巴西多中心研究：评估使用BGStar（®）血糖仪对1型和2型糖尿病胰岛素治疗患者进行血糖自我监测的患者满意度

Brazilian multicenter study for the evaluation of patients' satisfaction of blood glucose self-monitoring with BGStar(®) blood glucose meter in insulinized patients with diabetes mellitus type 1 and 2.

作者信息

Hissa Miguel Nasser

机构信息

Centro de Pesquisas em Diabetes e Doenças Endócrino-metabólicas, Medical School UNICHRISTUS, Rua Canuto de Aguiar, 500/100, Meireles, Fortaleza, Ceará 60160120 Brazil.

出版信息

Diabetol Metab Syndr. 2016 Sep 13;8(1):66. doi: 10.1186/s13098-016-0180-2. eCollection 2016.

DOI:10.1186/s13098-016-0180-2

PMID:27625706

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5020543/

Abstract

BACKGROUND

Diabetes mellitus (DM) is considered a global epidemic, and patient self-management education and support are critical in preventing and reducing the risk of complications. Self-monitoring of blood glucose (SMBG) is essential for care of individuals with DM, helping patients to achieve and maintain target blood glucose levels. The purpose of this study is to compare the satisfaction of insulinized DM patients on SMBG with use of investigational blood glucose meter (BGM) versus their routine device.

METHODS

A national, multicenter, open-label, phase 4 study was conducted on patients with type 1 or 2 DM under insulin therapy regimen, who were asked to use investigational BGM instead of their usual BGM device. The study was performed in 12 centers in Brazil for 12 weeks, with an extension period of 12 weeks. The primary endpoint was to measure the variation on the patients' level of satisfaction with investigational versus routine BGM, between visits, using a Visual Analogue Scale (VAS). Secondary endpoints addressed handling aspects, satisfaction, adherence and level of functionality and safety of investigational BGM.

RESULTS

The study included 292 patients (36.6 % DM1 and 63.4 % DM2), mean age 50.9 years old (±17.3 years), 57.5 % females. There was statistically significant improvement in global satisfaction with investigational BGM compared with routine BGM according to VAS [mean VAS score raised from 78.8 mm (SD = 18.0) to 90.8 mm (SD = 12.2) between visits]. After 12 weeks, level of satisfaction with investigational BGM according to questionnaires was superior to routine BGM regardless of age group (p < 0.001), type of DM (p < 0.001) or insulin regimen (p < 0.001). Investigational BGM was also regarded as safe, with 10 patients (3.4 %) reporting a total of 13 adverse events during the study.

CONCLUSIONS

Levels of satisfaction during SMBG were higher with use of investigational BGM and the device was deemed safe and easy to handle.

摘要

背景

糖尿病（DM）被视为一种全球性流行病，患者自我管理教育与支持对于预防和降低并发症风险至关重要。血糖自我监测（SMBG）对于糖尿病患者的护理至关重要，有助于患者实现并维持目标血糖水平。本研究旨在比较接受胰岛素治疗的糖尿病患者使用研究型血糖仪（BGM）与使用常规血糖仪时对SMBG的满意度。

方法

针对接受胰岛素治疗方案的1型或2型糖尿病患者开展了一项全国性、多中心、开放标签的4期研究，要求这些患者使用研究型BGM而非其常用的BGM设备。该研究在巴西的12个中心进行，为期12周，延长期为12周。主要终点是使用视觉模拟量表（VAS）测量患者在各次就诊期间对研究型BGM与常规BGM满意度的变化。次要终点涉及研究型BGM的操作方面、满意度、依从性以及功能和安全性水平。

结果

该研究纳入了292名患者（1型糖尿病患者占36.6%，2型糖尿病患者占63.4%），平均年龄50.9岁（±17.3岁），女性占57.5%。根据VAS，与常规BGM相比，研究型BGM的总体满意度有统计学意义的提高[各次就诊期间VAS平均评分从78.8毫米（标准差=18.0）提高到90.8毫米（标准差=12.2）]。12周后，无论年龄组（p<0.001）、糖尿病类型（p<0.001）或胰岛素治疗方案（p<0.001）如何，根据问卷调查，对研究型BGM的满意度均高于常规BGM。研究型BGM也被认为是安全的，有10名患者（3.4%）在研究期间共报告了13起不良事件。