A Prospective Study of Insulin Infusion Set Use for up to 7 Days: Early Replacement Reasons and Impact on Glycemic Control
Publication: Diabetes Technology & Therapeutics
Volume 22, Issue Number 10
Abstract
Background: There is limited evidence supporting a replacement interval of infusion sets for continuous subcutaneous insulin infusion (CSII). The aim of this study was to investigate if steel and soft cannula infusion sets can be used in CSII therapy for up to 7 days without negative impact on infusion sites or glycemic control.
Methods: The insulin infusion sets YpsoPump® Orbit®micro (steel needle) and YpsoPump® Orbit®soft (soft cannula) were each used for up to 7 days by 40 adult subjects with CSII. Each subject used both infusion set types twice. Early replacement reasons were documented and glycemic control was monitored.
Results: Of 160 inserted insulin infusion sets, 66% were used for 7 days with no obvious difference between steel and soft infusion sets. The mean wearing time was 6.2 ± 1.5 days. Main reasons for early infusion set replacements were occlusions (19%), plaster issues (4%), and accidental pull-out (4%). Comparing glycemic control during day 1–3 and 1–7, mean glucose was 146 ± 21 mg/dL versus 148 ± 18 mg/dL, coefficient of variation was 34% ± 7% versus 33% ± 5%, and insulin dose was 40 ± 11 U versus 41 ± 11 U. Only mild and nonserious infusion site reactions occurred.
Conclusions: In this study, 7 days indwelling time of insulin infusion sets did not show a clinically relevant impact on glycemic control or insulin requirements and the infectious risk appeared to be low. The replacement interval of infusion sets may be individualized beyond the currently labeled maximum use duration.
Get full access to this article
View all available purchase options and get full access to this article.
References
1. Bruttomesso D, Costa S, Baritussio A: Continuous subcutaneous insulin infusion (CSII) 30 years later: still the best option for insulin therapy. Diabetes Metab Res Rev 2009;25:99–111.
2. Pickup JC: Is insulin pump therapy effective in Type 1 diabetes? Diabet Med 2019;36:269–278.
3. 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.
4. Heinemann L: Insulin infusion sets: a critical reappraisal. Diabetes Technol Ther 2016;18:327–333.
5. Centers for Disease Control and Prevention: Toxic-shock syndrome in a patient using a continuous subcutaneous insulin infusion pump—Idaho. MMWR Morb Mortal Wkly Rep 1983;32:404–406, 412.
6. Pietri A, Raskin P: Cutaneous complications of chronic continuous subcutaneous insulin infusion therapy. Diabetes Care 1981;4:624–626.
7. Ardilouze JL, Menard J, Gobeil F, Jr., et al.: CSII: longer catheter usage time, a reasonable goal. J Diabetes Sci Technol 2016;10:989–990.
8. Freckmann G, Kamecke U, Waldenmaier D, et al.: Occlusion detection time in insulin pumps at two different basal rates. J Diabetes Sci Technol 2018;12:608–613.
9. Thethi TK, Rao A, Kawji H, et al.: Consequences of delayed pump infusion line change in patients with type 1 diabetes mellitus treated with continuous subcutaneous insulin infusion. J Diabetes Complications 2010;24:73–78.
10. Schmid V, Hohberg C, Borchert M, et al.: Pilot study for assessment of optimal frequency for changing catheters in insulin pump therapy-trouble starts on day 3. J Diabetes Sci Technol 2010;4:976–982.
11. Kerr D, Wizemann E, Senstius J, et al.: Stability and performance of rapid-acting insulin analogs used for continuous subcutaneous insulin infusion: a systematic review. J Diabetes Sci Technol 2013;7:1595–1606.
12. Pfützner A, Sachsenheimer D, Grenningloh M, et al.: Using insulin infusion sets in CSII for longer than the recommended usage time leads to a high risk for adverse events: results from a prospective randomized crossover study. J Diabetes Sci Technol 2015;9:1292–1298.
13. Patel PJ, Benasi K, Ferrari G, et al.: Randomized trial of infusion set function: steel versus teflon. Diabetes Technol Ther 2014;16:15–19.
14. Karlin AW, Ly TT, Pyle L, et al.: Duration of infusion set survival in lipohypertrophy versus nonlipohypertrophied tissue in patients with type 1 diabetes. Diabetes Technol Ther 2016;18:429–435.
15. International Organization for Standardization: In vitro diagnostic test systems—requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013). 2013.
16. Waldenmaier D, Zschornack E, Kalt L, et al.: First user experiences with a novel touchscreen-based insulin pump system in daily life of patients with type 1 diabetes experienced in insulin pump therapy. J Diabetes Sci Technol 2018;13:96–102.
17. Clausen TS, Kaastrup P, Stallknecht B: Effect of insulin catheter wear-time on subcutaneous adipose tissue blood flow and insulin absorption in humans. Diabetes Technol Ther 2009;11:575–580.
18. Hojbjerre L, Skov-Jensen C, Kaastrup P, et al.: Effect of steel and teflon infusion catheters on subcutaneous adipose tissue blood flow and infusion counter pressure in humans. Diabetes Technol Ther 2009;11:301–306.
19. Renard E, Guerci B, Leguerrier AM, Boizel R: 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.
20. Freckmann G, Arndt S, Fiesselmann A, et al.: Randomized cross-over study comparing two infusion sets for CSII in daily life. J Diabetes Sci Technol 2017;11:253–259.
21. Barola A, Tiwari P, Bhansali A, et al.: Insulin-related lipohypertrophy: lipogenic action or tissue trauma? Front Endocrinol 2018;9:638.
Information & Authors
Information
Published In
Diabetes Technology & Therapeutics
Volume 22 • Issue Number 10 • October 2020
Pages: 734 - 741
PubMed: 32167382
Copyright
Copyright 2020, Mary Ann Liebert, Inc., publishers.
History
Published online: 6 October 2020
Published in print: October 2020
Published ahead of print: 6 April 2020
Published ahead of production: 13 March 2020
Topics
Authors
Author Disclosure Statement
G.F. is general manager of the IDT (Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany), which carries out clinical studies on the evaluation of BG meters and medical devices for diabetes therapy on its own initiative and on behalf of various companies. G.F./IDT have received speakers' honoraria or consulting fees from Abbott, Ascensia, Dexcom, LifeScan, Menarini Diagnostics, Metronom Health, Novo Nordisk, Roche, Sanofi, Sensile and Ypsomed. D.W., E.Z., S.P., and C.H. are employees of the IDT. A.B. is employee of Ypsomed AG, Switzerland.
Funding Information
The study and scientific writing were funded by Ypsomed AG, Switzerland.
Metrics & Citations
Metrics
Citations
Export Citation
Export citation
Select the format you want to export the citations of this publication.
View Options
Get Access
Access content
To read the fulltext, please use one of the options below to sign in or purchase access.⚠ Society Access
If you are a member of a society that has access to this content please log in via your society website and then return to this publication.