Affiliation:
1. Department of Biostatistics, Harvard School of Public Health, Boston, Massachusetts
2. Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts
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.
RESEARCH DESIGN AND 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.
Publisher
American Diabetes Association
Subject
Advanced and Specialized Nursing,Endocrinology, Diabetes and Metabolism,Internal Medicine
Reference27 articles.
1. Diabetes Control and Complications Trial Research Group: The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med 329: 977–986, 1993
2. Reichard P, Nilsson BY, Rosenqvist U: The effect of long-term intensified insulin treatment on the development of microvascular complications of diabetes mellitus. N Engl J Med 329:304–309, 1993
3. Zgibor JC, Songer TJ, Kelsey SF, Weissfeld J, Drash AL, Becker D, Orchard TJ: The association of diabetes specialist care with health care practices and glycemic control in patients with type 1 diabetes: a crosssectional analysis from the Pittsburgh Epidemiology of Diabetes Complications Study. Diabetes Care 23:472–476, 2000
4. Muller UA, Femerling M, Reinauer KM, RisseA, Voss M, Jorgens V, Berger M, Muhlhauser I: Intensified treatment and education of type 1 diabetes as clinical routine: a nationwide quality-circle experience in Germany: ASD (the Working Group on Structured Diabetes Therapy of the German Diabetes Association). Diabetes Care 22 (Suppl. 2):B29–B34, 1999
5. Zambanini A, Newson RB, Maisey M, Feher MD: Injection related anxiety in insulin-treated diabetes. Diabetes Res Clin Pract 46:239–246, 1999
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