Pen devices for self-injection: contrasting measured injection force with users’ perceived ease of injection

References

• Pohlmeier H, Berard L, Brulle-Wohlhueter C, et al. Ease of use of the insulin Glargine 300 U/mL pen injector in insulin-naive people with type 2 diabetes. J Diabetes Sci Technol. 2016 Sep 23 PubMed PMID: 27664062. DOI:10.1177/1932296816668877
   Google Scholar
• Friedrichs A, Bohnet J, Korger V, et al. Dose accuracy and injection force of different insulin glargine pens. J Diabetes Sci Technol. 2013 Sep 01;7(5):1346–1353. PubMed PMID: 24124963; PubMed Central PMCID: PMC3876380.
   PubMedGoogle Scholar
• Mahony MC, Patterson P, Hayward B, et al. Human factors engineering and design validation for the redesigned follitropin alfa pen injection device. Expert Opin Drug Deliv. 2015 May;12(5):715–725. PubMed PMID: 25895897; PubMed Central PMCID: PMC4496816. DOI:10.1517/17425247.2015.1033395
   PubMed Web of Science ®Google Scholar
• Barone DA, Singer BA, Merkov L, et al. Survey of US patients with multiple sclerosis: comparison of the new electronic interferon Beta-1b Autoinjector (BETACONNECT) With Mechanical Autoinjectors. Neurol Ther. 2016 Dec;5(2):155–167. PubMed PMID: 27277705; PubMed Central PMCID: PMC5130914. DOI:10.1007/s40120-016-0047-3
   PubMed Web of Science ®Google Scholar
• Phillips JT, Fox E, Grainger W, et al. An open-label, multicenter study to evaluate the safe and effective use of the single-use autoinjector with an Avonex® prefilled syringe in multiple sclerosis subjects. BMC Neurol. 2011;11(1):126.
   PubMedGoogle Scholar
• Brand-Schieber E, Munjal S, Kumar R, et al. Human factors validation study of 3 mg sumatriptan autoinjector, for migraine patients. Med Devices. 2016;9:131–137. PubMed PMID: 27313479; PubMed Central PMCID: PMC4892851. DOI:10.2147/MDER.S105899
   Google Scholar
• Kivitz A, Segurado OG. HUMIRA pen: a novel autoinjection device for subcutaneous injection of the fully human monoclonal antibody adalimumab. Expert Rev Med Devices. 2007 Mar;4(2):109–116. PubMed PMID: 17359217. DOI:10.1586/17434440.4.2.109
   PubMed Web of Science ®Google Scholar
• Thakur K, Biberger A, Handrich A, et al. Patient perceptions and preferences of two etanercept autoinjectors for rheumatoid arthritis: findings from a patient survey in Europe. Rheumatol Ther. 2016 Dec;3(2):245–256. PubMed PMID: 27817152; PubMed Central PMCID: PMC5127972. DOI:10.1007/s40744-016-0048-9
   PubMed Web of Science ®Google Scholar
• Bailey T, Campos C. FlexTouch(R) for the delivery of insulin: technical attributes and perception among patients and healthcare professionals. Expert Rev Med Devices. 2012 May 9;(3):209–217. PubMed PMID: 22471783. DOI:10.1586/erd.12.13
   PubMed Web of Science ®Google Scholar
• Tschiedel B, Almeida O, Redfearn J, et al. Initial experience and evaluation of reusable insulin pen devices among patients with diabetes in emerging countries. Diabet Ther: Res, Treatment Edu Diabet Relat Dis. 2014 Dec 5;5(2):545–555. PubMed PMID: 25213801; PubMed Central PMCID: PMC4269642. DOI:10.1007/s13300-014-0081-z
   Google Scholar
• Collier DH, Bitman B, Coles A, et al. A novel electromechanical autoinjector, AutoTouch™, for self-injection of etanercept: real-world use and benefits. Postgrad Med. 2016;1–8. DOI:10.1080/00325481.2017.1251291
   Web of Science ®Google Scholar
• Lange J, Richard P, Bradley N. Usability of a new disposable autoinjector platform device: results of a formative study conducted with a broad user population. Med Devices (Auckland, NZ). 2015 Jun 03;8:255–264. DOI:10.2147/MDER.S85938
   PubMedGoogle Scholar
• Paul C, Lacour JP, Tedremets L, et al. Efficacy, safety and usability of secukinumab administration by autoinjector/pen in psoriasis: a randomized, controlled trial (JUNCTURE). J Eur Acad Dermatol Venereology: JEADV. 2015 Jun;29(6):1082–1090. PubMed PMID: 25243910. DOI:10.1111/jdv.12751
   PubMed Web of Science ®Google Scholar
• Schiff M, Koo J, Jin E, et al. Usability and acceptability of the abatacept pre-filled autoinjector for the subcutaneous treatment of rheumatoid arthritis. Adv Ther. 2016 Feb;33(2):199–213. PubMed PMID: 26833303; PubMed Central PMCID: PMC4769728. DOI:10.1007/s12325-016-0286-9
   PubMed Web of Science ®Google Scholar
• LaRue S, Malloy J. Evaluation of the dual-chamber pen design for the injection of exenatide once weekly for the treatment of type 2 diabetes. J Diabetes Sci Technol. 2015 Jul 9;9(4):815–821. PubMed PMID: 25759181; PubMed Central PMCID: PMC4525643. DOI:10.1177/1932296815576186
   PubMedGoogle Scholar
• Joshi RS, Egbuna OI, Cairns AS, et al. Performance of the pegfilgrastim on-body injector as studied with placebo buffer in healthy volunteers. Curr Med Res Opin. 2016;1–6. DOI:10.1080/03007995.2016.1257980
   Web of Science ®Google Scholar
• Bohannon N, Bergenstal R, Cuddihy R, et al. Comparison of a novel insulin bolus-patch with pen/syringe injection to deliver mealtime insulin for efficacy, preference, and quality of life in adults with diabetes: a randomized, crossover, multicenter study. Diabetes Technol Ther. 2011 Oct;13(10):1031–1037. PubMed PMID: 21732797; PubMed Central PMCID: PMC4346544. DOI:10.1089/dia.2011.0047
   PubMed Web of Science ®Google Scholar
• Antinori-Lent KJ. Analysis of comparison of patient preference for two insulin injection pen devices in relation to patient dexterity skills. J Diabetes Sci Technol. 2012 Jul 01;6(4):917–920. PubMed PMID: 22920819; PubMed Central PMCID: PMC3440164.
   PubMedGoogle Scholar
• Asakura T. Comparison of clinically relevant technical attributes of five insulin injection pens. J Diabetes Sci Technol. 2011 Sep 01;5(5):1203–1209. PubMed PMID: 22027319; PubMed Central PMCID: PMC3208882.
   PubMedGoogle Scholar
• Carter AW. Analysis of the injection force of solostar(R) compared with other disposable insulin pen devices at constant volume flow rates. J Diabetes Sci Technol. 2011 Jan 01 1;5:156–157. PubMed PMID: 21303638; PubMed Central PMCID: PMC3045222.
   PubMedGoogle Scholar
• Hu FB, Satija A, Manson JE. Curbing the diabetes pandemic: the need for global policy solutions. Jama. 2015 Jun 16;313(23):2319–2320. PubMed PMID: 25996138.
   PubMed Web of Science ®Google Scholar
• Asakura T, Seino H, Nakano R, et al. A comparison of the handling and accuracy of syringe and vial versus prefilled insulin pen (FlexPen). Diabetes Technol Ther. 2009 Oct;11(10):657–661. PubMed PMID: 19821758. DOI:10.1089/dia.2009.0006
   PubMed Web of Science ®Google Scholar
• Klonoff D, Nayberg I, Thonius M, et al. Accuracy and injection force of the Gla-300 injection device compared with other commercialized disposable insulin pens. J Diabetes Sci Technol. 2015 Aug 26;10(1):125–130. PubMed PMID: 26311720; PubMed Central PMCID: PMC4738217. DOI:10.1177/1932296815601441
   PubMedGoogle Scholar
• Pfutzner A, Bailey T, Campos C, et al. Accuracy and preference assessment of prefilled insulin pen versus vial and syringe with diabetes patients, caregivers, and healthcare professionals. Curr Med Res Opin. 2013 May;29(5):475–481. PubMed PMID: 23402225. DOI:10.1185/03007995.2013.775112
   PubMed Web of Science ®Google Scholar
• Aronson R, Gibney MA, Oza K, et al. Insulin pen needles: effects of extra-thin wall needle technology on preference, confidence, and other patient ratings. Clin Ther. 2013 Jul;35(7):923–933 e4. PubMed PMID: 23790553. DOI:10.1016/j.clinthera.2013.05.020
   PubMed Web of Science ®Google Scholar
• van der Burg T. Injection force of SoloSTAR(R) compared with other disposable insulin pen devices at constant volume flow rates. J Diabetes Sci Technol. 2011 Jan 01;5(1):150–155. PubMed PMID: 21303637; PubMed Central PMCID: PMC3045231.
   PubMedGoogle Scholar
• Fendler W, Roman-Liu D, Tokarski T, et al. Trigger matters: an ergonomy analysis of insulin pens. Diabetes Technol Ther. 2015 Mar;17(3):171–176. PubMed PMID: 25607378. DOI:10.1089/dia.2014.0177
   PubMed Web of Science ®Google Scholar
• Rees TM, Lennartz AH, Ignaut DA. A comparison of glide force characteristics between 2 prefilled insulin lispro pens. J Diabetes Sci Technol. 2015 Mar;9(2):316–319. PubMed PMID: 25591858; PubMed Central PMCID: PMC4604579. DOI:10.1177/1932296814567533
   PubMedGoogle Scholar
• Toraishi K, Yuizono Y, Nakamura N, et al. Force requirements and insulin delivery profiles of four injection devices. Diabetes Technol Ther. 2005 Aug;7(4):629–635. PubMed PMID: 16120038. DOI:10.1089/dia.2005.7.629
   PubMedGoogle Scholar
• Ignaut DA, Opincar MR, Clark PE, et al. Engineering study comparing injection force and dose accuracy between two prefilled insulin injection pens. Curr Med Res Opin. 2009 Dec;25(12):2829–2833. PubMed PMID: 19916727. DOI:10.1185/03007990903327993
   PubMed Web of Science ®Google Scholar
• Kroon L. Overview of insulin delivery pen devices. J Am Pharma Assoc: JAPhA. 2009 Sep-Oct;49(5):e118–31. PubMed PMID: 19692314. DOI:10.1331/JAPhA.2009.08125
   PubMed Web of Science ®Google Scholar
• Clarke A, Spollett G. Dose accuracy and injection force dynamics of a novel disposable insulin pen. Expert Opin Drug Deliv. 2007 Mar;4(2):165–174. PubMed PMID: 17335413. DOI:10.1517/17425247.4.2.165.
   PubMed Web of Science ®Google Scholar
• Ignaut DA, Opincar M, Lenox S. FlexPen and KwikPen prefilled insulin devices: a laboratory evaluation of ergonomic and injection force characteristics. J Diabetes Sci Technol. 2008 May;2(3):533–537. PubMed PMID: 19885222; PubMed Central PMCID: PMC2769724.
   PubMedGoogle Scholar
• Pfutzner A, Reimer T, Hohberg C, et al. Prefilled insulin device with reduced injection force: patient perception and accuracy. Curr Med Res Opin. 2008 Sep;24(9):2545–2549. PubMed PMID: 18674410.
   PubMed Web of Science ®Google Scholar
• Klonoff D, Nayberg I, Erbstein F, et al. Usability of the Gla-300 injection device compared with three other commercialized disposable insulin pens: results of an interview-based survey. J Diabetes Sci Technol. 2015 Jul;9(4):936–938. PubMed PMID: 26002837; PubMed Central PMCID: PMC4525641. DOI:10.1177/1932296815586219
   PubMedGoogle 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 Oct;27(10):2043–2052. PubMed PMID: 21916529. DOI:10.1185/03007995.2011.616190
   PubMed Web of Science ®Google Scholar
• Campos C, Lajara R, Deluzio T. Usability and preference assessment of a new prefilled insulin pen versus vial and syringe in people with diabetes, physicians and nurses. Expert Opin Pharmacother. 2012 Sep;13(13):1837–1846. PubMed PMID: 22873943. DOI:10.1517/14656566.2012.713350
   PubMed Web of Science ®Google Scholar
• Haak T, Edelman S, Walter C, et al. Comparison of usability and patient preference for the new disposable insulin device Solostar versus Flexpen, lilly disposable pen, and a prototype pen: an open-label study. Clin Ther. 2007 Apr;29(4):650–660. PubMed PMID: 17617288. DOI:10.1016/j.clinthera.2007.04.003
   PubMed Web of Science ®Google Scholar
• Lange J, Richard P, Bradley N. Usability of a new disposable autoinjector platform device: results of a formative study conducted with a broad user population. Med Devices. 2015;8:255–264. PubMed PMID: 26082667; PubMed Central PMCID: PMC4461121. DOI:10.2147/MDER.S85938
   Google Scholar
• Pachon JA, Kivitz AJ, Heuer KU, et al. Assessing usability, label comprehension, pen robustness and pharmacokinetics of a self-administered prefilled autoinjector pen of methotrexate in patients with rheumatoid arthritis. SAGE Open Med. 2014;2:2050312114564241. PubMed PMID: 26770759; PubMed Central PMCID: PMC4712753. DOI:10.1177/2050312114564241
   Google Scholar
• Siegmund T, Blankenfeld H, Schumm-Draeger PM. Comparison of usability and patient preference for insulin pen needles produced with different production techniques: “thin-wall” needles compared to “regular-wall” needles: an open-label study. Diabetes Technol Ther. 2009 Aug;11(8):523–528. PubMed PMID: 19698066. DOI:10.1089/dia.2009.0048
   PubMed Web of Science ®Google Scholar
• Kappelgaard AM, Hansen NA. Comparison of injection dose force, accuracy and precision among three growth hormone injection devices. Expert Rev Med Devices. 2013 May;10(3):321–327. PubMed PMID: 23560872. DOI:10.1586/erd.13.12
   PubMed Web of Science ®Google Scholar
• Pfutzner A, Forst T, Niemeyer M, et al. Assessment for ease of use and preference of a new prefilled insulin pen (FlexTouch Degludec U100/U200) versus the SoloSTAR insulin pen by patients with diabetes and healthcare professionals. Expert Opin Drug Deliv. 2014 Sep;11(9):1381–1389. PubMed PMID: 24921223.
   PubMed Web of Science ®Google Scholar
• Pfutzner A, Schipper C, Niemeyer M, et al. Comparison of patient preference for two insulin injection pen devices in relation to patient dexterity skills. J Diabetes Sci Technol. 2012 Jul 01;6(4):910–916. PubMed PMID: 22920818; PubMed Central PMCID: PMC3440163.
   PubMedGoogle Scholar
• Ahmann A, Szeinbach SL, Gill J, et al. Comparing patient preferences and healthcare provider recommendations with the pen versus vial-and-syringe insulin delivery in patients with type 2 diabetes. Diabetes Technol Ther. 2014 Feb;16(2):76–83. PubMed PMID: 24266497. DOI:10.1089/dia.2013.0172
   PubMed Web of Science ®Google Scholar
• Lim WH, Chan D, Boudville N, et al. Patients’ perceptions of subcutaneous delivery of darbepoetin alfa by autoinjector prefilled pen versus prefilled syringe: a randomized, crossover study. Clin Ther. 2012 Sep;34(9):1948–1953. PubMed PMID: 22902097. DOI:10.1016/j.clinthera.2012.07.012
   PubMed Web of Science ®Google Scholar
• Hirsch L, Byron K, Gibney M. Intramuscular risk at insulin injection sites–measurement of the distance from skin to muscle and rationale for shorter-length needles for subcutaneous insulin therapy. Diabetes Technol Ther. 2014 Dec;16(12):867–873. PubMed PMID: 25329935; eng. DOI:10.1089/dia.2014.0111
   PubMed Web of Science ®Google Scholar
• Frid AH, Hirsch LJ, Menchior AR, et al. Worldwide injection technique questionnaire study: population parameters and injection practices. Mayo Clinic Proc. 2016 Sep 01;91(9):1212–1223. DOI:10.1016/j.mayocp.2016.06.011
   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 Oct;8(10):1259–1269. PubMed PMID: 21905942. DOI:10.1517/17425247.2011.615830
   PubMed Web of Science ®Google Scholar
• Clark PE, Okenfuss CR, Campbell M. Half-unit dose accuracy with HumaPen Luxura HD: an insulin pen for patients who need precise dosing. J Diabetes Sci Technol. 2010 Mar 01;4(2):353–356. PubMed PMID: 20307396; PubMed Central PMCID: PMC2864171.
   PubMedGoogle Scholar
• Callis Duffin K, Bukhalo M, Bobonich MA, et al. Usability of a novel disposable autoinjector device for ixekizumab: results from a qualitative study and an open-label clinical trial, including patient-reported experience. Med Devices. 2016;9:361–369. PubMed PMID: 27785115; PubMed Central PMCID: PMC5067052. DOI:10.2147/MDER.S113752
   Google Scholar
• Lange J, Thompson I. Self-injection devices. In: Swarbrick J, editor. Encyclopedia of pharmaceutical science and technology. 4th ed. New York, NY: Taylor and Francis; 2013. p. 3132–3143.
   Google Scholar
• von Hippel E. Lead users: a source of novel product concepts. Manage Sci. 1986 Jun 01;32(7):791–805. DOI:10.1287/mnsc.32.7.791.
   Web of Science ®Google Scholar
• Chatterji AK, Fabrizio KR. Using users: when does external knowledge enhance corporate product innovation? Strategic Manag J. 2014;35(10):1427–1445. DOI:10.1002/smj.2168.
   Web of Science ®Google Scholar
• Vaquero Martín M, Reinhardt R, Gurtner S. Stakeholder integration in new product development: a systematic analysis of drivers and firm capabilities. R&D Manag. 2016;46(S3):1095–1112.
   Google Scholar
• Friedrichs A, Korger V, Adler S. Injection force of reusable insulin pens: novopen 4, Lilly Luxura, Berlipen, and ClikSTAR. J Diabetes Sci Technol. 2011 Sep 01;5(5):1185–1190. PubMed PMID: 22027315; PubMed Central PMCID: PMC3208878.
   PubMedGoogle Scholar
• Gotzche D, Rasmussen BO, Pedersen MT, et al. Injection force and dose accuracy of FlexTouch for the delivery of a new basal insulin. Expert Opin Drug Deliv. 2013 Dec;10(12):1613–1619. PubMed PMID: 24256325. DOI:10.1517/17425247.2013.863276
   PubMed Web of Science ®Google Scholar
• Rissler J, Jorgensen C, Rye Hansen M, et al. Evaluation of the injection force dynamics of a modified prefilled insulin pen. Expert Opin Pharmacother. 2008 Sep;9(13):2217–2222. PubMed PMID: 18710347. DOI:10.1517/14656566.9.13.2217
   PubMed Web of Science ®Google Scholar
• Schwarzenbach F, Dao Trong M, Grange L, et al. Results of a human factors experiment of the usability and patient acceptance of a new autoinjector in patients with rheumatoid arthritis. Patient Prefer Adher. 2014;8:199–209. PubMed PMID: 24627625; PubMed Central PMCID: PMC3931638. DOI:10.2147/PPA.S50583
   PubMed Web of Science ®Google Scholar