Schwedes Ulrich, Siebolds Markus, Mertes Gabriele
General Hospital Barmbek, Hamburg, Germany.
Diabetes Care. 2002 Nov;25(11):1928-32. doi: 10.2337/diacare.25.11.1928.
To investigate the effect of meal-related self-monitoring of blood glucose on glycemic control and well-being in non-insulin-treated type 2 diabetic patients.
This 6-month study, which included 6 months of follow-up, adopted a prospective, multicenter, randomized controlled design. Subjects were randomized to two groups: one group used a blood glucose-monitoring device, kept a blood glucose/eating diary, and received standardized counseling; the control group received nonstandardized counseling on diet and lifestyle. The primary efficacy parameter was the change in HbA(1c). Secondary efficacy variables included changes in body weight, lipids, and microalbumin and changes in treatment satisfaction and well-being.
In the per-protocol analysis, the use of a self-monitoring blood glucose device significantly reduced HbA(1c) levels by 1.0 +/- 1.08% compared with 0.54 +/- 1.41% for the control group (P = 0.0086); subgroup analysis showed three types of responders. Body weight, total cholesterol, and microalbumin improved when using a glucometer, but there was no statistically significant difference between the two groups. Treatment satisfaction increased in both groups to a similar extent (P = 0.9). Self-monitoring resulted in a marked improvement of general well-being with significant improvements in the subitems depression (P = 0.032) and lack of well-being (P = 0.02).
Meal-related self-monitoring of blood glucose within a structured counseling program improved glycemic control in the majority of non-insulin-treated type 2 diabetic patients in this study. The finding of three types of responders will be important for future planning of counseling and educational interventions.
探讨非胰岛素治疗的2型糖尿病患者进行与进餐相关的血糖自我监测对血糖控制及健康状况的影响。
这项为期6个月的研究包括6个月的随访,采用前瞻性、多中心、随机对照设计。受试者被随机分为两组:一组使用血糖监测设备,记录血糖/饮食日记,并接受标准化咨询;对照组接受关于饮食和生活方式的非标准化咨询。主要疗效参数是糖化血红蛋白(HbA1c)的变化。次要疗效变量包括体重、血脂、微量白蛋白的变化以及治疗满意度和健康状况的变化。
在符合方案分析中,与对照组糖化血红蛋白水平下降0.54±1.41%相比,使用自我监测血糖设备使糖化血红蛋白水平显著降低1.0±1.08%(P = 0.0086);亚组分析显示有三种反应类型。使用血糖仪时体重、总胆固醇和微量白蛋白有所改善,但两组之间无统计学显著差异。两组治疗满意度均有相似程度的提高(P = 0.9)。自我监测使总体健康状况显著改善,其中抑郁(P = 0.032)和健康欠佳(P = 0.02)等子项目有显著改善。
在本研究中,在结构化咨询项目中进行与进餐相关的血糖自我监测可改善大多数非胰岛素治疗的2型糖尿病患者的血糖控制。三种反应类型的发现对未来咨询和教育干预的规划具有重要意义。