Monitoring the Infusion Pressure in Insulin Infusion Sets in Healthy Adults

NCT ID: NCT02382536

Last Updated: 2017-02-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2014-08-31

Brief 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

Study Groups

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).

BD Scarlett Infusion set

Intervention Type: DEVICE

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.

Medtronic QuickSet Infusion Set

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Becton, Dickinson and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Phillip LaStella, MD

Role: PRINCIPAL_INVESTIGATOR

TKL Research

Locations

TKL Research

Fair Lawn, New Jersey, United States

Countries

United States

Other Identifiers

DBC-14SCARL06

Identifier Type: -

Identifier Source: org_study_id