title: Comparison of standard (self-directed) versus intensive patient training for the human insulin inhalation powder (HIIP) delivery system in patients with type 2 diabetes: efficacy, safety, and training measures.
abstract: BACKGROUND
  The Lilly/Alkermes human insulin inhalation powder (HIIP) delivery system [AIR (a registered trademark of Alkermes, Inc., Cambridge, MA) Inhaled Insulin System] was designed to be easy to use. Training methods were compared in insulin-naive patients with type 2 diabetes.
  
  
  METHODS
  Patients (n = 102) were randomized to standard or intensive training. With standard training, patients learned how to use the HIIP delivery system by reading directions for use (DFU) and trying on their own. Intensive training included orientation to the HIIP delivery system with individual coaching and inspiratory flow rate training. Both groups received preprandial HIIP + metformin with or without a thiazolidinedione for 4 weeks. Overall 2-h postprandial blood glucose (PPBG) excursion was the primary measure. Noninferiority was defined as the upper limit of the two-sided 95% confidence interval of the mean difference between groups being 1.2 < or = mmol/L.
  
  
  RESULTS
  Overall 2-h PPBG excursions (least squares mean +/- SE) at endpoint were -0.11 +/- 0.38 (standard training) and 0.23 +/- 0.36 (intensive training) mmol/L. The mean difference (standard minus intensive training) and two-sided 95% confidence interval were -0.35 (-1.02, 0.33) mmol/L. No statistically or clinically significant differences were observed between training methods in premeal, postmeal, or bedtime blood glucose values, HIIP doses at endpoint, or blood glucose values after a test meal. No discontinuations occurred because of difficulty of use or dislike of the HIIP system. DFU compliance was >90% in both training groups. There were no significant differences between training methods in safety measures.
  
  
  CONCLUSIONS
  The HIIP delivery system is easy to use, and most patients can learn to use it by reading the DFU without assistance from health care professionals.
authors.affiliation: Dallas Diabetes and Endocrine Center at Medical City, Dallas, Texas 75230, USA. juliorosenstock@dallasdiabetes.com
authors.forename: Julio
authors.initials: J
authors.lastname: Rosenstock
authors.forename: Masako
authors.initials: M
authors.lastname: Nakano
authors.forename: Bernard L
authors.initials: BL
authors.lastname: Silverman
authors.forename: Bin
authors.initials: B
authors.lastname: Sun
authors.forename: Amparo
authors.initials: A
authors.lastname: de la Peña
authors.forename: Ajit
authors.initials: A
authors.lastname: Suri
authors.forename: Douglas B
authors.initials: DB
authors.lastname: Muchmore
mesh_terms: D000280:Administration, Inhalation; D000368:Aged; D001835:Body Weight; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007003:Hypoglycemia / Q000209:etiology; 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*; D013902:Radiography, Thoracic; D011897:Random Allocation; D012129:Respiratory Function Tests; D016037:Single-Blind Method; D016896:Treatment Outcome
chemical_list: D007004:Hypoglycemic Agents; D007328:Insulin