Department of Primary Health Care, University of Oxford, and NIHR School for Primary Care Research, Oxford OX1 2ET, UK.
BMJ. 2012 Feb 27;344:e486. doi: 10.1136/bmj.e486.
To assess the effectiveness of self monitoring blood glucose levels in people with non-insulin treated type 2 diabetes compared with clinical management without self monitoring, and to explore the effects in specific patient groups.
Meta-analysis based on individual participant data.
Medline, Embase, and a recent systematic review of trials on self monitoring of blood glucose. Chief investigators of trials published since 2000 were approached for additional information and individual patient data.
Randomised controlled trials in patients with non-insulin treated type 2 diabetes comparing an intervention using self monitoring of blood glucose with clinical management not using self monitoring. Trials published from 2000 with at least 80 participants were included.
Individual patient data were collected from electronic files and checked for integrity.
All randomised participants were analysed using the intention to treat principle. A random effects model of complete cases was used to assess efficacy, a sensitivity analysis comprised imputed data, and prespecified subgroup analyses were carried out for age, sex, previous use of self monitoring, duration of diabetes, and levels of glycated haemoglobin (HbA(1c)) at baseline.
2552 patients were randomised in the six included trials. A mean reduction in HbA(1c) level of -2.7 mmol/mol (95% confidence interval -3.9 to -1.6; 0.25%) was observed for those using self monitoring of blood glucose levels compared with no self monitoring at six months. The mean reduction in HbA(1c) level between groups was 2.0 mmol/mol (3.2 to 0.8; 0.25%) at three months (five trials) and 2.5 mmol/mol (4.1 to 0.9; 0.35%) at 12 months (three trials). These estimates were unchanged after imputing missing data, and estimates of effect in trials with higher loss to follow-up or a possibility of co-intervention compared with those with lower loss to follow-up and no co-intervention did not differ significantly (P=0.21). The difference in HbA(1c) levels between groups was consistent across age, baseline HbA(1c) level, sex, and duration of diabetes, although the numbers of older and younger people and those with HbA(1c) levels >86 mmol/mol (10%) were insufficient for interpretation. No changes occurred in systolic blood pressure (-0.2 mm Hg, 95% confidence interval -1.4 to 1.0), diastolic blood pressure (-0.1 mm Hg, -0.9 to 0.6), or total cholesterol level (-0.1 mol/L, 95% confidence interval -0.2 to 0.1).
Evidence from this meta-analysis of individual patient data was not convincing for a clinically meaningful effect of clinical management of non-insulin treated type 2 diabetes by self monitoring of blood glucose levels compared with management without self monitoring, although the difference in HbA(1c) level between groups was statistically significant. The difference in levels was consistent across subgroups defined by personal and clinical characteristics.
评估与不进行自我监测的临床管理相比，非胰岛素治疗 2 型糖尿病患者自我监测血糖的效果，并探索在特定患者群体中的作用。
基于个体参与者数据的荟萃分析。
Medline、Embase 和最近对血糖自我监测试验的系统评价。联系了自 2000 年以来发表的试验的首席研究员，以获取额外信息和个体患者数据。
在非胰岛素治疗的 2 型糖尿病患者中比较使用自我监测血糖的干预措施与不使用自我监测的临床管理的随机对照试验。纳入了 2000 年以后发表且至少有 80 名参与者的试验。
从电子文件中收集个体患者数据，并检查其完整性。
所有随机参与者均根据意向治疗原则进行分析。使用完整案例的随机效应模型评估疗效，敏感性分析包括插补数据，并且对年龄、性别、之前使用自我监测、糖尿病病程和基线糖化血红蛋白 (HbA1c) 水平进行了预设的亚组分析。
纳入的 6 项试验共随机分配了 2552 名患者。与不进行自我监测相比，使用自我监测血糖的患者在 6 个月时 HbA1c 水平平均降低 -2.7mmol/mol（95%置信区间 -3.9 至 -1.6；0.25%）。两组之间 HbA1c 水平的平均降低在 3 个月（5 项试验）时为 2.0mmol/mol（3.2 至 0.8；0.25%），在 12 个月（3 项试验）时为 2.5mmol/mol（4.1 至 0.9；0.35%）。在插补缺失数据后，这些估计值保持不变，并且与随访丢失率较高或可能存在联合干预的试验相比，随访丢失率较低且无联合干预的试验的效果估计值差异无统计学意义（P=0.21）。虽然年龄较大和较小的人群以及 HbA1c 水平 >86mmol/mol（10%）的人数不足以进行解释，但组间 HbA1c 水平的差异在年龄、基线 HbA1c 水平、性别和糖尿病病程方面是一致的。收缩压（-0.2mmHg，95%置信区间 -1.4 至 1.0）、舒张压（-0.1mmHg，-0.9 至 0.6）或总胆固醇水平（-0.1mmol/L，95%置信区间 -0.2 至 0.1）没有变化。
本荟萃分析的个体参与者数据证据并不能令人信服地证明与不进行自我监测相比，非胰岛素治疗 2 型糖尿病患者通过自我监测血糖的临床管理具有临床意义的效果，尽管组间 HbA1c 水平差异具有统计学意义。在根据个人和临床特征定义的亚组中，水平差异是一致的。
