Niche Science & Technology Ltd. are leading the team today awarded a Euro 7.5M grant to investigate the effectiveness of a multimodal intervention in frail and prefrail older people with type 2 diabetes on frailty and quality of life.
The prevalence of diabetes in people ≥ 65 years approaches 25% (40% of all patients with diabetes are > 65 years). This number will increase 4-fold in people > 70 years in 2050. Diabetes results in a high personal and social health burden, and a significant public health burden in terms of rising healthcare costs. Diabetes is associated with increased functional decline in older people and may explain up to 20% of their excess risk of disability. Our project focuses on the use of interventions to improve functional status and enhance quality of life. This is justified because there has been a lack of intervention studies in this population and improvements in function and well-being may be of more clinical benefit in older patients than attention to metabolic control alone.
The MID-Frail Study is a Phase IIb open randomised clinical trial to evaluate the effectiveness of a multi-modal intervention (optimising medical management, resistance-based exercise program and educational/nutritional intervention) in 1,704 frail or pre-frail subjects ≥ 70 years with T2D to prevent functional decline and maintain or improve quality of life and its associated costs.
The study to be conducted at 16 centres in seven countries across Europe will run for approx. 4 years. A consortium of 16 organisations, involving experts in the fields of health of the elderly and diabetes, have come together to look at how exercise, education and dietary advice can improve the quality of life of older people with diabetes. In support of this pioneering clinical research, the consortium has been awarded a multi-million euro grant by the prestigious Seventh Framework Programme for Research and Technological Development (7FP), run by the EU Commission. The grant underlines recognition of the high-profile support for continued research into the value of non-drug clinical interventions by bodies involved in planning for future healthcare delivery in an ageing population. During 2013, the consortium will be initiating this large clinical trial in older patients with T2DM recruited across seven EU countries. The study is spearheaded by Professor Alan Sinclair (Institute of Diabetes for Older People, UK) and Professor Leocadio Rodríguez Mañas (Hospital Universitario de Getafe, Spain) and has the support of Diabetes UK, a major patient and family advocacy organisation.
This approach is original (both the intervention and outcomes are unique for studies in diabetes), relevant (it concerns 25% of people with diabetes), pertinent and feasible. The project is highly aligned with objectives pursued by two topics of this call: investigator-driven clinical trials in elderly populations and in diabetes complications. Niche will play a pivotal role in both managing the clinical operations and exploitation of the study findings in terms of dissemination. Do you like the logo we developed for the project (see above)?
The study aims to demonstrate a reduction of 20% in that risk, which will mean an annual prevention of around 700,000 incident cases of some disability in old people, with a major impact on global quality of life and financial costs. This is especially true in older women. Three research-intensive SMEs will play a leading role in this project and it also has the support of Diabetes UK, a major patient and family advocacy organisation.
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