Effect of standard (self-directed) training versus intensive training for Lilly/Alkermes human insulin inhalation powder delivery system on patient-reported outcomes and patient evaluation of the system.

BACKGROUND: Inhaled insulin may provide patients with diabetes a safe, efficacious method of insulin delivery without the burden of injection, but complexity of and time required for training in proper use of delivery systems have not been evaluated. METHODS: This 4-week, multicenter, single-blind, randomized parallel-group study compared the effect of self-directed [written text-graphic directions for use (DFU) with patient-assistance phone number] or intensive (same DFU, personal training by study personnel, inspiratory flow rate coaching) training for the Lilly/Alkermes human insulin inhalation powder (HIIP) delivery system on patient-reported outcomes (PROs). Patients with type 2 diabetes poorly controlled on oral therapy (n = 102, mean hemoglobin A1C = 9.3%) were administered measures of vitality, diabetes-associated symptoms, fear of hypoglycemia, insulin-delivery system satisfaction, and a delivery system-specific evaluation questionnaire. Analysis of covariance models were used to compare the effect on PROs of treatment of diabetes for 1 month following the two training methods. Paired t tests were used to determine change in PROs after treatment with HIIP. RESULTS: PROs did not differ significantly between training groups. Patients in both groups positively evaluated the delivery system, but the intensive group agreed significantly (P < 0.05) more strongly that the DFU was easy to follow. Improvements in vitality and symptoms of fatigue and increases in fear of hypoglycemia were detected among all patients after using HIIP (P < 0.05). CONCLUSION: Training for this HIIP delivery system can be self-directed without detrimental effects on PROs, making it potentially a more patient-friendly insulin-delivery method that should appeal to both clinicians and patients.

AIR Inhaled Insulin System: a novel insulin-delivery system for patients with diabetes.

Over time, most patients with Type 2 diabetes require insulin-replacement therapy to attain and sustain the increasingly stringent glycemic goals. Initiation of subcutaneous insulin may be delayed due to patient or provider resistance. This delay may increase the risk of complications from long-term hyperglycemia. The development of inhaled insulin-delivery systems has been pursued to facilitate earlier initiation and optimization of insulin therapy to achieve better treatment outcomes. The AIR((R)) Inhaled Insulin System utilizes relatively large, low-density particles, allowing efficient drug delivery to the deep lung from a simple inhaler. In clinical studies it has provided similar postprandial glycemic control compared with subcutaneously injected, short-acting insulin, and was preferred by more patients. The purpose of this article is to describe the AIR Inhaled Insulin System, provide an overview of other insulin-delivery systems and discuss future strategies for the treatment of diabetes.

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

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.