The execution of clinical trials can be expensive and present logistical challenges regarding recruitment and retention of participants. Innovative research design fostering convenience by eliminating research facility visits may enhance recruitment and retention. We examined the feasibility of a remote clinical trial in people living with type 2 diabetes (T2D) . People with recently diagnosed T2D were recruited across the UK and Canada to the MOTIVATE T2D trial (NCT04653532) ; a feasibility randomised controlled trial investigating two exercise and physical activity interventions. Participants received a self-testing kit, via mail, at baseline and post-intervention (6 months) . Measures included, HbA1c, lipid profile, anthropometrics and blood pressure and 14-day flash glucose and physical activity monitoring. Between Jan 2021 and Jan 2022 286 patients were eligible, of whom 110 (UK n=63, Can n=47, male n=58, white n=95) consented. Mean journey time from research facilities was ≤1h in 18%, 1-2h in 50% and >2h in 33% of participants. Availability of outcome data is presented in Table 1. Remote testing resulted in benefits to recruitment and good participant retention and protocol adherence. As such, remote clinical trials are feasible in people with T2D and future clinical trials should consider a remote clinical trial based approach as an alternative to conventional designs.
A. P. Davies: None. K. Hesketh: None. J. Low: None. V. S. Sprung: None. H. Jones: None. A. M. Mcmanus: None. M. Cocks: None. Motivate team: n/a.
UK Medical Research Council (MR/T032189/1) , Canadian Institute for Health Research (UCD-170587)