IntroductionThe majority of people living with type 1 diabetes (PLWT1D) struggle to access high-quality care in low-income countries (LICs), and lack access to technologies, including continuous glucose monitoring (CGM), that are considered standard of care in high resource settings. To our knowledge, there are no studies in the literature describing the feasibility or effectiveness of CGM at rural first-level hospitals in LICs.Methods and analysisThis is a 3-month, 2:1 open-randomised trial to assess the feasibility and clinical outcomes of introducing CGM to the entire population of 50 PLWT1D in two hospitals in rural Neno, Malawi. Participants in both arms will receive 2 days of training on diabetes management. One day of training will be the same for both arms, and one will be specific to the diabetes technology. Participants in the intervention arm will receive Dexcom G6 CGM devices with sensors and solar chargers, and patients in the control arm will receive Safe-Accu home glucose metres and logbooks. All patients will have their haemoglobin A1c (HbA1c) measured and take WHO Quality of Life assessments at study baseline and endline. We will conduct qualitative interviews with a selection of participants from both arms at the beginning and end of study and will interview providers at the end of the study. Our primary outcomes of interest are fidelity to protocols, appropriateness of technology, HbA1c and severe adverse events.Ethics and disseminationThis study is approved by National Health Sciences Research Committee of Malawi (IRB Number IR800003905) and the Mass General Brigham (IRB number 2019P003554). Findings will be disseminated to PLWT1D through health education sessions. We will disseminate any relevant findings to clinicians and leadership within our study catchment area and networks. We will publish our findings in an open-access peer-reviewed journal.Trial registration numberPACTR202102832069874.

Background. Self-monitoring of blood glucose (SMBG) is a widely accepted standard of practice for management of insulin-dependentdiabetes, yet is largely unavailable in rural sub-Saharan Africa (SSA). This prospective cohort study is the first known report ofimplementation of SMBG in a rural, low-income country setting.Objectives. To evaluate adherence and change in clinical outcomes with SMBG implementation at two rural hospitals in Neno, Malawi.Methods. Forty-eight patients with type 1 and insulin-dependent type 2 diabetes were trained to use glucometers and logbooks. Participantsmonitored preprandial glucose daily at rotating times and overnight glucose once a week. Healthcare providers were trained to evaluateglucose trends, and adjusted insulin regimens based on results. Adherence was measured as the frequency with which patients checked anddocumented blood glucose at prescribed times, while clinical changes were measured by change in glycated haemoglobin (HbA1c) over a6-month period.Results. Participants brought their glucometers and logbooks to the clinic 95 - 100% of the time. Adherence with measuring glucose valuesand recording them in logbooks eight times a week was high (mean (standard deviation) 69.4% (15.7) and 69.0% (16.6), respectively). MeanHbA1c decreased from 9.0% (75 mmol/mol) at enrolment to 7.8% (62 mmol/mol) at 6 months (mean difference 1.2% (95% confidenceinterval (CI) 0.6 - 2.0; p=0.0005). The difference was greater for type 1 diabetes (1.6%; 95% CI 0.6 - 2.7; p=0.0031) than for type 2 diabetes(0.9%; 95% CI 0.1 - 1.9; p=0.0630). There was no documented increase in hypoglycaemic events, and no hospitalisations or deaths occurred.Conclusion. SMBG is feasible for patients with insulin-dependent diabetes in a rural SSA population, and may be associated with improvedHbA1c levels. Despite common misconceptions, all patients, regardless of education level, can benefit from SMBG. Further research onlong-term retention of SMBG activities and the benefits of increasing frequency of monitoring is warranted.

Background The prevalence of type 1 diabetes (T1D) is increasing in low-income countries including Malawi. In this setting, care is frequently impacted by challenges in diagnosis and management. Access to high-quality T1D care remains limited in Malawi, with fairly low availability and high cost of insulin and other supplies and diagnostics, lack of T1D knowledge, and absence of readily accessible guidelines. In the Neno district, Partners In Health established advanced care clinics at district hospitals to provide comprehensive, free care for T1D and other noncommunicable diseases. Prior to this study, experiences in care for people living with T1D (PLWT1D) at these clinics remained unexplored. Here we examine the impact of living with T1D, knowledge and self-management of, and facilitators and barriers to T1D care in Neno District, Malawi. Methods We conducted a qualitative study utilizing behavior change theory that consisted of twenty-three semi-structured interviews conducted in Neno, Malawi in January 2021 with PLWT1D, their families, providers, and civil society members to explore the psychosocial and economic impact of living with T1D, T1D knowledge and self-management, and facilitators and barriers to accessing care. Interviews were analyzed thematically using a deductive approach. Results We found that PLWT1D had good knowledge and practice of self-management activities for T1D. Key facilitators to care identified by informants included extensive patient education and availability and provision of free insulin and supplies. Significant barriers included distance from health facilities, food insecurity, and low literacy/numeracy. Informants described T1D as having a notable psychosocial and economic impact on PWLT1D and their families, notably worrying about having a lifelong condition, high transportation costs, and reduced working ability. While home visits and transport refunds helped facilitate access to the clinic, informants reported the refunds as inadequate given high transport costs faced by patients. Conclusions T1D was found to have a significant impact on PLWT1D and their families. Our findings represent important areas of consideration in design and implementation of effective programs for treating PLWT1D in resource-limited settings. Facilitators to care identified by informants may be applicable and beneficial in similar settings, while persisting barriers represent areas for continued improvement in Neno.

Background The prevalence of type 1 diabetes (T1D) is thought to be growing in low-income countries such as Malawi, despite a lack of epidemiological data and published literature in many areas. In low-income countries, T1D care is frequently impacted by challenges in diagnosis and management, including misdiagnosis and access to insulin, which can increase prevalence of severe complications and affect T1D outcomes. Access to high-quality T1D care remains limited in Malawi, with fairly low availability and high cost of insulin as well as other supplies and diagnostics, lack of T1D knowledge, and absence of readily accessible guidelines. In the Neno district, Partners In Health established advanced care clinics at district hospitals provide comprehensive, free care for T1D and other noncommunicable diseases. Here we seek to examine the impact of living with T1D, knowledge and self-management, and facilitators and barriers to T1D care in this district. Methods We conducted a qualitative study consisting of interviews conducted in Neno, Malawi with people living with type 1 diabetes (PLWT1D), their families, providers, and civil society members to explore the psychosocial and economic impact of living with T1D, T1D knowledge and self-management, and facilitators and barriers to accessing care. Results This study found that PLWT1D had good knowledge and practice of self-management activities for T1D. Key facilitators to care identified by informants included extensive patient education and availability and provision of free insulin and supplies. Significant barriers included distance from health facilities, food insecurity, and low literacy/numeracy. Informants described T1D as having a notable psychosocial and economic impact on PWLT1D and their families, notably worrying about having a lifelong condition, high transportation costs, and reduced ability to work. While home visits and transport refunds helped facilitate access to the clinic, informants reported the refunds as inadequate given high transport costs faced by patients. Conclusions T1D was found to have a significant impact on PLWT1D and their families. Our findings represent important areas of consideration in design and implementation of effective programs for treating PLWT1D in resource-limited settings. Facilitators to care identified by informants may be applicable and beneficial in similar settings, while persisting barriers represent areas for continued improvement in Neno.