Diabetes is a high prevalence disorder in ageing populations (20% in people ≥ 65 yrs) with a chronic disease time-course and is associated with considerable medical co-morbidity, functional loss and frailty, visual and lower limb disability, multiple medication usage and impaired quality of life and results in a high personal and social health burden, and a significant public health burden. Diabetes is associated with increased frailty and functional decline in older people and may explain up to 20% of the excess risk of disability in an elderly population, with an annual relative risk of developing any disability around 2.0.

Stemming from the results of three EU-funded projects (MIDFRAIL, FRAILOMIC and VIVIFRAIL), DIABFRAIL-LATAM intends to make a scaling up of a multimodal intervention in older people with diabetes very vulnerable because of their frailty status. The scaling up will take place in 5 Latin-American countries (1 HIC and 4 LMICs), in different settings of care. The project embraces three main parts: 1) a validation study (an open Randomized Clinical Trial) that mimics the intervention to be transferred and that was shown to be effective and with a good cost-effective relationship; 2) a feasibility study that will include an economic analysis, adherence assessment and an analysis of the barriers and key factor of success; and 3) a proper scaling up process using a methodology based on the recommendations of the WHO (“WHO ExpandNet model”) and the European Union (“Maturity Model” and “11 success factors” suggested by the Expert Group on Health Systems Performance Assessment) that will take place not only in the five countries participating in the validation of the intervention, but also in other four countries, under the auspices of the Pan-American Health Organization and the cooperation of the local governments.

The validation of the intervention will be done by an international, multicentre, single-blind, two parallel groups, pragmatic randomised Research Clinical Trial. It will be carried out by investigators in several Latin American countries (Argentina, Chile, Colombia, Mexico and Peru) and with random allocation 1:1 of the participants to Usual Care Group (UCG) or Intervention Group (IG). Each country will select 5 trial sites that will recruit 51 participants (255 participants per country) except Mexico which will select 2 sites to recruit 50 participants each one (100 participants). Finally, 1120 subjects will be involved in the project.

The primary outcome are the changes in function and quality of life as measured by changes in the scores used to assess them between baseline and 1-year follow-up. Function will be assessed by the Short Physical Performance Battery-SPPB.

This study is focused on an older population (≥ 65 years) with diabetes and a frail or prefrail status

The intervention includes:

• Education program in small groups: 7 sessions in the clinical trial sites (2 sessions a week for the first 3-4 weeks)
• Exercise program (16 weeks): learning phases in clinical trial site for 3-4 first week (coincident with the educational program sessions) and the rest at home.
• Adaptation of targets of HbA1c and blood pressure (BP).

UCG Usual care group consists in level of care usually given in Health Care system.

General design of the DIABFRAIL-LATAM project

Abbreviations: e-CRF: Electronic Case Report Form, ERB Ethic Review Board; TS: Trial Sites, CT: Clinical Trial.