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

NCT02662842 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 75

Last updated 2017-04-13

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Becton, Dickinson and Company

    lead INDUSTRY

Principal Investigators

  • Laurence Hirsch, MD · Becton Dickinson, World Wide VP Diabetes Care

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2016-02-29
Completion
2016-02-29

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02662842 on ClinicalTrials.gov