Reduced Silent Occlusions with a Novel Catheter Infusion Set (BD FlowSmart): Results from Two Open-Label Comparative...

Area of Science:

• Biomedical Engineering
• Medical Device Technology
• Endocrinology

Background:

• Insulin pump therapy is associated with unexplained hyperglycemia.
• Silent occlusions, or insulin flow interruptions without alarms, are a potential cause.
• Silent occlusions may necessitate insulin infusion set replacement.

Purpose of the Study:

• To compare the incidence of flow interruption events between a novel dual-ported insulin infusion set (BD FlowSmart™) and an existing set (Quick-set®).
• To evaluate the effectiveness of the BD FlowSmart™ set in reducing silent occlusions and other flow interruptions.

Main Methods:

• Two studies were conducted using insulin diluent infusions in healthy adults.
• Study 1: Pilot study comparing BD FlowSmart™ and Quick-set® with manual or device-assisted insertion (n=25).
• Study 2: Larger study comparing BD FlowSmart™ and Quick-set® after manual insertions (n=60), focusing on flow interruption reduction.

Main Results:

• BD FlowSmart™ demonstrated significantly fewer silent occlusions compared to Quick-set® in both manual and mechanical insertions (Study 1).
• Overall flow interruption events were significantly reduced with BD FlowSmart™ in Study 2 (75% risk reduction).
• The percentage of time with flow interruption was consistently lower for BD FlowSmart™ sets across both studies.

Conclusions:

• The novel side-ported BD FlowSmart™ insulin infusion set significantly reduces flow interruptions, including silent occlusions.
• This reduction in flow interruptions suggests a potential improvement in insulin delivery accuracy.
• The findings indicate that the BD FlowSmart™ set may offer a more reliable alternative for insulin pump users.