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N/A N=20 Randomized Prevention

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

Diabetes Mellitus

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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