Trial Outcomes & Findings for Duration of Infusion Set Function: Quick-Set Teflon Catheter Versus Sure-T Steel Infusion Set Catheter (NCT NCT01288729)

NCT ID: NCT01288729

Last Updated: 2017-02-27

Results Overview

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).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 20 participants
• Primary outcome timeframe: 5 weeks
• Results posted on: 2017-02-27

Participant Flow

Participant milestones

Measure	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 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.
Overall Study STARTED	10	10
Overall Study COMPLETED	9	10
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	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 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.
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Group 1 - Steel Cathetar, Then Teflon n=10 Participants 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 2 - Teflon Cathetar, the Steel n=10 Participants 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.	Total n=20 Participants Total of all reporting groups
Age, Continuous	22.3 years STANDARD_DEVIATION 8.8 • n=5 Participants	22.3 years STANDARD_DEVIATION 8.8 • n=7 Participants	22.3 years STANDARD_DEVIATION 8.8 • n=5 Participants
Gender Female	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Gender Male	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	10 participants n=7 Participants	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 5 weeks

Population: Participants with available data were analyzed.

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).

Outcome measures

Measure	Sure-T Steel Infusion Set Catheter n=19 Participants Participants will wear Sure-T Steel Infusion Set Catheter for 7 days (for a total of 14 days for the duration of the study) Sure-T Stell 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 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	Quick-Set Teflon Catheter n=20 Participants Participants will wear the Quick-Set Teflon catheter for 7 days (for a total of 14 days for the duration of the study). Sure-T Stell 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 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
Length of Wear of Infusion Site	137 hours Interval 87.0 to 168.0	145 hours Interval 99.0 to 167.0

Adverse Events

Sure-T Steel Infusion Set Catheter

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Quick-Set Teflon Catheter

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Sure-T Steel Infusion Set Catheter n=20 participants at risk Participants will wear Sure-T Steel Infusion Set Catheter for 7 days (for a total of 14 days for the duration of the study) Sure-T Stell 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 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	Quick-Set Teflon Catheter n=20 participants at risk Participants will wear the Quick-Set Teflon catheter for 7 days (for a total of 14 days for the duration of the study). Sure-T Stell 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 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
Skin and subcutaneous tissue disorders Skin reaction to infusion set	25.0% 5/20 • Number of events 5 • 5 weeks Safety data is presented according to the intervention (Steel or Teflon catheter).	15.0% 3/20 • Number of events 3 • 5 weeks Safety data is presented according to the intervention (Steel or Teflon catheter).
Endocrine disorders ketosis	10.0% 2/20 • Number of events 2 • 5 weeks Safety data is presented according to the intervention (Steel or Teflon catheter).	20.0% 4/20 • Number of events 4 • 5 weeks Safety data is presented according to the intervention (Steel or Teflon catheter).

Additional Information

Bruce Buckingham

Stanford Childrens Health

Phone: 650725-6549

Email: buckingham@stanford.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place