Understanding the benefits and risks of treatments to be used by older individuals (≥65 years old) is critical for informed therapeutic decisions. Glucose‐lowering therapy for older patients with diabetes should be tailored to suit their clinical condition, comorbidities and impaired functional status, including varying degrees of frailty. However, despite the rapidly growing population of older adults with diabetes, there are few dedicated clinical trials evaluating glucose‐lowering treatment in older people. Conducting clinical trials in the older population poses multiple significant challenges. Despite the general agreement that individualizing treatment goals and avoiding hypoglycaemia is paramount for the therapy of older people with diabetes, there are conflicting perspectives on specific glycaemic targets that should be adopted and on use of specific drugs and treatment strategies. Assessment of functional status, frailty and comorbidities is not routinely performed in diabetes trials, contributing to insufficient characterization of older study participants. Moreover, significant operational barriers and problems make successful enrolment and completion of such studies difficult. In this review paper, we summarize the current guidelines and literature on conducting such trials, as well as the learnings from our own clinical trial (IMPERIUM) that assessed different glucose‐lowering strategies in older people with type 2 diabetes. We discuss the importance of strategies to improve study design, enrolment and attrition. Apart from summarizing some practical advice to facilitate the successful conduct of studies, we highlight key gaps and needs that warrant further research.

中文翻译：

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评估老年糖尿病患者的降糖治疗：IMPERIUM 试验的教训。

了解老年人（≥65 岁）使用的治疗的益处和风险对于做出明智的治疗决策至关重要。老年糖尿病患者的降糖治疗应根据他们的临床状况、合并症和功能受损状态（包括不同程度的虚弱）进行调整。然而，尽管患有糖尿病的老年人口迅速增长，但很少有专门的临床试验评估老年人的降糖治疗。在老年人群中进行临床试验带来了多重重大挑战。尽管普遍认为个体化治疗目标和避免低血糖对于老年糖尿病患者的治疗至关重要，对于应采用的特定血糖目标以及特定药物和治疗策略的使用存在相互矛盾的观点。在糖尿病试验中不常规评估功能状态、虚弱和合并症，导致老年研究参与者的特征不充分。此外，重大的操作障碍和问题使成功注册和完成此类研究变得困难。在这篇综述文章中，我们总结了当前开展此类试验的指南和文献，以及我们自己的临床试验 (IMPERIUM) 中的经验，该试验评估了老年 2 型糖尿病患者的不同降糖策略。我们讨论了改进研究设计、入学和减员的策略的重要性。