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BMJ Open Diabetes Research & Care

BMJ

All preprints, ranked by how well they match BMJ Open Diabetes Research & Care's content profile, based on 16 papers previously published here. The average preprint has a 0.02% match score for this journal, so anything above that is already an above-average fit. Older preprints may already have been published elsewhere.

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The descriptive epidemiology of type 2 diabetes in the United Kingdom from 2004 to 2021

Currie, C. J.

2024-03-04 epidemiology 10.1101/2024.03.04.24303693 medRxiv
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PurposeTo provide contemporary estimates of the incidence and prevalence of type 2 diabetes in the UK. MethodsData from UK primary care (CPRD) were analyzed using an automated, analytical platform that produces validated, rapid analytics-Livingstone. ResultsWe selected 1,125,028 people with type 2 diabetes (44.7% female). The crude incidence was stable. In 2004 the incidence rate was 4.18 cases per 1,000 people, reducing to 4.13/1,000 in 2021. There was a shift in age-specific incidence to earlier age-groups. The crude prevalence showed a marked increase, rising from 2.95% to 5.41%, levelling off slightly in later years. Increases in prevalence were observed in all groups. Northern Ireland consistently had the lowest prevalence, and Wales had a notably higher prevalence, increasing from 3.71% in 2004 to 6.37%. The mean age at diagnosis decreased in females by 5.5 years to 58.5 years, and by 2.5 years in men, to 58.8 years. ConclusionsThe incidence of type 2 diabetes was largely stable over 20 years but there were changes over time in age-specific groups resulting from a shift to earlier onset or earlier diagnosis. The shift to earlier diagnosis was far more pronounced in women than in men. Prevalence increased markedly, but the rate of increase appeared to be leveling-off a little. There were notable differences in the epidemiology of type 2 diabetes between the four constituent countries of the UK. The number of younger people diagnosed with type 2 diabetes remains a concern. GuarantorCraig Currie is the guarantor of this work and, as such, had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

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Prevalence and predictors of microvascular and macrovascular diabetes complications in adult Ugandans: a systematic review and meta-analysis

Kibirige, D.; Olum, R.; Turyamureeba, W.; Morgan, B.; Kyazze, A. P.; Nsubuga, Y.; Okot, J.; Lumu, W.; Bongomin, F.

2024-10-17 endocrinology 10.1101/2024.10.15.24315542 medRxiv
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IntroductionThere is a growing prevalence of diabetes and related chronic complications in Uganda. We conducted a systematic review and meta-analysis to document the prevalence and predictors of five microvascular and macrovascular diabetes complications in adult Ugandans with diabetes. Materials and MethodsWe searched Medline, EMBASE, CINAHL, Cochrane Library, and Africa Journal Online databases. We included studies on the prevalence and predictors of any chronic microvascular or macrovascular diabetes complications of interest. We conducted a random effect meta-analysis to determine the pooled prevalence of each diabetes complication. A narrative review was used to describe the significant predictors. ResultsA total of 20 studies involving 11,400 participants were included. The pooled mean (standard deviation) age of the participants was 54.8 (3.6) years, with the majority being female (pooled proportion of 61.1%, 95% confidence interval [CI] 57.1-65.2). For the microvascular diabetes complications, the pooled prevalence of diabetic neuropathy, retinopathy, and nephropathy was 56.8% (95% CI 44.9-68.7, I2 = 98.56%, p<0.001), 19.5% (95% CI 3.9-35.2, I2 = 99.60%, p<0.001), and 17.7% (95% CI 7.3-28.0, I2 = 99.36%, p<0.001), respectively. For the macrovascular diabetes complications, the pooled prevalence of peripheral arterial disease and diabetic foot disease was 32.2% (95% CI 15.8-48.7, I2 = 97.67%, p<0.001) and 5.5% (95% CI 1.7-9.2, I2= 90.22%, p<0.001), respectively. Hypertension comorbidity, physical inactivity, family history of diabetes, body mass index [&le;]30 kg/m2, and pregnancy were predictors of diabetic nephropathy in three studies. In two studies, a history of a foot ulcer and age >60 years were predictors of diabetic neuropathy while female sex, hypertension comorbidity, and use of glibenclamide were predictors of peripheral arterial disease. DiscussionChronic diabetes complications are very common in adult Ugandans with diabetes, especially diabetic neuropathy and peripheral arterial disease. Regular screening and optimal management of diabetes and its complications should be emphasised in Uganda.

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Psychometric and biomedical outcomes of glycated haemoglobin target-setting in adults with type 1 and type 2 diabetes: A mixed-methods parallel-group randomised feasibility study

Westall, S. J.; Watmough, S.; Narayanan, R. P.; Irving, G.; Hardy, K. J.

2025-01-14 endocrinology 10.1101/2025.01.11.24319632 medRxiv
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BackgroundGlycated haemoglobin (HbA1c) targets are commonly used to guide patient management in diabetes to reduce future risk of diabetes complications, but little is known of the psychological impact of HbA1c target-setting. We explored the feasibility of undertaking a conclusive study evaluating the impact of setting explicit HbA1c targets in adults with diabetes. MethodsA randomised, mixed-methods study design was used to quantitatively and qualitatively evaluate the psychometric and biomedical impact of intensified or relaxed glycaemic targets in adults with diabetes. Alongside baseline measurement of HbA1c, blood pressure and body mass index, patients completed baseline validated psychometric questionnaires (EuroQoL-5D-5L, Problem Areas In Diabetes, Summary of Diabetes Self-Care Activities, Well-Being Quetionnaire-12, Diabetes Empowerment Scale-Long Form) and were randomised 1:1. Participants in group A received explicit HbA1c target intervention targets 5 mmol/mol above current HbA1c. Participants in group B received explicit HbA1c targets 5 mmol/mol below current HbA1c. Rates of eligibility, recruitment, retention and questionnaire response were recorded. Outcomes were re-measured 3-months post-intervention. Patients and healthcare professionals attended semi-structured interviews for qualitative evaluation. ResultsFifty participants were recruited. Withdrawal rate was 34% (n=17). Endpoint evaluation revealed no significant between-group differences in patient-reported outcome measures or HbA1c levels. Overall, levels of distress (-4.4, p=.009), self-efficacy (.25 [.09-.41], p=.004) and subsequent HbA1c readings (-2.8 [-5.0--.7], p=.012) improved, with non-significant changes seen in health-related quality of life, wellbeing, and self-care. Patients and healthcare professional interviews demonstrated study acceptability alongside specific motivators (e.g., target achievability, hypoglycaemia avoidance) and demotivators (e.g., lack of understanding, lack of target achievability) for striving to reach glycaemic targets. Combined qualitative data from patient and healthcare professional interviews and quantitative study aspects triangulated, enhancing data trustworthiness, and informing future hypotheses and methodologies. DiscussionThis mixed-methods study demonstrates feasibility and provides a novel insight into the psychological implications of HbA1c target-setting. Trial registrationThe study is registered with the ISRCTN (registration number: 12461724; date registered: 11th June 2021).

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Association Between Insulin Therapy and Cardiovascular Morbidity in Adults with Type 2 Diabetes: Analysis of BRFSS 2022-2023 Data

Assinnari, A. A.; Althobaiti, S. A.

2025-08-12 endocrinology 10.1101/2025.08.07.25333260 medRxiv
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BackgroundInsulin therapy is a cornerstone in the management of Type 2 Diabetes Mellitus (T2DM), although its relationship with cardiovascular outcomes remains an area of discussion. While it effectively used in managing either types of diabetes, evidence regarding its cardiovascular safety is mixed. ObjectiveTo investigate the association between insulin therapy, timing and duration, and cardiovascular outcomes among adults with T2DM, while accounting for biological, psychological, and social factors, using data from the 2022-2023 Behavioral Risk Factor Surveillance System (BRFSS). MethodsMultivariate logistic regression was used on a de-identified cross-sectional BRFSS data of adults with self-reported T2DM to estimate the association between insulin use and cardiovascular outcomes, while adjusting for age, hypertension, dyslipidemia, smoking status, psychological comorbidities, and medication use. ResultsInsulin users exhibited significantly higher rates of coronary heart disease (21.8% vs. 14.2%) and stroke (13.4% vs. 6.6%) compared to non-users (p < 0.001). It was found that early initiation and longer duration of insulin therapy were independently associated with increased cardiovascular risk. These associations persisted after adjusting for biological and psychosocial variables. ConclusionIn this nationally representative sample, insulin therapy, particularly when initiated early or sustained long-term, was associated with higher odds of cardiovascular morbidity in adults with T2DM. These findings highlight the need for individualized treatment approaches that consider both glycemic control and broader biopsychosocial factors.

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Differences in rates of uptake of NICE clinical guidelines between Type 1 diabetes mellitus (T1DM) and Type 2 diabetes mellitus (T2DM) as evidenced by National Diabetes Audit of England and Wales

Hayward, R. C.; Watkins, J.; Ariti, C.

2020-08-06 endocrinology 10.1101/2020.08.05.20168914 medRxiv
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OBJECTIVESTo investigate whether there were important differences in uptake of NICE clinical guidelines according to diabetes mellitus type in England and Wales from 2013 to 2018, test the hypothesis that guidelines are more successfully implemented with T2DM than T1DM, and explore possible explanations for differences. DESIGNRetrospective cross-sectional analyses of aggregated patient level data from the National Diabetes Audit (NDA) dataset owned by NHS Digital and commissioned by Healthcare Quality Improvement Partnership. SETTINGDiabetes specialist services, primary care (GP surgeries submitting NDA data) across England and Wales. PARTICIPANTS1 739 175 patients with diabetes aged [&ge;]20 in England and Wales in 2013-14, 1 871 320 individual patients in 2014-15, 2 688 106 individual patients in 2015-16, 3 095 275 individual patients in 2016-17, and 3 357 055 individual patients in 2017-18. INTERVENTIONSRecommended care for diabetes mellitus as outlined in relevant NICE guidelines and delivered by either specialist clinicians or GPs. MAIN OUTCOME MEASURESThe recorded attainment of NICE treatment targets: HbA1c levels =<7.5% (58.5 mmol/mol), blood pressure <140/80mmHg, blood cholesterol <5mmol/l; and clinical processes: at least annual monitoring of HbA1c, blood pressure, cholesterol, albumin:creatinine ratio, smoking status, Body Mass Index. RESULTSAnnual collections (2013-14, 2014-15, 2015-16, 2016-17 and 2017-18) were individually analysed, testing associations between diabetes type and attainment of clinical targets or processes using a multivariable logistic regression model, adjusted for age and sex. Increased odds of meeting clinical targets if patients had T2DM compared with T1DM was consistent across the five years, except for cholesterol levels <5mmol/l where T2DM patients had lower odds (all associations p<.0001). Greatest differences in all five years between T1DM and T2DM was observed with patients meeting the HbA1c=<7.5% target, the largest being in 2015-16 (Odds Ratio 3.43, 95% confidence interval 3.39 to 3.47). CONCLUSIONSThe differences between T1DM and T2DM in HbA1c target attainment is key and potentially reflects challenges of managing T1DM with insulin but suggests a point of focus for that patient population. Other important elements for consideration could be specific setting for delivery (primary care versus secondary care) and duration of illness. O_TEXTBOXWHAT IS ALREADY KNOWN ON THIS TOPICNHS Digital publishes reports on the NDA every year, however much of this is descriptive rather than analytical. Very few published studies have explored NDA data and none have particularly compared clinical outcomes of T1DM and T2DM. WHAT THIS STUDY ADDSDifferences between age structures of T1DM and T2DM patient groups are adjusted and success in meeting NICE clinical processes and treatment targets are compared. This study highlights the different challenges faced by these different groups and conditions and raises questions about the suitability of applying identical targets to the diabetes subtypes given aetiological, clinical and therapeutic differences. C_TEXTBOX

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Utility of Technology in the Treatment of Type 1 Diabetes: Current State of the Art and Precision Evidence

Jacobsen, L.; Sherr, J.; Consindine, E.; Chen, A.; Peeling, S.; Hulsman, M.; Charleer, S.; Urazbayeva, M.; Tosur, M.; Alamarie, S.; Redondo, M. J.; Hood, K.; Gottlieb, P.; Gillard, P.; Wong, J.; Hirsch, I.; Pratley, R.; Laffel, L.; Mathieu, C.

2023-04-19 endocrinology 10.1101/2023.04.15.23288624 medRxiv
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The greatest change in the treatment of people living with type 1 diabetes in the last decade has been the explosion of technology assisting in all aspects of diabetes therapy, from glucose monitoring to insulin delivery and decision making. Through screening of 835 peer-reviewed articles followed by systematic review of 70 of them (focusing on randomized trials and extension studies with [&ge;]50 participants from the past 10 years), we conclude that novel technologies, ranging from continuous glucose monitoring systems, insulin pumps and decision support tools to the most advanced hybrid closed loop systems, improve important measures like HbA1c, time in range, and glycemic variability, while reducing hypoglycemia risk. Several studies included person-reported outcomes, allowing assessment of the burden or benefit of the technology in the lives of those with type 1 diabetes, demonstrating positive results or, at a minimum, no increase in self-care burden compared with standard care. Important limitations of the trials to date are their small size, the scarcity of pre-planned or powered analyses in sub-populations such as children, racial/ethnic minorities, people with advanced complications, and variations in baseline glycemic levels. In addition, confounders including education with device initiation, concomitant behavioral modifications, and frequent contact with the healthcare team are rarely described in enough detail to assess their impact. Our review highlights the potential of technology in the treatment of people living with type 1 diabetes and provides suggestions for optimization of outcomes and areas of further study for precision medicine-directed technology use in type 1 diabetes. Preface (Lay Abstract)We reviewed literature of the last decade to evaluate the impact of technology on the treatment of people living with type 1 diabetes. Screening of 835 articles and in-depth review of 70 showed that novel technologies, ranging from continuous glucose monitoring systems, insulin pumps and decision support tools to the most advanced hybrid closed loop systems, improve important measures like HbA1c and time in range, while reducing hypoglycemia risk. Of importance, several studies showed a positive impact on person-reported outcomes, like quality of life or, at a minimum, no increase in self-care burden compared with standard care.

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Toward more patient-centered diabetes care in Switzerland: Patient perspectives and practical solutions

Giger, O.-F.

2025-12-08 endocrinology 10.64898/2025.12.06.25341746 medRxiv
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This study investigates the challenges and enablers of self-management in type 2 diabetes, the role of primary care in diabetes management, and patients preferences for additional support services in Switzerland. Participants reported significant difficulties in sustaining behavioral changes and emphasized the need for more structured guidance to improve self-management. Many felt unsupported in primary care, stating that their general practitioners could have intervened earlier when they were at high risk but before an official diagnosis. Additionally, patients highlighted the lack of centralized, up-to-date diabetes resources in Switzerland, contrasting it with structured systems like the National Health Service in the United Kingdom. There was also a strong demand for a unified digital health platform to consolidate glucose readings, blood pressure data, and medication lists, ensuring seamless integration with healthcare providers. These findings underscore the need for patient-centered diabetes management strategies that integrate digital innovations, proactive primary care interventions, and accessible, evidence-based resources to enhance self-management.

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Publication Bias in Abstracts Presented at the American Diabetes Association Scientific Sessions: A Retrospective Cohort Study

Pinedo-Torres, I.; Taype-Rondan, A.; Vera-Luza, A. A.; Zegarra-Lizana, P. A.; Rojas-Vilca, J. L.; Yovera-Aldana, M.

2026-08-31 epidemiology 10.64898/2026.08.26.26361486 medRxiv
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Objective. To determine the publication rate of abstracts presented at the American Diabetes Association Scientific Sessions and to evaluate the association between statistical significance of study results and subsequent publication. Research Design and Methods. We conducted a retrospective cohort study of abstracts presented at the 2018 American Diabetes Association Scientific Sessions. The primary exposure was study result category (statistically significant vs. non-statistically significant findings), and the primary outcome was publication in an indexed journal within 5 years after conference presentation. Publication status was determined through PubMed/MEDLINE and Scopus searches. Adjusted relative risks (RRs) and 95% CIs were estimated using generalized linear models with Poisson distribution and robust variance. Results. Among 541 included abstracts, 321 (59.3%) were subsequently published in indexed journals. Abstracts reporting statistically significant findings had a higher publication rate than those reporting non-statistically significant findings (61.9% vs. 42.3%; p=0.002). In the adjusted analysis, abstracts with non-statistically significant findings had a lower likelihood of publication compared with those reporting statistically significant findings (adjusted RR 0.71 [95% CI 0.55-0.93]; p=0.013). Conclusions. Approximately four in ten abstracts presented at the ADA Scientific Sessions were not published within 5 years. Abstracts reporting non-statistically significant findings had a lower likelihood of subsequent publication, suggesting persistent publication bias in diabetology research. Future initiatives promoting the interpretation of effect estimates, confidence intervals and clinical relevance, rather than statistical significance alone, may help reduce selective dissemination of evidence

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Measuring implementation of clinical guidelines through the COVID-19 pandemic, using linked national health records: a national study of type 2 diabetes in England

Biglarbeigi, P.; Dale, C.; Lambarth, A.; Mason, A.; Takher, R.; Ballabio, G.; Minshull, J.; Mamas, M. A.; Tomlinson, C.; Rowark, S.; Rayman, G.; Pearson, E. R.; Khunti, K.; Sattar, N.; Sofat, R.

2026-08-10 health policy 10.64898/2026.08.07.26359950 medRxiv
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Objectives: To examine the conformance to type 2 diabetes NICE guidelines across cardiovascular risk strata; and to quantify geographical variation in treatment pathways following the COVID-19 pandemic, encompassing guideline changes. Design: We carried out a retrospective observational study using linked electronic health records across England. Process mining, a data driven method that can reconstruct clinical treatment pathways, was applied to map 12-month treatment trajectories after treatment initiation. Conformance with NICE NG28 (2022) was quantified using a structural similarity index. Further, behavioural and entropy-based similarity (capturing treatment variability and complexity) measures were used to assess sequencing and heterogeneity of treatment. Setting: Primary and secondary care in England datasets within the National Health Service England Secure Data Environment (NHSE SDE), analysed first at national level and then across 42 Integrated Care Boards (ICBs) which are the devolved health care geographical delivery regions in England. Participants: 822,650 individuals with newly diagnosed T2DM between 1-February-2022 and 1-November-2025, stratified into low cardiovascular risk (LR-C; QRISK3<10), high risk (HR-C; QRISK3>=10 or receiving statins/blood pressure lowering treatment), and established cardiovascular disease (eCVD-C). Participants were followed for 12 months after first dispensed glucose lowering therapy. Main outcome measure: First line therapy, treatment intensification and switching within 12 months; change in glycated haemoglobin (HbA1c); quantified conformance to NICE recommended pathways; and regional variation in broader similarity measures. Results: Metformin monotherapy was the dominant initiation strategy in LR-C and HR-C cohorts (92.4% and 90.2%, respectively), whereas eCVD-C showed lower uptake of metformin (68.9%) and higher uptake of SGLT2 inhibitors (26.3%). Intensification from metformin to combination therapy was infrequent across all cohorts (<1%), although HR-C demonstrated the highest treatment transitions and switching behaviour. Dispensed SGLT2 inhibitor use was nearly threefold higher in eCVD-C (26.7%) than in LR-C (9.0%) or HR-C (10.7%). Overall, conformance to NICE-recommended pathways remained modest nationally, particularly in LR-C and HR-C. Across 42 ICBs, substantial regional heterogeneity in treatment pathways and guideline conformance was observed, with conformance ranging from 0.29 to 1.00 in LR-C pathways, 0.40 to 1.00 in HR-C pathways, and 0.54 to 0.92 in eCVD pathways. Conclusion: National T2DM treatment pathways for post-pandemic showed higher alignment to NICE guidelines in eCVD-C compared to the other risk groups, with ongoing gaps and large regional variations in other risk groups. Process mining offers a scalable approach to monitor implementation of guideline recommended care that could support learning health systems. Using T2DM during and post COVID-19 pandemic as a case study, this work demonstrates how these methods can assess the use of existing and innovative therapies, identify gaps and guide future adoption to ensure recommended treatments reach the right patient groups.

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Structured Diabetes Education: virtual access was as effective as face-to-face access to a structured diabetes education programme (EMPOWER T2n) for people with type 2 diabetes in England.

Sutton, D.; Palin, R.; Swift, J.; Barker, C.; Pridige, C.; Ghosh, S.

2024-02-28 endocrinology 10.1101/2024.02.27.24303369 medRxiv
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Introduction & objectivesStructured diabetes education (SDE) is an evidence-based intervention for type 2 diabetes. The goal of this study was to compare SDE whether accessed face to face or virtually and determine if any differences existed in key endpoint attainment. This study helps address the absence of evaluations comparing these access modalities. Research design and methodsAll data were sourced from English SDE participants themselves, and their General Practices and routinely collected for service evaluation between 2016 and 2023. All data were observational, and all participants accessed usual care. The primary endpoint was the increase in the percentage of patients with glycated haemoglobin (HbA1c) at target [48mmol/mol (International Federation of Clinical Chemistry and Laboratory Medicine) / 6.5% (National Glycohemoglobin Standardization Program)] in virtually accessed SDE participants (V-SDE) versus face-to-face accessed SDE participants (F2F-SDE) on unchanged medicines for glycaemia. All data were non-normally distributed. Wilcoxon signed rank tests were used to analyse paired data, Mann-Whitney U-tests used for independent data and Chi-square tests used for observed versus expected data. ResultsThe 3,493 SDE participants with pre and post HbA1c data had a 10.2mmol/mol (16.4%) reduction in HbA1c, 389 days post their pre-SDE HbA1c measure. In the 2,334 (66.8%) participants who remained on the same medicines regime, the mean reduction in HbA1c was 9.1mmol/mol (15.2%), (p<0.001). All 617 V-SDE participants had a mean reduction in HbA1c of 13.6mmol/mol (20.9%) vs. 9.5mmol/mol (15.3%) in all 2,876 F2F-SDE participants, (p<0.001). The V-SDE on unchanged medicines had superior reductions in HbA1c to F2F-SDE (11.6 [n=404] vs. 8.6mmol/mol [n=1930], p=0.019), respectively. The overall increase in medicines for glycaemia was +12.45% F2F-SDE versus +4.21% V-SDE, (p<0.001). The primary endpoint was the increase in the percentage of patients with HbA1c to target in V-SDE versus F2F-SDE in patients with unchanged medicines for glycaemia. Previous database analyses found a 30% increase in F2F-SDE patients at target who were on the same medicines regime. A non-inferiority limit was set at 10% for V-SDE versus F2F-SDE and required 360 patients per arm. The primary endpoint was attained with 52.2% of V-SDEs at target (+33.7%), versus the F2F-SDE gain of 29.6%. VSDE was not superior to F2F-SDE (p=0.16). Blood pressure, total cholesterol and weight were improved (all endpoints, p<0.001) with no differences between the interventions. Medicines use was unrecorded for these health endpoints. ConclusionsV-SDE met its non-inferiority goal, which was set in a population in which fewer V-SDE patients required increased medicines for glycaemia. These endpoints were subject to the limitations of unlinked, and routinely collected observational data.

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Knowledge, Attitudes, and Practices of Foot Self-Care Among Diabetic Patients in the West Bank, Palestine: A Cross-Sectional Study

Amro, A. M.; deeb, s.; Alfrookh, M. H.; Makhamra, B. M.; amro, L.; Assi, A. K.; Makhamreh, O. J.; Jobran, A. W. M.

2025-09-28 endocrinology 10.1101/2025.09.25.25336691 medRxiv
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BackgroundDiabetic foot complications are a leading cause of morbidity, disability, and healthcare costs worldwide, yet they are largely preventable through proper self-care. In Palestine, evidence on patient adherence to recommended practices is scarce. This study aimed to assess the knowledge, attitudes, and practices of foot self-care among adults with diabetes in the West Bank and to identify factors associated with adherence. MethodsA cross-sectional study was conducted among 300 diabetic patients attending primary care clinics across the West Bank. Data were collected using a structured and validated questionnaire covering knowledge, attitudes, and practices. Statistical analyses included reliability testing, factor analysis, bivariate correlations, and multivariable regression models to identify independent predictors of adherence. ResultsAdherence to recommended foot care practices was generally low, with only 13% of participants reporting daily engagement in all recommended behaviors. While daily foot washing was widely practiced (80.9%), preventive measures were less consistent: 33.1% inspected their feet daily, 45.1% dried between toes, and 40.3% inspected shoes. Risky practices were also common, including foot soaking (28.6%), barefoot walking (20.2%), and wearing shoes without socks (15.9%). Reliability testing of the foot care scale revealed poor internal consistency (Cronbachs alpha = 0.39), suggesting a multidimensional structure. Multivariable regression showed that higher education (adjusted B = -4.05 for no schooling vs. undergraduate, p = 0.049), higher income (B = +3.91, p = 0.028), and longer diabetes duration (B = +1.02 per 5 years, p = 0.035) were associated with better adherence. Male sex was linked to lower adherence (OR 0.46, p = 0.017). Exposure to structured education and professional foot examinations also strongly predicted improved practices. ConclusionAdherence to preventive foot self-care among diabetic patients in the West Bank is suboptimal, particularly in practices directly related to ulcer prevention. Socioeconomic disparities, health literacy, and limited clinical reinforcement emerged as key barriers. Culturally tailored education, structured provider counseling, and policy-level interventions are urgently needed to reduce the burden of diabetic foot disease in Palestine.

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Participant outcomes evaluation of the DWELL (Diabetes and WELLbeing) type 2 diabetes 12-week psychoeducational self-management programme across four European countries

Hatzidimitriadou, E.; Manship, S.; Morris, R.; Thompson, T.; Moore, J.; Hulbert, S.; Vernon, D.

2025-01-17 endocrinology 10.1101/2025.01.13.25320460 medRxiv
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IntroductionType 2 diabetes mellitus (T2DM) is a lifelong condition that has large societal, economic and clinical implications, and treatment should be supported by healthy lifestyle factors. Interventions for effective self-management are essential to the sustainability of treatment, however there is no standard approach. Research Design and MethodsSix hundred and five participants diagnosed with Type 2 Diabetes Mellitus were recruited from four countries (UK, France, Netherlands, Belgium) to complete the 12-week DWELL (Diabetes and WELLbeing) psychoeducational intervention. The programme was delivered at community and hospital-based settings and comprised of four key areas: education, nutrition, physical activity and wellbeing. Metabolic health (weight, waist size, BMI and HbA1c) and self-reported psychological measures were taken at four points: pre- and post-intervention, and two follow up points (at 6 and 12 months) to assess the impact of the programme. ResultsParticipants showed a significant reduction in all metabolic health measures, with improvements in both weight and BMI being maintained at 6-month follow-up. Participation in the programme also led to enhanced levels of participant empowerment, with significant improvements also seen in perceptions of diabetes, eating behaviours, mental and physical health, and self-care behaviours. ConclusionsThe study results demonstrated that an empowerment-based, holistic and flexible approach to diabetes self-management education programmes has a wider impact in improving longer term coping behaviours which help in achieving and sustaining positive metabolic and psychological changes. Key Messages What is already known on this topicDiabetes education has evolved from a compliance and knowledge-oriented approach to an empowerment and self-management-oriented approach. Yet, type 2 diabetes self-management education (DSME) programmes are mainly evaluated in relation to impact on metabolic (glycaemic) outcomes than on wider psychosocial outcomes. What this study addsParticipation in the DWELL programme led to significant improvements in metabolic health measures and produced significant positive changes across a range of psychological measures such as patient empowerment, illness perceptions, eating behaviours and self-care behaviours. How this study might affect research, practice or policyThe DWELL DSME programme which was co-designed with patients, healthcare professionals and family carers, focussed on patient empowerment and self-control, by offering flexibility and choice of options as well as peer support. Programme outcomes indicated that this approach led to positive changes in empowering and enabling health behaviour changes and improvements in metabolic health. The study adds to the body of knowledge of patient-led DSME practice with a holistic approach. Further research could shed light on the cultural and intersectional aspects of such approach that can inform more targeted programmes supporting T2DM patients with multiple co-morbidities such as serious mental health conditions.

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COVID-19 Impact on Individuals with Type 1 and Type 2 Diabetes: Comparison of Pre- and Post-COVID-19 Hospitalizations for Diabetes-Related Amputation

Ionova, Y.; Zhong, L.; Vargas, R.; Ma, Y.; Wilson, L.

2026-01-03 endocrinology 10.64898/2026.01.02.25342941 medRxiv
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BackgroundThe COVID-19 pandemic disrupted healthcare services, potentially affecting diabetes management and complications. ObjectiveTo investigate the impact of the pandemic on lower extremity amputation (LEA) rates among individuals with type 1 and type 2 diabetes mellitus, focusing on social determinants of health. MethodsA retrospective observational cohort study using de-identified claims data from a large U.S. health plan. LEA rates were compared before and after the onset of the COVID-19 pandemic using interrupted time series analysis. ResultsIndividuals with type 2 diabetes experienced an initial decline in LEA rates followed by a significant increase (p=0.022) as delayed care needs were addressed. Individuals with type 1 diabetes showed no significant fluctuations in amputation rates. Social determinants were significantly associated with changes in LEA rates among individuals with type 2 diabetes. Lower-income ([&le;]$40,000/year) and less educated individuals experienced significant increases in amputation rates (p=0.027 and p=0.043, respectively). Individuals aged 45-64 years showed a significant increase in LEA rates (p=0.013), while those aged 18-44 experienced a decrease (p=0.017). Metropolitan residents saw significant increases in LEA rates (p=0.021). ConclusionsThe COVID-19 pandemic significantly disrupted healthcare access for individuals with type 2 diabetes, leading to increased LEA rates. Social determinants of health exacerbated existing disparities in diabetes outcomes. These findings underscore the need for targeted interventions to address healthcare disparities, especially during public health crises.

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Systematic Review of Monogenic Diabetes Prognostics

Naylor, R. N.; Amouyal, C.; Philipson, L. H.; Vatier, C.; Dickens, L. T.; American Diabetes Association/European Association for the Study of Diabetes Precision Medicine Init, ; Greeley, S. A. W.

2023-05-21 endocrinology 10.1101/2023.05.19.23290220 medRxiv
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BackgroundIndividuals with monogenic diabetes are at risk for diabetes-related complications; however, overall prognosis and whether prognosis is similar to other diabetes forms is poorly understood. AimTo assess diabetes-related microvascular and macrovascular complications in the common forms of monogenic diabetes. MethodsSystematic review with data sources from Pubmed, Medline and Embase was performed to assess diabetes-related complications in KCNJ11-neonatal diabetes, ABBC8-neontal diabetes, HNF1A-diabetes, HNF4-diabetes and GCK-related hyperglycemia. ResultsData was extracted from 67 studies. Most studies had moderate to high risk of bias. In neonatal diabetes, 16 of 20 studies reported at least one microvascular complication, with complications occurring as early as the second decade of life. Macrovascular complications were reported in only 1 individual who was 40 years old at the time of study. Diabetes complications were frequent in HNF1A-diabetes and HNF4A-diabetes, but did show a temporal trend of improved prognosis (e.g., 47% versus 13.6% retinopathy) and better prognosis compared to type 1 diabetes. Death due to cardiovascular disease was higher in HNF1A-diabetes compared to unaffected relatives (66% versus 43%). GCK-related hyperglycemia showed overall low rates of complications. ConclusionWhile KCNJ11-neonatal diabetes, ABBC8-neontal diabetes, HNF1A-diabetes and HNF4-diabetes are clearly at risk for diabetes-related complications, microvascular complications were infrequently reported before the third decade of life. GCK-related hyperglycemia showed a low prevalence of complications with rates not significantly different from control groups except for mild retinopathy. Future prospective studies to determine age at onset of complications and the impact of precision therapy are warranted to best guide surveillance practices for each subtype.

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The Influence of Polypharmacy on Type 2 Diabetes Adverse Cardiovascular Outcomes in a Rural Cohort

Li, J. W.; Crew, L. A.; Cox, T. M.; Canine, B. F.

2026-04-03 endocrinology 10.64898/2026.04.02.26350053 medRxiv
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Objective: In this study, we utilized a large-scale clinical database to evaluate the relationship between polypharmacy and adverse outcomes among type 2 diabetes patients in rural Montana to inform strategies that improve adherence, reduce preventable complications, and promote equitable diabetes care in underserved regions. Research Design and Methods: 591 patients from the Big Sky Care Connect Database (BSCC) with type 2 diabetes and medication history were stratified into 3 cohorts based on prescribed number of medications: (1-4 medications, non-polypharmic), (5-9 medications, polypharmic), and ([&ge;]10 medications, hyperpolypharmic). Each cohort was examined for Major Adverse Cardiovascular Events (MACE) and Diabetes Complication Severity Index (DCSI). Descriptive statistics, multivariate logistic regressions, linear regression, and Poisson regression analyses were performed. Results: Medication count was associated with male gender ({beta} = -2.1341, p < 0.001). Both medication count (IRR 1.06 per additional medication, p < 0.001) and age (IRR 1.03 per year, p < 0.001) were significant predictors of MACE. Neuropathy and nephropathy prevalence was statistically significant (p < 0.001) across patient cohorts and increased with medication count.

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Financial factors: a mixed methods survey-based study of barriers and facilitators to physical activity in type 1 diabetes

Anderson, K. C.; Mauro, S. A.; Panzer, A. A.; Igudesman, D.; Fitzgibbon, K. S.; Zaslow, S.; Love, K. M.

2025-12-19 endocrinology 10.64898/2025.12.18.25342586 medRxiv
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AimsTo identify barriers and facilitators to physical activity (PA) in adults with type 1 diabetes (T1D) living in the United States (U.S.) and identify sociodemographic factors related to meeting recommended PA. MethodsWe conducted a cross-sectional online survey study of adults with T1D aged [&ge;]18 years recruited through online-based platforms. Quantitative questions related to exercise quantity and intensity, demographic characteristics, and exercise barriers and facilitators. Wilcoxon rank sum tests or independent t-tests were used to compare quantitative responses in individuals meeting or below target PA. Barriers and facilitators were also assessed qualitatively with open-ended questions. Logistic regression was performed to determine if the following characteristics were independently associated with meeting PA recommendations: age, sex, income level, and automated insulin delivery system use. ResultsOf 281 respondents who completed questions about exercise quantity, 162 (57.7%) were women, mean age 52.6 {+/-} 16.6 years, and 151 (53.7%) met PA guideline recommendations. Common barrier themes related to T1D included hypoglycemia, time, lack of knowledge about glycemic management, cost, and failure of available treatments to accommodate exercise. Common facilitator themes were insurance reimbursement of exercise program/facility, peer exercise groups, health/fitness advising, and T1D tailored fitness. Middle (vs. upper) income level was independently associated with lower odds of meeting PA recommendations (adjusted odds ratio 0.46, 95% CI: 0.27, 0.78, p = 0.004). ConclusionsIn this predominately U.S. cohort with T1D, financial factors were common novel themes related to PA. Further validation in more socioeconomically diverse cohorts and research examining PA reimbursement cost-efficacy are needed. Novelty statementO_ST_ABSWhat is already known?C_ST_ABSO_LIIn prior qualitative studies in type 1 diabetes, hypoglycemia is a commonly reported barrier to physical activity (PA) engagement. Most studies were conducted outside the United States (U.S.). C_LI What this study foundO_LIIn a predominately U.S. cohort of adults with type 1 diabetes, cost is a newly identified barrier to PA. C_LIO_LIInsurance reimbursement of PA programs/facilities was a reported facilitator. C_LIO_LIIndividuals with highest income were 54% more likely to achieve recommended PA compared to other income categories. C_LI What are the implications of the study?O_LICost-efficacy research examining PA programs/facility reimbursement in type 1 diabetes is needed. C_LI

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QBSafe: a Randomized Trial of a Novel Intervention to Improve Care for People Living With Type 2 Diabetes

Lipska, K. J.; Branda, M. E.; Camp, A. W.; Montosa, M.; McCoy, R.; Montori, V.; Larios, F.; Montori, V. M.

2026-02-09 endocrinology 10.64898/2026.02.06.26345768 medRxiv
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BackgroundEffective interventions are needed to support co-creation of diabetes care plans that fit patients lives. We evaluated the QBSafe agenda-setting kit (14 conversation cards) for its impact on care fit and glycemic control when added to usual primary care. MethodsThis single-center, clinician-level cluster-randomized, open-label trial was conducted at a federally qualified health center in New Haven, Connecticut (ClinicalTrials.gov NCT05553912). Clinicians and their patients with type 2 diabetes and HbA1c >8% were randomized 1:1 to usual care with or without QBSafe cards. In the intervention arm, patients selected up to 3 cards highlighting concerns about life with diabetes prior to their visit. Primary outcomes were change at 6 months in care fit (Illness Intrusiveness Ratings Scale, IIRS) and HbA1c, analyzed by intention to treat. Secondary outcomes were treatment burden (Treatment Burden Questionnaire, TBQ) and diabetes distress (Diabetes Distress Scale, DDS), and satisfaction with visits. ResultsBetween February 2023 and July 2024, 143 participants (mean age 56 years; 61% female; 73% Hispanic; mean HbA1c 10%) were enrolled: 74 received usual care with QBSafe, 69 usual care alone. At 6 months, there were no significant between-arm differences in changes in IIRS (-3.9 [95% CI -10.4, 2.6]), HbA1c (-0.2% [95% CI -0.9, 0.5]), TBQ (1.0 [95% CI -16.6, 18.6]), or DDS (-0.1 [95% CI -0.4, 0.2]). Clinicians reported greater satisfaction when using QBSafe. Patient satisfaction was high and did not differ across arms. ConclusionsQBSafe cards improved clinician satisfaction but did not improve care fit or glycemic control. Future tools should focus on helping clinicians respond effectively to patient-identified challenges.

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The Influence of Age, Sex, and Socioeconomic Status on Glycemic Control Among People with Type 1 and Type 2 Diabetes in Canada: A Patient-Led Longitudinal Retrospective Cohort Study

Mousavi, S.; Tannenbaum Greenberg, D.; Ndjaboue, R.; Greiver, M.; Drescher, O.; Chipenda Dansokho, S.; Boutin, D.; Chouinard, J.-M.; Dostie, S.; Fenton, R.; Greenberg, M.; McGavock, J.; Najam, A.; Rekik, M.; Weisz, T.; Willison, D. J.; Durand, A.; Witteman, H. O.

2021-12-16 endocrinology 10.1101/2021.12.14.21267759 medRxiv
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BackgroundClinical guidelines for most adults with diabetes recommend maintaining hemoglobin A1c (HbA1c) [&le;]7.0% (<53 mmol/mol) to avoid microvascular and macrovascular complications. People with diabetes of different ages, sexes, and socioeconomic statuses may differ in their ease of attaining this goal. As a team of people with diabetes, researchers, and health professionals, we aimed to explore patterns in HbA1c results among people with type 1 or type 2 diabetes in Canada. Our research question was identified by people living with diabetes. MethodsWe used generalized estimating equations to analyze the effects of age, sex and socioeconomic status in 947,543 HbA1c results measured from 2010 to 2019 among 90,770 people living with type 1 or 2 diabetes in Canada. People living with diabetes reviewed and interpreted the results. ResultsHbA1c results at or below 7.0% represented 30.5% (male people living with type 1 diabetes), 21.0% (female people living with type 1 diabetes), 55.0% (male people living with type 2 diabetes) and 59.0% (female people living with type 2 diabetes) of results in each subcategory. We observed higher HbA1c values during adolescence and, for people living with type 2 diabetes, among people living in lower income areas. Among those with type 1 diabetes, female people tended to have lower HbA1c than male people during childbearing years but higher HbA1c than male people during menopausal years. Team members living with diabetes confirmed that the patterns we observed reflected their own life courses and suggested these results be communicated to health professionals and other stakeholders to improve treatment for people living with diabetes. InterpretationA substantial proportion of people with diabetes in Canada are insufficiently supported to maintain guideline-recommended glycemic control goals. Blood sugar management goals may be particularly challenging for people who are going through adolescence, menopause, or living with fewer financial resources. Health professionals should be aware of the challenging nature of glycemic management and policymakers in Canada should provide more support for people with diabetes to live healthy lives.

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Understanding Patient Perceptions of Genetic Testing to Predict Type 2 Diabetes Risk After Gestational Diabetes

Patel, R.; Christodoulou, M.; Taylor, Z.; Shetty, P.; Zollner, J.

2025-11-04 genetic and genomic medicine 10.1101/2025.11.02.25339227 medRxiv
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AimsWomen with gestational diabetes mellitus (GDM) face increased lifetime risk of type 2 diabetes (T2DM). Genetic risk-predictive testing could help identify those at highest risk and guide preventative care. We aimed to assess perceptions of genetic risk scores to help inform future implementation. MethodsAn online survey of 112 women with current or prior GDM assessed willingness for genetic and non-genetic risk testing, attitudes lifestyle motivation, and data-use concerns. Quantitative analyses were complemented by thematic analysis of free-text responses. ResultsOverall, willingness was high for both genetic testing (83.9%) and non- genetic (90.2%), with no significant difference between them (p = 0.083). Participants identifying as White reported greater willingness for genetic testing (p = 0.020) and stronger agreement that testing should be available on the NHS (p = 0.032) than N=non-White participants. Attitudes toward genetic testing were positive and associated with both willingness to test and support for NHS availability (p < 0.001). Younger participants were more motivated to modify lifestyle behaviours (p = 0.015). Overall, concerns around data collection were low; although free-text responses highlighted health insurance implications, psychological burden, actionability of results, and timing of testing as salient themes. ConclusionsWomen with GDM were receptive to genetic risk-prediction for T2DM, with low concerns around data usage. Demographic differences in acceptability and motivation highlight the need for inclusive, targeted communications and lifestyle support alongside integration testing into postnatal-GDM care. What is already known?We know that women with Gestational Diabetes Mellitus (GDM) have an increased risk of developing Type 2 Diabetes Mellitus (T2DM) later in life. Genetic risk scores can stratify women by their likelihood of developing T2DM following GDM. This risk information could help to inform womens lifestyle choices and help prevent progression to T2DM. However, evidence is limited regarding womens willingness to undergo genetic testing, how risk information might shape lifestyle behaviours, and their concerns about data collection and privacy. What this study has found?Our study found that our participants with current or previous GDM were fairly receptive to genetic testing to predict their future risk of T2DM. There was no significant difference between reported acceptability of a non-genetic test and a genetic test. Participants held positive attitudes towards genetic testing and fairly low concerns about data use and privacy. However, the acceptability of this testing and motivation for lifestyle changes varied by participant demographics (including age, education and ethnicity). Additionally, free-text responses identified concerns over implications for health insurance, the timing of testing, psychological burden of knowing results and the actionability of results. What are the implications of the study?To support equitable engagement and uptake of genetic risk-prediction testing, inclusive education and communication strategies are needed - particularly on the actionability of results and data collection/storage policies. Although not directly measured, our findings point to the value of culturally responsive, trust-building communication--delivered with cultural humility and empathy--to address uncertainties and enable informed choice. These findings support the use of genetic predictive testing within postnatal GDM care in addition to targeted interventions to support lifestyle changes and prevent progression to type 2 diabetes.

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Evaluation of Multifaceted Patient-Peer Delivered Intervention for Type-2 Diabetes Control and Remission in Rural Locations in India: Open-Label Cluster Randomised Pilot Study

Sharma, K. K.; Hegde, S. K. B.; Valaulikar, R.; Garigipati, S.; Ernst-Stegeman, A.-M.; Coles, E.; Pijl, H.; Hazarika, N.; Gali, D.; Choudhury, M.; Vig, A.; Baruah, C.; Ballala, R.; Boers, A. C.; Bredius, L.; Habib, G. L.; Vergou, E.; Yousuf, H.; van der Zilj, N.; Lodha, S.; Hofstra, L.; van den Berg, J.; Gupta, R.

2026-03-09 endocrinology 10.64898/2026.03.08.26347876 medRxiv
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ObjectiveTo evaluate the effectiveness of a multifaceted lifestyle intervention delivered by patient peers and supported by healthcare workers and technology to achieve control and remission of type 2 diabetes. MethodsOpen-label, cluster-randomised controlled trial conducted in rural Assam, India. Type 2 diabetes patients identified through a screening program in 25 villages (clusters) were randomly assigned to intervention or standard care. At baseline, all participants underwent assessment of diet, physical activity, quality of life, medicine intake, physical measurements and biochemical evaluation. The intervention was a contextually designed package, delivered during fortnightly group counselling by patient-peers and healthcare workers, focusing on carbohydrate-restricted healthy diet, physical activity, diabetes management, and medication de-escalation. Nutrition data were transferred to the study management for suggestions and modifications on smartphones. Intervention was implemented for 3 months, when anthropometric and biochemical parameters were reassessed. Primary outcomes were diabetes control (HbA1c, fasting glucose) and remission (HbA1c <6.5% without medications). Modified intention-to-treat analysis has been performed. Results353 patients in rural locations (intervention=193, standard care=160) were enrolled. Baseline sociodemographic, lifestyle, clinical and biochemical parameters were not different in intervention and standard-care groups. At 3 months, in the intervention vs standard-care group there was significantly lower median (interquartile range) HbA1c 7.9% (7.0-8.7) vs 8.6% (7.6-9.8), p<0.001; and fasting glucose 188.0 mg/dl (146.2-253.5) vs 210.0 mg/dl (166.0-282.0), p=0.001. Diabetes remission was in 9 participants (5.0%) in intervention vs 4 (2.7%) in standard care (p=0.249). ConclusionsPatient-peers delivered and healthcare worker- and technology-supported diet and lifestyle intervention for type 2 diabetes led to significant improvement in diabetes control in rural patients in India. Diabetes remission was observed in a low proportion. Trial registrationRegistered with Clinical Trials Registry of India at www.ctri.nic.in; registration number CTRI/2022/03/041302 dated 22 March 2022. STRENGTHS AND LIMITATIONS OF THE STUDYO_LIMultifaceted diet and lifestyle intervention for type-2 diabetes control and remission, delivered by patient-peers with health worker and technology support, is feasible in rural populations in India. C_LIO_LIThis cluster-randomised trial shows that the intervention led to significantly better diabetes control. Diabetes remission occurred in a small proportion. C_LIO_LILarger and longer prospective studies are required to confirm the effectiveness of such lifestyle strategies for diabetes control and remission in India, lower-middle, and low-income countries. C_LI