Change in glycaemic control with structured diabetes self-management education in urban low-resource settings: multicentre randomised trial of effectiveness.

BACKGROUND: In high-resource settings, structured diabetes self-management education is associated with improved outcomes but the evidence from low-resource settings is limited and inconclusive. AIM: To compare, structured diabetes self-management education to usual care, in adults with type 2 diabetes, in low-resource settings. DESIGN: Single-blind randomised parallel comparator controlled multi-centre trial. Adults (> 18 years) with type 2 diabetes from two hospitals in urban Ghana were randomised 1:1 to usual care only, or usual care plus a structured diabetes self-management education program. Randomisation codes were computer-generated, and allotment concealed in opaque numbered envelopes. The intervention effect was assessed with linear mixed models. MAIN OUTCOME: Change in HbA1c after 3-month follow-up. Primary analysis involved all participants. CLINICALTRIAL: gov identifier:NCT04780425, retrospectively registered on 03/03/2021. RESULTS: Recruitment: 22nd until 29th January 2021. We randomised 206 participants (69% female, median age 58 years [IQR: 49-64], baseline HbA1c median 64 mmol/mol [IQR: 45-88 mmol/mol],7.9%[IQR: 6.4-10.2]). Primary outcome data was available for 79 and 80 participants in the intervention and control groups, respectively. Reasons for loss to follow-up were death (n = 1), stroke(n = 1) and unreachable or unavailable (n = 47). A reduction in HbA1c was found in both groups; -9 mmol/mol [95% CI: -13 to -5 mmol/mol], -0·9% [95% CI: -1·2% to -0·51%] in the intervention group and -3 mmol/mol [95% CI -6 to 1 mmol/mol], -0·3% [95% CI: -0·6% to 0.0%] in the control group. The intervention effect was 1 mmol/mol [95%CI:-5 TO 8 p = 0.726]; 0.1% [95% CI: -0.5, 0.7], p = 0·724], adjusted for site, age, and duration of diabetes. No significant harms were observed. CONCLUSION: In low-resource settings, diabetes self-management education might not be associated with glycaemic control. Clinician's expectations from diabetes self-management education must therefore be guarded.

Epidemiology and Control of diabetes - tuberculosis comorbidity in Eswatini: protocol for the prospective study of tuberculosis patients on predictive factors, treatment outcomes and patient management practices.

INTRODUCTION: Previous studies indicate people with diabetes mellitus (DM) may have varying treatment outcomes when receiving treatment for tuberculosis (TB) and that TB infection or its treatment may predispose them to develop an abnormal blood glucose or type 2 DM. This has implications for Eswatini which is a high TB burden country and with increasing cases of non-communicable diseases including DM. This study will describe the epidemiology of DM-TB comorbidity in a prospective cohort of patients receiving TB treatment and identify best practices for integration of care for non-communicable diseases into TB services in Eswatini. METHODS AND ANALYSIS: This study will employ a mixed-methods approach. Data from a prospective cohort of newly enrolled patients with TB at 12 health facilities from 1 June 2022 to 30 September 2022, and followed up to 30 April 2023, will be used. For the qualitative, key informants who provide TB services at the health facilities will be interviewed. Quantitative data from patients will be analysed descriptively and by tests of association and multivariate modelling. Key informant interviews from healthcare workers will be analysed using content analysis. ETHICS AND DISSEMINATION: This research has been approved by the Eswatini Health and Human Research Review Board and participant confidentiality will be maintained. COVID-19 safety measures to reduce the risk of infection or transmission by researchers and participants have been instituted. Key programmatic findings and how they can impact healthcare delivery and access will be presented to the specific programme in the Eswatini Ministry of Health and other relevant stakeholders.

Applying systems thinking to identify enablers and challenges to scale-up interventions for hypertension and diabetes in low-income and middle-income countries: protocol for a longitudinal mixed-methods study.

INTRODUCTION: There is an urgent need to reduce the burden of non-communicable diseases (NCDs), particularly in low-and middle-income countries, where the greatest burden lies. Yet, there is little research concerning the specific issues involved in scaling up NCD interventions targeting low-resource settings. We propose to examine this gap in up to 27 collaborative projects, which were funded by the Global Alliance for Chronic Diseases (GACD) 2019 Scale Up Call, reflecting a total funding investment of approximately US$50 million. These projects represent diverse countries, contexts and adopt varied approaches and study designs to scale-up complex, evidence-based interventions to improve hypertension and diabetes outcomes. A systematic inquiry of these projects will provide necessary scientific insights into the enablers and challenges in the scale up of complex NCD interventions. METHODS AND ANALYSIS: We will apply systems thinking (a holistic approach to analyse the inter-relationship between constituent parts of scaleup interventions and the context in which the interventions are implemented) and adopt a longitudinal mixed-methods study design to explore the planning and early implementation phases of scale up projects. Data will be gathered at three time periods, namely, at planning (TP), initiation of implementation (T0) and 1-year postinitiation (T1). We will extract project-related data from secondary documents at TP and conduct multistakeholder qualitative interviews to gather data at T0 and T1. We will undertake descriptive statistical analysis of TP data and analyse T0 and T1 data using inductive thematic coding. The data extraction tool and interview guides were developed based on a literature review of scale-up frameworks. ETHICS AND DISSEMINATION: The current protocol was approved by the Monash University Human Research Ethics Committee (HREC number 23482). Informed consent will be obtained from all participants. The study findings will be disseminated through peer-reviewed publications and more broadly through the GACD network.