Self-monitoring of blood glucose significantly improves metabolic control in patients with type 2 diabetes mellitus: the Auto-Surveillance Intervention Active (ASIA) study
Self-monitoring of blood glucose significantly improves metabolic control in patients with type 2 diabetes mellitus: the Auto-Surveillance Intervention Active (ASIA) study
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DOI：
10.1016/s1262-3636(07)70073-3
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发表时间：
2003-12-01
影响因子：
7.2
通讯作者：
Charbonnel, B
中科院分区：
文献类型：
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作者：
Guerci, B;Drouin, P;Charbonnel, B
目的：2型糖尿病患者的血糖自我监测（SMBG）是当前关注的主题（增加的医疗保健成本与改善治疗和饮食依从性之间的不平衡）。一项开放标签随机前瞻性研究旨在比较仅接受常规建议治疗的患者在6个月内代谢控制的变化（常规评估组）或结合SMBG。研究设计和方法：未接受胰岛素治疗或既往自我监测的患者，年龄40 - 75岁，诊断为2型糖尿病> 1年且标准化HbA（1c）水平大于或等于7.5且小于或等于11%的患者随机分为对照组或SMBG组。在24周内每6周对他们进行一次随访。SMBG组的患者使用相同的器械（Ascensia Esprit（R）Discmeter，Bayer），每周至少进行6次毛细血管测定（每周3天，包括周末）。对患者进行了标准化管理，包括药物、饮食和体力活动。主要疗效标准为意向治疗（ITT）患者的HbA（1c）水平变化。使用校准的DCA 2000（R）设备（Bayer）在基线、3个月和6个月进行测定。结果：265名全科医生随机分配了988名患者（ITT人群），但689名患者可用于主要标准评估。终点时，SMBG组的HbA（1c）（8.1 ± 1.6%）低于常规治疗组（8.4 ± 1.4%，P = 0.012）。基线和终点之间HbA（1c）水平的变化分为两类：如果变化> 0.5%，则为改善;如果变化小于或等于0.5%，则为稳定或恶化; SMBG组157.1%的患者vs对照组46.8%的患者在3个月后HbA（1c）水平改善（P = 0.007）。在过去3个月内达到稳定状态。进行了多变量logistic回归分析，确定了HbA（1c）水平改善的预测因素：基线时HbA（1c）：比值比（OR）= 1.749（P < 0.001），SMBG组（参考值：SMBG组）：OR = 0.665糖尿病病程OR = 0.953（P = 0.015）（P = 0.001）和BMI：OR=0.962（P = 0.039）。这项研究是第一个多中心，对照，在大量患者中进行的前瞻性试验表明，SMBG与更好的代谢质量具有统计学相关性2型糖尿病的治疗方法有哪些？
Objective: Self monitoring of blood glucose (SMBG) in type 2 diabetes is a topic of current interest (imbalance between increased health-care costs and improvement in compliance with treatment and diet). An open label randomized prospective study was designed to compare changes in metabolic control over 6 months in patients managed with usual recommendations alone (conventional assessment group) or combined with SMBG.Research design and methods: Patients not treated with insulin or previously self monitored, 40 to 75 years of age, with a diagnosis of type 2 diabetes > 1 year and standardized HbA(1c) level greater than or equal to 7.5 and less than or equal to 11% were randomized to either a control group or SMBG group. They were followed up every 6 weeks over 24 weeks. Patients in the SMBG group were given the same device (Ascensia Esprit(R) Discmeter, Bayer) and were required to perform at least 6 capillary assays a week (3 different days of the week, including weekend). Management of patients was standardized, including drugs, diet and physical activity. The primary efficacy criterion was change in HbA(1c) level in Intent To Treat (ITT) patients. Assays were performed at baseline, at 3 and 6 months using the calibrated DCA 2000(R) device (Bayer).Results: Two hundred sixty five general practitioners randomized 988 patients (ITT Population), but 689 patients were evaluable for the primary criterion. At the endpoint, HbA(1c) was lower in the SMBG group (8.1 +/- 1.6%) than in the conventional treatment group (8.4 +/- 1.4%, P = 0.012). The change in HbA(1c) levels between baseline and endpoint was classified into two classes: improvement if a change > 0.5% occurred, stability or worsening in case of a change less than or equal to 0.5%; 157.1% of patients in the SMBG group vs 46.8% in the control group had an improvement in HbA(1c) level (P = 0.007) after 3 months. A steady state was reached during the last 3 months. A multivariate logistic regression analysis was performed and identified factors predictive of improvement in HbA(1c) levels: HbA(1c) at baseline: odd ratio (OR) = 1.749 (P < 0.001), SMBG group (reference value: SMBG group): OR = 0.665 (P = 0.015), duration of diabetes: OR = 0.953 (P = 0.001) and BMI: OR=0.962 (P = 0.039).Conclusions: This study is the first multicenter, controlled, prospective trial conducted on a large number of patients demonstrating that SMBG was statistically associated with a better quality of metabolic control than usual traditional recommendations alone in type 2 diabetes.