PMID- 17288697 OWN - NLM STAT- MEDLINE DCOM- 20070315 LR - 20221207 IS - 1473-4877 (Electronic) IS - 0300-7995 (Linking) VI - 23 IP - 2 DP - 2007 Feb TI - Effect of inhaled insulin on patient-reported outcomes and treatment preference in patients with type 1 diabetes. PG - 435-42 AB - OBJECTIVE: To 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 METHODS: Multi-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 MEASURES: SF-36 Vitality Subscale, Diabetes Symptom Checklist-Revised subscales, Diabetes Treatment Satisfaction Questionnaire, Insulin Delivery System Questionnaire, HIIP-specific questionnaire, preference question. RESULTS: Of 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. CONCLUSIONS: Some 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. FAU - Hayes, Risa P AU - Hayes RP AD - Global Health Outcomes, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN 46285, USA. hayes_clarice@lilly.com FAU - Muchmore, Douglas AU - Muchmore D FAU - Schmitke, Jennifer AU - Schmitke J LA - eng SI - ClinicalTrials.gov/NCT00063128 PT - Clinical Trial, Phase II PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't PL - England TA - Curr Med Res Opin JT - Current medical research and opinion JID - 0351014 RN - 0 (Glycated Hemoglobin A) RN - 0 (Hypoglycemic Agents) RN - 0 (Insulin) RN - 0 (Insulin Lispro) RN - 0 (Insulin, Long-Acting) RN - 0 (Powders) RN - 2ZM8CX04RZ (Insulin Glargine) SB - IM MH - Administration, Inhalation MH - Adult MH - Cross-Over Studies MH - Diabetes Mellitus, Type 1/*drug therapy MH - Female MH - Glycated Hemoglobin/analysis MH - Humans MH - Hypoglycemic Agents/administration & dosage/*therapeutic use MH - Injections, Subcutaneous MH - Insulin/administration & dosage/*analogs & derivatives/*therapeutic use MH - Insulin Glargine MH - Insulin Lispro MH - Insulin, Long-Acting MH - Male MH - Middle Aged MH - Patient Satisfaction/*statistics & numerical data MH - Powders MH - Surveys and Questionnaires MH - Treatment Outcome EDAT- 2007/02/10 09:00 MHDA- 2007/03/16 09:00 CRDT- 2007/02/10 09:00 PHST- 2007/02/10 09:00 [pubmed] PHST- 2007/03/16 09:00 [medline] PHST- 2007/02/10 09:00 [entrez] AID - 10.1185/030079906X167381 [doi] PST - ppublish SO - Curr Med Res Opin. 2007 Feb;23(2):435-42. doi: 10.1185/030079906X167381.