A novel pen-based Bluetooth-enabled insulin delivery system with insulin dose tracking and advice

References

• Centers for Disease Control and Prevention. National Diabetes Statistics Report: estimates of diabetes and its burden in the United States, 2014. Atlanta, GA: US Department of Health and Human Services; 2014.
   Google Scholar
• American Association of Clinical Endocrinologists and the American College of Endocrinology. Consensus statement by the American Association of Clinical Endocrinologists/American College of Endocrinology Insulin Pump Management Task Force. Endocr Pract. 2014;20:466.
   Web of Science ®Google Scholar
• The Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993;329:977–986.
   PubMed Web of Science ®Google Scholar
• Nathan DM, Cleary PA, Backlund JY, et al., Diabetes C, Complications Trial/Epidemiology of Diabetes I, Complications Study Research G. Intensive diabetes treatment and cardiovascular disease in patients with type 1 diabetes. N Engl J Med. 2005;353:2643–2653.
   PubMed Web of Science ®Google Scholar
• Ahola AJ, Makimattila S, Saraheimo M, et al. Many patients with type 1 diabetes estimate their prandial insulin need inappropriately. J Diabetes. 2010;2:194–202.
   PubMed Web of Science ®Google Scholar
• Polonsky WH, Fisher L, Guzman S, et al. Psychological insulin resistance in patients with type 2 diabetes: the scope of the problem. Diabetes Care. 2005;28:2543–2545.
   PubMed Web of Science ®Google Scholar
• Bloomgarden Z. Fear of hypoglycemia. J Diabetes. 2016;9:108–110.
   PubMed Web of Science ®Google Scholar
• Marden S, Thomas PW, Sheppard ZA, et al. Poor numeracy skills are associated with glycaemic control in type 1 diabetes. Diabet Med. 2012;29:662–669.
   PubMed Web of Science ®Google Scholar
• Zaugg SD, Dogbey G, Collins K, et al. Diabetes numeracy and blood glucose control: association with type of diabetes and source of care. Clin Diabetes. 2014;32:152–157.
   PubMedGoogle Scholar
• Cavanaugh K, Huizinga MM, Wallston KA, et al. Association of numeracy and diabetes control. Ann Intern Med. 2008;148:737–746.
   PubMed Web of Science ®Google Scholar
• Schmidt S, Norgaard K. Bolus calculators. J Diabetes Sci Technol. 2014;8:1035–1041.
   PubMedGoogle Scholar
• Heise T, Meneghini LF. Insulin stacking versus therapeutic accumulation: understanding the differences. Endocr Pract. 2014;20:75–83.
   PubMed Web of Science ®Google Scholar
• Walsh J, Roberts R, Heinemann L. Confusion regarding duration of insulin action: a potential source for major insulin dose errors by bolus calculators. J Diabetes Sci Technol. 2014;8:170–178.
   PubMedGoogle Scholar
• Blackwell M, Wheeler BJ. Clinical review: the misreporting of logbook, download, and verbal self-measured blood glucose in adults and children with type I diabetes. Acta Diabetol. 2016;54:1–8.
   PubMed Web of Science ®Google Scholar
• Mazze RS, Shamoon H, Pasmantier R, et al. Reliability of blood glucose monitoring by patients with diabetes mellitus. Am J Med. 1984;77:211–217.
   PubMed Web of Science ®Google Scholar
• Bailey TS. Diabetes data management in the clinic. J Diabetes Sci Technol. 2007;1:888–891.
   PubMedGoogle Scholar
• Marcus A. Diabetes care – insulin delivery in a changing world. Medscape J Med. 2008;10:120.
   PubMedGoogle Scholar
• Reinke T. Though costly, insulin pens facilitate better adherence. Manag Care. 2013;22:20–21.
   PubMedGoogle Scholar
• Ramadan WH, Khreis NA, Kabbara WK. Simplicity, safety, and acceptability of insulin pen use versus the conventional vial/syringe device in patients with type 1 and type 2 diabetes mellitus in Lebanon. Patient Prefer Adherence. 2015;9:517–528.
   PubMed Web of Science ®Google Scholar
• Luijf YM, DeVries JH. Dosing accuracy of insulin pens versus conventional syringes and vials. Diabetes Technol Ther. 2010;12(Suppl 1):S73–7.
   PubMed Web of Science ®Google Scholar
• Asakura TSH, Nakano R, Muto T, et al. 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
• 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
• Grabner M, Chu J, Raparla S, et al. Clinical and economic outcomes among patients with diabetes mellitus initiating insulin glargine pen versus vial. Postgrad Med. 2013;125:204–213.
   PubMed Web of Science ®Google Scholar
• Lasalvia P, Barahona-Correa JE, Romero-Alvernia DM, et al. Pen devices for insulin self-administration compared with needle and vial: systematic review of the literature and meta-analysis. J Diabetes Sci Technol. 2016;10:959–966.
   PubMedGoogle Scholar
• Barnard K, Parkin CG, Buskirk A, et al. Use of automated bolus advisors may improve adherence to multiple daily insulin injection therapy. J Diabetes Sci Technol. 2012;6:1233–1234.
   PubMedGoogle Scholar
• Ziegler R, Cavan DA, Cranston I, et al. Use of an insulin bolus advisor improves glycemic control in multiple daily insulin injection (MDI) therapy patients with suboptimal glycemic control: first results from the ABACUS trial. Diabetes Care. 2013;36:3613–3619.
   PubMed Web of Science ®Google Scholar
• Barnard KD, Parkin CG, Young A, et al. Use of an automated bolus calculator reduces fear of hypoglycemia and improves confidence in dosage accuracy in patients with type 1 diabetes mellitus treated with multiple daily insulin injections. J Diab Sci Tech. 2012;6:144–149.
   PubMedGoogle Scholar
• Schmidt S, Meldgaard M, Serifovski N, et al. Use of an automated bolus calculator in MDI-treated type 1 diabetes: the boluscal study, a randomized controlled pilot study. Diabetes Care. 2012;35:984–990.
   PubMed Web of Science ®Google Scholar
• Hommel E, Schmidt S, Vistisen D, et al. Effects of advanced carbohydrate counting guided by an automated bolus calculator in type 1 diabetes mellitus (StenoABC): a 12-month, randomized clinical trial. Diabet Med. 2016.
   Web of Science ®Google Scholar
• Garg SK, Bookout TR, McFann KK, et al. Improved glycemic control in intensively treated adult subjects with type 1 diabetes using insulin guidance software. Diabetes Technol Ther. 2008;10:369–375.
   PubMed Web of Science ®Google Scholar
• Hirsch IB, Parkin CG. Unknown safety and efficacy of smartphone bolus calculator apps puts patients at risk for severe adverse outcomes. J Diabetes Sci Technol. 2016;10:977–980.
   PubMedGoogle Scholar
• Walsh JFG, Roberts R, Heinemann L. Bolus calculator safety mandates a need for standards. J Diabetes Sci Technol. 2017;1:3–6.
   Google Scholar
• Huckvale K, Adomaviciute S, Prieto JT, et al. Smartphone apps for calculating insulin dose: a systematic assessment. BMC Med. 2015;13:106.
   PubMed Web of Science ®Google Scholar
• Rex J, Jensen KH, Lawton SA. A review of 20 years’ experience with the Novopen® family of insulin injection devices. Clin Drug Investig. 2006;26:367–401.
   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;13:1837–1846.
   PubMed Web of Science ®Google Scholar
• Cavan DA, Ziegler R, Cranston I, et al. Automated bolus advisor control and usability study (ABACUS): does use of an insulin bolus advisor improve glycaemic control in patients failing multiple daily insulin injection (MDI) therapy? [NCT01460446]. BMC Fam Pract. 2012;13:102.
   PubMed Web of Science ®Google Scholar
• Cavan DAZR, Cranston I, Barnard K, et al. Use of an insulin bolus advisor facilitates earlier and more frequent changes in insulin therapy parameters in suboptimally controlled patients with diabetes treated with multiple daily insulin injection therapy: results of the ABACUS trial. Diabetes Technol Ther. 2014;16:310–316.
   PubMed Web of Science ®Google Scholar
• Parkin CG, Barnard K, Hinnen DA. Safe and efficacious use of automated bolus advisors in individuals treated with multiple daily insulin injection (MDI) therapy: lessons learned from the automated bolus advisor control and usability study (ABACUS). J Diabetes Sci Technol. 2015;9:1138–1142.
   PubMedGoogle Scholar
• FDA Indications for Use Approval Form, [cited 2017 Mar 23] Available from: https://www.accessdata.fda.gov/cdrh_docs/pdf16/K160629.pdf
   Google Scholar
• Foos V, Varol N, Curtis BH, et al. Economic impact of severe and non-severe hypoglycemia in patients with type 1 and type 2 diabetes in the United States. J Med Econ. 2015;18:420–432.
   PubMed Web of Science ®Google Scholar
• Wirtz VKR, Cao C, Mehrtash H, et al. Insulin market profile. Amsterdam, The Netherlands: Health Action International; 2016.
   Google Scholar
• Riddle MC. The treat-to-target trial and related studies. Endocr Pract. 2006;12(Suppl 1):71–79.
   PubMedGoogle Scholar
• Rodbard, D., Berger, M., and Pernick, N.  Computer, networking, and information systems to facilitate delivery of health care to patients with diabetes. In: Baba, S., and Kaneko, T. (Eds.), Diabetes 1994, Proceedings of the 15th International Diabetes Federation Congress, Kobe, 6 - 11 November 1994. Elsevier, Amsterdam. 1995; 800–803.
   Google Scholar