Challenges in recruiting subjects to a pilot trial of patient-managed in-hospital insulin

Emily K. Acton, Charles E. Leonard, Mark H. Schutta, Serena Cardillo, Andrea B. Troxel, Rebecca Trotta, Sean Hennessy

To examine the feasibility of implementing clinician-supported inpatient self-managed insulin to aid in the planning of a randomized clinical trial. We conducted a proof-of-concept interventional study of inpatients with diabetes mellitus who had hospital orders for basal-bolus or sliding scale insulin. Patients meeting inclusion criteria were offered the opportunity to manage their own basal-bolus insulin with support from a diabetes nurse practitioner. Over a three-month screening period, we conducted 361 screens in 336 patients, only eleven of whom met all inclusion criteria. None of these eleven eligible patients elected to enroll. The most common reason for refusal was lack of interest in self-managing insulin while acutely ill (36 %). Future studies of patient-managed in-hospital insulin should consider enrolling less acutely ill patients with longer anticipated lengths of stay. NCT02144441.