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Objective: The AERx^® Insulin Diabetes Management System [AERx iDMS, jointly developed by Novo Nordisk (Bagsvaerd, Denmark) and Aradigm Corp. (Hayward, CA)] provides insulin by pulmonary administration. This investigation was designed as a pilot trial to demonstrate the ability of patients to use the electronic device to deliver mealtime inhaled insulin doses and explore the impact on compliance.

Methods: AERx iDMS was evaluated in a substudy of a 12-week, multicenter open trial by adult patients with type 2 diabetes previously on any insulin regimen. The device was used for dosing fast-acting human insulin immediately before main meals, in combination with bedtime NPH insulin. The AERx iDMS device recorded the date and time of each insulin inhalation, insulin units used, and inhalation technique during aerosol delivery. Compliance was defined as the percentage of prescribed doses taken during the treatment period, dose timing, and the efficiency of dosing technique.

Results: Insulin dosing for 49 patients (age 59.1 ± 7.7 years) using AERx iDMS was monitored for 78.9 ± 10 days (range, 41–94 days) with 226 ± 35 doses (range, 122–272 doses). Patients inhaled on average 2.9 ± 0.3 doses of insulin daily, taking an average of 11.8 ± 5.6 units per dose. Compliance with the prescribed regimen was 94.3 ± 9.1% (range, 45–100%). Overall, 4.2 ± 9.5% of prescribed doses were omitted. Hemoglobin A1c decreased 0.77 ± 0.96% from baseline to the end of the study. Inhalation technique was excellent, with 97% of patients experiencing fewer than five inadequate doses.

Conclusions: Excellent compliance with AERx iDMS dosing, timing, and inhalation technique showed that the device was well accepted by patients. The electronic monitoring feature could be used as an educational tool to help patients and clinicians manage insulin dosing.