BACKGROUND: Type 2 diabetes, a highly prevalent chronic disease, is associated with increasing frailty and functional decline in older people. We aimed to evaluate the effectiveness of a multimodal intervention on functional performance in frail and pre-frail participants aged ≥70 years with type 2 diabetes mellitus. METHODS: The MID-Frail study was a cluster-randomized multicenter clinical trial conducted in 74 trial sites across seven European countries. The trial recruited 964 participants who were aged >70 years [mean age in intervention group, 78.4 (SD 5.6) years, 49.2% male and 77.6 (SD 5.29) years, 52.4% male in usual care group], with type diabetes mellitus and determined to be frail or pre-frail using Fried's frailty phenotype. Participants were allocated by trial site to follow either usual care (UCG) or intervention procedures (IG). Intervention group participants received a multimodal intervention composed of (i) an individualized and progressive resistance exercise programme for 16 weeks; (ii) a structured diabetes and nutritional educational programme over seven sessions; and (iii) Investigator-linked training to ensure optimal diabetes care. Short Physical Performance Battery (SPPB) scores were used to assess change in functional performance at 12 months between the groups. An analysis of the cost-effectiveness of the intervention was undertaken using the incremental cost-effectiveness ratio (ICER). Secondary outcomes included mortality, hospitalization, institutionalization, quality of life, burden on caregivers, the frequency and severity of hypoglycaemia episodes, and the cost-effectiveness of the intervention. RESULTS: 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. CONCLUSIONS: 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.

1st Faculty of Medicine Charles University Prague Czech Republic

Centre for Trials Research Cardiff University Cardiff UK

Centre Hospitalier Universitaire de Bordeaux Bordeaux France

Centre Hospitalier Universitaire de Toulouse Toulouse France

Department of Geriatrics Ghent University Hospital Ghent Belgium

Department of Mathematics University of Exeter Exeter UK

Foundation for Biomedical Research Hospital Universitario de Getafe Madrid Spain

Foundation for Diabetes Research in Older People Diabetes Frail Ltd Luton UK

Gerontology Department Vrije Universiteit Brussel Brussels Belgium

IdiSNA Navarra Institute for Health Research Public University of Navarra Pamplona Spain

Niche Science and Technology Ltd Richmond UK

Servicio de Geriatría Hospital Universitario de Getafe Madrid Spain

Ulm University Ulm Germany

Università Cattolica Sacro Cuore Rome Italy

University Castilla La Mancha University Toledo Spain

University of Campania Luigi Vanvitelli Naples Italy

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Long-term frailty and physical performance transitions in older people with type-2 diabetes. The MIDFRAIL randomized clinical study

Multicomponent intervention to prevent mobility disability in frail older adults: randomised controlled trial (SPRINTT project)