Type 1 Diabetes Mellitus Clinical Trial
Official title:
BD FlowSmart™ User Claims Study
Continuous Subcutaneous Insulin Infusion (CSII) via insulin pump therapy has been shown to
improve quality of life and glucose control in many patients with diabetes opting for this
treatment modality. Despite significant innovation and advancement in pump technology,
insulin infusion sets have been an area where innovation has been significantly lacking with
no clinical studies performed prior to product launches.
BD has developed a subcutaneous infusion set with FlowSmart™ Technology designed to address
patient comfort, insulin delivery and flow interruptions. According to preliminary animal
and clinical studies, this technology results in lower infusion pressure indicating more
consistent insulin delivery.
The FlowSmart infusion set has been previously tested in prototype form with healthy
non-diabetic subjects with the sets inserted by nurses, and with CSII-using patients who
self-inserted the FlowSmart infusion set in a clinical research setting.
The purpose of this study is to determine if insulin pump users prefer using the BD
FlowSmart infusion set compared to their current set with respect to insertion pain and wear
comfort.
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