title: Effect of standard (self-directed) training versus intensive training for Lilly/Alkermes human insulin inhalation powder delivery system on patient-reported outcomes and patient evaluation of the system.
abstract: BACKGROUND
  Inhaled insulin may provide patients with diabetes a safe, efficacious method of insulin delivery without the burden of injection, but complexity of and time required for training in proper use of delivery systems have not been evaluated.
  
  
  METHODS
  This 4-week, multicenter, single-blind, randomized parallel-group study compared the effect of self-directed [written text-graphic directions for use (DFU) with patient-assistance phone number] or intensive (same DFU, personal training by study personnel, inspiratory flow rate coaching) training for the Lilly/Alkermes human insulin inhalation powder (HIIP) delivery system on patient-reported outcomes (PROs). Patients with type 2 diabetes poorly controlled on oral therapy (n = 102, mean hemoglobin A1C = 9.3%) were administered measures of vitality, diabetes-associated symptoms, fear of hypoglycemia, insulin-delivery system satisfaction, and a delivery system-specific evaluation questionnaire. Analysis of covariance models were used to compare the effect on PROs of treatment of diabetes for 1 month following the two training methods. Paired t tests were used to determine change in PROs after treatment with HIIP.
  
  
  RESULTS
  PROs did not differ significantly between training groups. Patients in both groups positively evaluated the delivery system, but the intensive group agreed significantly (P < 0.05) more strongly that the DFU was easy to follow. Improvements in vitality and symptoms of fatigue and increases in fear of hypoglycemia were detected among all patients after using HIIP (P < 0.05).
  
  
  CONCLUSIONS
  Training for this HIIP delivery system can be self-directed without detrimental effects on PROs, making it potentially a more patient-friendly insulin-delivery method that should appeal to both clinicians and patients.
authors.affiliation: Global Health Outcomes, Eli Lilly and Company, Indianapolis, Indiana 46285, USA. hayes_clarice@lilly.com
authors.forename: Risa P
authors.initials: RP
authors.lastname: Hayes
authors.forename: Masako
authors.initials: M
authors.lastname: Nakano
authors.forename: Douglas
authors.initials: D
authors.lastname: Muchmore
authors.forename: Jennifer
authors.initials: J
authors.lastname: Schmitke
mesh_terms: D000280:Administration, Inhalation; D000368:Aged; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D007328:Insulin / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D008297:Male; D008875:Middle Aged; D010353:Patient Education as Topic / Q000379:methods*; D017060:Patient Satisfaction; D011897:Random Allocation; D016037:Single-Blind Method; D016896:Treatment Outcome
chemical_list: D007004:Hypoglycemic Agents; D007328:Insulin