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

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.

SUBMITTER: Freckmann G

PROVIDER: S-EPMC5478026 | biostudies-other | 2017 Mar

REPOSITORIES: biostudies-other

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

Freckmann Guido G Arndt Stephan S Fießelmann Albrecht A Klausmann Gerhard G Pralle Kristina K Künsting Thomas T Petersen Bettina B

Journal of diabetes science and technology 20160925 2

<h4>Background</h4>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.<h4>Methods</h4>In an open-label, randomized, crossover, multicenter 8-week study 80 type 1 diabetic subjects on CSII (20-74 years, mean 46.5 ± 1 ...[more]

PMID: 27605591

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

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

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