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Randomized Cross-Over Study Comparing Two Infusion Sets for CSII in Daily Life
Guido Freckmann1, Stephan Arndt2, Albrecht Fießelmann3
11 Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany.
Journal of Diabetes Science and Technology
|September 9, 2016
Summary
Continuous subcutaneous insulin infusion (CSII) therapy uses insulin infusion sets (IIS). This study found two soft-cannula IIS were safe and effective for type 1 diabetes management, with no significant difference in insertion pain.
Area of Science:
- Endocrinology
- Medical Devices
- Diabetes Management
Background:
- Continuous subcutaneous insulin infusion (CSII) is crucial for type 1 diabetes.
- Insulin infusion sets (IIS) are key components of CSII systems.
- Limited research exists on IIS performance and safety.
Purpose of the Study:
- To compare the performance and safety of two soft-cannula insulin infusion sets (IIS).
- To evaluate user experience and adverse events associated with two specific IIS models.
Main Methods:
- An 8-week, open-label, randomized, crossover, multicenter study.
- 80 type 1 diabetes patients on CSII evaluated Accu-Chek® FlexLink Plus (FL Plus) and Accu-Chek® FlexLink (FL) IIS for 4 weeks each.
- Data collected via patient diaries and visual analogue scale (VAS) for insertion pain.
Main Results:
- No significant difference in insertion pain between FL Plus (VAS 6.1 mm) and FL (VAS 5.8 mm).
- Unplanned changes occurred in 20.0% (FL Plus) and 16.0% (FL) of IIS changes.
- 13 adverse events (2 serious) occurred over 4243 patient days, with some related to IIS.
- 18.7% of cannulas kinked; overall patient satisfaction was high for both IIS.
Conclusions:
- Both evaluated IIS are safe and effective for CSII therapy.
- There is no discernible difference in insertion pain between the two IIS.
- Both IIS demonstrate acceptable safety and efficacy profiles for managing type 1 diabetes.
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