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Cited by 14

Randomized Cross-Over Study Comparing Two Infusion Sets for CSII in Daily Life

Freckmann, Guido, Arndt, Stephan, Fießelmann, Albrecht, Klausmann, Gerhard, Pralle, Kristina, Künsting, Thomas, Petersen, Bettina·2017·Journal of Diabetes Science and Technology
DOI 10.1177/1932296816667510
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Abstract

Background: Continuous subcutaneous insulin infusion (CSII) therapy is a valuable option especially for people with type 1 diabetes. Although insulin infusion sets (IIS) are essential components of most insulin pump systems, only few studies have been conducted on their performance and safety. In this study 2 IIS with soft cannulas were compared. Methods: In an open-label, randomized, crossover, multicenter 8-week study 80 type 1 diabetic subjects on CSII (20-74 years, mean 46.5 ± 12.9 years, 58.8% male) were enrolled to evaluate the use of 2 IIS. The Accu-Chek® FlexLink Plus (FL Plus) and the Accu-Chek® FlexLink infusion set (FL) were used 4 weeks each under real-life conditions at home. All patients had to record details about every IIS change in a diary. Insertion-related pain was assessed by means of a visual analogue scale (VAS). Results: The mean pain noted during insertion was similar for both IIS (VAS 6.1 ± 6.4 mm for the FL Plus and 5.8 ± 6.3 mm for the FL, P = .92). 20.0% of the 895 IIS changes with FL Plus and 16.0% of the 854 with FL were unplanned. During the 4243 patient days of the study, 13 patients had adverse events. Among these, 2 serious adverse events occurred. Both serious events and 1 nonserious adverse event were considered as related to the IIS. Of the patients, 18.7% had kinked cannulas. Most patients were satisfied with both IIS. Conclusion: Both IIS are safe and effective. The 2 IIS did not differ from each other with respect to pain observed during insertion.

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  • In Freckmann et al.'s study, 18.7% had kinked cannulas.

    “In Freckmann et al.'s study, where the study participants (N = 80 total) inserted their IIS devices (Accu-Chek™ FlexLink infusion set and Accu-Chek FlexLink Plus infusion set [Roche Diabetes Care, Mannheim, Germany]), 18.7% had kinked cannulas.19”

    From Evaluation of Extended Infusion Set Performance in Adults with Type 1 Diabetes: Infusion Set Survival Rate and Glycemic Outcomes from a Pivotal Trial (2022) · cites this paper as [19]

  • While early standard IIS device studies confirmed manufacturer indications for 2- to 3-day use due to increased risk of IIS site reactions or compromised glycemic control, more recent studies with greater numbers of study participants have reported minimal or no issues with glycemia over time or fewer adverse events associated with extended IIS wear.

    “Thus, while early standard IIS device studies confirmed manufacturer indications for 2- to 3-day use due to increased risk of IIS site reactions or compromised glycemic control, more recent studies with greater numbers of study participants have reported minimal or no issues with glycemia over time or fewer adverse events associated with extended IIS wear.8,9,18,19”

    From Evaluation of Extended Infusion Set Performance in Adults with Type 1 Diabetes: Infusion Set Survival Rate and Glycemic Outcomes from a Pivotal Trial (2022) · cites this paper as [19]

  • One randomized crossover study investigating intended real-world 3-day use of standard IIS devices reported comparable failure rates (or unplanned IIS changes) of 16%-20%, and ∼40% were due to unexpected high glucose, occlusion alarms, or backflow of insulin.

    “It is also important to note that one randomized crossover study investigating intended real-world 3-day use of standard IIS devices reported comparable failure rates (or unplanned IIS changes) of 16%–20% and that ∼40% were due to unexpected high glucose, occlusion alarms, or backflow of insulin.19”

    From Evaluation of Extended Infusion Set Performance in Adults with Type 1 Diabetes: Infusion Set Survival Rate and Glycemic Outcomes from a Pivotal Trial (2022) · cites this paper as [19]

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Authors
Freckmann, G., Arndt, S., Fießelmann, A., Klausmann, G., Pralle, K., Künsting, T., & Petersen, B.
Affiliations
  • Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany
  • Praxiszentrum für Diabetologie und Endokrinologie, Rostock, Germany
  • Praxisgemeinschaft Spandau, Berlin, Germany
  • Clinical Research Centre for Hematology, Oncology and Diabetic Disease, Aschaffenburg, Germany and Gemeinschaftspraxis Drs. Klausmann, Aschaffenburg, Germany
  • Diabeteszentrum am Sophie-Charlotte Platz, Berlin, Germany
  • Roche Diabetes Care GmbH, Mannheim, Germany
Venue
Journal of Diabetes Science and Technology
Publisher
SAGE Publications
Published
2016-09-25
Volume
11
Issue
2
Pages
253-259
ISSN
1932-2968
DOI
10.1177/1932296816667510
Cited by
14
References
9
Language
en
Licence
journals.sagepub.com/page/policies/text-and-data-mining-license (tdm)

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