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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bruce A. Buckingham, Stanford University
ClinicalTrials.gov Identifier:
NCT01288729
First received: January 31, 2011
Last updated: January 6, 2017
Last verified: January 2017
  Purpose
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.

Condition Intervention
Diabetes Mellitus
Device: Sure-T Steel Infusion Set Catheter
Device: Quick-Set Teflon Catheter

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Duration of Infusion Set Function: A Study Comparing the Quick-Set Teflon Catheter vs Sure-T Steel Infusion Set Catheter

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Length of Wear of Infusion Site [ Time Frame: 5 weeks ]
    Comparison of the length of wear (hours) of Sure-T Steel Infusion Set Catheter versus Quick-Set Teflon Catheter. Infusion sets are currently approved for wear 2-3 days (24-72 hours). Participants wore each set for up to 7 days twice. Outcome measure is presented according to the intervention (Steel or Teflon catheter).


Enrollment: 20
Study Start Date: January 2011
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Device: Sure-T Steel Infusion Set Catheter
Participants will wear Quick-Set Teflon Catheter or Sure-T Steel Infusion Set Catheter for 2 weeks each during the active study time
Device: Quick-Set Teflon Catheter
Participants will wear Quick-Set Teflon Catheter or Sure-T Steel Infusion Set Catheter for 2 weeks each during the active study time
Experimental: Group 2 - Teflon Cathetar, the Steel
Participants will alternate between wearing the Quick-Set Teflon catheter for 7 days, then the Quick-Set Teflon for 7 days. They will wear each set twice starting with the Quick-Set Teflon set.
Device: Sure-T Steel Infusion Set Catheter
Participants will wear Quick-Set Teflon Catheter or Sure-T Steel Infusion Set Catheter for 2 weeks each during the active study time
Device: Quick-Set Teflon Catheter
Participants will wear Quick-Set Teflon Catheter or Sure-T Steel Infusion Set Catheter for 2 weeks each during the active study time

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   12 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of type 1 diabetes for at least one year and using an insulin pump for at least 3 months
  • The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.
  • Age 12 to 45 years
  • For females, not currently known to be pregnant
  • An understanding of and willingness to follow the protocol and sign the informed consent
  • Hemoglobin A1c level less than or equal to 10%
  • Medtronic Continuous subcutaneous insulin infusion pump
  • Must be able to understand spoken or written English

Exclusion Criteria:

  • Diabetic ketoacidosis in the past 6 months
  • Severe hypoglycemia resulting in seizure or loss of consciousness in the 6 months prior to enrollment
  • Current treatment for a seizure disorder
  • Cystic fibrosis
  • Active infection
  • A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol such as the following examples:
  • Inpatient psychiatric treatment in the past 6 months for either the subject or the subject's primary care giver (i.e., parent or guardian)
  • Presence of a known adrenal disorder
  • If on antihypertensive, thyroid, anti-depressant or lipid lowering medication, lack of stability on the medication for the past 2 months prior to enrollment in the study
  • Abuse of alcohol
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01288729

Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Bruce A. Buckingham Stanford University
  More Information

Publications:
Responsible Party: Bruce A. Buckingham, Principle Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT01288729     History of Changes
Other Study ID Numbers: SU-01272011-7439 
Study First Received: January 31, 2011
Results First Received: October 28, 2015
Last Updated: January 6, 2017
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on February 28, 2017