Division of Global Health Equity, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA
Partners in Health, Neno, Malawi.
BMJ Open. 2022 Feb 23;12(2):e052134. doi: 10.1136/bmjopen-2021-052134.
The 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.
This 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.
This 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.
PACTR202102832069874.
大多数 1 型糖尿病患者（PLWT1D）在低收入国家（LIC）难以获得高质量的医疗服务，并且缺乏包括连续血糖监测（CGM）在内的技术，而 CGM 在高资源环境中被认为是标准治疗方法。据我们所知，目前文献中尚无研究描述 CGM 在 LIC 农村一级医院的可行性或有效性。
这是一项为期 3 个月、2:1 的开放性随机试验，旨在评估在马拉维农村 Neno 的两家医院将 CGM 引入 50 名 PLWT1D 患者的整个人群中的可行性和临床结果。两组参与者都将接受 2 天的糖尿病管理培训。其中一天的培训内容对两组都相同，另一天则专门针对糖尿病技术。干预组的参与者将获得 Dexcom G6 CGM 设备、传感器和太阳能充电器，对照组的参与者将获得 Safe-Accu 家用血糖仪和记录簿。所有患者将在研究基线和终点时测量血红蛋白 A1c（HbA1c）并进行世界卫生组织生活质量评估。我们将在研究开始和结束时对两组的部分参与者进行定性访谈，并在研究结束时对提供者进行访谈。我们感兴趣的主要结果是方案的执行情况、技术的适宜性、HbA1c 和严重不良事件。
这项研究得到了马拉维国家卫生科学研究委员会（IRB 编号 IR800003905）和马萨诸塞州综合医院（IRB 编号 2019P003554）的批准。研究结果将通过健康教育课程向 PLWT1D 传播。我们将把任何相关的发现传播给我们研究范围内的临床医生和领导层以及网络。我们将在开放获取的同行评议期刊上发表我们的发现。
PACTR202102832069874。
