Monitoring the Infusion Pressure in Insulin Infusion Sets in Healthy Adults

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02382536
• Other study ID #: DBC-14SCARL06
• Status: Completed
• Phase: N/A
• First received: February 27, 2015
• Last updated: February 8, 2017
• Start date: August 2014
• Est. completion date: August 2014

Study information

• Verified date: February 2017
• Source: Becton, Dickinson and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	TKL Research	Fair Lawn	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Becton, Dickinson and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Primary	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	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