• Curr Med Res Opin · Feb 2007

    Randomized Controlled Trial Multicenter Study

    Effect of inhaled insulin on patient-reported outcomes and treatment preference in patients with type 1 diabetes.

    • Risa P Hayes, Douglas Muchmore, and Jennifer Schmitke.
    • Global Health Outcomes, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN 46285, USA. hayes_clarice@lilly.com
    • Curr Med Res Opin. 2007 Feb 1; 23 (2): 435442435-42.

    ObjectiveTo compare patient-reported outcomes and treatment preference between preprandial inhaled insulin and preprandial subcutaneous (SC) insulin in the context of a clinical trial of crossover design with a primary objective of comparing HbA(1C) between groups.Research Design And MethodsMulti-center, randomized, open-label, two-arm crossover trial conducted in the US and Canada with two 12-week periods comparing preference between preprandial human insulin inhalation powder (HIIP; AIR inhaled insulin) and preprandial SC insulin (regular human insulin or insulin lispro) in patients with type 1 diabetes. Patients received HIIP plus insulin glargine during period 1 and SC insulin plus insulin glargine during period 2, or the reverse sequence.Main Outcome MeasuresSF-36 Vitality Subscale, Diabetes Symptom Checklist-Revised subscales, Diabetes Treatment Satisfaction Questionnaire, Insulin Delivery System Questionnaire, HIIP-specific questionnaire, preference question.ResultsOf 137 patients entered, 119 completed the study (54% female, mean age 40.9 +/- 12.4 years, mean HbA(1C) 8.1 +/- 1.0%). Patients had significantly greater treatment satisfaction and more positive evaluation of their insulin delivery system (easier to control blood sugar, less lifestyle impact) with HIIP than with SC insulin (all p < 0.01). Patients preferring HIIP (80%) were significantly more confident about (p = 0.005) and comfortable with (p = 0.003) using the system than those preferring SC insulin. Results may not be generalizable to all patients with type 1 diabetes.ConclusionsSome patients desire alternatives to insulin injection. In this study 80% preferred HIIP to injected insulin. Other patients feel more comfortable with familiar insulin delivery. Healthcare providers should help patients find insulin delivery that corresponds to individual preferences.

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