Faculty of Pharmacy, Medical University of Sofia, Sofia, Bulgaria.
Bioengineering and Telemedicine Group, Centro de Tecnología Biomédica, Escuela Técnica Superior de Ingenieros de Telecomunicación, Universidad Politécnica de Madrid, Madrid, Spain.
Front Endocrinol (Lausanne). 2021 Mar 16;12:636959. doi: 10.3389/fendo.2021.636959. eCollection 2021.
Diabetes monitoring systems (DMS) are a possible approach for regular control of glucose levels in patients with Type 1 or 2 diabetes in order to improve therapeutic outcomes or to identify and modify inappropriate patient behaviors in a timely manner. Despite the significant number of studies observing the DMS, no collective evidence is available about the effect of all devices.
To review and consolidate evidences from multiple systematic reviews on the diabetes monitoring systems and the outcomes achieved.
Internet-based search in PubMed, EMBASE, and Cochrane was performed to identify all studies relevant to the research question. The data regarding type of intervention, type of diabetes mellitus, type of study, change in clinical parameter(s), or another relevant outcome were extracted and summarized.
Thirty-three out of 1,495 initially identified studies, involving more than 44,100 patients with Type 1, Type 2, or gestational diabetes for real-time or retrospective Continuous Glucose Monitoring (CGMS), Sensor Augmented Pump Therapy (SAPT), Self-monitoring Blood Glucose (SMBG), Continuous subcutaneous insulin infusion (CSII), Flash Glucose Monitoring (FGM), Closed-loop systems and telemonitoring, were included. Most of the studies observed small nominal effectiveness of DMS. In total 11 systematic reviews and 15 meta-analyses, with most focusing on patients with Type 1 diabetes (10 and 6, respectively), reported a reduction in glycated hemoglobin (HbA1c) levels from 0.17 to 0.70% after use of DMS.
Current systematic review of already published systematic reviews and meta-analyses suggests that no statistically significant difference exists between the values of HbA1c as a result of application of any type of DMS. The changes in HbA1c values, number and frequency of hypoglycemic episodes, and time in glucose range are the most valuable for assessing the appropriateness and effectiveness of DMS. Future more comprehensive studies assessing the effectiveness, cost-effectiveness, and comparative effectiveness of DMS are needed to stratify them for the most suitable diabetes patients' subgroups.
糖尿病监测系统(DMS)是一种可能的方法,可以定期控制 1 型或 2 型糖尿病患者的血糖水平,以改善治疗效果,或及时发现和纠正不当的患者行为。尽管有大量研究观察了 DMS,但目前还没有关于所有设备效果的综合证据。
回顾和整合来自多个关于糖尿病监测系统和所取得结果的系统评价的证据。
在 PubMed、EMBASE 和 Cochrane 上进行了基于互联网的搜索,以确定与研究问题相关的所有研究。提取并总结了有关干预类型、糖尿病类型、研究类型、临床参数变化或其他相关结果的数据。
从最初确定的 1495 项研究中,有 33 项研究涉及超过 44100 名 1 型、2 型或妊娠期糖尿病患者,研究内容涉及实时或回顾性连续血糖监测(CGMS)、传感器增强型泵治疗(SAPT)、自我监测血糖(SMBG)、连续皮下胰岛素输注(CSII)、瞬态血糖监测(FGM)、闭环系统和远程监测。大多数研究观察到 DMS 的效果很小。共有 11 项系统评价和 15 项荟萃分析,其中大多数(分别为 10 项和 6 项)关注的是 1 型糖尿病患者,报告称使用 DMS 后糖化血红蛋白(HbA1c)水平降低了 0.17%至 0.70%。
对已发表的系统评价和荟萃分析进行的系统回顾表明,应用任何类型的 DMS 后,HbA1c 值之间没有统计学上的显著差异。HbA1c 值的变化、低血糖发作的次数和频率以及血糖范围的时间是评估 DMS 的适当性和有效性的最有价值的指标。未来需要进行更全面的研究,评估 DMS 的有效性、成本效益和比较效果,以便对其进行分层,以适用于最适合的糖尿病患者亚组。