A randomized, cross-over comparison of preference between two reusable insulin pen devices in pen-naïve adults with diabetes.

OBJECTIVE: To evaluate final preference and ease-of-use attributes of two reusable pen injectors, HPS (HumaPen Savvio) and HPL (HumaPen Luxura), in adults with type 1 or type 2 diabetes.

RESEARCH DESIGN AND METHODS: This was a 1 day, randomized, two-period crossover, open-label, simulated-injection study in 203 pen-naïve subjects (mean age 58.4 years).

MAIN OUTCOME MEASURES: Functional and ease-of-use attributes of insulin pen injectors were evaluated using a 16-item survey (7 point scale) where higher scores reflected greater preference and equal scores reflected no preference. The primary objective was final pen preference, with statistical gate-keeping to the ease of detecting an insufficient remaining dose (IRD) of insulin upon dose selection.

RESULTS: For final overall pen preference, HPS was chosen by 150 of 203 subjects (73.9%, 95% confidence interval [CI] = 67.3%-79.8%). For the IRD item, 'It is easy to know when there is not enough insulin left in the cartridge for the dose I need before I inject', HPS was preferred by 94 of 107 subjects with a preference (87.9%, 95% CI = 80.1%-93.4%). In 14 of the remaining 15 survey items, 64.3% to 87.7% of subjects with a preference statistically significantly preferred HPS over HPL. To confirm the results, subjects with no preference for either pen, which ranged between 95 and 148, were included in a Bayesian analysis.

KEY LIMITATIONS: Injection simulation, use of an unvalidated survey, and office setting which did not allow for direct clinical experience with the devices.

CONCLUSIONS: The majority of pen-naïve subjects preferred HPS over HPL. For all ease-of-use attributes, the majority of subjects with a preference chose HPS over HPL. Some attributes of both pens were equally acceptable, as many subjects had no preference.