Prospective, randomized trial on intensive SMBG management added value in non-insulin-treated T2DM patients (PRISMA): a study to determine the effect of a structured SMBG intervention.
Prospective, randomized trial on intensive SMBG management added value in non-insulin-treated T2DM patients (PRISMA): a study to determine the effect of a structured SMBG intervention.
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对非胰岛素治疗的T2DM患者（PRISMA）的预期，随机试验增加了价值：确定结构化SMBG干预效果的研究。
DOI：
10.1007/s00592-011-0357-y
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发表时间：
2013-10
影响因子：
3.8
通讯作者：
Cucinotta, Domenico
中科院分区：
文献类型：
--
作者：
Scavini, Marina;Bosi, Emanuele;Ceriello, Antonio;Giorgino, Francesco;Porta, Massimo;Tiengo, Antonio;Vespasiani, Giacomo;Bottalico, Davide;Marino, Raffaele;Parkin, Christopher;Bonizzoni, Erminio;Cucinotta, Domenico
关键词：
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以一种结构化的方式进行，并准确解释数据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对非胰岛素治疗的2型糖尿病（T2DM）患者血糖控制的影响。强化SMBG管理对非胰岛素治疗T2DM患者附加值的前瞻性随机试验（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，旨在评估口服药物和/或饮食治疗T2DM患者强化、结构化SMBG方案的附加值。1000名患者（每组500人）将在意大利的39个临床站点入组。符合条件的患者将随机分为强化结构化监测（ISM）组或主动对照（AC）组，糖化血红蛋白（HbA1c）目标<7.0%。干预将包括(1)结构化SMBG（每周3天，每日4点血糖分析[ISM]；任意，非结构化SMBG [AC]）；(2)患者综合教育（两组）；(3)临床医生使用针对SMBG水平、HbA1c和低血糖（ISM）或HbA1c和低血糖（AC）的算法调整糖尿病药物。干预和试验设计建立在先前的研究基础上，强调患者和医生对SMBG的适当和协作使用。使用每个方案和意向治疗分析有助于评估干预措施。纳入多个因变量使我们能够评估干预的更广泛影响，包括患者和医生态度和行为的变化。ClinicalTrials.gov (NCT00643474)。
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. ClinicalTrials.gov (NCT00643474).
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影响因子：
39.3
作者：
Hanefeld, M;Cagatay, M;Rupp, M
通讯作者：
Rupp, M
影响因子：
158.5
作者：
Holman, Rury R.;Paul, Sanjoy K.;Neil, H. Andrew W.
通讯作者：
Neil, H. Andrew W.
影响因子：
158.5
作者：
Gerstein, Hertzel C.;Miller, Michael E.;Friedewald, William T.
通讯作者：
Friedewald, William T.
影响因子：
4.5
作者：
Duran, Alejandra;Martin, Patricia;Luis Calle-Pascual, Alfonso
通讯作者：
Luis Calle-Pascual, Alfonso
影响因子：
5.8
作者：
Cavalot, F;Petrelli, A;Trovati, M
通讯作者：
Trovati, M