Diabetes Care：强化结构性SMBG有益于血糖控制

为了评价强化自我血糖监测(SMBG)(以一定的时间和频率测定)在非胰岛素治疗2型糖尿病患者中的附加值，来自意大利米兰San Raffaele医院和科学研究所的Emanuele Bosi博士等人进行了一项研究，研究发现，在血糖控制相对较好的非胰岛素治疗2型糖尿病患者中，使用结构性SMBG可改善血糖控制，为开具糖尿病药物处方提供指导。研究结果在线发表于2013年6月4日的美国《糖尿病治疗》(Diabetes Care)杂志上。

这是一项在意大利39个糖尿病诊所进行的为期12个月的随机临床试验，研究纳入1,024名非胰岛素治疗的2型糖尿病患者，基线HbA_1c中位数为7.3%[IQR 6.9-7.8%]。对参与者进行标准化培训后，501名患者随机分配进行结构性血糖监测(ISM)，每周测定3天内4个时间点的血糖谱(空腹、餐前、餐后2h和吸收后)；523名患者分配到积极控制组(AC)，分别于基线、6个月和12个月时测定上述4个时间点的血糖谱。两个研究终点采取分层的顺序进行测定：12月时 HbA_1c变化值、处于低血糖和高血糖指数风险目标的患者百分比。

意向治疗分析结果显示，12个月内，ISM组患者HbA_1c降低幅度(-0.39%)较AC组患者(-0.27%)大，组间差异为-0.12%(95% CI -0.210至-0.024；P=0.013)。符合方案集分析显示，组间差异为-0.21%(95% CI -0.331 至 -0.089; P = 0.0007)。研究结束时，ISM组有临床意义的HbA_1c降低(>0.3%, >0.4%或>0.5%)的患者比例比AC组多(P<0.025)。12个月时，ISM组和AC组达到/保持在风险目标的患者比例相当，分别为74.6%和70.1%(P=0.131)。第2、3和4次就诊时，ISM组患者糖尿病药物较AC组患者更换频繁(P<0.001)。

研究表明，在血糖控制相对较好的非胰岛素治疗2型糖尿病患者中，使用结构性SMBG可改善血糖控制，为开具糖尿病药物处方提供指导。

Intensive Structured Self-Monitoring of Blood Glucose and Glycemic Control in Noninsulin-Treated Type 2 Diabetes: The PRISMA Randomized Trial.
Abstract
OBJECTIVEWe aimed to evaluate the added value of intensive self-monitoring of blood glucose (SMBG), structured in timing and frequency, in noninsulin-treated patients with type 2 diabetes.RESEARCH DESIGN AND METHODSThe 12-month, randomized, clinical trial enrolled 1,024 patients with noninsulin-treated type 2 diabetes (median baseline HbA1c, 7.3% [IQR, 6.9-7.8%]) at 39 diabetes clinics in Italy. After standardized education, 501 patients were randomized to intensive structured monitoring (ISM) with 4-point glycemic profiles (fasting, preprandial, 2-h postprandial, and postabsorptive measurements) performed 3 days/week; 523 patients were randomized to active control (AC) with 4-point glycemic profiles performed at baseline and at 6 and 12 months. Two primary end points were tested in hierarchical order: HbA1c change at 12 months and percentage of patients on target for being at risk for low and high blood glucose index.RESULTSIntent-to-treat analysis showed greater HbA1c reductions over 12 months in ISM (-0.39%) than in AC patients (-0.27%), with a between-group difference of -0.12% (95% CI, -0.210 to -0.024; P = 0.013). In the per-protocol analysis, the between-group difference was -0.21% (-0.331 to -0.089; P = 0.0007). More ISM than AC patients achieved clinically meaningful reductions in HbA1c (>0.3, >0.4, or >0.5%) at study end (P < 0.025). The proportion of patients reaching/maintaining the risk target at month 12 were similar in ISM (74.6%) and AC (70.1%) patients (P = 0.131). At visits 2, 3, and 4, diabetes medications were changed more often in ISM than in AC patients (P < 0.001).CONCLUSIONSUse of structured SMBG improves glycemic control and provides guidance in prescribing diabetes medications in patients with relatively well-controlled noninsulin-treated type 2 diabetes.