title: Satisfaction and quality of life with premeal inhaled versus injected insulin in adolescents and adults with type 1 diabetes.
abstract: OBJECTIVE
  We sought to compare and evaluate the impact of inhaled versus injected insulin on potential mediators of patient acceptance of insulin therapy while maintaining comparable A1C levels.
  
  
  METHODS
  During a noninferiority efficacy trial conducted in 40 centers in the U.S., we surveyed treatment satisfaction, quality of life, and adherence barriers at weeks -4, -1, 6, 12, 20, and 24 in adolescents aged 12-17 years and adults with type 1 diabetes who received premeal regular plus twice-daily NPH insulin during a 4-week run-in; then, subjects were randomized to premeal inhaled human insulin plus twice-daily NPH (adults, n = 102; adolescents, n = 60) (inhaled) or remaining on run-in therapy (n = 105 and 60, respectively) (subcutaneous injection).
  
  
  RESULTS
  Overall treatment satisfaction (0-100) increased by 13.2 +/- 1.1 units for inhaled insulin (baseline = 63.3 +/- 1.2) compared with 1.7 +/- 0.8 for subcutaneous insulin injection (baseline = 64.1 +/- 1.2, P < 0.0001). All 12 satisfaction subscales favored inhaled insulin (all P < 0.01), and effects did not vary by age or sex. Despite similar baseline-adjusted end point A1C for inhaled (7.7 +/- 0.1%) and subcutaneous (7.9 +/- 0.1%) regimens, quality-of-life scales of mental health, symptoms, health status, cognitive functioning, and adherence barriers during treatment were more favorable for inhaled insulin (all P < 0.05). Greater satisfaction was associated with fewer barriers to insulin adherence (rho = -0.78, P < 0.0001) and a greater reduction in A1C (rho = -0.18, P < 0.001).
  
  
  CONCLUSIONS
  Treatment satisfaction was substantially more favorable, adherence barriers moderately lower, and quality of life moderately higher for inhaled compared with subcutaneous regimen. It remains to be demonstrated whether these patient-reported outcomes will translate into improved adherence and glycemic control.
authors.affiliation: Department of Biostatistics, Harvard School of Public Health, Boston, Massachusetts 02115, USA. testa@hsph.harvard.edu
authors.forename: Marcia A
authors.initials: MA
authors.lastname: Testa
authors.forename: Donald C
authors.initials: DC
authors.lastname: Simonson
mesh_terms: D000280:Administration, Inhalation; D000293:Adolescent; D000328:Adult; D002648:Child; D003922:Diabetes Mellitus, Type 1 / Q000188:drug therapy* / Q000503:physiopathology / Q000523:psychology; D004334:Drug Administration Schedule; D004435:Eating; D005260:Female; D006442:Glycated Hemoglobin / Q000187:drug effects / Q000378:metabolism; D006801:Humans; D007279:Injections, Subcutaneous; D007336:Insulin, Isophane / Q000008:administration & dosage* / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009790:Occupations; D010349:Patient Compliance; D017060:Patient Satisfaction; D011788:Quality of Life
chemical_list: D006442:Glycated Hemoglobin; D007336:Insulin, Isophane