1. Patients with Growth-Related Disorders and Caregivers Prefer the Somapacitan Device to the Somatrogon Device: Results from a Randomized Crossover Study Assessing Device Preference and Ease of Use Following Simulated Injections
- Author
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Akhtar S, Berg B, Medina J, Gonczi MN, Hamilton S, Hildebrand E, Kelepouris N, Neergaard JS, Sværke C, Ter-Borch G, and Rasmussen NK
- Subjects
growth hormone deficiency ,long-acting growth hormone ,device preference ,ease of use ,somapacitan ,somatrogon ,Medical technology ,R855-855.5 - Abstract
Shahid Akhtar,1 Birgitte Berg,2 Johan Medina,3 Maya Nicole Gonczi,4 Sophie Hamilton,5 Emily Hildebrand,4 Nicky Kelepouris,6 Jesper Skov Neergaard,7 Claus Sværke,8 Gitte Ter-Borch,2 Niklas Kahr Rasmussen3 1Devices & Digital Health, Novo Nordisk A/S, Søborg, Denmark; 2Clinical Operations, Obesity, Liver Diseases & Devices, Novo Nordisk A/S, Søborg, Denmark; 3Medical & Science, Devices & Digital Health, Novo Nordisk A/S, Søborg, Denmark; 4Human Factors, Research Collective, Tempe, AZ, USA; 5Rare Endocrine Rare Renal Diseases, Novo Nordisk Inc, Plainsboro, NJ, USA; 6Rare Endocrine Disorders, Novo Nordisk Inc, Plainsboro, NJ, USA; 7Safety Surveillance, Cardiovascular Disease, Novo Nordisk A/S, Søborg, Denmark; 8Global Development, Novo Nordisk A/S, Søborg, DenmarkCorrespondence: Shahid Akhtar, Medical & Science, Devices & Digital Health, Novo Nordisk A/S, Vandtårnsvej 108– 110, Søborg, DK-2860, Denmark, Email SAHT@novonordisk.comPurpose: Adherence to growth hormone treatment is known to affect growth outcomes. Both device preference and ease of use have been shown to affect treatment adherence. In this study, we assessed device preference and ease of use with two long-acting growth hormones, somapacitan (Sogroya®, Novo Nordisk A/S) and somatrogon (Ngenla®, Pfizer).Patients and Methods: In a randomized, crossover study conducted between September 20 and November 2, 2023, we recruited 33 adolescents with a growth-related disorder, and 37 caregivers, at six locations in the United States. Each participant was trained in the use of both devices and asked to perform a simulated injection. Device training time, preparation and injection time, and injection completeness were recorded. Participants also completed the Device Handling and Preference Questionnaire (DHPAQ) to indicate their device preference and ease of use opinions. Following conclusion of the “standard” visit, 10 adolescents and 10 caregivers were randomly selected to participate in a sub-study to validate the relevance, comprehensiveness, and comprehension of the DHPAQ.Results: The majority of participants (84.3%; 95% confidence interval [CI]: 74;92) preferred the somapacitan device to the somatrogon device (p
- Published
- 2024