Lee Alexandra K, Mejia Jose J, Ferguson Clarissa, Li Brookelle H, Grant Richard W, Sudore Rebecca L
Division of Geriatrics, Department of Medicine, University of California, San Francisco, San Francisco, CA, USA; San Francisco Veterans Affairs Medical Center, San Francisco, CA, USA.
Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA.
Contemp Clin Trials. 2025 Jun;153:107913. doi: 10.1016/j.cct.2025.107913. Epub 2025 Apr 11.
As adults with type 2 diabetes (T2D) age, they are increasingly vulnerable to treatment-related hypoglycemia and subsequent complications including falls and hospitalizations. Care planning helps patients communicate what is most important for their medical care with their family, friends, and clinicians and could help reduce treatment-related complications of T2D in older adults.
We applied an expanded care planning paradigm to the specific clinical problem of type 2 diabetes management in older patients. Applying user-centered design methods, we developed an educational, web-based program called "PREPARE for Your Diabetes Care," incorporating input and feedback from patient and provider key informants. A randomized controlled trial (RCT) of this program vs. usual care is being conducted among Kaiser Permanente Northern California members ≥75 years of age, prescribed insulin or sulfonylureas, and at high risk for hypoglycemia. The primary outcome of the RCT is clinically significant hypoglycemia episodes (self-reported 3+ symptomatic episodes of hypoglycemia, self-reported severe hypoglycemia, and/or ED or hospitalization for hypoglycemia). Secondary outcomes will include medication de-intensification, 5-item RAND Patient Satisfaction, and 5-item Perceived Efficacy in Patient - Physician Interactions.
This study has completed enrollment and randomized 673 participants; trial completion is expected in late 2025.
This research will evaluate an expanded care planning intervention to reduce treatment-related hypoglycemia in older adults with T2D. If successful, this web-based expanded care planning strategy could be applied to a wide variety of geriatric conditions requiring individualization of treatment based on patients' preferences.
NCT05263310; Pre-results.
随着2型糖尿病（T2D）成年患者年龄增长，他们越来越容易发生与治疗相关的低血糖及随后的并发症，包括跌倒和住院。护理计划有助于患者与家人、朋友及临床医生沟通其医疗护理中最重要的事项，并可能有助于减少老年2型糖尿病患者与治疗相关的并发症。
我们将扩展的护理计划范式应用于老年患者2型糖尿病管理这一特定临床问题。采用以用户为中心的设计方法，我们开发了一个名为“为糖尿病护理做好准备”的基于网络的教育项目，纳入了患者和提供者关键信息提供者的意见和反馈。正在对北加利福尼亚凯撒医疗集团年龄≥75岁、正在使用胰岛素或磺脲类药物且低血糖风险高的成员进行该项目与常规护理的随机对照试验（RCT）。RCT的主要结局是具有临床意义的低血糖发作（自我报告的3次以上低血糖症状发作、自我报告的严重低血糖，和/或因低血糖而急诊或住院）。次要结局将包括药物减量、5项兰德患者满意度，以及患者与医生互动中的5项感知效能。
本研究已完成入组并随机分配了673名参与者；预计试验将于2025年末完成。
本研究将评估一种扩展的护理计划干预措施，以减少老年2型糖尿病患者与治疗相关的低血糖。如果成功，这种基于网络的扩展护理计划策略可应用于需要根据患者偏好进行个体化治疗的各种老年疾病。
NCT05263310；预结果。
