随着持续葡萄糖监测（CGM）技术的普及，葡萄糖目标范围内时间（TIR）已作为临床试验中的次要终点，和糖化血红蛋白（HbA1c）联合评估降糖药物的有效性。已有研究表明TIR降低与糖尿病微血管并发症及大血管并发症之间具有相关性，TIR适合短期疗效评估和血糖波动分析，近年来多项国际指南、共识均明确提出将TIR纳入血糖控制目标，用于糖尿病患者的血糖管理。TIR能否用于降糖药物上市后优化剂量的主要终点，监管机构尚未达成共识。为推动TIR用于糖尿病药物研发及监管决策，未来需要更多长期研究验证TIR与HbA1c之间、TIR与临床结局之间的相关性；需要公认的可靠TIR控制切点；需要规范化的CGM临床试验的设计及实施。如果拟采用TIR开展药物注册临床试验，建议和监管机构进行沟通。

With the widespread adoption of continuous glucose monitoring(CGM) technology, time in range(TIR) has been established as a secondary endpoint in clinical trials, jointly assessing the efficacy of glucose-lowering drugs alongside glycated hemoglobin(HbA1c). Existing research indicates a correlation between reduced TIR and diabetic microvascular and macrovascular complications. TIR is suitable for short-term efficacy evaluation and blood glucose variability analysis. In recent years, multiple international guidelines and consensus documents have explicitly recommended incorporating TIR into blood glucose control targets for diabetes management. However, regulatory agencies have yet to reach consensus on whether TIR can serve as the primary endpoint for optimizing post-marketing dosing of glucose-lowering drugs. To advance the application of TIR in diabetes drug development and regulatory decision-making, future research is needed to validate the relationships between TIR and HbA1c, as well as between TIR and clinical outcomes. Standardized control thresholds for TIR and the design and implementation of CGM-based clinical trials are also required. If TIR is to be used in drug registration clinical trials, it is advisable to engage with regulatory authorities.

R977