite a slightly elevated blood glucose level, it does not induce long-term vascular complications, nor does it require pharmacological treatment. Genetic testing for the diagnosis of MODY2 is currently reserved for genetic specialists and some physicians. Still, access to it by primary care healthcare professionals (HCPs), coupled with appropriate training, would improve the diagnosis and management of patients with MODY2. Thus, to evaluate the implementation in primary care of genetic testing for the screening of MODY2 (iMOgene study), an implementation pilot study has been designed supported by the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework., Method and Analysis: Two primary care clinics will be involved in the region of Saguenay-Lac-Saint-Jean (Québec, Canada). An asynchronous online training on MODY2 and genetic testing, including pre/post questionnaires, will be provided to the HCPs. Satisfaction, adoption and maintenance indicators will be collected throughout the project for each clinic. Questionnaires for patients and professionals and focus groups with HCPs will be conducted to assess implementation. This study will document the implementation process of genetic testing in primary care by identifying facilitating and limiting factors to establish specifications for scaling up., Ethics and Dissemination: The present protocol has been approved by the research ethic committee of the 'C entre intégré universitaire de santé et de services sociaux of Saguenay-Lac-Saint-Jean' (CIUSSS-SLSJ) on 9 January 2024 and by the 'C omité central d'éthique de la recherche ' (CCER) of the ' Ministère de la Santé et des Services Sociaux ' of Quebec (Canada) on 30 January 2024. The informed consent of participants will be obtained orally. Dissemination of the study results will involve peer-review publications, presentations at major national and international scientific conferences., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group.)

Introduction: Several cardiovascular outcome trials have been conducted to assess the cardiovascular safety and efficacy of glucagon-like peptide-1 receptor agonists (GLP1-RAs) on cardiorenal outcomes in patients with type-2 diabetes (T2D). However, the strict requirements of randomised controlled trials to avoid most confounding factors are at the expense of external validity. Using national real-world data, we aimed to evaluate the effectiveness of GLP-1RAs in association with metformin especially on cardiovascular events, hospitalisation for heart failure and all-cause death in comparison with other diabetes treatment schemes using dipeptidyl peptidase IV inhibitors, sulfonylureas/glinides or insulin also associated with metformin. Sodium-glucose transport protein 2 inhibitors (SGLT-2i) will be excluded as comparators, as this class of oral hypoglycaemic agents just started in 2020 to be marketed in France., Methods and Analysis: The Système National des Données de Santé is a comprehensive nationwide administrative healthcare database in France that covers approximately 67 million people.Several cohorts of adult patients with T2D initiating any GLP1-RA in dual or triple therapies, as recommended by the French Health authorities, will be identified in this database over the period 2016-2021. These cohorts will be defined by the combination of glucose-lowering drugs prescribed simultaneously with GLP1-RA and diabetes treatment received over a 6-month period before GLP1-RA initiation. They will be first matched with T2D controls (1:3 ratio) based on the year of drug initiation and treatment regimens before and simultaneously with GLP1-RA in the different selected cohorts. Comparative analyses will be conducted versus these control groups, adjusting for cardiovascular event history and a propensity score considering age, sex, area of residence, deprivation index, comorbidities, duration of diabetes, use of lipid-lowering drugs, anticoagulants, antiplatelet therapies and blood pressure-lowering therapies. Comparative analyses will be conducted versus these control groups, using a high-dimensional propensity scores method and fixed baseline characteristics. Treatment effects on the different outcomes measured will be estimated for each GLP1-RA group, through HR and their corresponding CIs (95% CI) using Cox regressions and/or competitive risk regressions when necessary., Ethics and Dissemination: The study has been approved by an independent ethics committee (Comité éthique et scientifique pour les recherches, les études et les évaluations dans le domaine de la santé, Paris, France; reference: 8699786, dated 2 June 2022) and has been registered with the French National Data Protection Commission (Commission Nationale de l'Informatique et des Libertés, Paris, France; reference: 922161, dated 26 June 2022). The findings of this study will be published in peer-reviewed scientific journals and presented at international conferences., Trial Registration Number: F20220803152803., Competing Interests: Competing interests: ND has received fees for giving talks or participating to advisory boards, or support for attending meetings from: Amgen, AstraZeneca, Bayer, BMS, Boehringer Ingelheim, Bouchara-Recordati, IBSA, Maincare, MSD, NovoNordisk, Pfizer, Servier, UCB and Vifor. GL has received fees and honoraria from Alnylam, Amarin, Amgen, Astra Zeneca, Bayer, Bristol Myers Squibb, Boehringer Ingelheim, Boston Scientific, MSD, Novartis, Novo Nordisk, Organon, Pfizer, Recordati and Sanofi Aventis. MM has received fees and honoraria from Acticor Biotech, Astra Zeneca, Boehringer Ingelheim, Novartis, Novo Nordisk. KM has received consulting fees from Novo Nordisk; honoraria for lectures, presentations, or speaker bureaus from Novo Nordisk, Astra Zeneca, Boehringer-Ingelheim, Eli Lilly, Sanofi, Lifescan, Abbott, and Bayer; and participation to Advisory Board from Novo Nordisk, Sanofi and Amarin. FS has received research grants from and/or was speaker (with or without lecture fees) on a.o. (CME accredited) meetings sponsored by Amgen, Bayer, Novartis, Novo Nordisk, Sanofi Aventis, Recordati, Servier, Mylan and AstraZeneca. IS has received fees and honoraria from Novonordisk, Sanofi Synthé-Labo, Servier, Boheringer Ingelheim, Astra-Zeneca and Medtronic. AC, CE and CN are employees of CEMKA, a French heath care Clinical Research Organization. LV and CM are employees of NovoNordisk. BD has received fees from Astra-Zeneca, CEMKA, Novo-Nordisk, Abbott, Sanofi Winthrop Industry, Lumanity, Continuum+ and CERBA. LF has received consulting fees from AstraZeneca, Bayer, BMS/Pfizer, Boehringer Ingelheim, Novo and XO, and speaker activities for AstraZeneca, Bayer, BMS/Pfizer, Boehringer Ingelheim, Boston Scientific, Medtronic and Zoll., (© Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group.)

Introduction: Type 2 diabetes mellitus (T2DM) is a major burden on public health worldwide. To reduce adverse events and complications, effective T2DM self-management is required. Self-management and glycaemic control are generally poorer in lower educated people compared with higher educated people. This study aims to assess the (cost-)effectiveness and to conduct a process evaluation of a diabetes self-management programme, 'Powerful Together With Diabetes' (PTWD), which is specifically developed for patients from lower educational groups., Methods and Analysis: The PTWD programme is focused on attaining basic knowledge and skills for effective diabetes self-management. In a previous study (the Diabetes in Social Context (DISC) study), lower-educated participants enjoyed the PTWD programme as well as improved their T2DM-related behaviours. The design of the study is an effectiveness-implementation hybrid type 2 trial. We will conduct mixed methods effectiveness, process and economic evaluations. To investigate the (cost-)effectiveness, a two-arm quasi-experimental trial will be conducted with a parallel mixed method process evaluation. The primary outcome of the study is change in haemoglobin A1c levels from baseline to 12 months. Secondary outcomes include use of primary and secondary care, medication use, blood biomarkers, T2DM self-management health behaviours, anthropometrics, and quality of life. Data will be collected with questionnaires, physical activity trackers and registration data from general practitioner registries. To see if the results are maintained, we will also measure the outcomes 24 months after baseline. Study participants are patients from lower educational groups living with T2DM between 35 and 70 years old. Participants will be recruited through general practices, and the intervention will be held in community centres. Our aim is to include 114 participants in the intervention group and 570 participants in the control group., Ethics and Dissemination: This study has been approved by the Medical Ethics Committee of the Academic Medical Center in Amsterdam (#2021&#95;222). Participants will sign an informed consent form prior to enrolment. Manuscripts with the results of the effectiveness, economic and process evaluations will be published in peer-reviewed journals., Trial Registration Number: ISRCTN12982302 ISRCTN registry (registered on 29 March 2022)., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group.)

Objective: The study aims to assess the effect of intrauterine metformin exposure on offspring adiposity measures in childhood., Design: Systematic review and meta-analysis., Data Sources: Medline, Embase and Cochrane Central were searched from inception to 4 October 2024., Eligibility Criteria for Selecting Studies: Follow-up studies of randomised-controlled trials and observational studies involving metformin use in pregnancy for any insulin-resistant maternal condition were included., Data Extraction and Synthesis: Two reviewers independently extracted data and completed risk-of-bias assessments using either Cochrane Risk-Of-Bias tool V.2 or Risk of Bias in Non-Randomised Studies of Exposure depending on study design. Meta-analyses were conducted using the generic inversed variance method in a random-effects model. Grading of Recommendations Assessment, Development and Evaluation methodology was used to assess certainty of evidence., Results: 18 studies reporting on 7975 children with metformin exposure in utero and over 1 million children without metformin exposure were included. At the oldest age of follow-up reported (weighted mean age of 4.4 years), children with metformin exposure for any maternal indication had comparable body mass index (BMI) with their non-exposed peers (standardised mean difference (SMD) -0.02; 95% CI: -0.11, 0.07; low certainty). When stratified by age at follow-up, while metformin-exposed children had slightly higher BMI at 1-3 years of age (SMD 0.15; 95% CI: 0.04, 0.27; low certainty), no difference remained between the two groups by ages 3-6 and 6-11 years. When stratified by maternal diagnosis, no difference in BMI was found in the diabetes and obesity subgroups, while in the polycystic ovary syndrome subgroup metformin-exposed children were heavier than non-exposed peers (SMD 0.31; 95% CI: 0, 0.62; low certainty). No difference was seen in overweight, obesity or waist circumference., Conclusions: Metformin-exposed children did not differ in adiposity measures compared with their non-exposed peers in later childhood. This adds to the growing body of evidence supporting the long-term safety of metformin use in pregnancy., Prospero Registration Number: CRD42023394464., Competing Interests: Competing interests: DSF reports in-kind donations of metformin and placebo from Apotex for the MiTy trial. Other unrelated grants include those from the Canadian Institute of Health Research, an investigator-initiated grant from Dexcom, in-kind donations from Dexcom and Tandem and honoraria from Novo Nordisk for speaking and from Ypsomed for participating in an Advisory Panel. JH participates in unrelated industry trials (Rhythm Pharmaceuticals, Eli Lilly) and has received honoraria for participation in advisory panel (Novo Nordisk, Rhythm Pharmaceuticals). JH holds the University of Toronto Mead Johnson Chair in Nutritional Science which provides unrestricted research funds. JF, NT, KEM and GT have no conflicts of interest to declare., (© Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group.)

Introduction: Glycated haemoglobin (HbA1c) is currently the gold standard for assessing glycaemic control in diabetes, given the established relationship with microvascular and macrovascular complications in this condition. However, HbA1c is affected by non-glycaemic factors, while also failing to provide data on hypoglycaemic exposure and glucose variability, which are associated with adverse vascular outcomes. Continuous glucose monitoring (CGM)-derived glucose metrics provide a more comprehensive assessment of glycaemia, but their role in predicting future vascular complications remains unclear. Here, we present the protocol for a real-world cohort study, aiming to establish the relationship between CGM-derived glycaemic metrics and the incidence of macrovascular and/or microvascular complications in people with diabetes., Methods and Analysis: This cohort study will use data from all CGM new users (FreeStyle Libre system) in France who uploaded their glycaemic values onto the LibreView cloud-based system, linked with data from the French nationwide Système National des Données de Santé claims database. The study is expected to include a minimum of 70 000 individuals with diabetes with a first date of glucose data upload to the LibreView platform after 1 January 2018 and with a 6-year follow-up period. The primary outcomes are the first occurrence of new macrovascular or microvascular complications, analysed as a composite outcome and separately. Secondary outcomes will include all-cause mortality and hospital admissions for any cause. This longitudinal study will provide key data on the relationship between CGM-derived glycaemic metrics and micro/macrovascular complications in diabetes. This will have an impact on routine clinical practice by setting targets for the different glycaemic markers, based on robust outcome data, thus helping to optimise glucose management in diabetes., Ethics and Dissemination: The study data-collection protocol is approved by the French National Commission for Informatics and Liberties, including approval from the Comité Ethique et Scientifique pour les Recherches, les Etudes et les Evaluations dans le domaine de la Santé . This study complies with French and European regulations, including those relating to the General Data Protection Regulation. This study uses pseudonymous information, not requiring informed consent. Dissemination plans include full publication of the study outcomes in peer-reviewed journal(s) with open access and presentations at national and international diabetes and cardiovascular conferences., Competing Interests: Competing interests: TB has served on advisory panels for Novo Nordisk, Sanofi, Eli Lilly, Boehringer, Medtronic, Abbott and Indigo Diabetes, and has received honoraria for participating as a speaker for Eli Lilly, Novo Nordisk, Medtronic, Abbott, Sanofi, Dexcom, Aventis, Astra Zeneca and Roche. TB’s institution has received research grant support from Abbott, Medtronic, Novo Nordisk, Sanofi, Novartis, Sandoz, Zealand Pharma, the Slovenian Research Agency, the National Institutes of Health and the European Union. EC has received honoraria for presentations and/or consultancy and/or research funding from Abbott Diabetes Care, Astra Zeneca, AlphaDiab, Lilly, Medtronic, MSD, Novartis, Novo Nordisk, Roche Diagnostics, Sanofi-Avantis and YpsoMed. FLG is employed by Abbott Diabetes Care. RAA has received honoraria for presentations and/or consultancy and/or research funding from Abbott Diabetes Care, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Meyers Squibb, Eli Lilly, GlaxoSmithKline, LifeScan, Menarini Pharmaceuticals, Merck-Sharp & Dohme, Novo Nordisk, Roche, Sanofi and Takeda. JS has received honoraria for talks and/or consultancy and/or research funding from Abbott Diabetes Care, Apitope, AstraZeneca, Bayer, Berlin Chemie, Boehringer Ingelheim, Bristol-Meyers Squibb, Eli Lilly, GI-Dynamics, GlaxoSmithKline, Intarcia, Ipsen, Janssen, LifeScan, MedScape, MSD, Novartis, Novo Nordisk, OmniaMed, Pfizer, Roche, Sanofi, Servier, Takeda and Ypsomed. MJ has received consultant fees and/or research grants from Abbott, Air Liquide Santé International, Amgen, Asdia, AstraZeneca, Bayer, BMS, Boehringer-Ingelheim, Dexcom, Dinno Santé, Glooko, Insulet, Lifescan, Lilly, LVL médical, Medtronic, MSD, Nestle HomeCare, Novo Nordisk, Organon, Orkyn, Roche Diabetes, Sanofi, Tandem, Vitalaire and Voluntis. LCB and PB declare no conflicts of interest, (© Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group.)

Objective: To evaluate the association between thyroid disease and diabetes markers., Design: Retrospective cohort study., Setting: The study was conducted in a diagnostic setting where the primary care providers recommended the patients to test for thyroid and diabetes panels., Participants: The thyroid and diabetes markers were tested in 32 787 subjects with suspected thyroid and related conditions who visited Vibrant America Clinical Laboratory between January 2015 and June 2019., Results: Our general prevalence results showed that homeostatic model assessment-insulin resistance (HOMA-IR) was elevated in overt hypothyroid subjects (43.7%) and overt hyperthyroid subjects (42.2%). Glycated hemoglobin (HbA1C) was elevated in subclinical hypothyroid subjects (19.2%), overt hypothyroid subjects (22.3%) and overt hyperthyroid subjects (21.2%). Glucose was significantly elevated in subclinical hypothyroid subjects (24.2%) and overt hyperthyroid subjects (31.0%). Insulin was significantly elevated in overt hypothyroid subjects (15.1%). Interestingly, we found that 70.3% of subjects who had their HOMA-IR score escalated from negative (HOMA-IR<2.7) to positive (HOMA-IR>2.7) during their multiple visits had anti-thyroid peroxidase (anti-TPO) 369 (±242) days prior to the onset of this change., Conclusion: Our findings showed that anti-TPO levels are elevated before the onset of insulin resistance, indicating its potential use as a predictive marker., Competing Interests: Competing interests: The authors have read the journal’s policy, and the authors of this manuscript have the following competing interests: TS and QS are paid employees of Vibrant America. KK, VJ, TW, KB, HK and JJR are paid employees of Vibrant Sciences. Vibrant Sciences or Vibrant America could benefit from increased testing based on the results. There are no patents, products in development or marketed products to declare., (© Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group.)

Background: The association between serum uric acid (SUA) and dyslipidaemia is still unclear in patients with type 2 diabetes mellitus (T2DM). This study aimed to examine the association between SUA and dyslipidaemia and to explore whether there is an optimal SUA level corresponding to the lower risk of suffering from dyslipidaemia., Research Design and Methods: This cross-sectional study included 1036 inpatients with T2DM and the clinical data were extracted from the hospital medical records. Multivariate logistic regression analysis was performed to assess the association between hyperuricaemia and dyslipidaemia. Restricted cubic splines (RCS) analysis was performed to determine the optimal SUA level for the lower risk of dyslipidaemia., Results: After adjustment for the potential confounders, hyperuricaemia was significantly associated with dyslipidaemia (OR=3.72, 95% CI: 2.28, 6.07) and hypertriglyceridaemia (OR=2.63, 95% CI: 1.68, 4.12). Notably, mediation analysis revealed a significant mediating effect of SUA in this relationship (indirect effect=0.08, p<0.001), elucidating 20.1% of the total relationship., Conclusions: Hyperuricaemia was positively associated with dyslipidaemia and hypertriglyceridaemia. SUA mediated the effect of insulin resistance on triglyceride metabolism in patients with T2DM. A potential benefit of stricter control of SUA levels among patients with T2DM is possibly reducing the risk of dyslipidaemia., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group.)

Objectives: Diabetes distress can negatively affect the well-being of individuals with type 1 diabetes (T1D). Voice-based (VB) technology can be used to develop inexpensive and ecological tools for managing diabetes distress. This study explored the competencies to engage with digital health services, needs and preferences of individuals with T1D or caring for a child with this condition regarding VB technology to inform the tailoring of a co-designed tool for supporting diabetes distress management., Design: We used a mixed methods design. We performed a qualitative reflexive thematic analysis of semistructured interviews of people living with T1D or caring for a child with T1D, complemented by quantitative analysis (descriptive statistics)., Setting: 12 adults living with T1D who attended diabetes centres or cared for a child with this condition participated in semistructured interviews to collect opinions about voice technology. They also responded to three questionnaires on sociodemographics and diabetes management, diabetes distress and e-health literacy., Outcome Measures: Main: Patient experiences and perceptions derived from the coded transcriptions of interview data. Secondary: Quantitative data generated from Socio-Demographic and Diabetes Management questionnaire; Problem Areas in Diabetes Scale and e-Health Literacy Questionnaire., Results: Five major themes were generated from the participants' interview responses: (1) Experience of T1D, (2) Barriers to VB technology use, (3) Facilitators of VB technology, (4) Expectations of VB technology management in T1D, (5) Role of healthcare professionals in implementing VB technology for T1D. Most participants expressed a favourable view of voice technology for diabetes distress management. Trust in technology and healthcare professionals emerged as the predominant sentiment, with participants' current device type impacting anticipated barriers to adopting new technologies., Conclusion: The results highlighted positive participant views towards VB technology. Device use, previous experience and health professional endorsement were influential facilitators of novel VB digital health solutions. Further research involving younger people with T1D could further contribute to the successful development of these tools., Trial Registration Number: ClinicalTrials.gov, NCT05517772., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group.)

Introduction: People with cystic fibrosis (PwCF) are at high risk for developing cystic fibrosis (CF)-related diabetes (CFRD), which worsens morbidity and mortality. Although the pathological events leading to the development of CFRD are complex and not completely understood, dietary factors may play a role. For example, habitual intake of dietary added sugar (i.e., sugar not naturally occurring in foods) has been shown to be increased in PwCF and this excess intake of added sugar could increase the risk of CFRD., Methods and Analysis/design: The goal of this ongoing double-blind, randomised, parallel-group clinical trial is to recruit approximately 60 clinically stable adults with CF to determine if a low-added sugar intervention improves beta-cell responsiveness and insulin sensitivity (Aim 1), reduces visceral adipose tissue (VAT) and other ectopic fat deposition (Aim 2) and improves plasma redox status (Aim 3) over 8 weeks compared with a typical CF diet. All foods will be provided. Participant selection criteria include confirmed CF diagnosis without CFRD, ≥18 years of age, and baseline estimated daily total added sugar intake >16 tsp. Eligible participants will be randomised to one of two arms: a low-added sugar diet (<5% of kcal from added sugars) or a high-added sugar (≥13% kcal from added sugars) diet. The two diets will be isocaloric and provide 35%-40% kcal from fat. Participants will be seen in the research unit for a screening, baseline/randomisation and 4-week and 8-week follow-up visits. Major study endpoints are changes in beta-cell responsiveness determined by a glucose-potentiated arginine stimulation test (primary endpoint), VAT assessed by magnetic resonance imagin (MRI) and fasted plasma cysteine redox potential. Diet tolerance, body weight and compliance are monitored weekly by phone by an unblinded study dietitian. All analyses will be intention-to-treat. Changes in study endpoints will be assessed with repeated-measures analysis. Models will assess the effects by study arm, time on study, and the interaction between arm and time on study., Ethics and Dissemination: The National Institutes of Health (NIH) funds this study (R01 DK133523). The study protocol was approved by the Emory Institutional Review Board (IRB approval number: 000004517). Any protocol modifications will be reviewed and approved by the IRB prior to implementation and communicated with the study team and participants, as relevant.We will provide reports of the findings to the NIH and Emory IRB in regular progress reports and post the findings on www., Clinicaltrials: gov. We will inform the findings of the study to the scientific community through presentations and peer-reviewed publications. Authorship for any resulting publications will follow the guidelines established by the International Committee of Medical Journal Editors., Trial Registration Number: This research study is registered at www., Clinicaltrials: gov (NCT05766774)., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Individuals with pre-diabetes are at high risk for developing type 2 diabetes mellitus (T2DM), which makes them prone to serious complications such as stroke, kidney failure, blindness and lower-limb amputation. Pre-diabetes can be reversed, and lifestyle modification is considered the best intervention method for diabetes prevention. However, it is difficult for individuals with pre-diabetes to maintain a long-term modified healthy lifestyle owing to psychological burnout in daily management over time due to poor adherence. We developed a novel virtual health management community (VHMC) model based on group interaction management. We present the protocol for the VHMC model applied to the pre-diabetic population-a randomised controlled trial (RCT)., Methods and Analysis: This study will be conducted to determine the effectiveness of the pre-diabetes VHMC-group interaction management model on improving long-term lifestyle intervention adherence to reduce the incidence of T2DM in China. We will conduct a prospective, multicentre, single-blinded, two-arm, RCT, and a total of 706 patients will be recruited. Those randomly assigned to the intervention group will receive group interaction management based on the VHMC platform. Measures of incidence of T2DM, diabetes outcomes, lifestyle modification and psychosocial outcomes will be assessed at baseline, 3, 6, 12, 24 and 36 months. If the VHMC-group interaction management model shows efficacy in improving the self-management of pre-diabetes or metabolic control, similar interventions may be applied to other chronic conditions. The cost-utility analysis of this model may indicate that this platform could be a potentially cost-effective and efficient way to integrate the VHMC platform into the health management of patients with pre-diabetes., Ethics and Dissemination: The Ethics Committee of the Third Affiliated Hospital of Sun Yat-sen University approved this study (No. RG2023-262-02). The results of this study will be disseminated through conference presentations and peer-reviewed publications., Trial Registration Number: ChiCTR2400081268. Study start: 1 July 2024, completion: 1 December 2026., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: Telemonitoring (TM) remotely monitors individuals' health. Awareness of personal clinical data has resulted in improved glycaemic control in adults with type-2 diabetes mellitus (T2DM). However, its effects on their health-seeking behaviour remain unclear. This study aims to explore and understand the effects of a multicomponent TM system on self-efficacy in adults with T2DM., Design: A qualitative study using semistructured interviews., Setting: A public primary care clinic which is located at an estate in north-eastern Singapore with a population of about 300 000 multiethnic Asian residents., Participants: 21 participants who completed 6 months of TM intervention which included immediate feedback on glucose and blood pressure readings, educational videos on exercise and nutrition, and personalised support with TM nurse when clinical parameters met high glucose or blood pressure thresholds., Results: The health belief model was used to explain the participants' behaviour change, including (1) immediate feedback from TM clinical parameters (blood pressure and glucose), raised their awareness of their health status and disease control to motivate behaviour change; (2) notification of higher glucose through TM allowed patients to reflect on their recent food consumption and nudged them to select healthier food options; (3) App teleeducation improved health literacy and supported lifestyle changes; (4) cues for action through personalised engagement with TM nurse and via automated reminders and (5) the TM system enhanced self-efficacy by modifying their multifaceted self-care behaviours., Conclusion: TM heightened understanding among adults with T2DM of their potential for health complications and increased awareness of the benefits of proper diabetes management. It also helped lower the barriers to self-management and further enhanced their self-efficacy in self-care. The system and care team provided users with cues for health which was perceived to lead to adapting their lifestyle in order to achieve better health outcomes., Clinical Trials Registration Number: NCT04306770., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: A variety of hypoglycaemic drugs are used to treat polycystic ovarian syndrome (PCOS), but their efficacy remains insufficient. Glucokinase activators (GKAs) are a unique class of hypoglycaemic medications with emerging potential, notably in significantly reducing insulin resistance (IR). Nevertheless, the efficacy of GKAs in treating PCOS, particularly in the absence or presence of IR, remains uncertain. The meta-analysis protocol aims to address this knowledge gap, furnish evidence-based data to support potential revisions in PCOS treatment guidelines and promote the utilisation of GKAs in clinical settings., Methods and Analysis: A comprehensive search will be conducted across the Cochrane Central Register of Controlled Trials, PubMed, Web of Science, Embase, Medline, Scopus, CNKI, Wanfang and VIP databases to identify randomised controlled trials investigating the use of GKAs in the treatment of PCOS, irrespective of the presence of IR. The search will encompass all available studies without language restrictions and cover the period from the inception of each database to 10 April 2024. Disputes will be resolved by talking with a third expert following the screening of articles and data extraction by two reviewers. The primary outcomes of interest encompass changes in anthropometric parameters, menstrual frequency, sex hormone levels, and glucose metabolism, while secondary objectives include lipid metabolism and adverse events. The methodological quality of each study will be assessed using Version 2 of the Cochrane Collaboration tool for assessing Risk of Bias (RoB 2.0), and the Grade of Recommendations, Assessment, Development and Evaluation (GRADE) technique will be used to assess the quality of evidence and degree of recommendation. The study duration of this study will be from 5 April 2024 to 10 April 2025., Ethics and Dissemination: Since this study just analyses data that are readily available to the public and does not directly involve patient participation, ethical approval is not necessary. The findings will be made public by being published in a medical journal that is subject to peer review., Prospero Registration Number: CRD42024535633., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group.)

Introduction: Metabolic disorders (type 2 diabetes, insulin resistance, hyperglycaemia, obesity, hyperlipidaemia, hypertension, non-alcoholic fatty liver disease and metabolic syndrome) are leading causes of mortality and disability worldwide. These disorders disproportionately affect older adults relative to those younger. Digital health technologies (DHTs), such as patient monitoring, digital diagnostics and digital therapeutics, emerge as promising tools for health promotion in day-to-day life. However, their role in targeting metabolic disorders, particularly among a key demographic of older adults, is not yet fully understood. Thus, this study aims to scope the use of DHTs in managing metabolic health disorders among older adults. To our knowledge, this is the first review to categorise DHTs for older adults with metabolic disorders, contributing to the growing literature in the intersection of metabolic disorders and DHTs., Methods and Analysis: We will conduct a scoping review following the recommended framework by Arksey and O'Malley. Our search will focus on three primary concepts: metabolic disorders, DHTs and older adults. We plan to search five online databases (Cochrane, ScienceDirect, PubMed, Scopus and Web of Science) to identify original research articles published between January 2014 and January 2024. Two independent reviewers will screen articles based on predefined eligibility criteria, with a third reviewer resolving conflicts. Data will be extracted using a standardised form, and results will be synthesised qualitatively and quantitatively. The database searches, data collection and analysis are planned and have not been conducted., Ethics and Dissemination: No ethics approval is required for this protocol and scoping review. Data will be used only from published studies with appropriate ethics approval. Results will be disseminated in a peer-reviewed publication., Competing Interests: Competing interests: PH, TK, EG and MJ are affiliated with the Centre for Digital Health Interventions, a joint initiative of the Institute for Implementation Science in Health Care, University of Zurich, the Department of Management, Technology and Economics at ETH Zurich, and the Institute of Technology Management and School of Medicine at the University of St.Gallen, Centre for Digital Health Interventions is funded in part by MavieNext, an Austrian health care provider, CSS, a Swiss health insurer and MTIP, a growth equity firm. TK is also a cofounder of Pathmate Technologies, a university spin-off company that creates and delivers digital clinical pathways. However, neither CSS, MTIP, nor Pathmate Technologies was involved in this protocol. All other authors have no conflicting interests., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Diabetic macular oedema (DMO), a serious ocular complication of diabetic retinopathy (DR), is a leading cause of vision impairment worldwide. If left untreated or inadequately treated, DMO can lead to irreversible vision loss and blindness. Intravitreal injections using antivascular endothelial growth factor (anti-VEGF) and laser are the current standard of treatment for DMO. These treatments are costly and invasive and must be repeated over several years with a high service load. Fenofibrate has been shown to reduce the progression of DR. However, there is a lack of high-quality data on the effects of fenofibrate on established DMO. This study aims to evaluate the effectiveness of oral fenofibrate for the treatment of DMO., Methods and Analysis: This randomised double-blind, placebo-controlled trial recruited 204 patients with DMO across three different clinics in Sydney. Participants will be randomly allocated in a 1:1 ratio to intervention and control groups. The intervention group will receive oral fenofibrate (145 mg) taken once daily for 24 months, while the control group will receive placebo tablets taken once daily for 24 months. Standard care with anti-VEGF injections, focal lasers or observation will also be provided to all participants regardless of their group allocation. The primary outcome is the reduction in DMO measured using central macular subfield thickness (CSMT) on optical coherence tomography imaging at 24 months. Secondary outcomes at 24 months include the proportion of eyes with CSMT <250 µm, number of anti-VEGF injections, number of laser sessions needed, best-corrected visual acuity letter score gains, rates of adverse events, progression in DR lesions and changes in quality of life measures. Comparison between groups will be evaluated using analysis of variance. Multiple regression analyses adjusting for age, glycated haemoglobin, number of injections and other covariates will also be performed., Ethics and Dissemination: Ethics approval has been granted by the University of Sydney Human Ethics Committee (HREC-2019/892), and the trial has been registered with the Australia New Zealand Clinical Trials Registry (ACTRN12618000592246). The study adheres to the principles of the Helsinki Declaration and the National Health and Medical Research Council National Statement on Ethical Conduct in Human Research. Trial results will be disseminated to the public in de-identified form through publications in peer-reviewed journals., Trial Registry Name: Australian New Zealand Clinical Trials Registry., Trial Registration Number: ACTRN12618000592246., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ Group.)

Introduction: Type 2 diabetes mellitus (T2DM) is a highly heterogeneous and complex metabolic disease harbouring different metabolic characteristics. Adequate characterisation of subjects is essential to allow the implementation of precision medicine for the prevention, diagnosis, prognosis and treatment of this condition., Methods and Analysis: This prospective observational cohort study aims to identify and characterise relevant clinical clusters that are reproducibly associated with various clinical outcomes in T2DM in our Mediterranean region. The COPERNICAN study will include 1200 subjects with newly diagnosed T2DM from 28 primary care centres from the city of Barcelona and the healthcare district of Lleida in Catalonia (Spain). Participants will undergo a comprehensive phenotypic evaluation including, among others, six relevant variables: age, antibodies against glutamic acid decarboxylase, body mass index, glycated haemoglobin (HbA1c), indexes of insulin sensibility (HOMA2-IR) and secretion (HOMA2-beta). We will collect additional comprehensive data on glucose-lowering and other drug treatments, clinical evaluation (including complications), laboratory parameters, advanced lipoprotein profile, dietary habits and physical activity. The linkage with the population database will be done to perform a pragmatic follow-up of participants as part of their usual clinical care. A state-of-the-art cluster analysis (k-means and hierarchical clustering) will be performed., Ethics and Dissemination: The present study complies with all the ethical aspects and protection of participant subjects complying with all current local and European Union legislation. All Ethics Committees from the institutions involved in the study (IR Sant Pau Ethics Committee, Ethics Committee for Drug Research at IDIAP Jordi Gol and University Hospital of Bellvitge Ethics Committee for Research) approved this protocol. Confidentiality and anonymity of the data are ensured according to the current Spanish Organic Law 3/2018 of 05 December., Trial Registration Number: ClinicalTrials.gov. registration number NCT05333718, 27 January 2023., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: To examine inpatient COVID-19-related outcomes among patients with and without diabetes alone or with a history of established heart failure (HF) or established atherosclerotic cardiovascular disease (ASCVD)., Design: Observational study; longitudinal analysis of registry data., Setting: Hospitals in the USA reporting to the American Heart Association (AHA) COVID-19 Registry from January 2020 to May 2021., Participants: 20 796 individuals with diabetes (11 244 men; mean age 64.2) and 30 798 without diabetes (15 980 men; mean age 59.0) hospitalised for COVID-19 in the USA., Primary and Secondary Outcome Measures: Primary outcome measures were all-cause mortality, inpatient major adverse cardiovascular events (MACE) and/or inpatient mechanical ventilation. Secondary outcome measures included the association with diabetes and these outcomes among those with and without pre-existing ASCVD and HF and the association with insulin use and these outcomes in patients hospitalised for COVID-19., Results: After adjustment for relevant covariates diabetes increased the risk of mortality (HR 1.12, 95% CI: 1.03 to 1.21), MACE (HR 1.32, 95% CI: 1.17 to 1.48) and mechanical ventilation (HR 1.33, 95% CI: 1.26 to 1.42). Among patients with established ASCVD or HF, diabetes did not modify the risk of adverse outcomes. There was a significant difference in the risk of mortality between patients taking insulin compared with those who were not (HR 1.32, 95% CI: 1.01 to 1.26); however, there was no difference in the risk of MACE or mechanical ventilation., Conclusions: Diabetes was associated with a higher risk of in-hospital all-cause mortality, MACE and need for mechanical ventilation in patients hospitalised for COVID-19. Diabetes was independently associated with adverse outcomes, particularly among those without pre-existing cardiovascular disease., Competing Interests: Competing interests: FP reports research support (to Emory University) from Insulet, Dexcom, Novo Nordisk, Tandem and Ideal Medical Technologies and consulting for Dexcom and Medscape. UG, LTV, AG, AQ, CA and SD have no interests to declare., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: We codesigned an intervention with a low-resourced community with the aim to investigate the effects of time-restricted eating (TRE) on changes in body weight and associated cardiometabolic outcomes in South African women living with overweight/obesity and HIV who have initiated dolutegravir (DTG)-based antiretroviral therapy (ART)., Methods and Analysis: Women with overweight or obesity (body mass index ≥25 kg/m², no upper limit), aged 20-45 years, living with HIV and in a low-resourced community, and receiving DTG-based ART for less than 2 years will be recruited from a community healthcare centre in Khayelitsha, Cape Town (n=152). Participants will be randomised 1:1 to the TRE group (n=76) or standard of care control group (n=76) for 12 months. The TRE group will be required to restrict their eating window to ~8-10 hours/day and will receive nutritional information sessions at baseline and at 3, 6, 9 and 12 months. The primary outcome of body weight will be assessed at baseline and monthly. Cardiometabolic measures will be reported as secondary outcomes. At baseline, 6- and 12 months, an oral glucose tolerance test (to estimate insulin sensitivity and beta-cell function), questionnaires (sociodemographic, food insecurity, quality of life, social support and sleep quality) and a quantified food frequency questionnaire (total energy and macronutrient composition) will be completed. Every 3 months, appetite ratings, bioelectrical impedance (fat mass and fat-free mass), fasting venous bloods (glucose, insulin, gut hormones and systemic inflammation) and process evaluation (qualitative interviews) will be completed. Monthly monitoring will also include anthropometry and blood pressure., Ethics and Dissemination: The study is conducted in accordance with the Declaration of Helsinki and has been approved by the Human Research Ethics Committee of the University of Cape Town (628/2021). Verbal and written consent is required from study participants. Results of this study will be published in peer-reviewed journals and presented at conferences., Trial Registration Number: PACTR202302484999720., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: To analyse the impacts of multiple rounds of National Centralised Drug Procurement Policy (NCDP) and National Drug Price Negotiation Policy (NDPN) on the utilisation, expenditure and daily cost of novel hypoglycaemic drugs., Design: The drug procurement data were obtained from the Shanghai Medical Procurement Agency between January 2016 and December 2022. We examined changes in volume, expenditure of overall hypoglycaemic drugs by descriptive analysis. For novel hypoglycaemic drugs, we employed interrupted time series analysis with segmented regression to investigate the change in usage, expenditure and daily cost of specific drug affected by related policies., Setting: All the public and private hospitals in Shanghai, China., Primary Outcome Measures: Volume, expenditure and daily cost of novel hypoglycaemic drugs., Results: From 2016 to 2022, the overall usage and expenditure of hypoglycaemic drugs in Shanghai have been gradually increasing. Consumption of novel hypoglycaemic drugs had shown a rapid increase, which was significantly increased by 212.28 defined daily doses (95% CI 188.25, 236.31, p<0.001) after policy implementation. For each specific drug, daily cost was significantly decreased immediately after policy implementation (p<0.001). Dulaglutide, loxenatide, liraglutide, semaglutide and dapagliflozin had all seen significant increases in consumption and expenditure after NDPN implementation (p<0.001). Vildagliptin and saxagliptin, which were affected by the NCDP, experienced a significant decrease in usage. Empagliflozin and canagliflozin, which were regulated by both NCDP and NDPN, experienced an initial increase, followed by a significant decline. Consumption of beinaglutide and exenatide was not upregulated by NDPN., Conclusion: Implementation of NDPN and NCDP had successfully cut-off the price of novel hypoglycaemic drugs and significantly increased their utilisation. In the future, the government needs to control pharmaceutical expenses more strictly while ensuring the rational use of the drugs., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Type 1 diabetes mellitus (T1DM) is a disorder that arises following the selective autoimmune destruction of the insulin-producing beta cells. Beta-cell protective or beta-cell regenerative approaches have gained wider attention, and pharmacological approaches to protect the patient's own insulin-producing beta-cell mass have been proposed. Verapamil is an L-type calcium channel blocker that has been reported to effectively lowers beta-cell thioredoxin-interacting protein expression in rodent beta cells and islets, as well as in human islets, and thus promotes functional beta-cell mass., Methods and Analysis: The trial is a multicentre, randomised, double-blind, placebo-controlled trial in participants with T1DM, investigating the effect of verapamil on preservation of beta-cell function (Ver-A-T1D). A total of 120 participants will be randomised in a 2:1 ratio between 360 mg verapamil and placebo, administered orally once daily. T1DM patients aged ≥18 and <45 years will be eligible for recruitment within 6 weeks of diagnosis (defined as day of starting insulin therapy). The primary objective will be to determine the changes in stimulated C-peptide response during the first 2 hours of a mixed meal tolerance test at baseline and after 12 months for 360 mg verapamil administered orally once daily versus placebo. Secondary objectives include the effects of 360 mg verapamil on (1) fasting C-peptide, (2) dried blood spot C-peptide, (3) glycated haemoglobin, (4) daily total insulin dose, (5) time in range by intermittent continuous glucose monitoring measures, (6) other biomarkers related to immunological changes and beta-cell death and (6) safety (vital signs, ECG)., Ethics and Dissemination: Ethics approval was sought from the research ethics committee of all participating countries. All participants provided written informed consent before joining the study. Ver-A-T1D received first regulatory and ethical approvals in Austria. The publication policy is set in the innovative approach towards understanding and arresting type 1 diabetes grant agreement (www.innodia.eu)., Trial Registration Number: EudraCT, 2020-000435-45; ClinicalTrials.gov, NCT04545151., Protocol Version: Version 8.0 (08 November 2021)., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Mental illness remains a significant global health concern that affects diverse populations, including individuals living with hypertension and/or type 2 diabetes, predominantly in lower-income to middle-income countries. The association between non-communicable diseases (NCDs) and mental illness is firmly established globally, however, this connection has yet to be comprehensively explored in West Africa. Our systematic review and meta-analysis aim to synthesise existing evidence on the prevalence, incidence, and risk factors for comorbid mental illness with hypertension and/or type 2 diabetes in West Africa. This effort seeks to contribute to bridging the knowledge gap and facilitating the implementation of interventions tailored to this context., Methods and Analysis: A comprehensive search will be conducted across multiple databases (PubMed, Google Scholar, PsycINFO, Carin Info and CINAHL), supplemented by searches on the websites of the WHO and various countries' ministries of health, and references cited in relevant papers. Inclusion criteria specify studies conducted in countries from the Economic Community of West African States, reported from January 2000 until date of search, focusing on adults with hypertension and/or type 2 diabetes and mental illness. Exclusion criteria encompass studies outside the specified time frame, involving pregnant women, or lacking relevant outcomes. There will be no language restrictions for inclusion. Study selection, data extraction and risk of bias assessment will be carried out independently by at least two reviewers. We will employ pooled proportions of OR, risk ratio and mean differences to assess prevalence, and incidence of mental illness and heterogeneity will be assessed., Ethics and Dissemination: This protocol does not require ethical approval; however, it is a part of a larger study on NCDs, which has received ethical clearance from the Ghana Health Service (ID NO: GHS-ERC 013/02/23). The results will be presented to stakeholders (policymakers and practitioners) and disseminated through conferences and peer-reviewed publications., Prospero Registration Number: CRD42023450732., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: Maternal obesity and gestational diabetes mellitus (GDM) are becoming major public health concerns in developing countries. Understanding their relationship can help in developing contextually appropriate and targeted prevention strategies and interventions to improve maternal and infant health outcomes. This study aimed to determine the association of maternal overweight and obesity with GDM among pregnant women in Ethiopia., Design: Case-control study., Setting: The study was conducted in selected public hospitals in Addis Ababa, Ethiopia, from 10 March to 30 July 2020., Participants: 159 pregnant women with GDM (cases) and 477 pregnant women without GDM (controls)., Outcome Measures and Data Analysis: Screening and diagnosis of GDM in pregnant women was done by a physician using the 2013 WHO criteria of 1-hour plasma glucose level of 10.0 mmol/L (180 mg/dL) or 2-hour plasma glucose level of 8.5-11.0 mmol/L (153-199 mg/dL) following a 75 g oral glucose load. Overweight and obesity were measured using mid-upper arm circumference (MUAC). Binary logistic regression with bivariate and multivariable models was done to measure the association of overweight and obesity with GDM. Adjusted ORs (AORs) with a 95% CI were computed, and statistical significance was determined at a value of p=0.05., Results: GDM was associated with obesity (MUAC≥31) (AOR 2.80; 95% CI 1.58 to 4.90), previous history of caesarean section (AOR 1.91; 95% CI 1.14 to 3.21) and inadequate Minimum Dietary Diversification Score <5 (AOR 3.55; 95% CI 2.15 to 5.86). The AOR for overweight (MUAC≥28 and MUAC<31) was 1.51 (95% CI 0.71 to 3.21). The odds of developing GDM were 72% lower in pregnant women who were engaging in high-level physical activity (AOR 0.28; 95% CI 0.12 to 0.67)., Conclusion: Obesity, but not overweight, was significantly associated with the development of GDM. Screening for GDM is recommended for pregnant women with obesity (MUAC≥31) for targeted intervention. Antenatal care providers should provide information for women of childbearing age on maintaining a healthy body weight before and in-between pregnancies and the need for healthy, diversified food and high-level physical activity., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Sodium-glucose co-transporter 2 inhibitors (SGLT2i) are associated with weight loss, diverse cardiorenal benefits and improved glycaemic control. However, the effects of SGLT2i on physical function and fitness are uncertain. The Dapagliflozin, Exercise Training and physicAl function trial investigates whether the SGLT2i dapagliflozin, alone or in combination with structured exercise training, improves physical function compared with diet-induced weight loss in adults with type 2 diabetes mellitus (T2DM), overweight/obesity and impaired physical function., Methods and Analysis: This single-centre randomised controlled trial will assign 1:1:1, 135 adults with T2DM and low physical function to receive one of three treatments: (1) dapagliflozin (10 mg once-daily) alone, (2) dapagliflozin (10 mg once-daily) plus structured exercise training or (3) diet control (where participants are supported to achieve 3% weight loss, equivalent to estimated weight loss with dapagliflozin treatment). Primary and secondary outcomes will be assessed at baseline, 12 and 24 weeks. The primary outcome is the difference in physical function, assessed using the modified Physical Performance Test, between the treatment groups and diet control at 24 weeks. Secondary outcomes include MRI-measured cardiac structure and function, maximal aerobic capacity, resting metabolic rate, device-measured physical activity and sleep, body composition, haemoglobin A1c and cardiovascular risk markers., Ethics and Dissemination: The Heath Research Authority (HRA) and the Medicines and Healthcare Products Regulatory Authority (MHRA) Research Ethics Committee have approved the study. The findings of the study will be published in peer-reviewed journals., Trial Registration Number: ISRCTN11459997., Eudract Number: 2019-004586-41., Competing Interests: Competing interests: JAS has received funding from Astra Zeneca UK in relation to an investigator-initiated trial. EA has received fellowship funding from Astra Zeneca. KK has acted as a consultant, speaker or received grants for investigator-initiated studies for Astra Zeneca, Bayer, Novartis, Novo Nordisk, Sanofi-Aventis, Lilly and Merck Sharp & Dohme, Boehringer Ingelheim, Oramed Pharmaceuticals, Roche and Applied Therapeutics. GPM has received grant funding from NIHR, BHF and research support from Circle CVi, Resonance Health. TY was a named investigator on the funding application for this trial and has received research funding from Abbott. MJD has acted as consultant, advisory board member and speaker for Boehringer Ingelheim, Eli Lilly, Novo Nordisk and Sanofi, an advisory board member Lexicon, Pfizer, ShouTi Pharma Inc, Astra Zeneca, Zealand Pharma and Medtronic and as a speaker for Astra Zeneca, Napp Pharmaceuticals, Novartis and Amgen. She has received grants from Astra Zeneca, Novo Nordisk, Boehringer Ingelheim, Janssen and Sanofi-Aventis and Eli Lilly. LB, JMB, NAC, GG, EJ, JK, ER, AR, EW and JW have no competing interests to declare., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: To investigate the association between the triglyceride-glucose (TyG) index, a surrogate marker of insulin resistance and the risk of kidney stones (KSs) in a Chinese population., Design: Case-control study., Setting: Three Physical Examination Centers in Shanghai, China, between January 2020 and December 2022., Participants: A total of 117 757 Chinese adults underwent health check-ups during the study period., Primary and Secondary Outcome Measures: The association between the TyG index and the risk of KS was assessed using multivariable logistic regression analysis. The dose-response relationship between the TyG index and KS risk was evaluated with a restricted cubic spline (RCS) analysis. Stratified analyses were conducted to explore whether factors such as age, sex, obesity, hypertension and diabetes modify the association between the TyG index and KS risk., Results: Out Of the 117 757 participants, 11 645 (9.9%) were diagnosed with KS using ultrasound. Individuals with KS had significantly higher TyG values than controls (p<0.001). The multivariable-adjusted ORs for KS increased across TyG quartiles, with the highest quartile showing an OR of 1.28 (95% CI 1.20 to 1.36) compared with the lowest quartile. Each SD increase in the TyG index was associated with a 10% higher risk of KS (OR: 1.10, 95% CI 1.08 to 1.13). RCS analysis revealed a significant positive and linear association between TyG index and KS (p overall<0.001, p non-linear=0.136). The positive association persisted across the subgroup and sensitivity analyses., Conclusions: The TyG index was positively associated with the risk of prevalent KS, suggesting that insulin resistance may be a risk factor for KS in the Chinese population., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Purpose: The current study aimed to investigate the associations between metabolic syndrome (MetS) with health-related quality of life (HRQoL) using multilevel analysis among the Iranian adult population., Methods: This cross-sectional study was conducted in the framework of the Tehran Lipid and Glucose Study (TLGS). Participants were 6113 participants (3318 women and 2795 men) aged≥20 years of the TLGS seventh phase who had completed data on HRQoL and MetS. HRQoL was assessed using the short-form 12-item health survey V.2 and MetS defined based on the guidelines outlined in the Joint Interim Statement. The two-level model was fitted to assess the association between MetS and HRQoL., Results: The prevalence of MetS and its components was higher in men, and regardless of metabolic status, men exhibited higher HRQoL values. The deleterious impact of MetS on HRQoL was more pronounced in women, while the detrimental effects of MetS on men's HRQoL were confined to specific subscales. These results were obtained through multilevel analysis, considering both familial and individual variation levels. Moreover, our investigation highlighted the positive influence of leisure-time physical activity on both the physical and mental component summaries (PCS and MCS, respectively), regardless of gender. Education had a greater positive impact on PCS in both sexes. Additionally, a history of cardiovascular diseases was associated with a decline in mental and physical HRQoL, while age was linked to a decline in PCS and MCS, and smoking was associated with a decline in MCS., Conclusion: This study revealed the significant influence of gender, as well as the unique characteristics and circumstances of individuals, on the relationship between MetS and HRQoL in a general population with low/middle income., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Optimal adherence to recommended diets is crucial to achieving long-term glycaemic control among individuals with type 2 diabetes (T2D) individuals. However, there is limited evidence on the effectiveness of interventions that target dietary adherence through social networks. Since social networks can influence individuals' health behaviours, it is important to thoroughly evaluate the impact of social network interventions on dietary adherence in adults with T2D. This systematic review protocol aimed to provide insights into future interventions and improve diabetes management strategies., Method and Analysis: PubMed, Embase, CINAHL Complete, Cochrane Central Register of Controlled Trials, ProQuest Dissertations and Theses and Google Scholar will be searched from inception to December 2023 for relevant randomised and non-randomised controlled trials of at least 3 months' duration. In addition, studies that compared interventions involving the social networks (families, friends and peers) of adults with T2D with usual care, no intervention or an intervention with no explicit social network component will be included. Two reviewers will independently screen search outputs according to inclusion and exclusion criteria, critically evaluate the selected literature and extract data on the study setting, design, participants' characteristics, interventions, controls, social network functions and duration of follow-up, using a standard data extraction form. Quantitative data analysis will be performed where studies are homogeneous in characteristics and provide adequate outcome data for meta-analysis. Otherwise, data will be synthesised using narrative synthesis. Finally, trials will be assessed for bias risk and overall evidence certainty using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system., Ethics and Dissemination: Ethical approval is not required for literature-based studies. The results will be disseminated through peer-reviewed publications., Prospero Registration Number: CRD42023441223., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Purpose: To study epidemiology, complications, risk factors, clinical course and treatment patterns of diabetes, the Nanjing Diabetes Cohort (NDC) was established using anonymised electronic health records from 650 hospitals and primary care since 2020. This cohort provides valuable data for researchers and policy-makers focused on diabetes management and public health strategies., Participants: Diabetes was defined as having inpatient or outpatient encounters with a diagnosis of diabetes International Classification of Diseases-9/10 codes, any use of insulin or oral hypoglycaemic drugs, or one encounter with haemoglobin A1C >4.8 mmol/mol or 6.5%. Patients with diabetes have been continuously enrolled on hospitals and primary care in Nanjing since 2020. Demographic, medications and comorbidities data were extracted from clinical notes, diagnostic codes, labs, prescriptions and vital signs among different types of diabetes., Findings to Date: The NDC consisted of 1 033 904 patients from 1 January 2020 to 31 December 2022, the majority were male (50.62%) and from the Gulou district (30.79%). The clinical characteristics and medication usage of patients with type 1 diabetes, type 2 diabetes, gestational diabetes and other diabetes were assessed. The prevalences of hypertension, ischemic heart disease, and cerebrovascular disease were 49.72%, 17.85% and 24.90%, respectively., Future Plans: NDC will annually enrol eligible patients and include socioeconomic data in future updates. The data of NDC are maintained by the Department of Medical Informatics at Nanjing Medical University., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: With the ageing of people living with HIV/AIDS (PLWHA), the prevalence of chronic comorbidities, especially hyperglycaemia, is increasing among elderly PLWHA. Antiretroviral therapy (ART) is associated with fasting plasma glucose (FPG) levels. This study aimed to investigate both short-term and long-term FPG characteristics and trends across different ART regimens in elderly Chinese PLWHA., Methods: This retrospective cohort study, based on hospital treatment information, classified ART regimens as this retrospective cohort study used hospital treatment data. ART regimens are classified into three categories: non-nucleoside reverse transcriptase inhibitors (NNRTIs) based, protease inhibitors (PIs) based and integrase strand transfer inhibitor (INSTIs) based. Propensity score matching was applied to control for confounding factors. Follow-up FPG characteristics were then described, and a generalised linear mixed model was employed to estimate FPG trends under different regimens within 1-year and 5-year periods following ART initiation., Results: Participants had an average age of 58.28 years, with 75.02% male. FPG increased following ART initiation, with the most significant rise within 1 year of ART, followed by stabilisation. The FPG increase within 1 year was slower in the PIs-based group compared with the NNRTIs-based group ( β =-0.08, 95% CI -0.15 to -0.01), while there was a higher prevalence of diabetes within 5 years of ART (31.55% vs 22.33%, standardised difference=0.357). The FPG increase within 1 year of ART did not differ between NNRTIs-based and INSTIs-based groups ( β =-0.01, 95% CI -0.20, 0.18)., Conclusion: Our study highlights that elderly Chinese PLWHA experience an increase in FPG levels, particularly during the first year of ART, with variations observed across different ART regimens. The higher long-term prevalence of diabetes in the PIs-based regimen group emphasises the need for tailored glucose management strategies. Routine glucose monitoring and proactive management are crucial for preventing and controlling diabetes in this population, particularly given the long-term metabolic risks associated with ART., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: The short synacthen test (SST) is widely used across the UK to assess adrenal reserve. The main objective of our study was to determine the morning serum cortisol level that will predict adrenal insufficiency (AI) thus reducing our reliance on SST.Design: This was a single centre retrospective study of 393 SST tests measuring 0 and 60 min cortisol levels after administration of 250 μg of synacthen (synthetic ACTH).Patients and Methods: All the SST tests for patients suspected of primary or secondary AI between April 2016 and October 2018 were included in this study. We used serum to determine circulating cortisol by a newer generation competitive electrochemiluminescence immunoassay (ECLIA) (Roche Diagnostics). A post-ACTH cortisol response of ≥420 nmol/L at 60 min was considered adequate to rule out AI. The data were analysed to ascertain the relationship between 0 min and 60 min serum cortisol.Results: A total of 393 SST results were included in this study. Overall, a total of 332 (84.5%) subjects achieved sufficient serum cortisol level at 60 min, while 61 subjects (15.5%) showed insufficient response. Using the logistic regression, we determined that a morning basal serum cortisol level of ≥354 nmol/L was able to predict normal adrenal function with 100% sensitivity. We were unable to find a lower cut-off value below which SST will not be required. By using this proposed cut-off point, approximately 37% of the SSTs tests could be avoided.Conclusions: Basal morning serum cortisol can be safely used as a first step in the evaluation of patients with suspected AI. This will enhance the number of patients being screened for this condition. [ABSTRACT FROM AUTHOR]