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



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).



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.



Both IIS are safe and effective. The 2 IIS did not differ from each other with respect to pain observed during insertion.
1 Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany.
Guido
G
Freckmann
2 Praxiszentrum für Diabetologie und Endokrinologie, Rostock, Germany.
Stephan
S
Arndt
3 Praxisgemeinschaft Spandau, Berlin, Germany.
Albrecht
A
Fießelmann
4 Clinical Research Centre for Hematology, Oncology and Diabetic Disease, Aschaffenburg, Germany and Gemeinschaftspraxis Drs. Klausmann, Aschaffenburg, Germany.
Gerhard
G
Klausmann
5 Diabeteszentrum am Sophie-Charlotte Platz, Berlin, Germany.
Kristina
K
Pralle
6 Roche Diabetes Care GmbH, Mannheim, Germany.
Thomas
T
Künsting
6 Roche Diabetes Care GmbH, Mannheim, Germany.
Bettina
B
Petersen
D000328:Adult; D000368:Aged; D018592:Cross-Over Studies; D003922:Diabetes Mellitus, Type 1 / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage*; D007328:Insulin / Q000008:administration & dosage*; D007332:Insulin Infusion Systems; D008297:Male; D008875:Middle Aged; D055815:Young Adult
D007004:Hypoglycemic Agents; D007328:Insulin
continuous subcutaneous insulin infusion; insulin infusion set; insulin therapy; pain