FlexPen^® for the delivery of insulin: accuracy, injection force and patient preference

References

• Intercontinental Marketing Services (IMS) Health. Estimated Number of Patients using FlexPen®, Based on Worldwide Sales in Number of Packs Sold, IMS World Wide Data Q4’07 and Daily Defined Dosage (DDD) for Insulin as Issued by WHO. Market Research Report. IMS, CT, USA (2007).
   Google Scholar
• Bohannon NJ. Insulin delivery using pen devices. Simple-to-use tools may help young and old alike. Postgrad. Med.106(5), 57–58, 61–64, 68 (1999).
   PubMed Web of Science ®Google Scholar
• Mollema ED, Snoek FJ, Ader HJ, Heine RJ, van der Ploeg HM. Insulin-treated diabetes patients with fear of self-injecting or fear of self-testing: psychological comorbidity and general well-being. J. Psychosom. Res.51(5), 665–672 (2001).
   PubMed Web of Science ®Google Scholar
• Mollema ED, Snoek FJ, Heine RJ, van der Ploeg HM. Phobia of self-injecting and self-testing in insulin-treated diabetes patients: opportunities for screening. Diabet. Med.18(8), 671–674 (2001).
   PubMed Web of Science ®Google Scholar
• Zambanini A, Newson RB, Maisey M, Feher MD. Injection related anxiety in insulin-treated diabetes. Diabetes Res. Clin. Pract.46(3), 239–246 (1999).
   PubMed Web of Science ®Google Scholar
• Hunt LM, Valenzuela MA, Pugh JA. NIDDM patients’ fears and hopes about insulin therapy. The basis of patient reluctance. Diabetes Care20(3), 292–298 (1997).
   PubMed Web of Science ®Google Scholar
• Hamilton JG. Needle phobia: a neglected diagnosis. J. Fam. Pract.41(2), 169–175 (1995).
   PubMed Web of Science ®Google Scholar
• Glasgow RE, Fisher EB, Anderson BJ et al.Behavioral science in diabetes. Contributions and opportunities. Diabetes Care22(5), 832–843 (1999).
   PubMed Web of Science ®Google Scholar
• Peyrot M, Rubin RR, Lauritzen T et al.Resistance to insulin therapy among patients and providers: results of the cross-national Diabetes Attitudes, Wishes, and Needs (DAWN) study. Diabetes Care28(11), 2673–2679 (2005).
   PubMed Web of Science ®Google Scholar
• Claxton AJ, Cramer J, Pierce C. A systematic review of the associations between dose regimens and medication compliance. Clin. Ther.23(8), 1296–1310 (2001).
   PubMed Web of Science ®Google Scholar
• Lee WC, Balu S, Cobden D, Joshi AV, Pashos CL. 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.28(10), 1712–1725 (2006).
   PubMed Web of Science ®Google Scholar
• Albano S; The ORBITER Study Group. Assessment of quality of treatment in insulin-treated patients with diabetes using a pre-filled insulin pen. Acta Biomed.75(1), 34–39 (2004).
   PubMedGoogle Scholar
• Lombardo F, Salzano G, Messina MF, De Luca F. Compliance and administration methods in management of Type 1 diabetes. Acta Biomed.76(Suppl. 3), 66–69 (2005).
   PubMedGoogle Scholar
• Summers KH, Szeinbach SL, Lenox SM. Preference for insulin delivery systems among current insulin users and nonusers. Clin. Ther.26(9), 1498–1505 (2004).
   PubMed Web of Science ®Google Scholar
• Thurman JE. Insulin pen injection devices for management of patients with Type 2 diabetes: considerations based on an endocrinologist’s practical experience in the United States. Endocr. Pract.13(6), 672–678 (2007).
   PubMedGoogle Scholar
• Rubin RR, Peyrot M. Quality of life, treatment satisfaction, and treatment preference associated with use of a pen device delivering a premixed 70/30 insulin aspart suspension (aspart protamine suspension/soluble aspart) versus alternative treatment strategies. Diabetes Care27(10), 2495–2497 (2004).
   PubMed Web of Science ®Google Scholar
• Stockl K, Ory C, Vanderplas A et al.An evaluation of patient preference for an alternative insulin delivery system compared to standard vial and syringe. Curr. Med. Res. Opin.23(1), 133–146 (2007).
   PubMed Web of Science ®Google Scholar
• Gnanalingham MG, Newland P, Smith CP. Accuracy and reproducibility of low dose insulin administration using pen-injectors and syringes. Arch. Dis. Child.79(1), 59–62 (1998).
   PubMed Web of Science ®Google Scholar
• Keith K, Nicholson D, Rogers D. Accuracy and precision of low-dose insulin administration using syringes, pen injectors, and a pump. Clin. Pediatr.(Phil.), 43(1), 69–74 (2004).
   PubMed Web of Science ®Google Scholar
• Lteif AN, Schwenk WF. Accuracy of pen injectors versus insulin syringes in children with Type 1 diabetes. Diabetes Care22(1), 137–140 (1999).
   PubMed Web of Science ®Google Scholar
• Graff MR, McClanahan MA. Assessment by patients with diabetes mellitus of two insulin pen delivery systems versus a vial and syringe. Clin. Ther.20(3), 486–496 (1998).
   PubMed Web of Science ®Google Scholar
• The Writing Team for the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Research Group. Effect of intensive therapy on the microvascular complications of Type 1 diabetes mellitus. JAMA287(19), 2563–2569 (2002).
   PubMed Web of Science ®Google Scholar
• Asakura T, Seino H. Insulin dosing accuracy with FlexPen® versus syringe by healthcare professionals and healthy volunteers. Diabetes54 (Suppl. 1), A498–A499 (2005).
   Google Scholar
• Asakura T, Seino H, Kageyama M, Yohkoh N. Dosing accuracy of two insulin pre-filled pens. Curr. Med. Res. Opin.24(5), 1429–1434 (2008).
   PubMed Web of Science ®Google Scholar
• Hänel H, Weise A, Sun W et al.Differences in the dose accuracy of insulin pens. J. Diabetes Sci. Tech.2(3), 478–481 (2008).
   PubMedGoogle Scholar
• Asakura T. Comparison of the dosing accuracy of two insulin injection devices. J. Clin. Res.8, 33–40 (2005).
   Google Scholar
• Nayak B, Clement S. Insulin pen delivery systems: comparison of dosage accuracy of OptiClik and FlexPen insulin pens. Diabetes56(Suppl. 1), 2106-PO (2007).
   Google Scholar
• Penfornis A, Horvat K. Dose accuracy comparison between SoloStar and FlexPen at three different dose levels. Diabetes Technol. Ther.10(5), 359–362 (2008).
   PubMed Web of Science ®Google Scholar
• Hermanns N, Kulzer B, Haak T. Dosing accuracy with a novel pen device (SoloStar) as performed by patients with diabetes in a clinical setting. Diabetes Technol. Ther.10(4), 322–327 (2008).
   PubMed Web of Science ®Google Scholar
• Pfützner A, Reimer T, Frokjaer LPF, Jorgensen C. Prefilled insulin device with reduced injection force: patient perception and accuracy. Curr. Med. Res. Opin.24(9), 2545–2549 (2008).
   PubMed Web of Science ®Google Scholar
• Weise A, Pfutzner JW, Borig J et al.Comparison of the dose accuracy of prefilled insulin pens. J. Diabetes Sci. Tech.3(1), 149–153 (2009).
   PubMedGoogle Scholar
• Korytkowski M, Bell D, Jacobsen C, Suwannasari R. 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.25(11), 2836–2848 (2003).
   PubMed Web of Science ®Google Scholar
• Dreyer M. Comparison of metabolic control, safety, handling and patient acceptance of FlexPen with NovoLet in Type 1 and Type 2 diabetes patients. J. Clin. Res.8, 1–7 (2005).
   Web of Science ®Google Scholar
• Asakura T, Seino H. A comparison of the usability of two types of disposable pen (FlexPen versus Humalog Kit) containing rapid-acting insulin analogues. Diabetes Metab.29, S236 (2003).
   Google Scholar
• Niskanen L, Jensen LE, Rastam J et al.Randomized, multinational, open-label, 2-period, crossover comparison of biphasic insulin aspart 30 and biphasic insulin lispro 25 and pen devices in adult patients with type 2 diabetes mellitus. Clin. Ther.26(4), 531–540 (2004).
   PubMed Web of Science ®Google Scholar
• Lawton SA, Berg B. Comparative evaluation of FlexPen, a new prefilled insulin delivery system, among patients and healthcare professionals. Diabetes50(Suppl. 2), A440 (2001).
   Web of Science ®Google Scholar
• Reimer T, Hohberg C, Jorgensen C, Jensen KH, Pfutzner A. Instruction time, intuitiveness and patient acceptance of a prefilled and reusable insulin injection device – the NovoMix® 30 FlexPen® and the HumanPen® Luxura. Diabetes56(Suppl. 1), 2101-PO (2007).
   Google Scholar
• Asakura T, Seino H. Assessment of dose selection attributes with audible notification in insulin pen devices. Diabetes Technol. Ther.7(4), 620–626 (2005).
   PubMedGoogle Scholar
• Haak T, Edelman S, Walter C, Lecointre B, Spollett G. 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.29(4), 650–660 (2007).
   PubMed Web of Science ®Google Scholar
• Muto T, Asakura T, Toraishi K, Nakano R. Comparison of new portable prefilled insulin pen with conventional insulin pens. Jpn. J. Pharm. Health Care Sci.32(10), 1065–1070 (2006).
   Google Scholar
• Sommavilla B, Jorgensen C, Jensen KH. Safety, simplicity and convenience of a modified prefilled insulin pen. Expert Opin. Pharmacother.9(13), 2223–2232 (2008).
   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.4(2), 165–174 (2007).
   PubMed Web of Science ®Google Scholar
• Starkman HS, Gleason RE, Rand LI, Miller DE, Soeldner JS. Limited joint mobility (LJM) of the hand in patients with diabetes mellitus: relation to chronic complications. Ann. Rheum. Dis.45(2), 130–135 (1986).
   PubMed Web of Science ®Google Scholar
• Savas S, Koroglu BK, Koyuncuoglu HR et al.The effects of the diabetes related soft tissue hand lesions and the reduced hand strength on functional disability of hand in Type 2 diabetic patients. Diabetes Res. Clin. Pract.77(1), 77–83 (2007).
   PubMed Web of Science ®Google Scholar
• Schady W, Abuaisha B, Boulton AJ. Observations on severe ulnar neuropathy in diabetes. J. Diabetes Complications12(3), 128–132 (1998).
   PubMed Web of Science ®Google Scholar
• Ziegler D, Gries FA, Spuler M, Lessmann F. The epidemiology of diabetic neuropathy. DiaCAN Multicenter Study Group. Diabet. Med.10(Suppl. 2), S82–S86 (1993).
   PubMed Web of Science ®Google Scholar
• Frey MI, Barrett-Connor E, Sledge PA, Schneider DL, Weisman MH. The effect of noninsulin dependent diabetes mellitus on the prevalence of clinical osteoarthritis. A population based study. J. Rheumatol.23(4), 716–722 (1996).
   PubMed Web of Science ®Google Scholar
• Rissler J, Jorgensen C, Rye Hansen M, Hansen N-A. Evaluation of injection force dynamics of a modified prefilled insulin pen. Expert Opin. Pharmacother.9(13), 2217–2222 (2008).
   PubMed Web of Science ®Google Scholar
• Asakura T. Rotary torque of the dose setting dial on insulin injecting systems and usability for patients with diabetes. American Diabetes Association.Diabetes 2033-PO 57(Suppl. 1) (2008).
   Google Scholar
• Cramer JA, Pugh MJ. The influence of insulin use on glycemic control: how well do adults follow prescriptions for insulin? Diabetes Care28(1), 78–83 (2005).
   PubMed Web of Science ®Google Scholar
• Morris AD, Boyle DI, McMahon AD et al.Adherence to insulin treatment, glycaemic control, and ketoacidosis in insulin-dependent diabetes mellitus. The DARTS/MEMO Collaboration. Diabetes Audit and Research in Tayside Scotland. Medicines Monitoring Unit. Lancet350(9090), 1505–1510 (1997).
   PubMed Web of Science ®Google Scholar
• Donnelly LA, Morris AD, Evans JM. Adherence to insulin and its association with glycaemic control in patients with Type 2 diabetes. QJM100(6), 345–350 (2007).
   PubMed Web of Science ®Google Scholar
• Pladevall M, Williams LK, Potts LA et al.Clinical outcomes and adherence to medications measured by claims data in patients with diabetes. Diabetes Care27(12), 2800–2805 (2004).
   PubMed Web of Science ®Google Scholar
• Krapek K, King K, Warren SS et al.Medication adherence and associated hemoglobin A1c in Type 2 diabetes. Ann. Pharmacother.38(9), 1357–1362 (2004).
   PubMed Web of Science ®Google Scholar
• Hepke KL, Martus MT, Share DA. Costs and utilization associated with pharmaceutical adherence in a diabetic population. Am. J. Manag. Care10(2 Pt 2), 144–151 (2004).
   PubMed Web of Science ®Google Scholar
• Pawaskar MD, Camacho FT, Anderson RT et al.Health care costs and medication adherence associated with initiation of insulin pen therapy in medicaid-enrolled patients with Type 2 diabetes: a retrospective database analysis. Clin. Ther.29(6 Pt 1), 1294–1305 (2007).
   Web of Science ®Google Scholar
• Kadiri A, Chraibi A, Marouan F et al.Comparison of NovoPen 3 and syringes/vials in the acceptance of insulin therapy in NIDDM patients with secondary failure to oral hypoglycaemic agents. Diabetes Res. Clin. Pract.41(1), 15–23 (1998).
   PubMed Web of Science ®Google Scholar
• Egekvist H, Bjerring P, Arendt-Nielsen L. Pain and mechanical injury of human skin following needle insertions. Eur. J. Pain3(1), 41–49 (1999).
   PubMed Web of Science ®Google Scholar