Research, Inshuti Mu Buzima, Partners In Health-Rwanda, Rwinkwavu, Rwanda
Non-Communicable Diseases Division, Rwanda Biomedical Center, Kigali, Rwanda.
BMJ Open. 2020 Jul 27;10(7):e036202. doi: 10.1136/bmjopen-2019-036202.
Most patients diagnosed with diabetes in sub-Saharan Africa (SSA) present with poorly controlled blood glucose, which is associated with increased risks of complications and greater financial burden on both the patients and health systems. Insulin-dependent patients with diabetes in SSA lack appropriate home-based monitoring technology to inform themselves and clinicians of the daily fluctuations in blood glucose. Without sufficient home-based data, insulin adjustments are not data driven and adopting individual behavioural change for glucose control in SSA does not have a systematic path towards improvement.
This study explores the feasibility and impact of implementing self-monitoring of blood glucose (SMBG) in patients with type 2 diabetes in rural Rwandan districts. This is an open randomised controlled trial comprising of two arms: (1) Intervention group-participants will receive a glucose metre, blood test strips, logbook, waste management box and training on how to conduct SMBG in additional to usual care and (2) Control group-participants will receive usual care, comprising of clinical consultations and routine monthly follow-up. We will conduct qualitative interviews at enrolment and at the end of the study to assess knowledge of diabetes. At the end of the study period, we will interview clinicians and participants to assess the perceived usefulness, facilitators and barriers of SMBG. The primary outcomes are change in haemoglobin A1c, fidelity to SMBG protocol by patients, appropriateness and adverse effects resulting from SMBG. Secondary outcomes include reliability and acceptability of SMBG and change in the quality of life of the participants.
This study has been approved by the Rwanda National Ethics Committee (Kigali, Rwanda No.102/RNEC/2018). We will disseminate the findings of this study through presentations within our study settings, scientific conferences and publication in a peer-reviewed journal.
PACTR201905538846394; pre-results.
在撒哈拉以南非洲（SSA），大多数被诊断患有糖尿病的患者血糖控制不佳，这与并发症风险增加和患者及卫生系统经济负担加重有关。在 SSA，依赖胰岛素的糖尿病患者缺乏适当的家庭血糖监测技术，无法了解自己和临床医生的血糖日常波动情况。如果没有足够的家庭数据，胰岛素调整就不是基于数据的，而且在 SSA 针对血糖控制采用个体行为改变也没有系统的改进途径。
本研究探讨了在卢旺达农村地区实施 2 型糖尿病患者自我监测血糖（SMBG）的可行性和影响。这是一项开放的随机对照试验，包括两个组：（1）干预组-参与者将接受血糖仪、血糖试纸、日志本、废物处理盒以及有关如何进行 SMBG 的培训，除此之外还将接受常规护理；（2）对照组-参与者将接受常规护理，包括临床咨询和常规每月随访。我们将在入组时和研究结束时进行定性访谈，以评估对糖尿病的了解。在研究结束时，我们将采访临床医生和参与者，以评估 SMBG 的实用性、促进因素和障碍。主要结果是糖化血红蛋白的变化、患者对 SMBG 方案的依从性、SMBG 的适当性和不良反应。次要结果包括 SMBG 的可靠性和可接受性以及参与者生活质量的变化。
本研究已获得卢旺达国家伦理委员会（卢旺达基加利，编号 102/RNEC/2018）的批准。我们将通过在我们的研究环境中进行演示、科学会议和在同行评审期刊上发表来传播这项研究的结果。
PACT R201905538846394；预结果。
