Research Institute of the Diabetes Academy Mergentheim (FIDAM), Bad Mergentheim, Germany.
Patient Educ Couns. 2012 Feb;86(2):226-32. doi: 10.1016/j.pec.2011.05.017. Epub 2011 Jun 28.
In a randomized, multi-centre trial, the effect of an education programme (MEDIAS 2 ICT) involving intensive insulin treatment for people with type 2 diabetes was compared with an established education programme as an active comparator condition (ACC).
We investigated whether MEDIAS 2 ICT was non-inferior to ACC in overall glycaemic control. Secondary outcomes were the diabetes-related distress, diabetes knowledge, quality of life, self-care behavior, lipids, blood pressure and weight.
186 subjects were randomized. After a six month follow-up the mean HbA1c decrease was 0.37% (from 8.2±1.1% to 7.8±1.5%) in the ACC and 0.63% (from 8.5±1.5% to 7.9±1.2%) in MEDIAS 2 ICT. The mean difference between both groups was -0.26% (95% CI -0.63 to -0.14) in favor of MEDIAS 2 ICT. This result was within the predefined limit for non-inferiority. Diabetes-related distress was significantly more reduced in MEDIAS 2 ICT (-3.4±7.1) than in ACC (0.4±9.0; p=0.31).
MEDIAS 2 ICT is as effective in lowering HbA1c as previously established education programmes, but showed superiority in reducing diabetes-related distress.
MEDIAS 2 ICT provides an alternative for education of people with type 2 diabetes treated by multiple injection therapy.
在一项随机、多中心试验中,比较了涉及 2 型糖尿病患者强化胰岛素治疗的教育计划(MEDIAS 2 ICT)与作为活性对照条件的既定教育计划(ACC)的效果。
我们调查了 MEDIAS 2 ICT 是否在整体血糖控制方面不劣于 ACC。次要结局为糖尿病相关困扰、糖尿病知识、生活质量、自我护理行为、血脂、血压和体重。
186 名受试者被随机分组。经过 6 个月的随访,ACC 组的平均 HbA1c 下降了 0.37%(从 8.2±1.1%降至 7.8±1.5%),而 MEDIAS 2 ICT 组下降了 0.63%(从 8.5±1.5%降至 7.9±1.2%)。两组之间的平均差异为-0.26%(95%CI-0.63 至-0.14),有利于 MEDIAS 2 ICT。这一结果在预先设定的非劣效性界限内。MEDIAS 2 ICT 组的糖尿病相关困扰显著降低(-3.4±7.1),而 ACC 组仅降低 0.4±9.0(p=0.31)。
MEDIAS 2 ICT 在降低 HbA1c 方面与以前确立的教育计划一样有效,但在降低糖尿病相关困扰方面表现出优越性。
MEDIAS 2 ICT 为接受多次注射治疗的 2 型糖尿病患者的教育提供了一种替代方案。