Glycaemia and ischaemia-reperfusion brain injury in patients with ischaemic stroke treated with mechanical thrombectomy (GLIAS-MT): an observational, unicentric, prospective study protocol.

INTRODUCTION: Poststroke hyperglycaemia is an independent risk factor for poorer outcomes in patients treated with mechanical thrombectomy (MT) and is associated with a lower probability of functional recovery and higher mortality at 3 months. This study aims to evaluate the association between glucose levels during cerebral reperfusion with MT and functional recovery at 3 months, measured by subcutaneous continuous glucose monitoring (CGM) devices. METHODS: This prospective observational study aims to recruit 100 patients with ischaemic stroke and large anterior circulation vessel occlusion, in whom MT is indicated. CGM will be performed using a Freestyle Libre ProIQ device (FSL-CGM, Abbott Diabetes Care, Alameda, California, USA), which will be implanted on admission to the emergency department, to monitor glucose levels before, during and after reperfusion. The study's primary endpoint will be the functional status at 3 months, as measured by the dichotomised modified Rankin Scale (0-2 indicating good recovery and 3-6 indicating dependency or death). We will analyse expression profiles of microRNA (miRNA) at the time of reperfusion and 24 hours later, as potential biomarkers of ischaemic-reperfusion injury. The most promising miRNAs include miR-100, miR-29b, miR-339, miR-15a and miR-424. All patients will undergo treatment according to current international recommendations and local protocols for the treatment of stroke, including intravenous thrombolysis if indicated. ETHICS AND DISSEMINATION: This study (protocol V.1.1, dated 29 October 2021, code 6017) has been approved by the Clinical Research Ethics Committee of La Paz University Hospital (Madrid, Spain) and has been registered in ClinicalTrials.gov (NCT05871502). Study results will be disseminated through peer-reviewed publications in Open Access format and at conference presentations. TRIAL REGISTRATION NUMBER: NCT05871502.

Effects of a carbohydrate-reduced high-protein diet delivered with meal kits to Danish people with type 2 diabetes: protocol for a 12-month randomised controlled trial.

INTRODUCTION: The cornerstone in the management of type 2 diabetes (T2D) is lifestyle modification including a healthy diet, typically one in which carbohydrate provides 45%-60% of total energy intake (E%). Nevertheless, systematic reviews and meta-analyses of trials with low carbohydrate diets (which are increased in protein and/or fat) for T2D have found improved glycaemic control in the first months relative to comparator diets with higher carbohydrate content. Studies lasting ≥1 year are inconclusive, which could be due to decreased long-term dietary adherence. We hypothesise that glucometabolic benefits can be achieved following 12 months of carbohydrate-restricted dieting, by maximising dietary adherence through delivery of meal kits, containing fresh, high-quality ingredients for breakfast, dinner and snacks, combined with nutrition education and counselling. METHODS AND ANALYSIS: This protocol describes a 12-month investigator-initiated randomised controlled, open-label, superiority trial with two parallel groups that will examine the effect of a carbohydrate-reduced high-protein (CRHP) diet compared with a conventional diabetes (CD) diet on glucometabolic control (change in glycated haemoglobin being the primary outcome) in 100 individuals with T2D and body mass index (BMI) >25 kg/m2. Participants will be randomised 1:1 to receive either the CRHP or the CD diet (comprised 30/50 E% from carbohydrate, 30/17 E% from protein and 40/33 E% from fat, respectively) for 12 months delivered as meal kits, containing foods covering more than two-thirds of the participants' estimated daily energy requirements for weight maintenance. Adherence to the allocated diets will be reinforced by monthly sessions of nutrition education and counselling from registered clinical dietitians. ETHICS AND DISSEMINATION: The trial has been approved by the National Committee on Health Research Ethics of the Capital Region of Denmark. The trial will be conducted in accordance with the Declaration of Helsinki. Results will be submitted for publication in international peer-reviewed scientific journals. TRIAL REGISTRATION NUMBER: NCT05330247. PROTOCOL VERSION: The trial protocol was approved on 9 March 2022 (study number: H-21057605). The latest version of the protocol, described in this manuscript, was approved on 23 June 2023.

Demographic and geographic distribution of diabetes and pre-diabetes risk in rural settings: results from a cross-sectional, countywide rural health survey in Sullivan County, New York.

OBJECTIVE: To perform a detailed characterisation of diabetes burden and pre-diabetes risk in a rural county with previously documented poor health outcomes in order to understand the local within-county distribution of diabetes in rural areas of America. DESIGN, SETTING, AND PARTICIPANTS: In 2021, we prospectively mailed health surveys to all households in Sullivan County, a rural county with the second-worst health outcomes of all counties in New York State. Our survey included questions on demographics, medical history and the American Diabetes Association's Pre-diabetes Risk Test. PRIMARY OUTCOME AND METHODS: Our primary outcome was an assessment of diabetes burden within this rural county. To help mitigate non-response bias in our survey, raking adjustments were performed across strata of age, sex, race/ethnicity and health insurance. We analysed diabetes prevalence by demographic characteristics and used geospatial analysis to assess for clustering of diagnosed diabetes cases. RESULTS: After applying raking procedures for the 4725 survey responses, our adjusted diagnosed diabetes prevalence for Sullivan County was 12.9% compared with the 2019 Behavioural Risk Factor Surveillance System (BRFSS) estimate of 8.6%. In this rural area, diagnosed diabetes prevalence was notably higher among non-Hispanic Black (21%) and Hispanic (15%) residents compared with non-Hispanic White (12%) residents. 53% of respondents without a known history of pre-diabetes or diabetes scored as high risk for pre-diabetes. Nearest neighbour analyses revealed that hotspots of diagnosed diabetes were primarily located in the more densely populated areas of this rural county. CONCLUSIONS: Our mailed health survey to all residents in Sullivan County demonstrated higher diabetes prevalence compared with modelled BRFSS estimates that were based on small telephone samples. Our results suggest the need for better diabetes surveillance in rural communities, which may benefit from interventions specifically tailored for improving glycaemic control among rural residents.

Effects of pre-existing type 1 diabetes mellitus on survival outcome following out-of-hospital cardiac arrest: a registry-based observational study in Sweden.

BACKGROUND: It has been estimated that 80% of cases of out-of-hospital cardiac arrest (OHCA) are due to cardiac causes. It is well-documented that diabetes is a risk factor for conditions associated with sudden cardiac arrest. Type 1 diabetes (T1D) displays a threefold to fivefold increased risk of cardiovascular disease and death compared with the general population. OBJECTIVE: This study aims to assess the characteristics and survival outcomes of individuals with and without T1D who experienced an OHCA. Design: A registry-based nationwide observational study with two cohorts, patients with T1D and patients without T1D. Setting: All emergency medical services and hospitals in Sweden were included in the study. PARTICIPANTS: Using the Swedish Cardiopulmonary Resuscitation Registry, we enrolled 54 568 cases of OHCA where cardiopulmonary resuscitation was attempted between 2010 and 2020. Among them, 448 patients with T1D were identified using International Classification of Diseases-code: E10. METHODS: Survival analysis was performed using Kaplan-Meier and logistic regression. Multiple regression was adjusted for age, sex, cause of arrest, prevalence of T1D and time to cardiopulmonary resuscitation. MAIN OUTCOME MEASURES: The outcomes were discharge status (alive vs dead), 30 days survival and neurological outcome at discharge. RESULTS: There were no significant differences in patients discharged alive with T1D 37.3% versus, 46% among cases without T1D. There was also no difference in neurological outcome. Kaplan-Meier curves yielded no significant difference in long-term survival. Multiple regression showed no significant association with survival after accounting for covariates, OR 0.99 (95% CI 0.96 to 1.02), p value=0.7. Baseline characteristics indicate that patients with T1D were 5 years younger at OHCA occurrence and had proportionally fewer cases of heart disease as the cause of arrest (57.6% vs 62.7%). CONCLUSION: We conclude, with the current sample size, that there is no statistically significant difference in long-term or short-term survival between patients with and without T1D following OHCA.

Study protocol for a prospective, multicentre study of hypercortisolism in patients with difficult-to-control type 2 diabetes (CATALYST): prevalence and treatment with mifepristone.

INTRODUCTION: Even with recent treatment advances, type 2 diabetes (T2D) remains poorly controlled for many patients, despite the best efforts to adhere to therapies and lifestyle modifications. Although estimates vary, studies indicate that in >10% of individuals with difficult-to-control T2D, hypercortisolism may be an underlying contributing cause. To better understand the prevalence of hypercortisolism and the impact of its treatment on T2D and associated comorbidities, we describe the two-part Hyper c ortisolism in P at ients with Difficult to Control Type 2 Di a betes Despite Receiving Standard-of-Care Therapies: Preva l ence and Treatment with Korl y m® (Mifepri st one) (CATALYST) trial. METHODS AND ANALYSIS: In part 1, approximately 1000 participants with difficult-to-control T2D (haemoglobin A1c (HbA1c) 7.5%-11.5% despite multiple therapies) are screened with a 1 mg dexamethasone suppression test (DST). Those with post-DST cortisol >1.8 µg/dL and dexamethasone level ≥140 ng/dL are identified to have hypercortisolism (part 1 primary endpoint), have morning adrenocorticotropic hormone (ACTH) and dehydroepiandrosterone sulfate (DHEAS) measured and undergo a non-contrast adrenal CT scan. Those requiring evaluation for elevated ACTH are referred for care outside the study; those with ACTH and DHEAS in the range may advance to part 2, a randomised, double-blind, placebo-controlled trial to evaluate the impact of treating hypercortisolism with the competitive glucocorticoid receptor antagonist mifepristone (Korlym®). Participants are randomised 2:1 to mifepristone or placebo for 24 weeks, stratified by the presence/absence of an abnormal adrenal CT scan. Mifepristone is dosed at 300 mg once daily for 4 weeks, then 600 mg daily based on tolerability and clinical improvement, with an option to increase to 900 mg. The primary endpoint of part 2 assesses changes in HbA1c in participants with hypercortisolism with or without abnormal adrenal CT scan. Secondary endpoints include changes in antidiabetes medications, cortisol-related comorbidities and quality of life. ETHICS AND DISSEMINATION: The study has been approved by Cleveland Clinic IRB (Cleveland, Ohio, USA) and Advarra IRB (Columbia, Maryland, USA). Findings will be presented at scientific meetings and published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT05772169.

Trends in antidiabetes medication use among hospitalised patients with type 2 diabetes: a retrospective single-centre cohort study.

OBJECTIVES: Novel antidiabetes medications with proven cardiovascular or renal benefit, such as sodium-glucose cotransporter-2 inhibitors (SGLT-2i) and glucagon-like peptide 1 receptor agonists (GLP-1 RA), have been introduced to the market. This study explored the 4-year trends of antidiabetes medication use among medical hospitalisations with type 2 diabetes (T2D). DESIGN: Retrospective cohort study. SETTING: Tertiary care hospital in Switzerland. PARTICIPANTS: 4695 adult hospitalisations with T2D and prevalent or incident use of one of the following antidiabetes medications (metformin, dipeptidyl peptidase-4 inhibitors (DPP-4i), sulfonylureas, GLP-1 RA, SGLT-2i, short-acting insulin or long-acting insulin), identified using electronic health record data. Quarterly trends in use of antidiabetes medications were plotted overall and stratified by cardiovascular disease (CVD) and chronic kidney disease (CKD). RESULTS: We observed a stable trend in the proportion of hospitalisations with T2D who received any antidiabetes medication (from 77.6% during 2019 to 78% in 2022; p for trend=0.97). In prevalent users, the largest increase in use was found for SGLT-2i (from 7.4% in 2019 to 21.8% in 2022; p for trend <0.01), the strongest decrease was observed for sulfonylureas (from 11.4% in 2019 to 7.2% in 2022; p for trend <0.01). Among incident users, SGLT-2i were the most frequently newly prescribed antidiabetes medication with an increase from 26% in 2019 to 56.1% in 2022 (p for trend <0.01). Between hospital admission and discharge, SGLT-2i also accounted for the largest increase in prescriptions (+5.1%; p<0.01). CONCLUSIONS: These real-world data from 2019 to 2022 demonstrate a significant shift in antidiabetes medications within the in-hospital setting, with decreased use of sulfonylureas and increased prescriptions of SGLT-2i, especially in hospitalisations with CVD or CKD. This trend aligns with international guidelines and indicates swift adaptation by healthcare providers, signalling a move towards more effective diabetes management.

Risk of hand and forearm conditions due to vibrating hand-held tools exposure: a retrospective cohort study from Sweden.

OBJECTIVES: The occurrence of hand and forearm disorders related to vibration exposure, adjusted for relevant background factors, is scarcely reported. We analysed the prevalence of such conditions in a large population cohort, stratified by sex, and associations with exposure to vibrating hand-held tools. DESIGN: This is a retrospective cohort study. SETTING: Individuals in the Malmö Diet and Cancer Study cohort (MDCS; inclusion 1991-1996; followed until 2018) were asked, 'does your work involve working with vibrating hand-held tools?' (response: 'not at all', 'some' and 'much'). Data were cross-linked with national registers to identify treatment for carpal tunnel syndrome (CTS), ulnar nerve entrapment (UNE), Dupuytren's disease, trigger finger or first carpometacarpal joint (CMC-1) osteoarthritis (OA). Cox regression models, unadjusted and adjusted (age, sex, prevalent diabetes, smoking, hypertension and alcohol consumption), were performed to analyse the effects of reported vibration exposure. PARTICIPANTS: Individuals in the MDCS who had answered the questionnaire on vibration exposure (14 342 out of the originally 30 446 individuals in MDCS) were included in the study. RESULTS: In total, 12 220/14 342 individuals (76%) reported 'no' exposure, 1392/14 342 (9%) 'some' and 730/14 342 (5%) 'much' exposure to vibrating hand-held tools. In men, 'much' exposure was independently associated with CTS (HR 1.71 (95% CI 1.11 to 2.62)) and UNE (HR 2.42 (95% CI 1.15 to 5.07)). 'Some' exposure was independently associated with UNE in men (HR 2.10 (95% CI 1.12 to 3.95)). 'Much' exposure was independently associated with trigger finger in women (HR 2.73 (95% CI 1.49 to 4.99)). We found no effect of vibration exposure on Dupuytren's disease or CMC-1 OA. 'Much' vibration exposure predicted any hand and forearm diagnosis in men (HR 1.44 (95% CI 1.08 to 1.80)), but not in women. CONCLUSIONS: Vibration exposure by hand-held tools increases the risk of developing CTS and UNE and any common hand and forearm conditions in men, whereas women only risk trigger finger and CMC-1 OA. Adjustment for relevant confounders in vibration exposure is crucial.

Incidence and predictors of diabetic foot ulcer among patients with diabetes mellitus in a diabetic follow-up clinic in Central Ethiopia: a retrospective follow-up study.

BACKGROUND: Diabetic foot ulcer is a major medical, social, and economic problem, and a leading cause of hospitalisations, increased morbidity, and mortality. Despite a rising occurrence, there is a dearth of data on the incidence and its predictors. OBJECTIVE: To assess the incidence and predictors of diabetic foot ulcers among patients with diabetes mellitus in a diabetic follow-up clinic in Central Ethiopia. DESIGN: Retrospective follow-up study design. PARTICIPANTS: A total of 418 newly diagnosed diabetes mellitus patients from 1 January 2012 to 31 December 2022. A computer-generated simple random sampling method was used to select the study participants. Data were collected using a structured data extraction checklist. The collected data were entered into Epi Info V.7.2 and exported to STATA V.14 for analysis. To estimate survival time, the Kaplan-Meier method was used, and the survival difference was tested using a log-rank test. OUTCOME MEASURES: The Cox proportional hazard model was fitted to identify the predictors of diabetic foot ulcer development. The strength of the association was estimated using an adjusted hazard ratio (AHR) with a 95% confidence interval (CI), and statistical significance was proclaimed at a p<0.05. RESULT: The overall incidence of diabetic foot ulcer was 1.51 cases (95% CI 1.03 to 2.22) per 100 person-years of observation. The cumulative incidence was 6.2% (95% CI 4.1% to 8.6%) over 10 years. The median time of follow-up was 45 months (IQR 21-73). Diastolic blood pressure of 90 mm Hg or above (AHR 2.91, 95% CI 1.25 to 6.77), taking combined medication (AHR 3.24, 95% CI 1.14 to 9.19) and having a peripheral arterial disease (AHR 5.26, 95% CI 1.61 to 17.18) were statistically significant predictors of diabetic foot ulcer development. CONCLUSION: The risk of occurrence of diabetic foot ulcer was relatively high. Diastolic blood pressure level, combined medication and peripheral arterial disease were independent predictors of diabetic foot ulcer development. Hence, close monitoring and proper interventions are essential.

Multicentre, retrospective cohort study protocol to identify racial and ethnic differences in acute kidney injuries in children and adolescents with diabetic ketoacidosis.

INTRODUCTION: Approximately 40% of children with diabetic ketoacidosis (DKA) develop acute kidney injury (AKI), which increases the risk of chronic kidney damage. At present, there is limited knowledge of racial or ethnic differences in diabetes-related kidney injury in children with diabetes. Understanding whether such differences exist will provide a foundation for addressing disparities in diabetes care that may continue into adulthood. Further, it is currently unclear which children are at risk to develop worsening or sustained DKA-related AKI. The primary aim is to determine whether race and ethnicity are associated with DKA-related AKI. The secondary aim is to determine factors associated with sustained AKI in children with DKA. METHODS AND ANALYSIS: This retrospective, multicentre, cross-sectional study of children with type 1 or type 2 diabetes with DKA will be conducted through the Paediatric Emergency Medicine Collaborative Research Committee. Children aged 2-18 years who were treated in a participating emergency department between 1 January 2020 and 31 December 2023 will be included. Children with non-ketotic hyperglycaemic-hyperosmolar state or who were transferred from an outside facility will be excluded. The relevant predictor is race and ethnicity. The primary outcome is the presence of AKI, defined by Kidney Disease: Improving Global Outcomes criteria. The secondary outcome is 'sustained' AKI, defined as having AKI ≥48 hours, unresolved AKI at last creatinine measurement or need for renal replacement therapy. Statistical inference of the associations between predictors (ie, race and ethnicity) and outcomes (ie, AKI and sustained AKI) will use random effects regression models, accounting for hospital variation and clustering. ETHICS AND DISSEMINATION: The Institutional Review Board of Children's Minnesota approved this study. 12 additional sites have obtained institutional review board approval, and all sites will obtain local approval prior to participation. Results will be presented at local or national conferences and for publication in peer-reviewed journals.

External validation of three diabetes prediction scores in a Spanish cohort: does adding high risk for depression improve the validation of the FINDRISC score (FINDRISC-MOOD)?

OBJECTIVES: To evaluate the external validity of the FINDRISC, DESIR and ADA risk scores for the prediction of diabetes in a Spanish population aged >45 years and to test the possible improvement of FINDRISC by adding a new variable of high risk of depression when Patient Health Questionnaire-9 (PHQ-9) questionnaire score ≥10 (FINDRISC-MOOD). DESIGN: Prospective population-based cohort study. SETTING: 10 primary healthcare centres in the north of the city of Madrid (Spain). PARTICIPANTS: A total of 1242 participants without a history of diabetes and with 2-hour oral glucose tolerance test (OGTT) plasma glucose <200 mg/dL (<11.1 mmol/L) were followed up for 7.3 years (median) using their electronic health records (EHRs) and telephone contact. PRIMARY AND SECONDARY OUTCOME MEASURES: Diabetes risk scores (FINDRISC, DESIR, ADA), PHQ-9 questionnaire and 2-hour-OGTT were measured at baseline. Incident diabetes was defined as treatment for diabetes, fasting plasma glucose ≥126 mg/dL (≥7.0 mmol/L), new EHR diagnosis or self-reported diagnosis. External validation was performed according to optimal cut-off, sensitivity, specificity and Youden Index. Comparison between diabetes risk scores, including FINDRISC-MOOD (original FINDRISC score plus five points if PHQ-9 ≥10), was measured by area under the receiver operating characteristic curve (AUROC). RESULTS: During follow-up, 104 (8.4%; 95% CI, 6.8 to 9.9) participants developed diabetes and 185 had a PHQ-9 score ≥10. The AUROC values were 0.70 (95% CI, 0.67 to 0.72) for FINDRISC-MOOD and 0.68 (95% CI, 0.65 to 0.71) for the original FINDRISC. The AUROCs for DESIR and ADA were 0.66 (95% CI, 0.63 to 0.68) and 0.66 (95% CI, 0.63 to 0.69), respectively. There were no significant differences in AUROC between FINDRISC-MOOD and the other scores. CONCLUSIONS: The results of FINDRISC-MOOD were like those of the other risk scores and do not allow it to be recommended for clinical use.

Assessing the feasibility and acceptability of a diabetes-specific nurse-led multicomponent smoking cessation intervention in diabetes education: study protocol for an open-label pragmatic randomised controlled trial.

INTRODUCTION: Smoking cessation is an essential, but often overlooked aspect of diabetes management. Despite the need for tailored smoking cessation support for individuals with diabetes, evidence of effective interventions for this cohort is limited. Additionally, individuals with diabetes do not easily adopt such interventions, resulting in low uptake and abstinence rates. This protocol describes a study that aims to assess the feasibility and acceptability of a unique smoking cessation intervention, based on the best evidence, theory and the needs of individuals with diabetes, among patients and service providers, the diabetes nurse educators. METHODS AND ANALYSIS: This is an open-label pragmatic randomised controlled trial. Between 80 and 100 individuals with type 1 or type 2 diabetes who smoke will be recruited from the diabetes outpatients at the main acute public hospital in Malta, starting in August 2023. Participants will be randomly assigned (1:1 ratio) to the intervention or control arm for 12 weeks. The experimental intervention will consist of three to four smoking cessation behavioural support sessions based on the 5As (Ask, Advise, Assess, Assist and Arrange) algorithm, and a 6-week supply of nicotine replacement therapy. The control intervention will consist of an active referral to the Maltese National Health Service's one-to-one smoking cessation support service, which is based on motivational interviewing. The primary feasibility and acceptability outcomes include the recruitment and participation rates, resources used, problems identified by the nurses, the nurses' perceived challenges and facilitators to implementation and the nurses' and patients' acceptability of the study intervention. Data analyses will be descriptive, with quantitative feasibility and acceptability outcomes reported with 95% confidence intervals. ETHICS AND DISSEMINATION: Ethical clearance was obtained from the Faculty of Health Sciences Research Ethics Committee, University of Malta. The study results will be disseminated through conference presentations and a publication in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: NCT05920096.

Cohort profile: the 'Biomarkers of heterogeneity in type 1 diabetes' study-a national prospective cohort study of clinical and metabolic phenotyping of individuals with long-standing type 1 diabetes in the Netherlands.

PURPOSE: The 'Biomarkers of heterogeneity in type 1 diabetes' study cohort was set up to identify genetic, physiological and psychosocial factors explaining the observed heterogeneity in disease progression and the development of complications in people with long-standing type 1 diabetes (T1D). PARTICIPANTS: Data and samples were collected in two subsets. A prospective cohort of 611 participants aged ≥16 years with ≥5 years T1D duration from four Dutch Diabetes clinics between 2016 and 2021 (median age 32 years; median diabetes duration 12 years; 59% female; mean glycated haemoglobin (HbA1c) 61 mmol/mol (7.7%); 61% on insulin pump; 23% on continuous glucose monitoring (CGM)). Physical assessments were performed, blood and urine samples were collected, and participants completed questionnaires. A subgroup of participants underwent mixed-meal tolerance tests (MMTTs) at baseline (n=169) and at 1-year follow-up (n=104). Genetic data and linkage to medical and administrative records were also available. A second cross-sectional cohort included participants with ≥35 years of T1D duration (currently n=160; median age 64 years; median diabetes duration 45 years; 45% female; mean HbA1c 58 mmol/mol (7.4%); 51% on insulin pump; 83% on CGM), recruited from five centres and measurements, samples and 5-year retrospective data were collected. FINDINGS TO DATE: Stimulated residual C-peptide was detectable in an additional 10% of individuals compared with fasting residual C-peptide secretion. MMTT measurements at 90 min and 120 min showed good concordance with the MMTT total area under the curve. An overall decrease of C-peptide at 1-year follow-up was observed. Fasting residual C-peptide secretion is associated with a decreased risk of impaired awareness of hypoglycaemia. FUTURE PLANS: Research groups are invited to consider the use of these data and the sample collection. Future work will include additional hormones, beta-cell-directed autoimmunity, specific immune markers, microRNAs, metabolomics and gene expression data, combined with glucometrics, anthropometric and clinical data, and additional markers of residual beta-cell function. TRIAL REGISTRATION NUMBER: NCT04977635.

Factors influencing optimal diabetes care and clinical outcomes in Thai patients with type 2 diabetes mellitus: a multilevel modelling analysis.

BACKGROUND: Increasing levels of poor glycaemic control among Thai patients with type 2 diabetes mellitus (T2DM) motivated us to compare T2DM care between urban and suburban primary care units (PCUs), to identify gaps in care, and to identify significant factors that may influence strategies to enhance the quality of care and clinical outcomes in this population. METHODS: We conducted a cross-sectional study involving 2160 patients with T2DM treated at four Thai PCUs from 2019 to 2021, comprising one urban and three suburban facilities. Using mixed effects logistic regression, we compared care factors between urban and suburban PCUs. RESULTS: Patients attending suburban PCUs were significantly more likely to undergo eye (adjusted OR (AOR): 1.83, 95% CI 1.35 to 1.72), foot (AOR: 1.61, 95% CI 0.65 to 4.59) and HbA1c (AOR: 1.66, 95% CI 1.09 to 2.30) exams and achieved all ABC (HbA1c, blood pressure (BP) and low-density lipoprotein cholesterol (LDL-C)) goals (AOR: 2.23, 95% CI 1.30 to 3.83). Conversely, those at an urban PCU were more likely to undergo albuminuria exams. Variables significantly associated with good glycaemic control included age (AOR: 1.51, 95% CI 1.31 to 1.79), T2DM duration (AOR: 0.59, 95% CI 0.41 to 0.88), FAACE (foot, HbA1c, albuminuria, LDL-C and eye) goals (AOR: 1.23, 95% CI 1.12 to 1.36) and All8Q (AOR: 1.20, 95% CI 1.05 to 1.41). Chronic kidney disease (CKD) was significantly linked with high triglyceride and HbA1c levels (AOR: 5.23, 95% CI 1.21 to 7.61). Elevated HbA1c levels, longer T2DM duration, insulin use, high systolic BP and high lipid profile levels correlated strongly with diabetic retinopathy (DR) and CKD progression. CONCLUSION: This highlights the necessity for targeted interventions to bridge urban-suburban care gaps, optimise drug prescriptions and implement comprehensive care strategies for improved glycaemic control, DR prevention and CKD progression mitigation among in Thai patients with T2DM. The value of the clinical target aggregate (ABC) and the process of care aggregate (FAACE) was also conclusively demonstrated.

Variations in health-related quality of life (EQ-5D) associated with cardiovascular health: a cross-sectional study of adults with diabetes in the Korean general population.

OBJECTIVES: Previous studies on the differences in the mechanism and complications of diabetes between men and women have indicated potential sex differences in cardiovascular health, which affect health-related quality of life (HRQoL). DESIGN: A cross-sectional cohort study. SETTING: To determine how sex differences can be noticed, acknowledged and applied in clinical practice, we aimed to determine the cardiovascular (CV) health status of men and women with diabetes and its effects on HRQoL. PARTICIPANTS: In total, 2829 individuals with diabetes (1518 men and 1311 women) aged ≥40 years who participated in the Korean National Health and Nutrition Examination Survey from 2013 to 2018 were enrolled. OUTCOME MEASURES: Individuals with diabetes were categorised into poor, intermediate and ideal groups based on CV health indicators recommended by the American Heart Association. We used EQ-5D-3L to compare HRQoL scores between the sexes. Multivariable ordinal logistic regression and analysis of covariance were used to analyse the outcome variables. RESULTS: In the poor CV health score group, female sex was associated with mobility problems (OR 1.93, 95% CI 1.46 to 2.54), problems with usual activities (OR1.71, 95% CI 1.24 to 2.35), pain/discomfort (OR 1.69, 95% CI 1.32 to 2.16) and anxiety/depression (OR 1.66 95% CI 1.16 to 2.38). In the intermediate and ideal CV health score groups, female sex was associated with pain/discomfort (OR 1.57, 95% CI 1.15 to 2.15). Men had higher EQ-5D index scores in the poor and intermediate CV health score groups than did women. CONCLUSIONS: Although women tended to have high health-related CV health scores, HRQoL was lower in women than in men, especially in the poor CV health score group and in the pain/discomfort domain.

Evaluating the implementation of group empowerment and training (GREAT) for diabetes in South Africa: convergent mixed methods.

OBJECTIVE: Type 2 diabetes is a leading contributor to the burden of disease in South Africa. Primary care is struggling to support self-management and lifestyle change. Group empowerment and training (GREAT) for diabetes is a feasible and cost-effective intervention in our setting. This study aimed to evaluate the implementation of GREAT for diabetes. DESIGN: A convergent mixed-methods study evaluated a range of implementation outcomes: acceptability, appropriateness, adoption, feasibility, fidelity, reach and cost. SETTING: Ten primary care facilities from a district in all nine provinces of South Africa. PARTICIPANTS: Descriptive exploratory individual semistructured interviews were conducted with 34 key stakeholders from national policy-makers to primary care providers. Three focus group interviews were held with 35 patients. RESULTS: The National Department of Health saw GREAT as an acceptable and appropriate intervention, but only five of the nine provinces adopted GREAT. District-level and facility-level managers also saw GREAT as an acceptable and appropriate intervention. Factors related to feasibility included physical space, sufficient staff numbers, availability of resource materials, the health information system, adaptation to the model of care (selection of facilities, patients, adjustment of patient flow and appointment systems, leadership from local managers and the whole clinical team) and inclusion in systems for quality improvement. No major changes were made to the design of GREAT and fidelity to the session content ranged from 66% to 94%. Incremental costs were US$494 per facility. Due to disruption from the COVID-19 pandemic, only 14 facilities implemented and reached 588 patients at the time of evaluation. CONCLUSION: Key lessons were learnt on how to implement GREAT for diabetes in a middle-income country setting. The findings informed the design of a programme theory using a health system framework. The programme theory will guide further scale-up in each province and scale-out to provinces that have not yet implemented. QUESTION: This study focused on evaluating how to implement GREAT for type 2 diabetes in primary care and to take it to scale in South Africa. FINDING: The findings led to a programme theory on how to successfully implement GREAT for diabetes in the South African context. MEANING: The study demonstrates relevant contextual factors that need to be considered in the implementation of group diabetes education programme in a middle-income country.

Gender differences in the association between physical activity and cognitive subdomains among elders with type 2 diabetes and mild cognitive impairment: a cross-sectional study.

OBJECTIVES: The objective of this study was to evaluate the gender differences in the correlation between physical activity (PA) and cognitive subdomains in elderly individuals with type 2 diabetes (T2D) and mild cognitive impairment (MCI). DESIGN: Cross-sectional study. SETTING: The research was carried out in communities located in Fuzhou, Fujian Province and Beijing Municipality. PARTICIPANTS: Community-dwelling elders with T2D and MCI aged 60 years or older were eligible for this study. PRIMARY OUTCOME MEASURES AND ANALYSES: The weekly PA score was assessed using the International Physical Activity Questionnaire (IPAQ). The cognitive subdomains were evaluated through a battery of cognitive assessments, including the Rey Auditory Verbal Learning Test (RAVLT), Trail Making Test Part B, Digit Symbol Substitution Test (DSST) and the Stroop Color-Word Test (SCWT). Multiple linear regression models were employed to examine the association between PA and cognitive subdomains in both male and female individuals. RESULTS: In older men, higher total IPAQ score was positively correlated with higher RAVLT (P=0.011) and SCWT (P=0.049). There was a significant interaction between the total PA score and gender in relation to RAVLT (P=0.008) and SCWT (P=0.027). Moreover, there was a positive correlation between moderate-vigorous PA level and RAVLT in older men (P=0.007). Additionally, a positive correlation was found between moderate-vigorous PA level and DSST in older women (P=0.038). CONCLUSION: In older individuals with T2D and MCI, the association between PA and cognitive subdomains differs between men and women. This discrepancy may impact the customisation of exercise recommendations.

A Qualitative evaluation in community settings in England exploring the experiences of coaches delivering the NHS Low Calorie Diet programme pilot to ethnically diverse participants.

BACKGROUND: The management of type 2 diabetes (T2D) within diverse ethnic populations requires a culturally tailored approach. However, little is known about the experiences of coaches delivering interventions for T2D, such as the National Health Service (NHS) Low Calorie Diet (LCD) programme, to people from diverse ethnic backgrounds. OBJECTIVE: To explore the experiences of coaches delivering an NHS programme using total diet replacement approaches to individuals from diverse ethnic backgrounds, to inform the effective tailoring and equitable delivery of future interventions. DESIGN: Qualitative study. SETTING: Individuals delivering the NHS LCD programme. PARTICIPANTS: One-to-one semistructured interviews were conducted with seven health coaches delivering the NHS LCD programme. Inclusion criteria included participants delivering the NHS LCD programme either from a minoritised ethnic background or delivering the programme to those from ethnic minority and white British backgrounds. MAIN OUTCOME MEASURES: Qualitative semistructured interviews conducted through different stages of the programme. Reflexive thematic analysis was used to analyse the transcripts. RESULTS: Key themes highlighted the following experiences of delivering the LCD programme: (1) training and support needs; (2) needing to understand culture and ethnicity; (3) the impact of language; (4) the use of resources in providing dietary advice and (5) experiences of cultural tailoring. The themes highlight the need to prioritise person-centred care, to integrate culturally tailored approaches and for provision of education and training to those delivering health programmes. CONCLUSION: These findings describe the experiences of health coaches in tailoring delivery and emphasise the role of cultural competence in ensuring equitable and effective healthcare interventions for diverse populations. This learning can inform future programmes and policies aimed at promoting inclusive healthcare practices.

Appropriateness and acceptability of continuous glucose monitoring in people with type 1 diabetes at rural first-level hospitals in Malawi: a qualitative study.

OBJECTIVES: The purpose of this qualitative study is to describe the acceptability and appropriateness of continuous glucose monitoring (CGM) in people living with type 1 diabetes (PLWT1D) at first-level (district) hospitals in Malawi. DESIGN: We conducted semistructured qualitative interviews among PLWT1D and healthcare providers participating in the study. Standardised interview guides elicited perspectives on the appropriateness and acceptability of CGM use for PLWT1D and their providers, and provider perspectives on the effectiveness of CGM use in Malawi. Data were coded using Dedoose software and analysed using a thematic approach. SETTING: First-level hospitals in Neno district, Malawi. PARTICIPANTS: Participants were part of a randomised controlled trial focused on CGM at first-level hospitals in Neno district, Malawi. Pretrial and post-trial interviews were conducted for participants in the CGM and usual care arms, and one set of interviews was conducted with providers. RESULTS: Eleven PLWT1D recruited for the CGM randomised controlled trial and five healthcare providers who provided care to participants with T1D were included. Nine PLWT1D were interviewed twice, two were interviewed once. Of the 11 participants with T1D, six were from the CGM arm and five were in usual care arm. Key themes emerged regarding the appropriateness and effectiveness of CGM use in lower resource setting. The four main themes were (a) patient provider relationship, (b) stigma and psychosocial support, (c) device usage and (d) clinical management. CONCLUSIONS: Participants and healthcare providers reported that CGM use was appropriate and acceptable in the study setting, although the need to support it with health education sessions was highlighted. This research supports the use of CGM as a component of personalised diabetes treatment for PLWT1D in resource constraint settings. TRIAL REGISTRATION NUMBER: PACTR202102832069874; Post-results.

Feasibility of continuous glucose monitoring in patients with type 1 diabetes at two district hospitals in Neno, Malawi: a randomised controlled trial.

OBJECTIVES: To assess the feasibility and change in clinical outcomes associated with continuous glucose monitoring (CGM) use among a rural population in Malawi living with type 1 diabetes. DESIGN: A 2:1 open randomised controlled feasibility trial. SETTING: Two Partners In Health-supported Ministry of Health-run first-level district hospitals in Neno, Malawi. PARTICIPANTS: 45 people living with type 1 diabetes (PLWT1D). INTERVENTIONS: Participants were randomly assigned to Dexcom G6 CGM (n=30) use or usual care (UC) (n=15) consisting of Safe-Accu glucose monitors and strips. Both arms received diabetes education. OUTCOMES: Primary outcomes included fidelity, appropriateness and severe adverse events. Secondary outcomes included change in haemoglobin A1c (HbA1c), acceptability, time in range (CGM arm only) SD of HbA1c and quality of life. RESULTS: Participants tolerated CGM well but were unable to change their own sensors which resulted in increased clinic visits in the CGM arm. Despite the hot climate, skin rashes were uncommon but cut-out tape overpatches were needed to secure the sensors in place. Participants in the CGM arm had greater numbers of dose adjustments and lifestyle change suggestions than those in the UC arm. Participants in the CGM arm wore their CGM on average 63.8% of the time. Participants in the UC arm brought logbooks to clinic 75% of the time. There were three hospitalisations all in the CGM arm, but none were related to the intervention. CONCLUSIONS: This is the first randomised controlled trial conducted on CGM in a rural region of a low-income country. CGM was feasible and appropriate among PLWT1D and providers, but inability of participants to change their own sensors is a challenge. TRIAL REGISTRATION NUMBER: PACTR202102832069874.

Intersectoral health interventions to improve the well-being of people living with type 2 diabetes: a scoping review protocol.

INTRODUCTION: Intersectoral collaboration is a collaborative approach between the health sectors and other sectors to address the interdependent nature of the social determinants of health associated with chronic diseases such as diabetes. This scoping review aims to identify intersectoral health interventions implemented in primary care and community settings to improve the well-being and health of people living with type 2 diabetes. METHODS AND ANALYSIS: This protocol is developed by the Arksey and O'Malley (2005) framework for scoping reviews and the Levac et al methodological enhancement. MEDLINE, Embase, CINAHL, grey literature and the reference list of key studies will be searched to identify any study, published between 2000 and 2023, related to the concepts of intersectorality, diabetes and primary/community care. Two reviewers will independently screen all titles/abstracts, full-text studies and grey literature for inclusion and extract data. Eligible interventions will be classified by sector of action proposed by the Social Determinants of Health Map and the conceptual framework for people-centred and integrated health services and further sorted according to the actors involved. This work started in September 2023 and will take approximately 10 months to be completed. ETHICS AND DISSEMINATION: This review does not require ethical approval. The results will be disseminated through a peer-reviewed publication and presentations to stakeholders.