Factors influencing effective recruitment to phase 1 interventional trials in new-onset type 1 diabetes: analysis of 12 months referrals to diabetes research centre [Abstract]

Aims and objectives: Interventional trials in new‐onset Type 1 diabetes rely on recruiting patients within a short time window, aiming for optimal residual c‐peptide levels. Conducting these trials is dependent on improving current recruitment strategies. We aimed to identify the factors influencing effective recruitment to interventional trials of new‐onset Type 1 diabetes. Methods: Factors and measures influencing recruitment to new‐onset Type 1 diabetes trials were examined for all referrals to the Diabetes Research Group at Cardiff University School of Medicine between January and December 2015. Results: From 65 patient referrals, 61.6% of were from local hospitals and 38.4% from other diabetes research networks. 81.5% of referred patients responded to the initial contact, 86.8% of them showed an interest in research. Forty four out of 45 patients who could commit their time to trials had Type 1 diabetes. Only 43.2% of these patients were eligible and willing to take part in the trials. Inconvenience, distance and work commitments counted for 52% of the reasons for unsuitability; leaving 13 patients. Only three out of 18 willing and eligible patients participated in trials after they received the information sheet. Conclusion: Recruiting patients with new‐onset Type 1 diabetes to clinical trials within a short time after diagnosis is challenging for patients and research teams. More than half of the recruitment barriers can be modified by taking extra steps to facilitate participation. Further studies including surveys on big cohorts of newly‐diagnosed patients are required to study the factors influencing recruitment with potential input when designing future trials