NCT02382536

Monitoring the Infusion Pressure in Insulin Infusion Sets in Healthy Adults

Infusion Pressure Delivering Insulin Diluent - BD's Scarlett vs. Medtronic's (MDT) Quickset in Healthy Adults

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 60 (actual)
• Sponsor: Becton, Dickinson and Company · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare the in-line fluid pressure (pressure of the fluid going through the tubing) and leakage (observation of fluid on and around the device) during and after subcutaneous infusion using two types of infusion sets. One infusion set is investigational, developed by BD, and the other is the Quick-set (Medtronic), which is commercially available. These infusion sets will be used with a commercially available insulin pump to deliver insulin diluent (an inactive liquid with no medication) for approximately 4 1/2 hours. During this time pressure and leakage will be continuously monitored.

Detailed description

This is a single center, open label study. Each subject is to receive up to 4 basal/bolus diluent infusions in the abdomen with the BD Scarlett and the Medtronic Quick-set®; 2 Scarlett infusion sets and 2 Quick-set infusion sets. The order of device placement will be randomized. After insertion, insulin diluent will be delivered at a rate of 0.01 mL/hour (equivalent in volume and rate to 1.0 unit/hour of U-100 insulin) via the insulin pump for a minimum of 3 hours. After 3 hours of basal infusion, a bolus of 0.1 mL (equivalent to 10 units) will be delivered via the insulin pump and basal infusion continued for a minimum of 1 additional hour. At the end of the final basal infusion period, the infusion set tubing will be clamped to mimic an occlusion event and allowed to run until either an occlusion alert ("no delivery") is signaled by the pump, or a minimum of 30 minutes, whichever comes first. Infusion pressure data will be collected during the entire infusion period, including the time the tubing is clamped. After removal of the device from the body, the presence of fluid on the application site skin (Leakage) will be determined by visual assessment then measured using gravimetric analysis, if applicable.

Conditions

• Diabetes

Interventions

Type	Name	Description
DEVICE	BD Scarlett Infusion set	Each subject will receive subcutaneous infusion from two investigational BD Scarlet infusion sets simultaneously, using a commercially available insulin pump to deliver insulin diluent (placebo) into the abdomen. Each infusion will run for approximately 4 1/2 hours.
DEVICE	Medtronic QuickSet Infusion Set	Each subject will receive subcutaneous infusion from two Medtronic infusion sets simultaneously, using a commercially available insulin pump to deliver insulin diluent (placebo) into the abdomen. Each infusion will run for approximately 4 1/2 hours.

Timeline

• Start date: 2014-08-01
• Primary completion: 2014-08-01
• Completion: 2014-08-01
• First posted: 2015-03-06
• Last updated: 2017-02-09

Locations

1 site across 1 country: United States