Details of Project
A randomised control trial taking place in 7 EU countries. It consists of a multimodal exercise and nutritional intervention in pre-frail and frail patients with Diabetes. Diabetes Frail is the lead organisation for this in the UK, which is taking place in hospitals and GP practices nationwide.
Seven countries across Europe will participate in this 4-year study, the project is co-ordinated by Professor Leocadio Rodríguez-Mañas (Hospital Universitario de Getafe, Madrid, Spain) and by Professor Alan Sinclair, Diabetes Frail, UK.
Supported by the European Union with funding of €6 million, the MID-Frail Study will run for four years and will investigate how a combined nutritional, exercise and educational intervention programme might improve the health and well-being of people over the age of 70 years with type 2 diabetes and who are becoming frail.
The MID-Frail study is an open, randomised, multicentre study, with random allocation by clusters (each trial site) to a usual care group or an intervention group. A total of 1,718 subjects will be randomised with each site enrolling on average 14 or 15 subjects. Difference in function after 2 years will be measured by changes in a summary ordinal score on the short physical performance battery (SPPB) of at least one point. Secondary outcomes include daily activities, economic evaluation, and quality of life.
The intervention group will take part in a supervised training programme with resistance exercises, alongside a nutritional and educational programme. Outcomes will be assessed against the usual care group, receiving routine diabetes care.
Aim of the Study
The primary aim is to evaluate, in comparison with usual clinical practice, the effectiveness of a multi-modal intervention (education, diet and exercise) in frail and pre-frail subjects aged equal or older than 70 years with T2D with respect to change in function and quality of life 24 months after they are randomized.
After 12 months, IG participants had mean SPPB scores 0.85 points higher than those in the UCG (95% CI, 0.44 to 1.26, P < 0.0001). Dropouts were higher in frail participants and in the intervention group, but significant differences in SPPB between treatment groups remained consistent after sensitivity analysis. Estimates suggest a mean saving following intervention of 428.02 EUR (2016) per patient per year, with ICER analysis indicating a consistent benefit of the described health care intervention over usual care. No statistically significant differences between groups were detected in any of the other secondary outcomes.
We have demonstrated that a 12 month structured multimodal intervention programme across several clinical settings in different European countries leads to a clinically relevant and cost‐effective improvement in the functional status of older frail and pre‐frail participants with type 2 diabetes mellitus.