Patient-reported outcomes from a randomized, crossover trial comparing a pen injector with insulin degludec versus a pen injector with insulin glargine U100 in patients with type 2 diabetes

References

• Sorli C. New developments in insulin therapy for type 2 diabetes. Am J Med. 2014;127:S39–S48.
   PubMed Web of Science ®Google Scholar
• Aronson D. Hyperglycemia and the pathobiology of diabetic complications. Adv Cardiol. 2008;45:1–16.
   PubMedGoogle Scholar
• Chamberlain JJ, Rhinehart AS, Shaefer CF Jr, et al. Diagnosis and management of diabetes: synopsis of the 2016 American Diabetes Association Standards of Medical Care in Diabetes. Ann Intern Med. 2016;164:542–552.
   PubMed Web of Science ®Google Scholar
• Peyrot M, Rubin RR, Kruger DF, et al. Correlates of insulin injection omission. Diabetes Care. 2010;33:240–245.
   PubMed Web of Science ®Google Scholar
• Peyrot M, Barnett AH, Meneghini LF, et al. Factors associated with injection omission/non-adherence in the global attitudes of patients and physicians in insulin therapy study. Diabetes Obes Metab. 2012;14:1081–1087.
   PubMed Web of Science ®Google Scholar
• Korytkowski M, Bell D, Jacobsen C, et al. A multicenter, randomized, open-label, comparative, two-period crossover trial of preference, efficacy, and safety profiles of a prefilled, disposable pen and conventional vial/syringe for insulin injection in patients with type 1 or 2 diabetes mellitus. Clin Ther. 2003;25:2836–2848.
   PubMed Web of Science ®Google Scholar
• Buysman E, Conner C, Aagren M, et al. Adherence and persistence to a regimen of basal insulin in a pre-filled pen compared to vial/syringe in insulin-naïve patients with type 2 diabetes. Curr Med Res Opin. 2011;27:1709–1717.
   PubMed Web of Science ®Google Scholar
• Slabaugh SL, Bouchard JR, Li Y, et al. Characteristics relating to adherence and persistence to basal insulin regimens among elderly insulin-naive patients with type 2 diabetes: pre-filled pens versus vials/syringes. Adv Ther. 2015;32:1206–1221.
   PubMed Web of Science ®Google Scholar
• Pfützner 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;29:475–481.
   PubMed Web of Science ®Google Scholar
• Lteif AN, Schwenk WF. Accuracy of pen injectors versus insulin syringes in children with type 1 diabetes. Diabetes Care. 1999;22:137–140.
   PubMed Web of Science ®Google Scholar
• Chandran A, Bonafede MK, Nigam S, et al. Adherence to insulin pen therapy is associated with reduction in healthcare costs among patients with type 2 diabetes mellitus. Am Health Drug Benefits. 2015;8:148–158.
   PubMed Web of Science ®Google Scholar
• Pearson TL. Practical aspects of insulin pen devices. J Diabetes Sci Technol. 2010;4:522–531.
   PubMedGoogle Scholar
• Pfützner 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;11:1381–1389.
   PubMed Web of Science ®Google Scholar
• Bailey T, Campos C. FlexTouch for the delivery of insulin: technical attributes and perception among patients and healthcare professionals. Expert Rev Med Devices. 2012;9:209–217.
   PubMed Web of Science ®Google Scholar
• Bohnet J, Schmitz M, Kamlot S, et al. Dosing accuracy and insulin flow rate characteristics of a new disposable insulin pen, FlexTouch, compared with SoloStar. J Diabetes Sci Technol. 2013;7:1021–1026.
   PubMedGoogle Scholar
• Götzche 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;10:1613–1619.
   PubMed Web of Science ®Google Scholar
• Nadeau DA, Campos C, Niemeyer M, et al. Healthcare professional and patient assessment of a new prefilled insulin pen versus two widely available prefilled insulin pens for ease of use, teaching and learning. Curr Med Res Opin. 2012;28:3–13.
   PubMed Web of Science ®Google Scholar
• Warren ML, Chaykin LB, Jabbour S, et al. Insulin degludec 200 units/ml is associated with lower injection frequency and improved patient-reported outcomes compared with insulin glargine 100 units/ml in patients with type 2 diabetes requiring high-dose insulin. Clin Diabetes. 2017;35:90–95.
   PubMedGoogle Scholar
• International Conference on Harmonisation. ICH Harmonised Tripartate Guideline. Good clinical practice [Internet]. 1996 May 1 [2018 Jun 18]. Available from: https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R1_Guideline.pdf
   Google Scholar
• World Medical Association. Declaration of Helsinki: ethical principles for medical research involving human subjects. Last amended by the 59th WMA Assembly Seoul, October 2008 [Internet]. 2008 [2018 Jun 18]. Available from: https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/
   Google Scholar
• Brod M, Christensen T, Hammer M, et al. Examining the ability to detect change using the TRIM–Diabetes and TRIM–Diabetes Device measures. Qual Life Res. 2011;20:1513–1518.
   PubMed Web of Science ®Google Scholar
• Brod M, Hammer M, Christensen T, et al. Understanding and assessing the impact of treatment in diabetes: the treatment-related impact measures for diabetes and devices (TRIM–Diabetes and TRIM–Diabetes Device). Health Qual Life Outcomes. 2009;7:83.
   PubMed Web of Science ®Google Scholar
• Anderson BJ, Redondo MJ. What can we learn from patient-reported outcomes of insulin pen devices? J Diabetes Sci Technol. 2011;5:1563–1571.
   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;16:76–83.
   PubMed Web of Science ®Google Scholar
• Perfetti R. Reusable and disposable insulin pens for the treatment of diabetes: understanding the global differences in user preference and an evaluation of inpatient insulin pen use. Diabetes Technol Ther. 2010;12:S79–S85.
   PubMed Web of Science ®Google Scholar
• Asche CV, Shane-McWhorter L, Raparla S. Health economics and compliance of vials/syringes versus pen devices: a review of the evidence. Diabetes Technol Ther. 2010;12:S101–S108.
   PubMed Web of Science ®Google Scholar
• Seggelke SA, Hawkins RM, Gibbs J, et al. Effect of glargine insulin delivery method (pen device versus vial/syringe) on glycemic control and patient preferences in patients with type 1 and type 2 diabetes. Endocr Pract. 2014;20:536–539.
   PubMed Web of Science ®Google Scholar
• Novo Nordisk A/S. Tresiba 100 units/mL, 200 units/mL Pre filled (FlexTouch), 100 units/mL Cartridge (Penfill) Summary of Product Characteristics [Internet]. 2017 [2018 Jun 18]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002498/WC500138940.pdf
   Google Scholar
• Sanofi-Aventis Deuchland GmBH. Lantus Summary of Product Characteristics [Internet]. 2017 [2018 Jun 18]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000284/WC500036082.pdf
   Google Scholar
• Asakura T, Jensen KH. Comparison of intuitiveness, ease of use, and preference in two insulin pens. J Diabetes Sci Technol. 2009;3:312–319.
   PubMedGoogle Scholar
• Garg S, Bailey T, DeLuzio T, et al. Preference for a new prefilled insulin pen compared with the original pen. Curr Med Res Opin. 2011;27:2323–2333.
   PubMed Web of Science ®Google Scholar
• Lajara R, Guerrero G, Thurman J. Healthcare professional and patient perceptions of a new prefilled insulin pen versus vial and syringe. Expert Opin Drug Deliv. 2012;9:1181–1196.
   PubMed Web of Science ®Google Scholar
• Lee WC, Balu S, Cobden D, et al. Medication adherence and the associated health-economic impact among patients with type 2 diabetes mellitus converting to insulin pen therapy: an analysis of third-party managed care claims data. Clin Ther. 2006;28:1712–1725.
   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;11:657–661.
   PubMed Web of Science ®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;27:2043–2052.
   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;8:1259–1269.
   PubMed Web of Science ®Google Scholar