Maran Alberto, Tschoepe Diethelm, Di Mauro Maurizio, Fisher William A, Loeffler Kurt, Vesper Iris, Bloethner Sandra, Mast Oliver, Weissmann Joerg, Amann-Zalán Ildikó, Moritz Annette, Parkin Christopher G, Kohut Taylor, Cranston Iain
Department of Medicine, University of Padua, Padua, Italy.
Heart and Diabetes Center Nordrhein-Westfalen, Ruhr University of Bochum, Bad Oeynhausen, Germany.
J Clin Transl Endocrinol. 2014 Sep 3;1(4):161-166. doi: 10.1016/j.jcte.2014.08.003. eCollection 2014 Dec.
We investigated the impact of using an integrated, strip-free system compared to the use of single-strip systems on testing frequency and glycemic control in individuals with insulin-treated diabetes.
This multinational, comparative, cluster-randomized, observational study included 311 patients with type 1 and insulin-treated type 2 diabetes who were performing SMBG at suboptimal frequencies. Sites were cluster-randomized to "integrated strip-free" system (EXP group) or any "single-strip" system (CNL group). Testing frequency and HbA1c were measured at baseline, 12 weeks and 24 weeks.
At week 24, the EXP group showed an increase in SMBG frequency from baseline of 4.17 tests/week (95% CI 2.76, 5.58) compared with an increase of 0.53 tests/week (95% CI -0.73, 1.79) among CNL patients, resulting in a between-group difference of 3.63 tests/week ( < 0.0002). Mixed-effects models for repeated measurements (MMRM) controlling for baseline frequency of testing, country and clinical site confirmed a higher SMBG testing frequency in the EXP group compared to the CNL group, with a between-group difference of 2.70 tests/week ( < 0.01). Univariate analysis showed greater HbA1c reductions in the EXP group than CNL group: -0.44% (95% CI -0.59, -0.29) vs. -0.13% (95% CI -0.27, 0.01), respectively, < 0.0002. MMRM analyses confirmed these HbA1c reductions. A greater percentage of EXP than CNL patients achieved HbA1c reductions of ≥0.5%: 45.1% vs. 29.1%, respectively, < 0.01.
The use of an integrated, strip-free SMBG system improved testing adherence and was associated with improvements in glycemic control.
我们研究了与使用单条试纸系统相比，使用集成无试纸系统对胰岛素治疗的糖尿病患者的检测频率和血糖控制的影响。
这项跨国、比较、整群随机、观察性研究纳入了311例1型糖尿病和胰岛素治疗的2型糖尿病患者，这些患者的自我血糖监测（SMBG）频率未达最佳。研究地点被整群随机分为“集成无试纸”系统组（实验组）或任何“单条试纸”系统组（对照组）。在基线、12周和24周时测量检测频率和糖化血红蛋白（HbA1c）。
在第24周时，实验组的SMBG频率较基线增加了4.17次/周（95%置信区间2.76，5.58），而对照组患者增加了0.53次/周（95%置信区间-0.73，1.79），组间差异为3.63次/周（P<0.0002）。控制检测基线频率、国家和临床地点的重复测量混合效应模型（MMRM）证实，与对照组相比，实验组的SMBG检测频率更高，组间差异为2.70次/周（P<0.01）。单因素分析显示，实验组的HbA1c降低幅度大于对照组：分别为-0.44%（95%置信区间-0.59，-0.29）和-0.13%（95%置信区间-0.27，0.01），P<0.0002。MMRM分析证实了这些HbA1c的降低。实现HbA1c降低≥0.5%的实验组患者百分比高于对照组：分别为45.1%和29.1%，P<0.01。
使用集成无试纸SMBG系统可提高检测依从性，并与血糖控制改善相关。
