CRONICAS Centre of Excellence in Chronic Diseases, Universidad Peruana Cayetano Heredia, Lima, Peru.
Division of Tropical and Humanitarian Medicine, University of Geneva and Geneva University Hospitals, Geneva, Switzerland.
J Diabetes Sci Technol. 2022 Jul;16(4):962-970. doi: 10.1177/1932296821997909. Epub 2021 Mar 9.
Self-management is an important pillar for diabetes control and to achieve it, glucose self-monitoring devices are needed. Currently, there exist several different devices in the market and many others are being developed. However, whether these devices are suitable to be used in resource constrained settings is yet to be evaluated.
To assess existing glucose monitoring tools and also those in development against the REASSURED which have been previously used to evaluate diagnostic tools for communicable diseases.
We conducted a scoping review by searching PubMed for peer-review articles published in either English, Spanish or Portuguese in the last 5 years. We selected papers including information about devices used for self-monitoring and tested on humans with diabetes; then, the REASSURED criteria were used to assess them.
We found a total of 7 continuous glucose monitoring device groups, 6 non-continuous, and 6 devices in development. Accuracy varied between devices and most of them were either invasive or minimally invasive. Little to no evidence is published around robustness, affordability and delivery to those in need. However, when reviewing publicly available prices, none of the devices would be affordable for people living in low- and middle-income countries.
Available devices cannot be considered adapted for use in self-monitoring in resource constraints settings. Further studies should aim to develop less-invasive devices that do not require a large set of components. Additionally, we suggest some improvement in the REASSURED criteria such as the inclusion of patient-important outcomes to increase its appropriateness to assess non-communicable diseases devices.
自我管理是控制糖尿病的重要支柱,为此需要使用血糖自我监测设备。目前,市场上存在几种不同的设备,还有许多其他设备正在开发中。然而,这些设备是否适合资源有限的环境仍有待评估。
根据之前用于评估传染病诊断工具的 REASSURED 标准,评估现有的血糖监测工具以及正在开发的工具。
我们通过在 PubMed 上搜索过去 5 年发表的英文、西班牙文或葡萄牙文同行评审文章,进行了范围综述。我们选择了包含用于自我监测并在糖尿病患者身上测试的设备信息的论文;然后,使用 REASSURED 标准对其进行评估。
我们共发现 7 组连续血糖监测设备、6 组非连续血糖监测设备和 6 组正在开发的设备。设备的准确性各不相同,大多数设备都是侵入性或微创性的。关于稳健性、可负担性以及向有需要的人提供设备的证据很少或没有。然而,在审查公开的价格时,没有一种设备对于生活在低收入和中等收入国家的人来说是负担得起的。
现有的设备不能被认为适用于资源有限环境下的自我监测。进一步的研究应旨在开发侵入性较小的设备,这些设备不需要大量组件。此外,我们建议对 REASSURED 标准进行一些改进,例如纳入患者重要的结果,以提高其评估非传染性疾病设备的适当性。