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

Abstract

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.

Keywords::

• Insulin
• Pen device
• Reusable
• Type 1 diabetes
• Type 2 diabetes

Transparency

Declaration of funding

This work was sponsored by Eli Lilly and Company and is related to Study Protocol H8L-MC-IQAR.

Declaration of financial/other relationships

M.W. and H.F. are employees of Eli Lilly and Company and own stock in Eli Lilly and Company. R.A. and M.A.C. are employees of Pharmanet/i3 which was contracted by Eli Lilly to perform the statistical analyses reported in this manuscript and to provide writing assistance.

CMRO peer reviewers may have received honoraria for their review work. The peer reviewers on this manuscript have disclosed that they have no relevant financial relationships.

Acknowledgments

This study was conducted by a contract research organization, Concentrics Research LLC, Indianapolis, IN, USA.

Notes

*HumaPen Savvio is a trademark of Eli Lily & Company, Indianapolis IN, USA

†HumaPen Luxura is a trademark of Eli Lilly & Company, Indianapolis, IN, USA

*HumaPen Luxura is a trademark of Eli Lilly & Company, Indianapolis, IN, USA

†HumaPen Savvio is a trademark of Eli Lily & Company, Indianapolis IN, USA