Duration of Infusion Set Function: Quick-Set Teflon Catheter Versus Sure-T Steel Infusion Set Catheter

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-07-31

Brief Summary

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This is an open-label cross over study looking to compare the length of infusion set wear between a teflon catheter (Quick-Set) or a steel (Sure-T) catheter.

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Detailed Description

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Currently infusion sets are approved for 2-3 days of wear. In this study subjects will wear each infusion set for up to 7 days or until the infusion set fails. Subjects will alternate between wearing the Quick-Set Teflon catheter and the Sure-T steel catheter each week. They will wear each infusion set twice.

For the study, subjects will be provided with an investigational Medtronic Real-Time Continuous Glucose Monitor (CGM) Enlite Sensor/Serter to help identify, serious hyperglycemia or hypoglycemia during the study. This sensor is not yet FDA approved, but is similar to commercially available sensors. If the sensor detects a high or low glucose, subject must obtain a fingerstick glucose to confirm the result. In the study, all insulin dose and other treatment decisions will be made using glucose meter results, and will not be based on sensor results. Subjects will be instructed on how to identify infusion set failures.

Infusion set failure are defined as: 1) Blood ketones greater than 0.6 mmol/L, 2) Evidence of infection at the infusion site (such as redness of more than 4 mm), or 3) Blood glucose that does not decrease by at least 50 mg/dL within 1 hour of a correction bolus to treat a blood glucose greater than 300 mg/dL.

Subjects will follow-up weekly in one of our test centers for a total of five visits.

At home subjects will be asked to keep a log recording measurements of redness and induration at the infusion site when it is changed prior to the study visit.

Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Group 1 - Steel Cathetar, then Teflon

Participants will alternate between wearing the Sure-T Steel Infusion Set Catheter for 7 days, then the Quick-Set Teflon for 7 days.They will wear each set twice starting with the Sure-T Steel Infusion Set.

Group Type EXPERIMENTAL