Diabetes Research Institute, University of Miami Miller School of Medicine, Miami, FL, United States.
Herbert Wertheim College of Medicine, Florida International University, Miami, FL, United States.
Front Endocrinol (Lausanne). 2024 Mar 15;15:1352302. doi: 10.3389/fendo.2024.1352302. eCollection 2024.
Blood glucose monitoring constitutes a pivotal element in the clinical management of Type 1 diabetes (T1D), a globally escalating metabolic disorder. Continuous glucose monitoring (CGM) devices have demonstrated efficacy in optimizing glycemic control, mitigating adverse health outcomes, and augmenting the overall quality of life for individuals afflicted with T1D. Recent progress in the field encompasses the refinement of electrochemical sensors, which enhances the effectiveness of blood glucose monitoring. This progress empowers patients to assume greater control over their health, alleviating the burdens associated with their condition, and contributing to the overall alleviation of the healthcare system. The introduction of novel medical devices, whether derived from existing prototypes or originating as innovative creations, necessitates adherence to a rigorous approval process regulated by the Food and Drug Administration (FDA). Diverse device classifications, stratified by their associated risks, dictate distinct approval pathways, each characterized by varying timelines. This review underscores recent advancements in blood glucose monitoring devices primarily based on electrochemical sensors and elucidates their regulatory journey towards FDA approval. The advent of innovative, non-invasive blood glucose monitoring devices holds promise for maintaining stringent glycemic control, thereby preventing T1D-associated comorbidities, and extending the life expectancy of affected individuals.
血糖监测是 1 型糖尿病（T1D）临床管理的关键要素，T1D 是一种在全球范围内不断加剧的代谢紊乱。连续血糖监测（CGM）设备已被证明在优化血糖控制、减少不良健康结果和提高 T1D 患者的整体生活质量方面具有疗效。该领域的最新进展包括电化学传感器的改进，这提高了血糖监测的效果。这一进展使患者能够更好地控制自己的健康，减轻与病情相关的负担，并有助于整体减轻医疗体系的负担。新型医疗设备的引入，无论是基于现有原型还是创新创造，都需要遵循食品和药物管理局（FDA）监管的严格审批程序。不同的设备分类，根据其相关风险进行分层，决定了不同的审批途径，每个途径的时间线都不同。本综述强调了基于电化学传感器的血糖监测设备的最新进展，并阐明了它们在获得 FDA 批准方面的监管历程。创新的、非侵入性的血糖监测设备的出现有望实现严格的血糖控制，从而预防 T1D 相关的合并症，并延长受影响个体的预期寿命。
