N/A
N=20
Duration of Infusion Set Function: Quick-Set Teflon Catheter Versus Sure-T Steel Infusion Set Catheter
Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT01288729 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Feb 2017
Primary outcome: Primary: Length of Wear of Infusion Site — 137; 145 hours
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Sure-T Steel Infusion Set Catheter (Device); Quick-Set Teflon Catheter (Device)
- Age
- Pediatric, Adult · 12+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Jul 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Length of Wear of Infusion Site |
137; 145 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01288729). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.