Diabetes Research Institute, San Raffaele Scientific Institute, Milan, Italy.
Acta Diabetol. 2013 Oct;50(5):663-72. doi: 10.1007/s00592-011-0357-y. Epub 2011 Dec 22.
Self-monitoring of blood glucose (SMBG) is a core component of diabetes management. However, the International Diabetes Federation recommends that SMBG be performed in a structured manner and that the data are accurately interpreted and used to take appropriate therapeutic actions. We designed a study to evaluate the impact of structured SMBG on glycemic control in non-insulin-treated type 2 diabetes (T2DM) patients. The Prospective, Randomized Trial on Intensive SMBG Management Added Value in Non-insulin-Treated T2DM Patients (PRISMA) is a 12-month, prospective, multicenter, open, parallel group, randomized, and controlled trial to evaluate the added value of an intensive, structured SMBG regimen in T2DM patients treated with oral agents and/or diet. One thousand patients (500 per arm) will be enrolled at 39 clinical sites in Italy. Eligible patients will be randomized to the intensive structured monitoring (ISM) group or the active control (AC) group, with a glycosylated hemoglobin (HbA1c) target of <7.0%. Intervention will comprise (1) structured SMBG (4-point daily glucose profiles on 3 days per week [ISM]; discretionary, unstructured SMBG [AC]); (2) comprehensive patient education (both groups); and (3) clinician's adjustment of diabetes medications using an algorithm targeting SMBG levels, HbA1c and hypoglycemia (ISM) or HbA1c and hypoglycemia (AC). The intervention and trial design build upon previous research by emphasizing appropriate and collaborative use of SMBG by both patients and physicians. Utilization of per protocol and intent-to-treat analyses facilitates assessment of the intervention. Inclusion of multiple dependent variables allows us to assess the broader impact of the intervention, including changes in patient and physician attitudes and behaviors.
自我血糖监测(SMBG)是糖尿病管理的核心组成部分。然而,国际糖尿病联合会建议 SMBG 应以结构化的方式进行,并且数据应准确解释并用于采取适当的治疗措施。我们设计了一项研究来评估结构化 SMBG 对未经胰岛素治疗的 2 型糖尿病(T2DM)患者血糖控制的影响。前瞻性、随机试验强化 SMBG 管理对未经胰岛素治疗的 T2DM 患者的附加价值(PRISMA)是一项为期 12 个月的前瞻性、多中心、开放、平行组、随机对照试验,旨在评估强化、结构化 SMBG 方案在口服药物和/或饮食治疗的 T2DM 患者中的附加价值。将在意大利的 39 个临床站点招募 1000 名患者(每组 500 名)。符合条件的患者将被随机分配到强化结构化监测(ISM)组或主动对照(AC)组,糖化血红蛋白(HbA1c)目标值<7.0%。干预措施包括(1)结构化 SMBG(每周 3 天每天 4 点血糖谱[ISM];随意、非结构化 SMBG[AC]);(2)综合患者教育(两组);(3)使用针对 SMBG 水平、HbA1c 和低血糖的算法调整糖尿病药物,由临床医生根据 SMBG 水平、HbA1c 和低血糖进行调整(ISM)或 HbA1c 和低血糖(AC)。干预和试验设计基于之前的研究,强调患者和医生适当且协作地使用 SMBG。使用符合方案和意向治疗分析有助于评估干预措施。纳入多个因变量可以评估干预措施的更广泛影响,包括患者和医生态度和行为的变化。