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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes
• Intervention / Treatment: Device: BD Scarlett Infusion set; Device: Medtronic QuickSet Infusion Set

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.

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Fair Lawn, New Jersey, United States, 07410
      • TKL Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Must be between the ages of 18-75 years of age (inclusive)
2. In stable health status with no acute or significant illness, in the opinion of the investigator.
3. Able to read, write and follow study instructions in English.
4. Able and willing to provide informed consent.
5. Able and willing to complete all study procedures.

Exclusion Criteria:

1. Pregnant (self-attestation)
2. BMI > 35
3. Currently taking anti-platelet therapy or anticoagulants (Use of up to 81 mg per day of aspirin is permitted)
4. History of bleeding disorder or easy bruising
5. Known blood borne infections
6. Diabetes on insulin therapy
7. History of recurrent dermatological condition or skin disorder (e.g. psoriasis, eczema)
8. Gross skin anomalies and abnormalities (e.g. scars, stretch marks, discolorations, tattoos, superficial masses, other) located at or very close to the intended infusion sites on the abdomen
9. Subjects with excessive hair on the abdomen who are unwilling to have excessive hair removed by Site Staff
10. Fear of needles, history of symptomatic low blood pressure or history of fainting (syncope) during hypodermic injections
11. History of allergic reaction to adhesives, metals, latex, or plastics.
12. Any other condition the PI or designee deems to pose a risk to the subject in the study.
13. Currently participating in any other clinical investigation that conflicts with this one, or who have participated in a study with the same indication within the prior 30 days that the Principal Investigator or designee believes will conflict with outcomes or ability of the subject to complete all activities required in this study.
14. Employed by, or currently serving as a contractor or consultant to BD

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Infusion set; Each subject will receive a total of 4 simultaneous subcutaneous infusions of insulin diluent, two using the investigational device (BD Scarlett Infusion Set) and two using the the comparator (Medtronic QuickSet Infusion Set).

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
In-line fluid pressure	Infusion pressure profiles will be measured by an inline pressure transducer and recorded by a data logger. Pressure profiles will be evaluated by type of infusion set. The occurrence of pressure events (continuous pressure rises or flow interruptions of at least 30 minutes) will be assessed.	Continuous measure for 4-5 hours after insertion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Leakage	Upon removal of the infusion set, the infusion site and device will be checked for fluid leakage. If leakage is observed, the infusion site device hub/skin interface will be swabbed for fluid with a pre-weighed swab. The swab will be re-weighed to determine the amount of fluid. Fluid collected at infusion site and the device/skin interface will not be classified as leakage if the measured volume is less than 0.005 mL (equivalent to 0.5 units U-100 insulin).	Immediately upon device removal

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of subjects with adverse events	During the study visit subjects will be asked about adverse events that may have occurred. All adverse events, e.g. skin irritation, allergic reaction, excessive pain, will be evaluated, appropriately treated and followed up as appropriate.	Approximately 6 hours from device application until study completion.

Collaborators and Investigators

• Sponsor: Becton, Dickinson and Company
• Investigators: Principal Investigator: Phillip LaStella, MD, TKL Research

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: February 27, 2015
• First Submitted That Met QC Criteria: March 3, 2015
• First Posted (Estimate): March 6, 2015

Study Record Updates

• Last Update Posted (Estimate): February 9, 2017
• Last Update Submitted That Met QC Criteria: February 8, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Diabetes; insulin pump; Insulin therapy; Infusion sets
• Other Study ID Numbers: DBC-14SCARL06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO