Scaling of an evidence-based intervention program in older people with diabetes and frailty in Latin America. Diabfrail-Latam clinical trial protocol.

OBJECTIVES: Diabfrail-Latam is a project funded by the Horizon 2020 program of the European Commission (EC) and the Global Alliance for Chronic Diseases (GACD). The main objective of this protocol is to describe the clinical validation of a multimodal intervention aimed at older people with type 2 diabetes mellitus (T2DM) and frailty in Latin America, involving multicomponent physical exercise (based on VIVIFRAIL), nutritional education, and adjustment of therapeutic targets to be scaled up to other countries in Latin American region. METHODS: The Diabfrail-Latam CE is international, multicenter, single-blind and with two parallel groups with 1:1 randomization (multimodal intervention or usual clinical practice). More than 700 people over 65 years of age, frail or pre-frail, with T2DM, are expected to be recruited in four countries (Colombia, Peru, Mexico and Chile). The primary objective of this clinical validation is to evaluate the effectiveness of the multimodal intervention in improving functionality (measured by the Short Physical Performance Battery, SPPB) after one year of follow-up. Secondary objectives include changes in frailty status, adherence, feasibility, economic impact, biomarkers and caregiver burden. The intervention is expected to significantly improve functionality, reduce frailty progression, and demonstrate feasibility for large-scale implementation in Latin American health systems. CONCLUSION: Diabfrail-Latam will allow to validate and adapt interventions that have demonstrated efficacy in previous studies in European population, providing solid evidence for scaling and replication in the Latin American region and its context.