Monitoring the Infusion Pressure in Insulin Infusion Sets in Healthy Adults

Completed · Has a placebo group

Conditions studied: Diabetes

In brief

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.

Key facts

Study ID

NCT02382536

Run by

Becton, Dickinson and Company

People needed

60

Starts

2014-08-01

Expected to finish

2014-08-01

Last updated by the study team

2017-02-09

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

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

Where it is running

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

Full record on ClinicalTrials.gov

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