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

Trial ID or NCT#

NCT01288729

Status

not recruiting iconNOT RECRUITING

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.

Official Title

Duration of Infusion Set Function: A Study Comparing the Quick-Set Teflon Catheter vs Sure-T Steel Infusion Set Catheter

Eligibility Criteria

Ages Eligible for Study: 12 Years to 45 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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
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Investigator(s)

Bruce Buckingham
Bruce Buckingham
Endocrinologist
Professor of Pediatrics (Endocrinology) at the Lucile Salter Packard Children's Hospital, Emeritus

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Contact

Parul Patel
6507235791

View on ClinicalTrials.gov