Monitoring the Infusion Pressure in Insulin Infusion Sets in Healthy Adults

NCT02382536 | Completed

• 1 other identifier: DBC-14SCARL06
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes

Keywords

Diabetes; Insulin therapy; insulin pump; Infusion sets

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Leakage

  Immediately upon device removal

Other Outcomes (1)

• Number of subjects with adverse events

  Approximately 6 hours from device application until study completion.

Study Arms (1)

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; Device: Medtronic QuickSet Infusion Set

Interventions

BD Scarlett Infusion set 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.

Infusion set

Medtronic QuickSet Infusion Set 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.

Infusion set

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pregnant (self-attestation)
• BMI \> 35
• Currently taking anti-platelet therapy or anticoagulants (Use of up to 81 mg per day of aspirin is permitted)
• History of bleeding disorder or easy bruising
• Known blood borne infections
• Diabetes on insulin therapy
• History of recurrent dermatological condition or skin disorder (e.g. psoriasis, eczema)
• 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
• Subjects with excessive hair on the abdomen who are unwilling to have excessive hair removed by Site Staff
• Fear of needles, history of symptomatic low blood pressure or history of fainting (syncope) during hypodermic injections
• History of allergic reaction to adhesives, metals, latex, or plastics.
• Any other condition the PI or designee deems to pose a risk to the subject in the study.
• 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.
• Employed by, or currently serving as a contractor or consultant to BD

Sponsors & Collaborators

• Becton, Dickinson and Company: lead

Study Sites (1)

TKL Research

Fair Lawn, New Jersey, 07410, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Phillip LaStella, MD

  TKL Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2015
• First Posted: March 6, 2015
• Study Start: August 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: February 9, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)