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NCT02662842 · ClinicalTrials.gov registry record
BD FlowSmart™ Subcutaneous Insulin Infusion Set User Preference and Claims Study
A clinical trial, sponsored by Becton, Dickinson and Company.
- Completed
- Registry status
- 75
- Enrollment target
NCT02662842: Completed study, sponsored by Becton, Dickinson and Company.
NCT02662842 is a clinical trial that has completed, run by Becton, Dickinson and Company. The registered enrollment target is 75 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02662842 has completed, sponsored by Becton, Dickinson and Company.
- COMPLETED
- Registry status
- 75 participants
- Enrollment target
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.
Primary Outcome
At the study visit after completing both study periods (Visit 3), subjects will use a 15 cm Visual Analog Scale (VAS) to indicate which insertion set was less painful to insert, the BD Flowsmart or their current infusion set. Effects of infusion set type will be tested for statistical significance using linear mixed models adjusting for the effect of subject, study site and period. The model will be used to generate a two-sided 95% confidence interval for the adjusted average pain rating using a
Interventions
- DEVICE FlowSmart Infusion Set
- DEVICE Current Infusion Set
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2016-01 |
| Est. Completion | 2016-02 |
What the finished NCT02662842 record still lists
NCT02662842 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 75 participants, a relatively small participant target.
The record links to 0 conditions, and to 2 interventions - of which FlowSmart Infusion Set is the first listed.
NCT02662842 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02662842 about?
NCT02662842 is a clinical study titled "BD FlowSmart™ Subcutaneous Insulin Infusion Set User Preference and 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...
What is the current status of trial NCT02662842?
This trial is currently completed. The enrollment target is 75 participants. The study started on 2016-01. Estimated completion is 2016-02.
What interventions are being tested in trial NCT02662842?
The interventions under investigation include: FlowSmart Infusion Set (DEVICE), Current Infusion Set (DEVICE).
Who is sponsoring clinical trial NCT02662842?
This trial is sponsored by Becton, Dickinson and Company, which has 33 total clinical trials registered on ClinicalTrials.gov.
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