Primary outcome measures.

Today, the prevalence of cognitive dysfunction and the prevalence of diabetes are increasing. Research shows that diabetes increases cognitive impairment risk, and cognitive impairment makes diabetes self-management more challenging. Diabetes self-management, essential to good glycemic control, requires patients to assimilate knowledge about their complex disease and to engage in activities such as glucose self-monitoring and the management of their medications. To test a comprehensive cognitive rehabilitation intervention—the Memory, Attention, and Problem-Solving Skills for Persons with Diabetes (MAPSS-DM) program. Our central hypothesis is that participants who take part in the MAPSS-DM intervention will have improved memory and executive function, increased use of compensatory cognitive skills, and improved self-management. We will also explore the role of glucose variability in those changes. This is a randomized controlled trial. Sixty-six participants with cognitive concerns and type 2 diabetes will be assigned to either the full MAPSS-DM intervention or an active control. Participants will use continuous glucose monitoring pre- and post-intervention to identify changes in glycemic variability. All participants will also be evaluated systematically via questionnaires and neuropsychological tests at three timepoints: baseline, immediately post-intervention, and 3 months post-intervention. This study will fill an important gap by addressing cognitive function in the management of diabetes. Diabetes is related to accelerated cognitive aging, cognitive deficits are related to poorer self-management, and improvements in cognitive performance as a result of cognitive rehabilitation can translate into improved performance in everyday life and, potentially, diabetes self-management. The results of the proposed study will therefore potentially inform strategies to support cognitive function and diabetes self-management, as well as offer new mechanistic insights into cognitive function through the use of continuous glucose monitoring.
Trial registration: This study has been registered at ClinicalTrials.gov (NCT04831775).

当今，认知功能障碍与糖尿病的患病率均呈上升态势。研究证实，糖尿病会升高认知损害风险，而认知损害又会进一步加剧糖尿病自我管理的难度。糖尿病自我管理是实现良好血糖控制的关键环节，要求患者掌握自身复杂疾病的相关知识，并开展血糖自我监测、药物管理等实践活动。本研究旨在验证一项综合性认知康复干预方案——糖尿病患者记忆、注意力与问题解决技能（Memory, Attention, and Problem-Solving Skills for Persons with Diabetes, MAPSS-DM）项目的效果。我们的核心假说为：接受MAPSS-DM干预的受试者，其记忆与执行功能将得到改善，代偿性认知技能的应用频率将提升，自我管理能力也将增强。此外，本研究还将探讨血糖变异性在上述干预效应中发挥的作用。本研究为随机对照试验，将纳入66名存在认知担忧且罹患2型糖尿病的受试者，随机分配至完整MAPSS-DM干预组与阳性对照组。受试者将在干预前与干预后接受持续血糖监测（continuous glucose monitoring），以评估血糖变异性的变化情况。所有受试者还将在三个时间点通过问卷与神经心理学测试接受系统评估：基线期、干预后即刻以及干预后3个月。本研究将填补糖尿病管理领域中认知功能相关研究的重要空白。糖尿病与认知老化加速存在关联，认知缺陷则与较差的自我管理能力相关；而通过认知康复改善认知表现，可转化为日常生活表现乃至糖尿病自我管理能力的提升。因此，本研究结果有望为支持认知功能与糖尿病自我管理的干预策略提供依据，同时通过持续血糖监测技术，为认知功能研究提供全新的机制性见解。试验注册：本研究已在ClinicalTrials.gov平台完成注册（注册编号：NCT04831775）。