NCT02662842

BD FlowSmart™ Subcutaneous Insulin Infusion Set User Preference and Claims Study

BD FlowSmart™ User Claims Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 75 (actual)
• Sponsor: Becton, Dickinson and Company · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	FlowSmart Infusion Set	Use of set for subcutaneous insulin infusion, with set change every three days.
DEVICE	Current Infusion Set	Use of set for subcutaneous insulin infusion, with set change every three days.

Timeline

• Start date: 2016-01-01
• Primary completion: 2016-02-01
• Completion: 2016-02-01
• First posted: 2016-01-26
• Last updated: 2017-04-13

Locations

4 sites across 1 country: United States