Insulin Infusion Set Use: European Perspectives and Recommendations

Dorothee Deiss, Peter Adolfsson, Marije Alkemade-van Zomeren, Geremia B Bolli, Guillaume Charpentier, Claudio Cobelli, Thomas Danne, Angela Girelli, Heiko Mueller, Carol A Verderese, Eric Renard, Dorothee Deiss, Peter Adolfsson, Marije Alkemade-van Zomeren, Geremia B Bolli, Guillaume Charpentier, Claudio Cobelli, Thomas Danne, Angela Girelli, Heiko Mueller, Carol A Verderese, Eric Renard

Abstract

Insulin pump users worldwide depend on insulin infusion sets (IISs) for predictable delivery of insulin to the subcutaneous tissue. Yet emerging data indicates that IISs are associated with many pump-related adverse events and may contribute to potentially life-threatening problem of unexplained hyperglycemia. The relative scarcity of published research on IISs to date, the heterogeneity of regional IIS practices, and the increasing demand for international standards guiding their use prompted convening of a panel of diabetologists and diabetes nurse educators last February, in Milan, Italy, to discuss a framework for optimizing IIS practice in Europe. The multinational panel was tasked, first, with identifying the often-overlooked IIS issues that can affect patients' experience of pump therapy-e.g., partial or complete blockage of the cannula, skin pathologies, unpredictable variations in insulin absorption, dislodgment, and the demands of site rotation and set changes-and, second, with establishing direction for developing cohesive protocols to assure long-term success. As reported in this article, the panel examined IIS-related complications of pump therapy encountered in clinical practice, considered country-wide policies to prevent and mitigate such complications, and updated priorities for improving IIS education on issues of device selection, skin care, and troubleshooting unexplained hyperglycemia. These recommendations may be more relevant with the possibility of closed-loop systems available in the near future.

Keywords: Insulin infusion sets; artificial pancreas; insulin pumps; lipohypertrophy; unexplained hyperglycemia.

Conflict of interest statement

Author Disclosures D.D. has received research support from BD, DexCom, Medtronic, and Roche. P.A. has received lecture honoraria from Novo Nordisk, Eli Lilly, Sanofi, Roche, Medtronic, Dexcom, Menarini, and Abbott, and participated in Advisory Boards for Eli Lilly, Abbott, Roche and Sanofi. P.A. is one of the founders and board member of Diasend Inc. M.A.Z. has no disclosures to report. G.B.B. has received honoraria for consultation and advice from Sanofi, Eli Lilly, Menarini. G.C. has no disclosures to report. C.C. has patent applications related to glucose sensors and the artificial pancreas; he has received non-financial support from Roche and Dexcom, and received research support, managed by University of Padova, from Dexcom, Sanofi, Adocia; he is a consultant/advisor for Novo Nordisk. T.D. has received research support or served as a consultant for Abbott, AstraZeneca, Bayer, BD, Boehringer, DexCom, Eli Lilly, Medtronic, Novo Nordisk, Roche, Sanofi, and Ypsomed. A.G. has no disclosures to report. H.M. is a consultant for Medtronic (German-Switzerland-Austria), Eli Lilly (Germany), Sanofi (Germany), Bayer Healthcare, and all regional German pharmacists associations. E.R. is a consultant/advisor for Menarini Diagnostics, Abbott, BD, Cellnovo, Dexcom, Eli Lilly, Johnson & Johnson (Animas, LifeScan), Medtronic, Novo Nordisk, Roche Diagnostics and Sanofi, and has received research grant/material support from Abbott, Dexcom, Insulet and Roche Diagnostics. C.A.V. has no disclosures to report.

References

    1. Heinemann L, Krinelke L: Insulin infusion set: the Achilles heel of continuous subcutaneous insulin infusion. J Diabetes Sci Technol 2012;6:954–964
    1. Heinemann L, Fleming GA, Petrie JR, Holl RW, Bergenstal RM, Peters AL: Insulin pump risks and benefits: a clinical appraisal of pump safety standards, adverse event reporting, and research needs: a joint statement of the European Association for the Study of Diabetes and the American Diabetes Association Diabetes Technology Working Group. Diabetes Care 2015;38:716–722
    1. Pickup JC, Yemane N, Brackenridge A, Pender S: Nonmetabolic complications of continuous subcutaneous insulin infusion: a patient survey. Diabetes Technol Ther 2014;16:145–149
    1. Patel PJ, Benasi K, Ferrari G, et al. : Randomized trial of infusion set function: steel versus teflon. Diabetes Technol Ther 2014;16:15–19
    1. Evert AB, Bode BW, Buckingham BA, et al. : Improving patient experience with insulin infusion sets: practical guidelines and future directions. Diabetes Educ 2016;42:470–484
    1. Boulton AJ, Del Prato S: Regulation of medical devices used in diabetology in Europe: time for reform? Diabetologia 2012;55:2295–2297
    1. JDRF: Request for expressions of interest: improved longevity for sub-cutaneous insulin infusion. RFA 20150806. Accessed March15, 2016
    1. Renard E: Insulin pump use in Europe. Diabetes Technol Ther 2010;12 (Suppl 1):S29–S32
    1. American Association of Diabetes Educators: Insulin pump therapy: best practices. Accessed March15, 2016
    1. Frid A, Kreugel G, Grassi G, et al. : New insulin delivery recommendations. Mayo Clin Proc 2016; in press
    1. Gibney M, Xue Z, Swinney M, Bialonczyk D, Hirsch L: Reduced silent occlusions with a novel catheter infusion set (BD FlowSmart): Results from two open-label comparative studies. Diabetes Technol Ther 2016;18:136–143
    1. Liebner T, Holl R, Heidtmann B, et al. : Insulinpumpenkatheter: komplikationen im Kindes- und Jugendalter. Diabetologie und Stoffwechsel 2011;6:S52
    1. Ross PL, Milburn J, Reith DM, Wiltshire E, Wheeler BJ: Clinical review: insulin pump-associated adverse events in adults and children. Acta Diabetol 2015;52:1017–1024
    1. Van Bon AC, Bode BW, Sert-Langeron C, DeVries JH, Charpentier G: Insulin glulisine compared to insulin aspart and to insulin lispro administered by continuous subcutaneous insulin infusion in patients with type 1 diabetes: a randomized controlled trial. Diabetes Technol Ther 2011;13:607–614
    1. Van Bon AC, Dragt D, DeVries JH: Significant time until catheter occlusion alerts in currently marketed insulin pumps at two basal rates. Diabetes Technol Ther 2012;14;447–448
    1. Keith S, McVey E, Pettis R: High sensitivity occlusion detection using fluid pressure monitoring during basal infusion. Presented ADA 2013, Chicago. Diabetes 2013;62(Suppl 1):A249–250
    1. Gibney M, Hirsch L, Swinney M, Xue Z: Continuous subcutaneous insulin infusion (CSII) sets – Reduced flow interruptions with a novel investigational catheter infusion set. Presented ATTD 2015. Diabetes Technol Ther 2015;17(Suppl 1):A-8
    1. Bolick N, Morel DR, Gerth SS, Woodley WD, Pettis RJ: Reduction of silent occlusion occurrence during continuous subcutaneous insulin infusion. Presented ATTD 2015. Diabetes Technol Ther 2015;17(Suppl 1):A-37
    1. Bolick NG, Sutter D, Pflug B, Hirsch L, Bode B, Pettis RJ: Performance qualification of a novel subcutaneous insulin infusion set using medical imaging. Presented American Diabetes Association 75th Scientific Sessions. Boston, USA. 2015. Diabetes 2015;64(Suppl 1):A-279
    1. Bolick NG, Morel DR, Alarcon J, et al. : In vivo flow evaluation and correlation to insulin pharmacokinetics of continuous subcutaneous insulin infusion sets. Presented American Diabetes Association 75th Scientific Sessions. Boston, USA. 2015. Diabetes 2015;64(Suppl 1):A274–A275
    1. Renard E, Guerci B, Leguerrier AM, Boizel R; Accu-Chek FlexLink Study Group: Lower rate of initial failures and reduced occurrence of adverse events with a new catheter model for continuous subcutaneous insulin infusion: prospective, two-period, observational, multicenter study. Diabetes Technol Ther 2010;12:769–773
    1. Walsh J, Roberts R, Weber D, Faber-Heinemann G, Heinemann L: Insulin pump and CGM usage in the United States and Germany: results of a real-world survey with 985 subjects. J Diabetes Sci Technol 2015;9:1103–1110
    1. Heinemann L: Insulin infusion sets: a critical reappraisal. Diabetes Technol Ther 2016;18:327–333
    1. Johansson UB, Adamson U, Lins PE, Wredling R: Patient management of long-term continuous subcutaneous insulin infusion. J Adv Nurs 2005;51:112–118
    1. Zisser H: Quantifying the impact of a short-interval interruption of insulin-pump infusion sets on glycemic excursions. Diabetes Care 2008;31:238–239
    1. Ponder SW, Skyler JS, Kruger DF, Matheson D, Brown BW: Unexplained hyperglycemia in continuous subcutaneous insulin infusion: evaluation and treatment. Diabetes Educ 2008;34:327–333
    1. Famulla S, Hövelmann U, Fischer A, et al. : Insulin injection into lipohypertrophic tissue: blunted and more variable insulin absorption and action, and impaired postprandial glucose control. Diabetes Care 2016. jun; dc160610.
    1. Walsh J, Roberts R, Bailey T: Guidelines for optimal bolus calculator settings in adults. J Diabetes Sci Technol 2011;5:129–135
    1. Wolfsdorf JI, Allgrove J, Craig ME, et al. : ISPAD Clinical Practice Consensus Guidelines 2014. Diabetic ketoacidosis and hyperglycemic hyperosmolar state. Pediatr Diabetes 2014;15 Suppl 20:154–179
    1. Lange K, Swift P, Pańkowska E, Danne T: Diabetes education in children and adolescents. Pediatr Diabetes 2014;15:77–85. doi:10.1111/pedi.12187.

Source: PubMed

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