The role of cognitive rehabilitation in people with type 2 diabetes: A study protocol for a randomized controlled trial

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).