title: Challenges in recruiting subjects to a pilot trial of patient-managed in-hospital insulin.
abstract: BACKGROUND
  To examine the feasibility of implementing clinician-supported inpatient self-managed insulin to aid in the planning of a randomized clinical trial.
  
  
  RESULTS
  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 %).
  
  
  CONCLUSIONS
  Future studies of patient-managed in-hospital insulin should consider enrolling less acutely ill patients with longer anticipated lengths of stay.
  
  
  BACKGROUND
  NCT02144441.
authors.affiliation: Department of Neurology, Hospital of the University of Pennsylvania, Philadelphia, PA, USA. eacton@sas.upenn.edu.
authors.forename: Emily K
authors.initials: EK
authors.lastname: Acton
authors.affiliation: Center for Clinical Epidemiology and Biostatistics, Department of Biostatistics and Epidemiology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA. celeonar@mail.med.upenn.edu.|Center for Pharmacoepidemiology Research and Training, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA. celeonar@mail.med.upenn.edu.
authors.forename: Charles E
authors.initials: CE
authors.lastname: Leonard
authors.affiliation: Penn Rodebaugh Diabetes Center, Division of Endocrinology, Diabetes, and Metabolism, Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA. Mark.Schutta@uphs.upenn.edu.
authors.forename: Mark H
authors.initials: MH
authors.lastname: Schutta
authors.affiliation: Center for Pharmacoepidemiology Research and Training, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA. Serena.Cardillo@uphs.upenn.edu.|Penn Rodebaugh Diabetes Center, Division of Endocrinology, Diabetes, and Metabolism, Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA. Serena.Cardillo@uphs.upenn.edu.
authors.forename: Serena
authors.initials: S
authors.lastname: Cardillo
authors.affiliation: Center for Clinical Epidemiology and Biostatistics, Department of Biostatistics and Epidemiology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA. atroxel@mail.med.upenn.edu.|Center for Pharmacoepidemiology Research and Training, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA. atroxel@mail.med.upenn.edu.
authors.forename: Andrea B
authors.initials: AB
authors.lastname: Troxel
authors.affiliation: Department of Nursing, Hospital of the University of Pennsylvania, Philadelphia, PA, USA. Rebecca.Trotta@uphs.upenn.edu.
authors.forename: Rebecca
authors.initials: R
authors.lastname: Trotta
authors.affiliation: Center for Clinical Epidemiology and Biostatistics, Department of Biostatistics and Epidemiology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA. hennessy@upenn.edu.|Center for Pharmacoepidemiology Research and Training, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA. hennessy@upenn.edu.|Department of Systems Pharmacology and Translational Therapeutics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA. hennessy@upenn.edu.
authors.forename: Sean
authors.initials: S
authors.lastname: Hennessy
mesh_terms: D006761:Hospitals; D006801:Humans; D007328:Insulin / Q000627:therapeutic use*; D018579:Patient Selection; D010865:Pilot Projects
chemical_list: D007328:Insulin