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Randomized Controlled Trial
. 2015 Sep 3;9(6):1292-8.
doi: 10.1177/1932296815604438.

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

Andreas Pfützner  1 , Daniela Sachsenheimer  2 , Marco Grenningloh  3 , Matthias Heschel  4 , Lene Walther-Johannesen  4 , Rabi Gharabli  4 , David Klonoff  5
Affiliations
Randomized Controlled Trial

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

Andreas Pfützner et al. J Diabetes Sci Technol. .

Abstract

Background: Infusion sets for use with insulin pumps are recommended for use for 2 to 3 days to avoid local skin reactions, for example, to the insulin formulation and preservatives like meta-cresol. However, many patients use the catheters longer for economic reasons. We performed this study to investigate the tolerability of 2-day use of infusion sets in comparison to 4-day use in a real-world setting.

Methods: This prospective randomized controlled crossover study with 2 × 3-month observation periods was performed with 24 type 1 patients. At baseline, patients were trained on the use of the infusion system (Medtronic /Mio® or inset™ II) and randomized to any of the 2 treatment sequences. Observation parameters included glycemic control, frequency and nature of device-related, and procedure-related adverse events and patient preference.

Results: The per-protocol analysis was performed with 22 patients (5 men, 17 women, age 39 ± 11 years, BMI 27.0 ± 3.5 kg/m2). The number of catheter related adverse events was 290 with 2-day use versus 495 with 4-day use (P < .05). The overall number of treatment related events was 750 with 2-day use versus 934 with 4-day use (P < .001). There was no difference in glycemic control between the treatment arms. Treatment satisfaction was higher with 2-day use (very high/high satisfaction: 90.4% versus 4 day-use: 77.3%, P < .05).

Conclusion: Our results demonstrate that using the infusion sets for a longer usage period of 2-3 days resulted in a clinically relevant increase in treatment-related tolerability problems. Patients should be trained and encouraged not to use insulin pump infusion sets for a longer than the recommended time period.

Keywords: insulin infusion set; insulin pump treatment; skin reactions; usage time.

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Conflict of interest statement

Declaration of Conflicting Interests: AP and DK have received research support and consulting fees from Unomedical/Convatec. MH, LWJ, and RG are/were employees of Unomedical/Convatec at the time of study conduct. All other authors have no conflict of interest.

Figures

Figure 1.
Figure 1.
Study design.
Figure 2.
Figure 2.
Absolute number and nature of catheter related events as confirmed by the investigator.
See this image and copyright information in PMC

Comment in

  • CSII: Longer Catheter Usage Time, a Reasonable Goal.
    Ardilouze JL, Ménard J, Gobeil F Jr, Gagnon-Auger M, Houde G, Pesant MH, Rabasa-Lhoret R, Baillargeon JP. Ardilouze JL, et al. J Diabetes Sci Technol. 2016 Jun 28;10(4):989-90. doi: 10.1177/1932296815622647. Print 2016 Jul. J Diabetes Sci Technol. 2016. PMID: 26682959 Free PMC article. No abstract available.
  • Longer Usage Time for CSII Catheters: An Underestimated Challenge.
    Pfützner A, Sachsenheimer D, Grenningloh M. Pfützner A, et al. J Diabetes Sci Technol. 2016 Jun 28;10(4):987-8. doi: 10.1177/1932296815626727. Print 2016 Jul. J Diabetes Sci Technol. 2016. PMID: 26856627 Free PMC article. No abstract available.

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