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# Background The epidemic of type 2 diabetes mellitus is growing at large globally, more so in Low- and Middle-Income Countries (LMIC) like India, who concurrently battles the burden of infectious diseases. In such a health setting, people with diabetes (PWD) often receive sub-optimal care due to lack of understanding, physician-patient time, social support, and financial resources. Thus, there is a need for innovative, feasible, targeted interventions that strengthen health system to reduce the impact of diabetes in the rural communities in India. We hypothesised that structured interventions delivered by trained community health workers (CHWs) would improve outcomes in PWD and sought to demonstrate non-inferiority compared to standard care. # Methods A phase II, non-randomized, controlled clinical trial was conducted in a rural block in Tamil Nadu, India. Two sub-center areas (cluster) each were allocated to the control and intervention arms, with 50 participants in each cluster. The control group received standard care routinely provided and the intervention group received interventions namely – CHW delivered, Engage communities, Screen, Examine, Refer and Follow up with the aid of ‘education tools’ and a ‘tablet based SmartHealth Application for follow-up’. Non-inferiority of the intervention in terms of early case detection, reduction in number of unnecessary physician consultations and glycaemic control was demonstrated using generalized estimating equation (GEE) for repeated measures with exchangeable correlation structure, adjusting for age, duration of diabetes and family history of diabetes. # Results Baseline characteristics of both groups were comparable. CHWs were successfully able to Engage, Screen, Examine, Refer and Follow-up patients in the community. The multipronged interventions delivered by CHWs were demonstrated to be non-inferior to standard care, with significant difference in case detection rate (P=0.003), early recognition of complications, reduction in unnecessary physician consultations (P=0.041) and better glycaemic control (P=0.036). # Conclusions The study has shown promising results in the limited sample size and a small geographic area and has been able to show that the task shifting to frontline community health workers for diabetes care works in this rural population. We recommend a scale up of the intervention by conducting a multicentric randomized controlled trial including cost-effectiveness analysis and taking into account stakeholders’ opinions regarding this model of diabetes care.

IntroductionUnderstanding context and how this can be systematically assessed and incorporated is crucial to successful implementation. We describe how context has been assessed (including exploration or evaluation) in Global Alliance for Chronic Diseases (GACD) implementation research projects focused on improving health in people with or at risk of chronic disease and how contextual lessons were incorporated into the intervention or the implementation process.MethodsUsing a web-based semi-structured questionnaire, we conducted a cross-sectional survey to collect quantitative and qualitative data across GACD projects (n = 20) focusing on hypertension, diabetes and lung diseases. The use of context-specific data from project planning to evaluation was analyzed using mixed methods and a multi-layered context framework across five levels; 1) individual and family, 2) community, 3) healthcare setting, 4) local or district level, and 5) state or national level.ResultsProject teams used both qualitative and mixed methods to assess multiple levels of context (avg. = 4). Methodological approaches to assess context were identified as formal and informal assessments, engagement of stakeholders, use of locally adapted resources and materials, and use of diverse data sources. Contextual lessons were incorporated directly into the intervention by informing or adapting the intervention, improving intervention participation or improving communication with participants/stakeholders. Provision of services, equipment or information, continuous engagement with stakeholders, feedback for personnel to address gaps, and promoting institutionalization were themes identified to describe how contextual lessons are incorporated into the implementation process.ConclusionsContext is regarded as critical and influenced the design and implementation of the GACD funded chronic disease interventions. There are different approaches to assess and incorporate context as demonstrated by this study and further research is required to systematically evaluate contextual approaches in terms of how they contribute to effectiveness or implementation outcomes.