Protocol: a Comprehensive Approach to Reduce Elderly functional decline in Diabetes: the CARED study

Background: Type 2 diabetes mellitus (T2DM) is a common chronic disease in older adults and a leading cause of death and disability worldwide. While recent diabetes guidelines introduce the Comprehensive Geriatric Assessment (CGA) as a key tool for managing diabetes treatments, evidence of its effectiveness in delaying functional impairment and achieving patient-reported outcomes (PROs) remains lacking. This article describes the protocol of a randomized parallel-group controlled trial aimed at evaluating the effect of a CGA-guided plan of care on physical performance changes over time as compared with a usual-care group. Methods: Three centers will participate in this study, each recruiting 60 older adults with T2DM from their outpatient clinics. Eligible patients will be randomized into either the usual-care or intervention group in a 1:1 allocation ratio. All patients will receive standard care according to current diabetes guidelines and undergo CGA. For the intervention group, the CGA will guide a multidimensional intervention. Follow-up visits will be scheduled at 6 and 12 months. The primary outcome will be the change in physical performance at the end of the follow-up, as assessed by the Short Physical Performance Battery score, with a comparison between the control and intervention groups. Discussion: From this study, we will contribute to the growing evidence of the impact of CGA on the assessment and management of older patients with T2DM and its complications. Results will be disseminated through a peer-reviewed journal and presentations at conferences. Final results will be shared with a broader audience through collaborations with patients with diabetes and their caregiver association at local and national levels. The findings will inform the extent to which a CGA-driven care plan may significantly reduce functional impairment and improve patient and caregiver satisfaction. Trial registration: ClinicalTrials.gov ID: NCT06842459 – registered February 24, 2025 – retrospectively registered.