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Abstract：
Introduction: Tracking of blood glucose levels by patients and care providers remains an integral component in the management of diabetes mellitus (DM). Evidence, primarily from high-income countries, has illustrated the effectiveness of self-monitoring of blood glucose (SMBG) in controlling DM. However, there is limited data on the feasibility and impact of SMBG among patients in the rural regions of sub-Saharan Africa. This study is aimed at assessing SMBG, its adherence, and associated factors on the effect of glycaemic control among insulin-treated patients with DM in northeastern Tanzania. Materials and Methods: This was a single-blinded, randomised clinical trial conducted from December 2022 to May 2023. The study included patients with DM who had already been on insulin treatment for at least 3 months. A total of 85 participants were recruited into the study and categorised into the intervention and control groups by a simple randomization method using numbered envelopes. The intervention group received glucose metres, test strips, logbooks, and extensive SMBG training. The control group received the usual care at the outpatient clinic. Each participant was followed for a period of 12 weeks, with glycated haemoglobin (HbA1c) and fasting blood glucose (FBG) being checked both at the beginning and at the end of the study follow-up. The primary and secondary outcomes were adherence to the SMBG schedule, barriers associated with the use of SMBG, and the ability to self-manage DM, logbook data recording, and change in HbA1c. The analysis included descriptive statistics, paired t-tests, and logistic regression. Results: Eighty participants were analysed: 39 in the intervention group and 41 in the control group. In the intervention group, 24 (61.5%) of patients displayed favourable adherence to SMBG, as evidenced by tests documented in the logbooks and glucometer readings. Education on SMBG was significantly associated with adherence. Structured SMBG improved glycaemic control with a HbA1c reduction of -1.01 (95% confidence interval (CI) -1.39, -0.63) in the intervention group within 3 months from baseline compared to controls of 0.18 (95% CI -0.07, 0.44) (p < 0.001). Conclusion: Structured SMBG positively impacted glycaemic control among insulin-treated patients with DM in the outpatient clinic. The results suggest that implementing a structured testing programme can lead to significant reductions in HbA1c and FBG levels. Trial Registration: Pan African Clinical Trials Registry identifier: PACTR202402642155729.
摘要：
简介：患者和护理提供者对血糖水平的跟踪仍然是糖尿病（DM）管理中不可或缺的组成部分。证据,主要来自高收入国家，说明了自我监测血糖（SMBG）在控制DM中的有效性。然而,关于SMBG在撒哈拉以南非洲农村地区患者中的可行性和影响的数据有限.本研究旨在评估SMBG，其坚持,以及相关因素对坦桑尼亚东北部接受胰岛素治疗的DM患者血糖控制效果的影响。材料和方法：这是一个单盲，随机临床试验于2022年12月至2023年5月进行.该研究包括已经接受胰岛素治疗至少3个月的DM患者。共有85名参与者被招募到研究中，并通过使用编号信封的简单随机方法将其分为干预组和对照组。干预组接受血糖仪,试纸,日志,和广泛的SMBG培训。对照组在门诊接受常规护理。每位参与者都接受了为期12周的随访，在研究开始和结束时进行糖化血红蛋白（HbA1c）和空腹血糖（FBG）检查。主要和次要结果是坚持SMBG计划，与使用SMBG相关的障碍，以及自我管理DM的能力，日志数据记录，和HbA1c的变化。分析包括描述性统计，配对t检验，和逻辑回归。结果：对80名参与者进行了分析：干预组39名，对照组41名。在干预组中，24（61.5%）的患者表现出对SMBG的良好依从性，日志和血糖仪读数中记录的测试证明了这一点。SMBG教育与依从性显著相关。与对照组的0.18（95％CI-0.07，0.44）相比，结构化SMBG在干预组的基线3个月内改善了血糖控制，HbA1c降低了-1.01（95％置信区间（CI）-1.39，-0.63）（p<0.001）。结论：在门诊接受胰岛素治疗的DM患者中，结构化SMBG对血糖控制有积极影响。结果表明，实施结构化测试计划可以导致HbA1c和FBG水平显着降低。试验注册：泛非临床试验注册标识符：PACTR202402642155729。
