Validation and ease of use of a new pen device for self-administration of recombinant human growth hormone: results from a two-center usability study

Robert Rapaport,¹ Paul Saenger,² Heinrich Schmidt,³ Yukihiro Hasegawa,⁴ Michel Colle,⁵ Sandro Loche,⁶ Sandra Marcantonio,⁷ Walter Bonfig,⁸ Markus Zabransky,⁹ Fima Lifshitz<sup>10

1</sup>Division of Pediatric Endocrinology and Diabetes, Mount Sinai School of Medicine, ²Winthrop University Hospital, Mineola, NY, USA; ³University Children's Hospital, Division of Endocrinology and Diabetology, Munich, Germany; ⁴Department of Endocrinology and Metabolism, Tokyo Metropolitan Children's Medical Center, Tokyo, Japan; ⁵25 rue Boudet, Bordeaux, France; ⁶Servizio di Endocrinologia Pediatrica, Ospedale Microcitemico ASL Cagliari, Cagliari, Italy; ⁷Clinica de Endocrinologia Pediátrica, Londrina, Brazil; ⁸Division of Pediatric Endocrinology, Technical University München, Munich, Germany; ⁹Sandoz International GmbH, Holzkirchen, Germany; ¹⁰Pediatric Sunshine Academics, Inc, Santa Barbara, CA, USA

Abstract: Close adherence to the recommended treatment regimen is important for the success of recombinant human growth hormone therapy, although nonadherence can be common. Ease of use and safety during use/storage are among several important factors in the design of a growth hormone injection device intended for long-term use. This study was performed to validate the usability and assess the ease of use of a new pen device (SurePal™) that has been developed to support daily administration of the recombinant human growth hormone product, Omnitrope^® (somatropin). The primary objectives of the study were to assess if study participants, representing intended users of the pen in clinical practice, were able to perform an injection procedure into an injection pad effectively and safely and disassemble the pen without receiving a needlestick injury. A total of 106 participants (61 adults and 45 children/adolescents) were enrolled at two study centers (one in the US, one in Germany). Results for both primary usability tasks met the predefined acceptance criteria, with >85% of participants successfully performing each task. All of the other tasks/handling steps assessed were also successfully performed by most participants, with high success rates reflected in the high proportion of participants who classified each task as "very easy" or "easy". After a second use of the device, 87%–97% of participants rated it as "very easy" or "easy" to use. In summary, the new pen device is safe and easy to use for both adults and children, and will help to support effective, long-term daily administration of the recombinant human growth hormone product, Omnitrope^®.

Keywords: ease of use, growth hormone, Omnitrope^®, SurePal™, pen device