Duration of Infusion Set Function: Quick-Set Teflon Catheter Versus Sure-T Steel Infusion Set Catheter
1 other identifier
interventional
20
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable diabetes-mellitus
Started Jan 2011
Shorter than P25 for not_applicable diabetes-mellitus
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 31, 2011
CompletedFirst Posted
Study publicly available on registry
February 2, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedResults Posted
Study results publicly available
February 27, 2017
CompletedFebruary 27, 2017
January 1, 2017
6 months
January 31, 2011
October 28, 2015
January 6, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Length of Wear of Infusion Site
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).
5 weeks
Study Arms (2)
Group 1 - Steel Cathetar, then Teflon
EXPERIMENTALParticipants 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 2 - Teflon Cathetar, the Steel
EXPERIMENTALParticipants 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.
Interventions
Participants will wear Quick-Set Teflon Catheter or Sure-T Steel Infusion Set Catheter for 2 weeks each during the active study time
Participants will wear Quick-Set Teflon Catheter or Sure-T Steel Infusion Set Catheter for 2 weeks each during the active study time
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Patel PJ, Benasi K, Ferrari G, Evans MG, Shanmugham S, Wilson DM, Buckingham BA. Randomized trial of infusion set function: steel versus teflon. Diabetes Technol Ther. 2014 Jan;16(1):15-9. doi: 10.1089/dia.2013.0119. Epub 2013 Oct 3.
PMID: 24090124RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
This was a single center study with 20 subjects enrolled in a cross-over study. A larger study would make results more robust. In addition, if each subject had worn each infusion set 3 to 6 times, it would make the study more robust.
Results Point of Contact
- Title
- Bruce Buckingham
- Organization
- Stanford Childrens Health
Study Officials
- PRINCIPAL INVESTIGATOR
Bruce A. Buckingham
Stanford University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
January 31, 2011
First Posted
February 2, 2011
Study Start
January 1, 2011
Primary Completion
July 1, 2011
Study Completion
July 1, 2011
Last Updated
February 27, 2017
Results First Posted
February 27, 2017
Record last verified: 2017-01
Data Sharing
- IPD Sharing
- Will not share