Farmer A J, Wade A N, French D P, Simon J, Yudkin P, Gray A, Craven A, Goyder L, Holman R R, Mant D, Kinmonth A-L, Neil H A W
Department of Primary Health Care, NIHR School of Primary Care Research, University of Oxford, UK.
Health Technol Assess. 2009 Feb;13(15):iii-iv, ix-xi, 1-50. doi: 10.3310/hta13150.
To determine whether self-monitoring of blood glucose (SMBG), either alone or with additional instruction in incorporating the results into self-care, is more effective than usual care in improving glycaemic control in non-insulin-treated diabetes.
An open, parallel group randomised controlled trial.
24 general practices in Oxfordshire and 24 in South Yorkshire, UK.
Patients with non-insulin-treated type 2 diabetes, aged > or = 25 years and with glycosylated haemoglobin (HbA1c) > or = 6.2%.
A total of 453 patients were individually randomised to one of: (1) standardised usual care with 3-monthly HbA1c (control, n = 152); (2) blood glucose self-testing with patient training focused on clinician interpretation of results in addition to usual care (less intensive self-monitoring, n = 150); (3) SMBG with additional training of patients in interpretation and application of the results to enhance motivation and maintain adherence to a healthy lifestyle (more intensive self-monitoring, n = 151).
The primary outcome was HBA1c at 12 months, and an intention-to-treat analysis, including all patients, was undertaken. Blood pressure, lipids, episodes of hypoglycaemia and quality of life, measured with the EuroQol 5 dimensions (EQ-5D), were secondary measures. An economic analysis was also carried out, and questionnaires were used to measure well-being, beliefs about use of SMBG and self-reports of medication taking, dietary and physical activities, and health-care resource use.
The differences in 12-month HbA1c between the three groups (adjusted for baseline HbA1c) were not statistically significant (p = 0.12). The difference in unadjusted mean change in HbA1c from baseline to 12 months between the control and less intensive self-monitoring groups was -0.14% [95% confidence interval (CI) -0.35 to 0.07] and between the control and more intensive self-monitoring groups was -0.17% (95% CI -0.37 to 0.03). There was no evidence of a significantly different impact of self-monitoring on glycaemic control when comparing subgroups of patients defined by duration of diabetes, therapy, diabetes-related complications and EQ-5D score. The economic analysis suggested that SMBG resulted in extra health-care costs and was unlikely to be cost-effective if used routinely. There appeared to be an initial negative impact of SMBG on quality of life measured on the EQ-5D, and the potential additional lifetime gains in quality-adjusted life-years, resulting from the lower levels of risk factors achieved at the end of trial follow-up, were outweighed by these initial impacts for both SMBG groups compared with control. Some patients felt that SMBG was helpful, and there was evidence that those using more intensive self-monitoring perceived diabetes as having more serious consequences. Patients using SMBG were often not clear about the relationship between their behaviour and the test results.
While the data do not exclude the possibility of a clinically important benefit for specific subgroups of patients in initiating good glycaemic control, SMBG by non-insulin-treated patients, with or without instruction in incorporating findings into self-care, did not lead to a significant improvement in glycaemic control compared with usual care monitored by HbA1c levels. There was no convincing evidence to support a recommendation for routine self-monitoring of all patients and no evidence of improved glycaemic control in predefined subgroups of patients.
确定血糖自我监测（SMBG）单独使用，或结合将结果纳入自我护理的额外指导，是否比常规护理在改善非胰岛素治疗糖尿病患者的血糖控制方面更有效。
一项开放性平行组随机对照试验。
英国牛津郡的24家普通诊所和南约克郡的24家普通诊所。
年龄≥25岁、糖化血红蛋白（HbA1c）≥6.2%的非胰岛素治疗2型糖尿病患者。
共453例患者被随机分为以下三组之一：（1）每3个月检测一次HbA1c的标准化常规护理（对照组，n = 152）；（2）除常规护理外，进行血糖自我检测并对患者进行培训，重点是临床医生对结果的解读（低强度自我监测，n = 150）；（3）SMBG，并对患者进行结果解读和应用的额外培训，以增强动力并维持对健康生活方式的依从性（高强度自我监测，n = 151）。
主要结局为12个月时的HbA1c，并进行了意向性分析，纳入所有患者。次要指标包括血压、血脂、低血糖发作次数以及使用欧洲五维健康量表（EQ - 5D）测量的生活质量。还进行了经济分析，并使用问卷来测量幸福感、对SMBG使用的看法以及服药、饮食和体育活动的自我报告以及医疗资源使用情况。
三组之间12个月时HbA1c的差异（校正基线HbA1c后）无统计学意义（p = 0.12）。对照组与低强度自我监测组之间HbA1c从基线到12个月的未校正平均变化差异为 - 0.14% [95%置信区间（CI）-0.35至0.07]，对照组与高强度自我监测组之间为 - 0.17%（95%CI -0.37至0.03）。在比较按糖尿病病程、治疗、糖尿病相关并发症和EQ - 5D评分定义的患者亚组时，没有证据表明自我监测对血糖控制有显著不同的影响。经济分析表明，SMBG导致额外的医疗费用，如果常规使用不太可能具有成本效益。在EQ - 5D上测量，SMBG似乎对生活质量有初始负面影响，并且与对照组相比，两个SMBG组在试验随访结束时因危险因素水平降低而潜在获得的额外终身质量调整生命年收益被这些初始影响所抵消。一些患者认为SMBG有帮助，并且有证据表明使用高强度自我监测的患者认为糖尿病后果更严重。使用SMBG的患者通常不清楚他们的行为与检测结果之间的关系。
虽然数据不排除对特定亚组患者在启动良好血糖控制方面有临床重要益处的可能性，但非胰岛素治疗患者进行SMBG，无论是否有将结果纳入自我护理的指导，与通过HbA1c水平监测的常规护理相比，并未导致血糖控制有显著改善。没有令人信服的证据支持对所有患者进行常规自我监测的建议，也没有证据表明在预定义的患者亚组中血糖控制得到改善。
