Comparative usability study of the dulaglutide single-use pen versus the insulin degludec FlexTouch^® among self-injection-naïve patients with type 2 diabetes mellitus in Japan

References

• International Diabetes Federation [Internet]. IDF Diabetes Atlas, 8th edn. IDF; 2017. Brussels, Belgium. Available online at: www.diabetesatlas.org accessed December 1, 2017
   Google Scholar
• Japan Diabetes Society [Internet]. Treatment guide for diabetes, 2014–2015. 2015. Tokyo, Japan. Available online at: www.jds.or.jp/modules/en/index.php?content_id = 1 access December 1, 2017
   Google Scholar
• Trulicity Ateos Eli Lilly Japan K.K. Ver 4. Revised March 2017. Kobe, Japan. Available online at: www.info.pmda.go.jp/downfiles/ph/PDF/530471_2499416G1029_1_10.pdf. Japanese accessed December 1, 2017
   Google Scholar
• Matfin G, Van Brunt K, Zimmermann AG, et al. Safe and effective use of the once weekly dulaglutide single-dose pen in injection-naïve patients with type 2 diabetes. J Diabetes Sci Technol 2015;9:1071-9
   PubMedGoogle Scholar
• Asakura T. The association between injection device and injection training time of insulin initial self-injection training. Prog Med 2003;23:3381-5. Japanese
   Google Scholar
• Asakura T, Seino H, Jensen KH. Patient acceptance and issues of education of two durable insulin pen devices. Diabetes Technol Ther 2008;10:299-304
   PubMed Web of Science ®Google Scholar
• Clark PE, Valentine V, Bodie JN, et al. Ease of use and patient preference injection simulation study comparing two prefilled insulin pens. Curr Med Res Opin 2010;26:1745-53
   PubMed Web of Science ®Google Scholar
• Ignaut DA, Schwartz SL, Sarwat S, et al. Comparative device assessments: Humalog KwikPen compared with vial and syringe and FlexPen. Diabetes Educ 2009;35:789-98
   PubMed Web of Science ®Google Scholar
• Yamada KC, Aoki K. Evaluation of usability of insulin self-injection devices. Jpn J Ergonom 2006;42:112-18. Japanese
   Google Scholar
• Lorenzi GSB, Osther J, Boardman M. Application of adult-learning principles to patient instructions: a usability study for an exenatide once-weekly injection device. Clin Diabetes 2010;28:157-62
   Google Scholar
• Stauder U, Enginee D, Elton H, et al. Comparative assessment of lixisenatide, exenatide, and liraglutide pen devices: a pilot user-based study. J Diabetes Sci Technol 2014;8:123-31
   PubMedGoogle Scholar
• Araki E, Inagaki N, Tanizawa Y, et al. Efficacy and safety of once-weekly dulaglutide in combination with sulphonylurea and/or biguanide compared with once-daily insulin glargine in Japanese patients with type 2 diabetes: a randomized, open-label, phase III, non-inferiority study. Diabetes Obes Metab 2015;17:994-1002
   PubMed Web of Science ®Google Scholar
• Miyagawa J, Odawara M, Takamura T, et al. Once-weekly glucagon-like peptide-1 receptor agonist dulaglutide is non-inferior to once-daily liraglutide and superior to placebo in Japanese patients with type 2 diabetes: a 26-week randomized phase III study. Diabetes Obes Metab 2015;17:974-83
   PubMed Web of Science ®Google Scholar
• Xie J, Suzuki S, Cos X, et al. Cross-national variation in physicians’ characteristics and their goals for patients taking insulin: evidence from the MOSAIc study [abstract 1538-P]. Poster presented at the 74th American Diabetes Association; Jun 13–17, 2014; San Francisco, CA.
   Google Scholar
• Muto T, Asakura T, Toraishi K, et al. Comparison of new portable prefilled insulin pen with conventional insulin pens. Jpn J Pharm Health Care Sci 2006;32:1065-70. Japanese
   Google Scholar
• Eli Lilly Japan K. K. Instructions for Use, Trulicity® [Internet]. 2017. Kobe, Japan. Available online at: https://www.diabetes.co.jp/hcp/tlc/shared/pdf/material/material01_170626.pdf. Japanese accessed December 1, 2017
   Google Scholar
• Novo Nordisk. Instructions for Use, Tresiba® FlexTouch® [Internet]. 2016. Tokyo, Japan. Available online at: https://www.novonordiskpro.jp/content/dam/nnpro/japan/ja/products/FlexTouch^®/Docs/FlexTouch^®_Instruction-Manual_Pt_2016.pdf. Japanese accessed December 1, 2017
   Google Scholar
• Onishi Y, Iwamoto Y, Yoo SJ, et al. Insulin degludec compared with insulin glargine in insulin-naïve patients with type 2 diabetes: a 26-week, randomized, controlled, Pan-Asian, treat-to-target trial. J Diabetes Investig 2013;4:605-12
   PubMed Web of Science ®Google Scholar
• Ministry of Education, Culture, Sports, Science and Technology, and Ministry of Health, Labour and Welfare [Internet]. Ethical guidelines for medical and health research involving human subjects. 2014. Tokyo, Japan. Available online at: http://www.mhlw.go.jp/file/06-Seisakujouhou-10600000-Daijinkanboukouseikagakuka/0000069410.pdf. Japanese accessed December 1, 2017
   Google Scholar
• Andre AD, Wang C, Berry B, et al. Comparative usability study of two once-weekly GLP-1RA pen injector products: Tanzeum™ and Bydureon® [abstract 1138-P]. Poster presented at the 75th American Diabetes Association; Jun 5–9, 2015; Boston, MA
   Google Scholar
• Smaby N, Johanson ME, Baker B, et al. Identification of key pinch forces required to complete functional tasks. J Rehabil Res Dev 2004;41:215-24
   PubMed Web of Science ®Google Scholar
• Gelhorn HL, Bacci ED, Poon JL, et al. Evaluating preferences for profiles of glucagon-like peptide-1 receptor agonists among injection-naive type 2 diabetes patients in Japan. Patient Prefer Adherence 2016;10:1337-48
   PubMed Web of Science ®Google Scholar
• Polinski JM, Curtis BH, Seeger JD, et al. Rationale and design of the multinational observational study assessing insulin use: the MOSAIc study. BMC Endocr Disord 2012;12:20
   PubMed Web of Science ®Google Scholar
• Asakura T, Hyllestad-Winge J, Hoshino T. Usability and performance evaluation on prefilled insulin devices: FlexTouch®, SoloSTAR® and MirioPen® among diabetic patients and health care professionals in Japan. Jpn J Pharm Diabetes 2014;3:147-56. Japanese
   Google Scholar
• Bailey T, Thurman J, Niemeyer M, et al. Usability and preference evaluation of a prefilled insulin pen with a novel injection mechanism by people with diabetes and healthcare professionals. Curr Med Res Opin 2011;27:2043-52
   PubMed Web of Science ®Google Scholar
• Oyer D, Narendran P, Qvist M, et al. Ease of use and preference of a new versus widely available prefilled insulin pen assessed by people with diabetes, physicians and nurses. Expert Opin Drug Deliv 2011;8:1259-69
   PubMed Web of Science ®Google Scholar
• The Ministry of Health and Welfare [Internet]. Patient survey; 2014. Tokyo, Japan. Available online at: www.e-stat.go.jp/SG1/estat/List.do?lid = 000001141596. Japanese accessed December 1, 2017
   Google Scholar
• Phillips LS, Branch WT, Cook CB, et al. Clinical inertia. Ann Intern Med 2001;135:825-34
   PubMed Web of Science ®Google Scholar
• Ishii H, Iwamoto Y, Tajima N. An exploration of barriers to insulin initiation for physicians in Japan: findings from the Diabetes Attitudes, Wishes And Needs (DAWN) JAPAN study. PLoS One 2012;7:e36361
   PubMed Web of Science ®Google Scholar
• Van Brunt K, Ignaut, DA, Zimmermann AG, et al. Patient experience with the single-use pen for injection of once weekly dulaglutide in injection-naïve patients with type 2 diabetes [abstract PDB125]. Poster presented at the International Society for Pharmacoeconomics 17th Annual European Congress; November 8–12, 2014; Amsterdam, The Netherlands
   Google Scholar
• Ahrén B. Avoiding hypoglycemia: a key to success for glucose-lowering therapy in type 2 diabetes. Vasc Health Risk Manag 2013;9:155-63
   PubMedGoogle Scholar
• Norrbacka K, Poon J, Gelhorn H, et al. Evaluating patients' preferences for dulaglutide versus insulin glargine medication profiles in T2D patient subgroups [abstract P-1210]. Poster presented at the International Diabetes Federation Congress; Dec 4–8, 2017; Abu Dhabi, United Arab Emirates
   Google Scholar
• Asakura T, Hoshino T, Niemeyer M. Comparison between FlexTouch® and InnoLet® in Japanese patients with diabetes stratified by disability in finger functions. Prog Med 2013;33:2245-54. Japanese
   Google Scholar
• Yu M, Brunt KV, Milicevic Z, et al. Patient-reported outcomes in patients with type 2 diabetes treated with dulaglutide added to titrated insulin glargine (AWARD-9). Clin Ther 2017;39:2284-95
   PubMed Web of Science ®Google Scholar